Cracking The Case of ISO 90012008 For Service PDF

Cracking the Case of
ISO 9001:2008
for Service
1356_Cianfrani.indd i 11/11/09 12:59:46 PM

1356_Cianfrani.indd ii 11/11/09 12:59:47 PM
Also available from ASQ Quality Press:
ISO 9001:2008 Explained, Third Edition

Charles A. Cianfrani, John E. (Jack) West, and Joseph J. Tsiakals
ISO 9001:2008 Explained, Third Edition (Spanish)

Cracking the Case of ISO 9001:2008 for Manufacturing

John E. (Jack) West and Charles A. Cianfrani
The ASQ ISO 9000:2000 Handbook

ISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-By-Step
Guidelines for Successful Internal Audits, Second Edition
Ann W. Phillips
How to Audit the Process-Based QMS

Dennis R. Arter, John E. (Jack) West, and Charles A. Cianfrani
Unlocking the Power of Your QMS: Keys to Business Performance Improvement

John E. (Jack) West and Charles A. Cianfrani
The ASQ Auditing Handbook, Third Edition

J.P. Russell, editing director
Quality Audits for Improved Performance, Third Edition

Dennis R. Arter
The Quality Toolbox, Second Edition

Nancy R. Tague
Mapping Work Processes, Second Edition

Bjørn Andersen, Tom Fagerhaug, Bjørnar Henriksen, and Lars E. Onsøyen
Lean Kaizen: A Simplified Approach to Process Improvements

George Alukal and Anthony Manos
Root Cause Analysis: Simplified Tools and Techniques, Second Edition

Bjørn Andersen and Tom Fagerhaug
The Certified Manager of Quality/Organizational Excellence Handbook, Third Edition

Russell T. Westcott, editor
To request a complimentary catalog of ASQ Quality Press publications, call 800-248-

1946, or visit our Web site at http://www.asq.org/quality-press.
1356_Cianfrani.indd iii 11/11/09 12:59:47 PM

1356_Cianfrani.indd iv 11/11/09 12:59:47 PM
Cracking the Case of
ISO 9001:2008
for Service
A Simple Guide to Implementing
Quality Management in
Service Organizations
Second Edition
Charles A. Cianfrani
and John E. (Jack) West
ASQ Quality Press

Milwaukee, Wisconsin
1356_Cianfrani.indd v 11/11/09 12:59:47 PM

American Society for Quality, Quality Press, Milwaukee 53203
© 2010 by American Society for Quality
All rights reserved. Published 2009
Printed in the United States of America
12 11 10 09 08 07 06 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Cianfrani, Charles A.
Cracking the case of ISO 9001:2008 for service : a simple guide to implementing
quality management in service organizations / Charles A. Cianfrani and John E.
(Jack) West. — 2nd ed.
p. cm.
Originally published under title: Cracking the case of ISO 9001:2000 for service.
Includes bibliographical references and index.
ISBN 978-0-87389-762-4 (alk. paper)
1. Quality control—Standards. 2. ISO 9001 Standard. I. West, Jack, 1944– II.
Cianfrani, Charles A. Cracking the case of ISO 9001:2000 for service. III. Title.
TS156.C73 2009
658.4’013—dc22
2009043600
No part of this book may be reproduced in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without the prior written permission
of the publisher.
Publisher: William A. Tony Acquisitions Editor: Matt Meinholz
Project Editor: Paul O’Mara Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and
community excellence worldwide through learning, quality improvement, and knowledge
exchange.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books,
videotapes, audiotapes, and software are available at quantity discounts with bulk
purchases for business, educational, or instructional use. For information, please contact
ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005,
Milwaukee, WI 53201-3005. To place orders or to request a free copy of the
ASQ Quality Press Publications Catalog, including ASQ membership information, call
800-248-1946. Visit our Web site at www asq.org or http://www.asq.org/quality-press.
Printed on acid-free paper
1356_Cianfrani.indd vi 11/11/09 12:59:47 PM

Contents
Chapter 1 Why Do ISO 9001:2008? . . . . . . . . . . . . . . . . . . . 1

Chapter 2 Principles and Key Concepts . . . . . . . . . . . . . . . 5
Quality Management Principles . . . . . . . . . . . . . . . . . . . . . 5
Customers—Customer Focus and Measuring
Satisfaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Process Approach—Activities, Process Management,
and the System Approach to Management . . . . . . . . . 9
Alignment—Quality Objectives, Process Measurement,
and Communications . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Continual Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Process Control to Facilitate Learning, Innovation, and
Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Leadership and Involvement at All Levels . . . . . . . . . . . . . . 15
Chapter 3 Implementing ISO 9001:2008 . . . . . . . . . . . . . . . 17
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Changes in ISO 9001:2008 from ISO 9001:2000 . . . . . . . . 18
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
1.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
1.2 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
2 Normative Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3 Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . 23
vii
1356_Cianfrani.indd vii 11/11/09 12:59:47 PM

viii Contents
4.1 General Requirements . . . . . . . . . . . . . . . . . . . . . . . . 24

4.2 Documentation Requirements . . . . . . . . . . . . . . . . . . . 27
4.2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.2.2 Quality Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.2.3 Control of Documents . . . . . . . . . . . . . . . . . . . . . . . 30
4.2.4 Control of Records . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.1 Management Commitment . . . . . . . . . . . . . . . . . . . . . 35
5.2 Customer Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.3 Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.4.1 Quality Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.4.2 Quality Management System Planning . . . . . . . . . . . 43
5.5.1 Responsibility and Authority . . . . . . . . . . . . . . . . . . . 45
5.5.2 Management Representative . . . . . . . . . . . . . . . . . . 46
5.5.3 Internal Communication . . . . . . . . . . . . . . . . . . . . . . 48
5.6 Management Review . . . . . . . . . . . . . . . . . . . . . . . . . 50
5.6.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5.6.2 Review Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
5.6.3 Review Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.1 Provision of Resources . . . . . . . . . . . . . . . . . . . . . . . . 56
6.2 Human Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.2.2 Competence, Awareness and Training . . . . . . . . . . . 60
6.3 Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
6.4 Work Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
7.1 Planning of Product Realization . . . . . . . . . . . . . . . . . 65
7.2.1 Determination of Requirements Related
to the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
7.2.2 Review of Requirements Related to the Product . . . . 70
7.2.3 Customer Communication . . . . . . . . . . . . . . . . . . . . 73
7.3 Design and Development . . . . . . . . . . . . . . . . . . . . . . 74
7.3.1 Design and Development Planning . . . . . . . . . . . . . 74
7.3.2 Design and Development Inputs . . . . . . . . . . . . . . . 76
7.3.3 Design and Development Outputs . . . . . . . . . . . . . . 79
1356_Cianfrani.indd viii 11/11/09 12:59:47 PM

Contents ix
7.3.4 Design and Development Review . . . . . . . . . . . . . . . 81

7.3.5 Design and Development Verification . . . . . . . . . . . . 83
7.3.6 Design and Development Validation . . . . . . . . . . . . . 85
7.3.7 Control of Design and Development Changes . . . . . . 87
7.4.1 Purchasing Process . . . . . . . . . . . . . . . . . . . . . . . . . 88
7.4.2 Purchasing Information . . . . . . . . . . . . . . . . . . . . . . 90
7.4.3 Verification of Purchased Product . . . . . . . . . . . . . . 92
7.5.1 Control of Production and Service Provision . . . . . . . 94
7.5.2 Validation of Processes for Production and
Service Provision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
7.5.3 Identification and Traceability . . . . . . . . . . . . . . . . . 100
7.5.4 Customer Property . . . . . . . . . . . . . . . . . . . . . . . . . . 102
7.5.5 Preservation of Product . . . . . . . . . . . . . . . . . . . . . . 104
7.6 Control of Monitoring and Measuring Devices . . . . . . . 106
8 Measurement, Analysis and Improvement . . . . . . . . . . . 111
8.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
8.2 Monitoring and Measurement . . . . . . . . . . . . . . . . . . . 114
8.2.1 Customer Satisfaction . . . . . . . . . . . . . . . . . . . . . . . 114
8.2.2 Internal Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
8.2.3 Monitoring and Measurement of Processes . . . . . . . 121
8.2.4 Monitoring and Measurement of Product . . . . . . . . . 123
8.3 Control of Nonconforming Product . . . . . . . . . . . . . . . 126
8.4 Analysis of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
8.5 Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
8.5.1 Continual Improvement . . . . . . . . . . . . . . . . . . . . . . 132
8.5.2 Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
8.5.3 Preventive Action . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Chapter 4 Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Tools Discussed in This Section . . . . . . . . . . . . . . . . . . . . . 139
Tool 1: Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Tool 2: Process Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Tool 3: Brainstorming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
1356_Cianfrani.indd ix 11/11/09 12:59:47 PM

x Contents
Tool 4: Gantt Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Tool 5: Run or Trend Chart . . . . . . . . . . . . . . . . . . . . . . . . . 153
Tool 6: Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Tool 7: Pareto Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Tool 8: Failure Modes and Effects Analysis . . . . . . . . . . . . . 162
Tool 9: Sampling Inspection . . . . . . . . . . . . . . . . . . . . . . . . 165
Tool 10: Cause-and-Effect Diagram
(Fishbone/Ishikawa Diagram) . . . . . . . . . . . . . . . . . . . 172
Tool 11: Problem Solving . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Tool 12: How to Conduct an Improvement Project . . . . . . . 178
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Additional Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
1356_Cianfrani.indd x 11/11/09 12:59:47 PM

Chapter 1
Why Do ISO 9001:2008?
I
SO 9001:2008 provides a model for quality management.
While no such model is perfect, this one has proven to be
applicable to virtually all sizes of organizations, in every
marketplace, and for every product category throughout the
world for over 20 years.
Why has ISO 9001 become the world’s most used stan-
dard? Why has it achieved such widespread acceptance and
use? Certainly not because of the elegance of the text in the
standard, for this writing is among the dullest, most boring
prose the human mind and hand have ever crafted. The ISO
9001 standard has survived and flourished because it adds
value to how organizations are managed, from the viewpoint
of both managers and workers.
Workers like ISO 9001 because it makes life simpler. In an
ISO 9001 system, workers have:
• A better understanding of what to do and how to do it
• The ability to ensure that their work meets
requirements
1356_Cianfrani.indd 1 11/11/09 12:59:47 PM

2 Chapter One Why Do ISO 9001:2008?
• The ability to adjust processes when results are not

meeting requirements
• A means to get help in solving problems
• Increased opportunities to communicate problems in a
nonthreatening manner by focusing on process issues
• An environment where they are not blamed for issues
that can be resolved only by managers
Middle managers have embraced ISO 9001 because it has
contributed to better control of processes and has resulted
in a higher level of consistency throughout the organization.
Middle managers find that ISO 9001 has:
• Made it easier to manage using facts and data rather
than opinions
• Enhanced communication throughout the organization
(between management and workers, between depart-
ments, and with executive management)
• Encouraged clarity of responsibility and accountability

Chapter One Why Do ISO 9001:2008? 3
• Standardized the
way things are done,
reducing variability
and making it easier
to solve problems
• Fostered continual
improvement as an
institutionalized core
value, and provided a
platform for mov-
ing to performance
excellence
Top managers find that adopting a formal ISO 9001 quality
management system (QMS) helps the organization focus on
meeting objectives. Top managers find that ISO 9001 has:
• Improved their organization’s ability to fully understand
and meet customer requirements in a consistent
manner
• Brought greater clarity to the goals and objectives of
the organization
• Helped align all employees and processes to meet
objectives
• Improved bottom-line performance by enhancing
revenue and reducing costs, created a competi-
tive advantage in some markets, and enabled their
organizations to compete in markets where most other
potential suppliers are registered

4 Chapter One Why Do ISO 9001:2008?
Perhaps the most important reason for doing ISO 9001 is

survival. In these times of uncertainty, people are concerned
about protecting their jobs.
All of these reasons for embracing ISO 9001:2008 can
be reduced to a single effect: It facilitates quality improve-
ment. And quality improvement has two positive impacts on
an organization:
• Better processes and reduced variation in production
can yield dramatic reductions in cost
• Better customer satisfaction can yield more sales
If an organization does not have a foundation of uncompro-
mising integrity, adventures into the world of performance
excellence or attempts to sustain improvement programs are
futile exercises. The requirements of ISO 9001 can be used to
create a foundation upon which a successful organization can
be built. They may not be sexy or exciting, but unless they are
performed consistently and well, an organization will not pros-
per and may not survive in the contemporary marketplace.
This guide is intended to help everyone in an organization
participate in creating and sustaining a foundation of integrity,
and meeting requirements and customer expectations to the
advantage of everyone in the organization and to each of its
customers.
Charlie Cianfrani
cianfranic@aol.com
Jack West
jwest92144@aol.com

Chapter 2
Principles and Key Concepts
T
his chapter describes the eight quality management
principles that were used as the basis for the develop-
ment of ISO 9001:2008. It also discusses several key
concepts that are important to fully understand.
QUALITY MANAGEMENT PRINCIPLES

The eight quality management principles were a key input in the
development of ISO 9001:2008. The principles may be found in
clause 0.2 of ISO 9000:2005, which is quoted as follows:
To lead and operate an organization success-

fully, it is necessary to direct and control it in a
systematic and transparent manner. Success can
result from implementing and maintaining a man-
agement system that is designed to continually
improve performance while addressing the needs
of all interested parties. Managing an organiza-
tion encompasses quality management amongst
other management disciplines.

6 Chapter Two Principles and Key Concepts
Eight quality management principles have been

identified that can be used by top management in
order to lead the organization towards improved
performance.
a. Customer focus. Organizations depend
on their customers and therefore should
understand current and future customer
needs, should meet customer requirements
and strive to exceed customer expectations.
b. Leadership. Leaders establish unity of purpose
and direction of the organization. They should
create and maintain the internal environment
in which people can become fully involved in
achieving the organization’s objectives.
c. Involvement of people. People at all levels
are the essence of an organization and their
full involvement enables their abilities to be
used for the organization’s benefit.
d. Process approach. A desired result is
achieved more efficiently when activities and
related resources are managed as a process.
e. System approach to management. Identify-
ing, understanding and managing inter-
related processes as a system contributes
to the organization’s effectiveness and
efficiency in achieving its objectives.
f. Continual improvement. Continual improve-
ment of the organization’s overall perfor-

Customers 7
mance should be a permanent objective of

the organization.
g. Factual approach to decision making. Effec-
tive decisions are based on the analysis of
data and information.
h. Mutually beneficial supplier relationships. An
organization and its suppliers are interdepen-
dent and a mutually beneficial relationship
enhances the ability of both to create value.
These eight quality management principles form
the basis for the quality management system stan-
dards within the ISO 9000 family. (Source: ANSI/
ISO/ASQ Q9000-2005)
More details on using the principles and the benefits of using
each can be found on the ISO Web site at http://www.iso.ch/
iso/en/iso900014000/iso9000/qmp.html.
CUSTOMERS—CUSTOMER FOCUS
AND MEASURING SATISFACTION
The purpose of ISO 9001 is to achieve customer satisfaction by
meeting customer requirements. While meeting requirements

and preventing nonconformities have been fundamental to

ISO 9001 since its initial issue in 1987, ISO 9001:2008 contin-
ues the enhanced emphasis on customers. There are key things
an organization needs to understand and implement that are
related to customer focus:
• Top management is required (clause 5.1) to com-
municate to all in the organization the importance of
meeting customer requirements.
• Top management is required (clause 5.2) to ensure
that processes are in place to determine and meet
customer requirements, with an aim to enhance cus-
tomer satisfaction.
• The quality policy is required (clause 5.3) to contain
a commitment to meet requirements. This includes
meeting customer requirements.
• Appointment of a management representative is
required. The management representative’s duties
include ensuring (clause 5.5.2) promotion of aware-
ness of customer requirements.
• Customer feedback is required (clause 5.6.2) as an input
to the management review process, and improvement
of services offered related to requirements is a required
management review output (clause 5.6.3).
• Resources are required (clause 6.1) to “. . . enhance cus-
tomer satisfaction by meeting customer requirements.”
• Customer requirements are the key input to product
realization. Processes are required to determine

Process Approach 9
(clause 7.2.1) and review (clause 7.2.2) those cus-

tomer requirements.
• Processes are required (clause 7.2.3) for communica-
tions with customers.
• Monitoring of information related to customer percep-
tion is required (clause 8.2.1).
Understanding this focus on the customer is critical to imple-
mentation of an effective ISO 9001 quality management system.
The organization needs to carefully think about the interrelated
processes that are needed to meet the ISO 9001 requirements
in a way that will enhance customer satisfaction.
PROCESS APPROACH—ACTIVITIES,
PROCESS MANAGEMENT, AND THE
SYSTEM APPROACH TO MANAGEMENT
Of particular importance among the eight quality management
principles are “system approach to management” and “pro-
cess approach.” People in any organization perform activi-
ties. These activities are interrelated. The process approach
involves managing the interrelated activities and associated
resources together to achieve a particular output.
Process
Inputs Outputs
Activity Activity
Activity

The system approach to management is basic to ISO

9001:2008. It encourages organizations to link interrelated
value-adding processes. This linked system of processes results
in the outputs that go to customers. Thus, the quality manage-
ment system needs to be composed of interrelated processes.
Clause 0.2 of ISO 9001:2008 describes this concept of a system
of processes within an organization.
This approach is easy to implement and has many
advantages:
• It maintains focus on the creation of value by managing
across the functional departments of the organization,
thereby reducing the number and severity of quality
problems that occur at department boundaries
• It helps the organization focus on what is important to
both itself and its customers through measurement of
product characteristics and performance of processes
• It encourages open communications—based on facts
supported with data—between internal customers,
between internal suppliers, and between levels in the
organization
• It encourages continual improvement, since any gaps
between customer requirements and process perfor-
mance are highlighted—quantitatively—and can be
targeted for improvement efforts
• It directly supports the principles of “leadership” and
“involvement of people” with improvements involving
everyone and every level of the organization
• It provides a framework for managing innovation and
changes

1356_Cianfrani.indd 11
Process
Inputs
Activity Activity
Outputs
Activity
$ Process $
V Inputs V
T Activity Activity T
U Outputs U
Activity
P Process Process
P
N Inputs Inputs N
F Activity Activity Activity Activity F
S Outputs Outputs S
Activity Activity
Quality management system

Process Approach
11
11/11/09 12:59:48 PM
In summary, the process approach is very generic and applicable

to all sectors and sizes of organizations. It helps create value by
managing horizontally across functional departments, thereby
reducing quality problems that typically occur between depart-
ments. And by tying key indicators of process performance to
customer needs and supplier performance, it focuses on what
is important to customers. It also strongly encourages continual
improvement since it helps identify gaps between customer
requirements and process performance. Finally, it involves
everyone and every level of the organization in meeting require-
ments, customer satisfaction, and continual improvement.
The ISO committee responsible for the ISO 9000 family of
standards has developed additional guidance on the process
approach. As of July 2009, N 544R3—ISO 9000 Introduction and
Support Package: Guidance on the Concept and Use of the Pro-
cess Approach for management systems was available as a free
download at http://www.bsi.org.uk/iso-tc176-sc2.
ALIGNMENT—QUALITY OBJECTIVES, PROCESS

MEASUREMENT, AND COMMUNICATIONS
ISO 9001:2008 requires that quality objectives be measurable
and aligned with the quality policy. It also requires that the
measurable objectives be deployed.
The intent of this requirement is to ensure that respon-
sibility and authority for key dimensions of the quality man-
agement system are understood and deployed throughout the
organization with the involvement of top management. Ensur-
ing that objectives are measurable is intended to enhance
improvement.

Continual Improvement 13
Clause 5.4.2 requires that the quality management system

be planned so that it meets the quality objectives. This means
that the processes of the organization need to be operated,
monitored, and measured with the organization’s objectives
in mind. Clause 8.2.3 requires that processes be measured
where applicable. It makes sense to measure the processes
that are key to achieving the organization’s quality objectives.
Objectives should be related to monitoring and measurement
of the processes of the organization. Developing and imple-
menting a process to address the establishment and deploy-
ment across the organization of measurable objectives that are
aligned with the quality policy and truly drive the effectiveness of
the quality management system is an ongoing and challenging
task, but it can be one of the major keys to success.
Properly deployed objectives with aligned process mea-
sures are important. Communication is also needed to
ensure that the organization’s people understand require-
ments (clauses 5.1, 5.2, and 5.5.2) and receive input on the
effectiveness of the system (clause 5.5.3).
CONTINUAL IMPROVEMENT
ISO 9001:2008 has a clear requirement for continual improve-
ment of quality management system effectiveness. Sustain-
able improvement of system effectiveness is accomplished by
improving the processes of the system. Clause 8.5.1 describes
an improvement system that includes at a minimum:
• Setting a quality policy with a commitment to continual
improvement of the effectiveness of the quality man-
agement system (clause 5.3).

• Establishing and deploying measurable objectives at

the relevant levels and functions of the organization.
The objectives must be set with the commitment to
improvement in mind (clauses 5.1 and 5.4.1).
• Collecting data (clause 8.4).
• Analyzing data (clause 8.4).
• Conducting meaningful management reviews to track
progress, identify improvement opportunities, establish
priorities, and provide resources (clauses 5.6, 6.1,
and 8.4).
• Taking corrective action by eliminating the causes of
nonconformities (clause 8.5.2).
• Taking preventive action to prevent high-risk
nonconformities or problems from ever occurring
(clause 8.5.3).
PROCESS CONTROL TO FACILITATE LEARNING,

INNOVATION, AND IMPROVEMENT
Many of the requirements of ISO 9001 involve the concept
that work is to be performed under controlled conditions. This
concept is found throughout clause 7 and is best described in
clause 7.5.1. Control of processes implies low variability, con-
sistency of process performance, and conformity of product
and process to customer and internal requirements.
Designing process controls is critical to success of the
quality management system. If done wrong, the controls can
stifle positive changes and continual improvement. But if the

Leadership and Involvement at All Levels 15
controls are properly integrated into the organization’s pro-

cesses, they can become important facilitators of learning,
innovation, and improvement. It is not a matter of “balancing”
control with learning, innovation, and change. Rather, it is a
matter of developing controls so that they will promote learn-
ing, innovation, and improvement. When a control is being
designed and implemented, always ask the question, how
will the control facilitate learning, innovation, and continual
improvement?
LEADERSHIP AND INVOLVEMENT

AT ALL LEVELS
Perhaps the two most important principles are leadership and
involvement of people.
Top Management—Responsibility
and Involvement
ISO 9001:2008 continues to emphasize the role of top man-
agement. There are specific activities in which top managers
need to be involved. Top management is required to:
• Communicate the importance of meeting customer
requirements
• Create and maintain awareness of quality policy
• Ensure that there are processes to determine and meet
customer requirements
• Establish measurable quality objectives at relevant
levels in the organization

• Ensure that the quality management system is planned

so that it meets requirements and the quality objectives
• Conduct management reviews
Top managers have a big role to play in ISO 9001:2008.
Management Representative
Clause 5.5.2 requires appointment of a representative of the
organization’s management to spearhead the establishment,
implementation, and maintenance of the quality management
system. The importance of this appointment cannot be over-
emphasized. This person needs to be able to work well with
top managers as well as with people at all other levels in the
organization.
All People in the Organization

Everyone has a role in the deployment of a quality man-
agement system that conforms to the requirements of ISO
9001:2008. Some people are involved every hour of every
day. Others may have periodic involvement. For a few people,
involvement may be indirect or infrequent. A key role of top
managers, supervisors, and the management representative
is to find ways to get and keep everyone in the organization
involved in the efficient and effective implementation and
improvement of the quality management system.

Chapter 3
Implementing ISO 9001:2008
INTRODUCTION
This chapter provides a simplified explanation of the require-
ments of each subclause of ISO 9001:2008, why it is required,
tips for implementation, and questions to ask. The format for
the explanations is as follows:
What Is the Requirement? Provides a brief description
of each requirement of ISO 9001:2008.
Why Do It? Gives a brief description from an organiza-
tional and management perspective of why the require-
ment should be addressed.
Implementation Tips Provides tips for your consider-
ation as you develop processes to meet the requirements.
1 Inthesome cases, tools are referenced by an icon in
margin. These tools are described in Chapter 4.
The number of the tool is given in the icon.
Questions to Ask Yourself Asks questions that should
be answered during implementation and auditing to ISO
9001:2008.
17

18 Chapter Three Implementing ISO 9001:2008
CHANGES IN ISO 9001:2008

FROM ISO 9001:2000
Before providing an explanation of the requirements of
each subclause of ISO 9001:2008, a brief summation of the
changes in ISO 9001 that occurred between the 2000 edi-
tion and the 2008 edition is presented. The summation is not
intended to be exhaustive, but rather to provide for those who
have worked with ISO 9001:2000 an overview of the kinds of
changes that were made.
The 2008 edition of ISO 9001 was targeted to provide clari-
fications of the existing requirements of ISO 9001:2000 and to
improve consistency with the ISO 14001:2004 environmen-
tal standard. Several wording changes were made to clarify
the intent of the standard, and some text was restructured to
enhance ease of understanding. It was not intended that the
changes in 2008 would create new requirements or expand
existing requirements.
From a practical point of view, if an organization was com-
plying with the intent and spirit of ISO 9001:2000, then dem-
onstrating compliance with ISO 9001:2008 will require little or
no additional actions.
A few of the kinds of changes that have been made in
clauses 4 through 8 that we consider of interest or significance
are indicated in the following table. This is not a listing of all
the changes between ISO 9001:2000 and ISO 9001:2008. A
more comprehensive indication of the changes can be found
in our book ISO 9001:2008 Explained in the chapters that
explain the content of each clause.

Changes in ISO 9001:2008 from ISO 9001:2000 19
Clause
number Nature of change Comment
4.1 4th Control of outsourced Requirement to define the
paragraph processes type and extent of controls
4.1 note 2, Added notes Clarifies what is an out-
note 3 sourced process and the
controls needed for such
processes
5.5.2 Clarifies who can be the It is now clear that the
management representa- management representa-
tive for an organization tive must be a member of
the management of the
organization
6.2.1 Clarifies the applicability A broader view that compe-
of competence require- tence is required of person-
ments nel who can indirectly affect
conformity of product to
requirements
7.5.4 To emphasize the Clarifies the requirement
requirement to report to to communicate lost or
a customer if customer damaged customer equip-
equipment is lost or other- ment to the customer
wise unsuitable for use
7.6 Note added regarding Clearly states the need
software used in calibra- to confirm the ability of
tion activities software to perform its
intend function
8.2.2 Clearer requirement for This change is a rewording
a procedure for planning of the 2000 standard
and conducting audits and requirements with emphasis
the requirement for audit on the need for records and
records and for correction the clarification that both
and corrective action correction and corrective
action are required
( Continued )

Clause
number Nature of change Comment
8.2.3 Note added to guide what The note clarifies the con-
to consider when deter- cept of suitable methods
mining suitable methods
8.3 Wording change to more It is now clear that a
clearly indicate the require- documented procedure is
ment for a documented required, as well as taking
procedure, and words action after delivery of
added to address taking nonconforming product
action after delivery
0. Introduction
1. Scope
2. Normative reference
3. Terms and definitions
ISO 9001:2008 4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis
and improvement

1 Scope, 1.1 General, 1.2 Application 21
1 SCOPE
1.1 GENERAL
1.2 APPLICATION
What Is the Requirement?

Clause 1.1 describes the scope of ISO 9001. ISO 9001:2008
is comprehensive in that it applies to all quality management
system processes from the identification of requirements to
the delivery and addressing of customer satisfaction. It is use-
ful for demonstrating the ability of an organization to consis-
tently meet customer requirements for services. The scope
makes it clear that an ISO 9001:2008–compliant quality man-
agement system is aimed at achieving customer satisfaction
by meeting requirements.
Clause 1.2 deals with limiting the scope of the organiza-
tion’s quality management system. It provides that where any
requirements of clause 7 in the standard cannot be applied
due to the nature of an organization and the services it pro-
vides, they can be considered for exclusion. Where exclusions
are made, claims of conformity to this International Standard
are not acceptable unless these exclusions are limited to
requirements in clause 7 and such exclusions do not affect
the organization’s ability, or responsibility, to provide service
that meets customer and applicable regulatory require-
ments. In ISO 9001:2008, “regulatory requirements” has
been changed to “statutory and regulatory requirements” to

ensure understanding that written laws (“statutes”) must be

considered as well as regulations.
Why Do It?
• To have an effective quality management system
focused on meeting customer requirements
• To demonstrate the quality management system
to customers either directly or through third-party
certification
• To exclude those requirements of clause 7 that do
not apply
Implementation Tips
• Develop and maintain a clear understanding of why the
organization is implementing ISO 9001
• Don’t confuse the scope of ISO 9001 with the scope of
your quality management system
• Carefully consider any exclusions and develop justifi-
cation for each
Questions to Ask Yourself

• Does the quality manual include the scope of the
quality management system, including details of
and justification for all exclusions taken under
clause 1.2?

2 Normative Reference, 3 Terms and Definitions 23
• Are exclusions appropriate and do they meet the

criteria described in clause 1.2?
• Does your quality management system ensure that you
consistently meet customer requirements for service?
2 NORMATIVE REFERENCE
3 TERMS AND DEFINITIONS

The only normative reference in ISO 9001:2008 is ISO
9000:2005. Clause 3 of ISO 9000 contains the terms and defi-
nitions used in the ISO 9000 family. When a term defined in ISO
9000 is used in ISO 9001, the ISO 9000 definition becomes
part of the requirements. Annex A of ISO 9000 provides concept
diagrams showing how the various terms relate to one another.
Annex A is informative and not part of the requirements.
ISO 9000:2005 defines a “product” as the “result of a pro-
cess.” Certainly by this definition a “service” can be consid-
ered a “product.” Clause 3 of ISO 9001:2008 points out that
in the text of ISO 9001:2005, “wherever the term ‘product’
occurs, it can also mean ‘service.’” In this pocket guide, the
term “service” is normally used instead of “product.”
Why Do It?
• Clause 2 of ISO 9000:2005 on the fundamentals of
quality management systems provides understanding
of basic concepts

• Definitions help the ISO 9001 user better understand

the intent of the requirements
Implementation Tip
• When a term is used in ISO 9001 and defined in
ISO 9000, the ISO 9000 definition is the official
meaning of the term
Question to Ask Yourself

• Have you obtained a copy of ISO 9000:2005
and become familiar with the fundamentals and
definitions?
4. Quality 4.1 General requirements

management
system 4.2 Documentation requirements
4.1 GENERAL REQUIREMENTS

The organization must establish, implement, and document
a quality management system. In order to do this, the pro-
cesses of the system must be identified and their sequence
and interaction understood. The criteria to effectively man-
age, operate, monitor, measure where applicable, analyze,

4.1 General Requirements 25
and control the processes must be determined. “Where

applicable” was added in ISO 9001:2008 to recognize that
sometimes measurement may not apply. Resources must be
made available to operate, monitor, measure, and improve
the processes. It is also necessary to provide for control of
any processes that are outsourced.
Why Do It?
• To ensure that activities and necessary resources are
managed effectively
• To understand and control the processes so that they
are managed effectively
• To ensure that all requirements are met
• To consistently provide products that meet
requirements
• To continually improve the effectiveness of the quality
management system by improving its processes
Implementation Tips
• Identify your processes
• Identify inputs and outputs for each process
• Decide how to measure inputs, outputs, and/or
3 process parameters
• Create process maps for key processes
2
• Use relationship diagrams to show the interactions
of the processes

• Develop a flowchart of the process

1
• Link process measures to your quality objectives
• Strive for simplicity

• Have the processes needed for quality management
been identified?
• Have the sequence and interaction of these processes
been determined?
• Have criteria and control methods been determined
for control of the processes in the quality management
system?
• Is information available to support the operation and
monitoring of the processes?
• Are processes measured, monitored, and analyzed,
with appropriate actions taken to achieve planned
results and continual improvement?
• Have process measures been determined and imple-
mented where appropriate?
• Is the quality management system established,
documented, implemented, maintained, and continually
improved?
• Have outsourced processes that affect conformity of
the services being provided been identified?
• Has provision been made to ensure control of quality
management system processes that are outsourced?

4.2 Documentation Requirements, 4.2.1 General 27
4.2 DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL

Documentation of the quality management system must
include a quality manual, the quality policy, the quality objec-
tives, the six documented procedures specifically called out
in ISO 9001, and other documents needed to effectively plan,
operate, and control the organization’s processes. The docu-
mentation also needs to include the records called out in the
various clauses of ISO 9001.
Why Do It?
• To ensure consistent performance of required activities
• To provide a baseline for improvement of the processes
• To provide a baseline for auditing the quality manage-
ment system
Implementation Tips
• Identify the processes and interactions first (see
clause 4.1)
• Simple processes with competent workers
and simple interactions may not need to be
documented
• Use process maps
2


• Have the processes needed for quality management
been identified?
• Are the quality policy and quality objectives docu-
mented and controlled?
• Are the procedures required by ISO 9001:2008
documented?
• Have the sequence and interaction of these processes
been determined?
• Have criteria and control methods been determined
for control of the processes in the quality management
system?
• Is information available to support the operation and
monitoring of the processes?
• Are processes measured as appropriate, monitored,
and analyzed, with appropriate actions taken to
achieve planned results and continual improvement?
• Is the quality management system established,
documented, implemented, maintained, and continually
improved?
• Has provision been made to ensure control of quality
management system processes that are outsourced?
• In determining the extent of documentation, has con-
sideration been given to the size of the organization,
the complexity of processes, and the skills, training,
and competence of your personnel?

4.2.2 Quality Manual 29
4.2.2 QUALITY MANUAL

The quality manual provides a basic description of the qual-
ity management system. It must describe the scope of the
quality management system and include the justification for
exclusions from clause 7 that the organization has found
appropriate. The quality manual either includes or references
the documented procedures established for the quality man-
agement system. The manual must describe the interactions
among the processes of the system.
Why Do It?
• To ensure consistent understanding of the overall
quality management system among members of the
organization
• To ensure consistent understanding of the overall qual-
ity management system among customers and other
interested parties
• To describe the basic commitments of the organization
that are related to the quality management system
• To provide a baseline for auditing the quality manage-
ment system
Implementation Tips
• Use diagrams to show process interactions
• Keep the quality manual short, simple, and structured
in the same manner in which the organization works

• Describe basics of processes in the quality manual; put

details in documented procedures or work instructions

• Does the quality manual describe the interaction of
processes in the quality management system?
• Does the quality manual either include or reference the
documented procedures describing the processes of
the quality management system?
• Does the quality manual include the scope of the
quality management system, including details of and
justification for any exclusions taken under clause 1.2?
• Is the quality manual a controlled document?
4.2.3 CONTROL OF DOCUMENTS

Quality management system documents require control. Con-
trol of documents is one of the six processes that require a
documented procedure. Control of each document starts with
an approval process to ensure adequacy before it is issued.
There is a requirement that relevant versions of applicable
documents be available where they need to be used and that
both changes and the current revision status of each docu-
ment be identified. The process must ensure that the docu-
ments remain legible and identifiable. Documents need to be
reviewed and updated as necessary. In cases where obsolete

4.2.3 Control of Documents 31
versions are retained, they need to be identified as obsolete to

preclude inadvertent use. The organization also has to identify
documents of external origin needed to plan and operate the
quality management system and control their distribution.
Why Do It?
• To ensure consistent performance of all activities
affecting quality
• To ensure controls are in place to approve and issue
documents
• To ensure that changes in requirements are communi-
cated to those who must implement them
• To prevent the use of obsolete information
• To make certain that people have up-to-date instruc-
tions and requirements
Implementation Tips
• Define the types of documents in the system
• Define the types of documentation that come from
other organizations (for example, standards, customer
documents)
• Define the control process appropriate for each type
of document; for example, the requirements for
computer-based documentation may be different from
those for paper drawings
• Records are a special type of document and require
different controls (see clause 4.2.4)


• Has a documented procedure been established for
document control?
• Are documents approved for adequacy prior to use?
• Are documents reviewed and updated as necessary?
• Are document changes reapproved to ensure adequacy
prior to use?
• Is current document revision status maintained?
• Are relevant versions of applicable documents avail-
able at points of use?
• Is there a process to ensure that documents remain
legible, readily identifiable, and retrievable?
• Are documents of external origin that are needed to
plan and operate the quality management system
identified, and their distribution controlled?
• Are obsolete documents that are retained for any pur-
pose suitably identified to prevent unintended use?
4.2.4 CONTROL OF RECORDS

There are two types of requirements in this clause. First, it
requires that the organization’s quality management sys-
tem address the identification of records needed to provide
evidence of the effective operation of the quality manage-

4.2.4 Control of Records 33
ment system. Also, evidence of conformity to requirements

is required. Several clauses also require specific records (see
clauses 5.6.1, 6.2.2, 7.2.2, 7.3.2, 7.3.4–7.3.7, 7.4.1, 7.5.3,
7.5.4, 7.6a, 7.6c, 8.2.2, 8.2.4, 8.3, 8.5.2e, and 8.5.3d). Sev-
eral other clauses require that the organization define the
records needed to ensure an effective system (see clauses
4.2.4, 5.5.2, 7.1d, 7.5.2d, and 8.2.2).
In addition to requirements to prepare records, clause
4.2.4 states requirements for their maintenance and dis-
position. The quality management system must provide for
control of storage, protection, retention time, and disposi-
tion. Control of records is one of the six processes for which a
documented procedure is required.
Why Do It?
• To provide evidence that products conform to
requirements
• To provide evidence that processes are operating to
requirements
• To provide evidence of an effective quality manage-
ment system
• To provide system discipline to ensure conformity
• To provide historical data for analysis of product or
system problems
• To provide means to collect data for analysis to
improve services delivered, processes, and the effec-
tiveness of the quality management system

Implementation Tips
• Define the types of records required for the quality
management system
• Make a matrix of record types with the specific con-
trols for each (retention location, storage protection
required, retention time, planned disposition)
• Design your record forms and retention procedures
so you can rapidly aggregate, analyze, and use the
recorded data

• Is there a documented procedure for the control of
records?
• Have the organization’s records been identified?
• Have retention times and disposition requirements
been determined for all records?
• Are records disposed of as required by the organiza-
tion’s documented procedures?
• Have storage and retrieval requirements been deter-
mined and implemented for records?
• Have protection requirements been determined and
implemented for records?

5.1 Management Commitment 35
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy

5. Management
responsibility 5.4 Planning
5.5 Responsibility, authority

and communication
5.6 Management review
5.1 MANAGEMENT COMMITMENT

The top managers of the organization are required to dem-
onstrate commitment to developing, implementing, and
continually improving the effectiveness of the quality man-
agement system. There are 10 basic requirements described
in clause 5 of ISO 9001:2008 that are the direct responsibil-
ity of top managers.
Clause 5.1 requires that top managers provide evidence
of commitment by (1) communicating the importance of
meeting requirements, (2) establishing the quality policy
(see clause 5.3 for details), (3) ensuring that quality objec-
tives are established (see clause 5.4.2 for details), (4) con-
ducting management reviews (see clause 5.6 for details),
and (5) ensuring that resources are available.

Clauses 5.2 through 5.6

give additional activities that
top managers are required to
accomplish: (6) ensure that
customer requirements are
determined and met (clause
5.2), (7) ensure that the
quality management system
is planned and its integrity
is maintained when changes
are made (clause 5.4.2),
(8) ensure that respon-
sibilities and authorities are defined and communicated
(clause 5.5.1), (9) appoint the management representative
(clause 5.5.2), (10) ensure that appropriate internal communi-
cations take place on the effectiveness of the quality manage-
ment system (clause 5.5.3).
Why Do It?
• Actions of top managers to support the quality
management system emphasize its importance to the
people in the organization
• Everyone in the organization needs to understand how
important it is to meet requirements, particularly those
of the customer
• Key policies need to be set by the top managers
• The quality policy should be one of the key policies of
any organization

5.1 Management Commitment 37
• Top managers are in the best position to ensure

alignment of quality objectives with overall business
objectives
• Management reviews need to take into account all the
needs of the organization to properly allocate resources
• Top managers control the resources of the organization
Implementation Tips
• Consider early in system implementation all of the
activities that top managers must perform
• Involve top managers very early in planning the quality
management system
• Train and coach top managers on their roles
• Align the quality objectives with the overall business
objectives
• Hold frequent, comprehensive management reviews
• It may be helpful to “script” top managers to encour-
age active leadership

• Has top management established a quality policy?
• Has top management developed quality objectives?
• Do top managers regularly perform management
reviews and assess opportunities for improvement?
• Does top management provide and regularly review
the adequacy of resources?

• Have the conditions in the work environment that must

be controlled to achieve conformity of service been
identified?
• Are processes in place to manage the human and
physical factors of the work environment needed to
achieve conformity of the services offered?
• Is there a process to ensure that employees under-
stand the importance of meeting customer, regulatory,
and statutory requirements?
• Is there evidence of top management commitment
to continually improve quality management system
effectiveness?
5.2 CUSTOMER FOCUS

The top managers of the organization are required to ensure
that customer requirements are determined and met.
Why Do It?
• To enhance customer satisfaction
• To retain current customers and gain new ones
Implementation Tips
• Develop and implement an integrated approach to
addressing customer requirements—see clauses 7.2.1

5.3 Quality Policy 39
(determination of requirements related to the services

provided), 8.2.1 (customer satisfaction), 5.4 (planning),
and 5.6 (management review)
• Top managers must ensure that needs and expecta-
tions of the market and customers are captured in
• Top managers must ensure that robust processes are
in place for determining requirements and measuring
customer satisfaction
• Top managers can use management review (see
clause 5.6) to ensure the effectiveness of the
quality management system in meeting customer
requirements
Question to Ask Yourself

• Is top management involved in the process to deter-
mine customer requirements and to ensure that they
are met?
5.3 QUALITY POLICY

The top managers of the organization are required to ensure
that the quality policy is appropriate for the organization,
communicated and understood within the organization, and
reviewed for continuing suitability. The policy must include
commitments to both meeting requirements and continual

improvement of the quality management system. The policy

is required to provide a framework for review of the organiza-
tion’s quality objectives.
Why Do It?
• To clearly state in one document the organization’s
policy on quality
• To ensure that the policy and the personnel of the
organization are in alignment
• To clearly state the intent of top management with
regard to quality
• To provide means to test objectives against the basic
policy and to ensure ongoing alignment
Implementation Tips
• Tie the quality policy to the overall mission and
vision of the organization
• Use appropriate techniques such as brainstorming
3 to get ideas for policy development
• Use words, structure, and content that reflect the
culture of the organization
• Be sure to reflect in the policy the basic overall
direction of the organization relating to quality
• Think about how objectives can be structured from
policy so that policy and objectives will be in align-
ment across the organization

5.4.1 Quality Objectives 41
• Make it easy for people to describe the policy in their

own words without quoting it word for word

• Has a quality policy been developed?
• Has top management determined that the quality policy
meets the needs of the organization and its customers?
• Does the quality policy include commitment to
meeting requirements and commitment to continual
improvement?
• Does the quality policy provide a framework for estab-
lishing and reviewing the quality objectives?
• Is the policy communicated to and understood by all in
the organization?
• Are the members of the organization clear as to their
roles in carrying out the policy?
• Is the quality policy included in the document control
process?
• Is the quality policy reviewed for continuing suitability?
5.4.1 QUALITY OBJECTIVES

Top management must ensure that quality objectives are
established, measurable, and consistent with the quality pol-
icy. This includes objectives related to the services provided

to customers. These objectives need to be established at the

relevant levels and functions of the organization.
Why Do It?
• To clearly align the quality objectives with the quality
policy throughout the organization
• To align everyday work with the quality policy
• To provide targets against which results can be mea-
sured and performance can be easily reviewed
• To drive improvement; what gets measured gets done
Implementation Tips
• Be sure quality objectives align with the quality policy
• Consider brainstorming to develop initial ideas
3 related to the objectives
• Avoid conflicting priorities by ensuring qual-
ity objectives align with other objectives of the
organization
• Align measures and objectives for processes with
the quality objectives
• Focus on measuring the right things
• Change the objectives, if required, as situations
change and as experience is gained with the
system
• Consider using a balanced scorecard, dashboard,
or similar process for monitoring progress

5.4.2 Quality Management System Planning 43

• Have quality objectives been established at each
relevant function and level in the organization?
• Do quality objectives include those needed to meet
requirements for the organization’s products and
services?
• Are the quality objectives consistent across the
organization?
• Are the quality objectives measurable?
• Are the quality objectives reviewed against the qual-
ity policy?
5.4.2 QUALITY MANAGEMENT

SYSTEM PLANNING

Top managers are required to ensure that the quality man-
agement system is planned. Planning needs to start with the
quality objectives of the organization and include the activi-
ties required in clause 4.1. This means that all the activities
related to identifying, understanding, and managing the pro-
cesses of the quality management system must be carried
out. It also means that the quality management system should
be planned so that it leads to meeting the quality objectives.
Top managers are also required to ensure that the integrity of
the quality management system is maintained as the system
is changed. This means that situations that will cause change

to the quality management system need to be identified and

those changes carefully planned.
Why Do It?
• To focus the quality management system on meeting
objectives rather than just carrying out activities
• To ensure that objectives are achieved effectively
• To avoid surprises as conditions change
• To maintain quality management system integrity dur-
ing periods of change
Implementation Tips
• Look for links between processes of your
quality management system and quality
objectives
• Focus on understanding the processes,
their inputs, outputs, interactions, and
measures (see clause 4.1)
• Use process maps and flowcharts
1 2
• Understand the resources required for
implementation
• Eliminate waste in the current process as
you plan the quality management system
• Look for opportunities for preventive action
(see clause 8.5.3) to keep problems from
occurring

5.5.1 Responsibility and Authority 45
• Consider possible exclusions carefully (see clause 1.2)

• Develop a process for managing system changes

• Have the activities and processes required to meet
objectives been identified? Quality management
system processes? Service-realization processes?
Verification processes? Exclusions under clause 1.2?
• Does quality planning include continual improvement
of the processes of the quality management system?
• Does quality planning take into account the needs of
the organization as changes occur?
5.5.1 RESPONSIBILITY AND AUTHORITY

The various roles of personnel in the organization must be
defined so that their responsibilities, authority, and interac-
tions are clear. These roles must be communicated clearly to
all in the organization who have a need to know them. This is
another job of top managers.
Why Do It?
• To show that clarity is important for all key personnel
• To ensure understanding of who is responsible for
identifying, analyzing, and approving nonconformities
• To have a clear understanding of process handoffs

Implementation Tips
• Create and maintain organization charts
• Use job descriptions
• Use organization charts to show functional
relationships
• Use Gantt charts to show responsibilities for projects
4
• Include in documented procedures who (by job
function) is responsible for activities

• Are the organization’s functions defined and communi-
cated to facilitate effective quality management?
• Are responsibilities and authorities defined and com-
municated to facilitate effective quality management?
5.5.2 MANAGEMENT REPRESENTATIVE

Top management is required to appoint a member of the orga-
nization’s management to be responsible for ensuring estab-
lishment, implementation, and maintenance of the processes
of the quality management system. The management repre-
sentative is also responsible for reporting the system’s perfor-
mance to top management and for making recommendations
for needed improvements. It is the job of the management
representative to promote within the organization the aware-
ness of customer requirements.

5.5.2 Management Representative 47
Why Do It?
• To make certain there is someone responsible for keeping
top managers advised on the status of the system
• To provide a contact point for outside organizations,
including customers and third parties
• To make certain there is a champion of customer
requirements in the organization who has access to
top managers
Implementation Tips
• Be sure the management representative has access to
and frequent contact with top managers and others at
all levels in the organization
• Look for good organizational and analytical skills in a
management representative
• Appoint someone who is able to talk the language of
service development and delivery (creation of new
services, verification and validation, techniques of
service delivery, measurement of service effectiveness,
schedules, and so on) and the language of top managers
(money, strategies, implications of retaining and losing
customers)
• Look for teaching ability
• Consider designating an alternate or backup manage-
ment representative
• In some situations it may be appropriate to divide
the job so that there is more than one management

representative or to appoint deputy management

representatives, especially if an organization has
multiple sites

• Has top management appointed one or more manage-
ment representatives as appropriate?
• Has top management defined the responsibilities and
authority of the management representative?
• Does the management representative ensure that
the processes of the quality management system are
established and maintained? How?
• Does the management representative report to top
management on the performance of the quality man-
agement system?
• Does the management representative promote
awareness of customer requirements throughout the
organization?
5.5.3 INTERNAL COMMUNICATION

Top management is required to ensure that communica-
tion processes are established in the organization. These
communication processes need to be appropriate for the

5.5.3 Internal Communication 49
organization. The effectiveness of the quality manage-

ment system needs to be included in the communication
processes.
Why Do It?
• To ensure that people in the organization have appro-
priate information on the effectiveness of the quality
management system
• To provide information that people in the organization
need to achieve quality objectives
Implementation Tips
• Consider using a variety of communication methods
such as postings on bulletin boards, work group meet-
ings, all employee meetings, newsletters, and e-mail
• Consider special needs of customer contact personnel
• Communicate results data related to the measurable
quality objectives
• Communicate audit results and customer feedback
information
• Combine communications on quality with communica-
tions on other topics

• Have appropriate communication processes been
developed?

• Is top management involved in ensuring that commu-

nication processes remain adequate?
• Do discussions with employees at all levels indi-
cate that the organization effectively communicates
processes of the quality management system and their
effectiveness?
5.6 MANAGEMENT REVIEW

5.6.1 GENERAL

Top management is required to review the quality manage-
ment system at planned intervals. This review is to determine
the suitability, adequacy, and effectiveness of the quality man-
agement system. The review should include assessment of
the need for changes to the quality policy, the quality objec-

5.6 Management Review, 5.6.1 General 51
tives, and the processes of the quality management system.

The review process also needs to focus on determining oppor-
tunities for improvement.
Why Do It?
• To ensure the continuing suitability of the quality
management system for meeting its current purpose
and the quality policy
• To ensure the continuing adequacy in terms of its
breadth and depth of coverage
• To ensure the continuing effectiveness of the quality
management system in meeting the quality objectives
and carrying out planned activities
• To discover issues that require changes to the system
to improve its effectiveness
• To determine opportunities for improvements to the
quality management system and its processes
• To provide necessary resources
• To reallocate resources, as appropriate, when changes
to the quality management system occur
• To remove roadblocks to improvement
• To make prioritization decisions
Implementation Tips
• Be sure management review is a process, not just a
meeting

• Be sure your top managers do the review personally; it

is not a responsibility that can be delegated
• Use an annual planning session to review the past year,
set next year’s objectives, and make resource allocations
• Hold management review meetings monthly or
quarterly to review progress, decide on actions, and
reallocate resources
• Be sure preparation by your staff is done competently
• Make the review meetings useful to top managers by
focusing on achieving results

• Does top management review the quality management
system at planned intervals to ensure its continuing
suitability, adequacy, and effectiveness?
• Do the management reviews include evaluation of the
need for changes to the organization’s quality manage-
ment system, including the quality policy and quality
objectives?
5.6.2 REVIEW INPUT

Inputs for the management reviews need to include customer
feedback, process and service performance, status of preven-
tive and corrective actions, changes that could affect the qual-
ity management system, and the results of audits. In addition,

5.6.2 Review Input 53
follow-up actions from earlier management reviews need to

be included.
Why Do It?
• To make the management review efficient and
effective
• To focus the review on important issues
• To provide data on which top managers can make
objective decisions and set priorities
Implementation Tips
• Consider including additional inputs beyond the
minimum requirements
• Have staff members provide the inputs; in small
organizations, data may be collected and provided
by top managers themselves
• Use appropriate simple charts to present trends in
5 quantitative data
• Provide the inputs to attendees prior to the review
meetings where feasible
• Use tools such as Pareto charts to focus the review
7 on those inputs that require top managers to make
decisions, implement change, or provide resources
• When there is a need to focus on variation, display
6 data using histograms or other appropriate tools
• Limit meetings to x hours (x < 2 is recommended)


• Does management review input include results of
audits, customer feedback, process performance,
service conformity, status of preventive and corrective
actions, follow-up actions from earlier management
reviews, and changes that could affect the quality
management system?
• Does management review input include analysis to focus
the discussion around areas needing improvement? Are
recommendations for improvement included?
5.6.3 REVIEW OUTPUT

Management reviews are required to identify opportunities to
improve the quality management system and its processes.
In addition, it is often necessary to improve the service itself
when customer requirements are not being fully met. Top
managers need to allocate or reallocate resources to make
the improvements happen.
Why Do It?
• To make the management review efficient and effective
• To focus the review on important issues
• To provide data on which top managers can make
objective decisions
• To focus on action and getting results

5.6.3 Review Output 55
Implementation Tips
• Consider actions that focus on process improvements,
including actions to eliminate waste, to simplify or
foolproof processes, to develop improved methods, to
improve documentation, and so on
• Include actions to address valid customer complaints,
field failures, and other failures to meet customer
expectations
• Since customer needs and expectations may change
often, organizations may want to consider anticipating
new customer requirements and implementing actions
to address such potential requirements
• Improvement of service beyond meeting customer
requirements may be prudent for business purposes
but is not a requirement of ISO 9001:2008
• Ensure that resources are provided as needed for
continual operation and improvement of the quality
management system

• Do the outputs of management reviews include actions
related to the improvement of the quality management
system and its processes?
• Do the outputs of management reviews include actions
related to the improvement of product related to cus-
tomer requirements?
• Do the outputs of management reviews include
resource needs?

• Are management review records maintained?

• Does management review input include results of
audits, customer feedback, process performance,
service conformity, status of preventive and corrective
actions, follow-up actions from earlier management
reviews, and changes that could affect the quality
management system?
6.1 Provision of resources
6.2 Human resources
6. Resource
management
6.3 Infrastructure
6.4 Work environment
6.1 PROVISION OF RESOURCES

The organization is required to determine and provide the
resources necessary to implement and maintain the quality
management system. There is also a requirement for deter-
mining and providing the resources needed to continually
improve the effectiveness of the system and to enhance cus-
tomers’ satisfaction by meeting their requirements.
Why Do It?
• To ensure availability of the people, equipment, and
infrastructure needed to meet customer requirements

6.1 Provision of Resources 57
• To ensure quality management system effectiveness

• To ensure customer satisfaction and build customer
loyalty
• To ensure that resources are properly applied for
the improvement of the overall organization and its
stakeholders
Implementation Tips
• Identify the processes of the quality management
system (see clause 4.2)
• Consider resource requirements for processes (person-
nel, time, buildings, equipment, utilities, materials,
supplies, instruments, software, transport facilities, other
infrastructure)
• Consider those parts of the organization that impact
service quality, not just the resources to operate the
“quality department”
• Consider short- and long-term resource needs; timing
can be everything
• Integrate longer-term needs into the organization’s
strategic and capital plans

• Have the resources necessary to implement the quality
management system been determined?
• Have the resources necessary to implement the quality
management system been planned for and provided?

• Have the resources necessary to improve the effec-

tiveness of the quality management system been
determined and provided?
• Have the resources necessary to meet customer
requirements been determined and provided?
• Have the resources necessary to enhance customer
satisfaction been determined and provided?
6.2 HUMAN RESOURCES

6.2.1 GENERAL

The organization is required to ensure that people who per-
form work affecting conformity to product requirements are
competent. ISO 9001:2008 uses the wording “affecting prod-
uct quality” with the same intent. The determination of com-
petence is based on appropriate education, training, skills,
and experience.

6.2 Human Resources, 6.2.1 General 59
Why Do It?
• To ensure that people have the capability to satisfy
customers by providing services that meet customer
requirements
• To ensure quality management system effectiveness
• To ensure that people have the capability to make the
quality management system effective
• To ensure that people have the capability to continually
improve the effectiveness of the quality management
system by improving its processes
Implementation Tips
• Use some form of written job requirements
• Competencies required should make sense for each
job type; find the right combination of education, train-
ing, skill, and experience
• Some job requirements may be only a performance
standard (for example, in a staffing agency, to place at
least five job seekers per week)
• Address competency requirements for personnel who
assess customer satisfaction

• Has the organization determined the competencies
required for each type of job?

• Are personnel who perform work affecting conformity

to service requirements competent based on educa-
tion, training, skills, and experience?
6.2.2 COMPETENCE, AWARENESS

AND TRAINING

Determination of the competency of the personnel whose
work affects conformity to service requirements is required.
Training or other action is required to fill any gaps between
the competency requirements and the actual education,
training, skills, and experience of personnel. Effectiveness
of these actions has to be measured. Appropriate compe-
tency (education, training, skills, and experience) records
are required. It is also necessary to make people aware of
(1) the relevance and importance or their work, and (2) how they
contribute to meeting the quality objectives of the organization.
Why Do It?
• To ensure that gaps between the competencies
required for a job and the actual competencies of the
personnel are defined and closed
• To ensure that people understand why their work is
important and how they contribute to the success of
the organization
• To maintain a recorded history so that improvements in
competencies can be tracked

6.2.2 Competence, Awareness and Training 61
Implementation Tips
• Assess on-the-job competencies against competency
requirements
• Focus on improving competency, not just on training
• Look for alternatives; training is not the only action that
can be used to close competency gaps
• Keep good records and measure the effectiveness of
actions you take to close gaps
• Determine if actual performance has improved

• Have the competency needs of the individual
performing activities affecting conformity to service
requirements, including additional training needs,
been determined?
• Is training provided or have other actions been taken to
satisfy these needs?
• Is the effectiveness of the actions taken, including
training, evaluated?
• Does your organization ensure that employees are
aware of the relevance and importance of their activities
and how they contribute to the achievement of the
organization’s quality objectives?
• Does your organization maintain records of education,
experience, training, and qualifications?

6.3 INFRASTRUCTURE

Determination and provision of the necessary buildings, work-
space and associated utilities, process equipment, communi-
cations, information systems, and services needed to achieve
conformity of products to requirements are required.
Why Do It?
• To ensure that the infrastructure is sufficient to ensure
conformity of service with customer requirements
• To ensure that the capability is available to continually
improve quality management system effectiveness
• To ensure that the capability is available to enhance
customer satisfaction
Implementation Tips
• Consider all physical resources needed to design and
provide a service to the customer, except people
• Go beyond service operations to include all other
activities and processes of the quality management
system
• Integrate resource needs with overall organizational
planning, including capital plans
• Consider the infrastructure needed to support customer
contact personnel who deliver services to the customer

6.4 Work Environment 63

• Have the workspace and associated facilities needed
to achieve conformity of product been determined,
provided, and maintained?
• Have the equipment, hardware, and software needed
to achieve conformity of product been determined,
provided, and maintained?
• Have the supporting services needed to achieve
conformity of product been determined, provided, and
maintained?
6.4 WORK ENVIRONMENT

The organization is required to determine the work environ-
ment necessary to achieve conformity of service. The organi-
zation is also required to manage that work environment so
that it actually does achieve conformity.
Why Do It?
• To ensure that the service delivery environment is suit-
able so that customer requirements are met
• To prevent product contamination, deterioration, or
other detrimental effects on material goods that are
related to the service being provided

Implementation Tips
• Consider the effect of the environment on the product
• Environmental, health, and safety systems focus on the
environment from the view of protecting the worker;
clause 6.4 focuses on environmental conditions from
the point of view of service delivery
• Consider integration of personnel safety concerns with
concerns related to product conformity
• Think broadly since there may be many environmental
considerations related to ensuring product conformity
• Set standards for the environments
• Ensure that facilities meet the standards
• Train personnel on standards pertaining to their work
• Prohibit unauthorized access to the work area
• Implement and maintain desired physical conditions
• Maintain records of the conditions as a means of
demonstrating compliance to the standards

• Have the conditions in the work environment that must
be controlled to achieve conformity of product been
identified?
• Are processes in place to manage the human and
physical factors of the work environment needed to
achieve conformity?

7.1 Planning of Product Realization 65
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7. Product
7.4 Purchasing
realization
7.5 Production and service

provision
7.6 Control of monitoring and

measuring devices
7.1 PLANNING OF PRODUCT REALIZATION

When planning product realization, think about the quality
objectives (see clause 5.4.1) and the requirements for the
service to be provided, which processes and documents need
to be established, which specific resources are needed for
each service, and which verification, validation, measure-
ment, monitoring, inspection, and test activities are required.
The word “measurement” was added in ISO 9001:2008 with
no intended change in the requirement. The criteria for ser-
vice acceptance need to be established. The organization also
needs to determine which records are required to provide evi-
dence that the realization processes and their outputs meet
requirements (see clause 4.2.4).

Why Do It?
• To achieve customer satisfaction
• To thoroughly understand the processes and activities
that will result in services that conform to customer
and regulatory/statutory requirements
• To foster continual improvement
Implementation Tips
• Map or flowchart the processes necessary
1 2 to produce services.
• Create quality plans for each service, if
appropriate.
• Consider processes to directly obtain cus-
tomer input on service requirements.
• Consider the interrelationship between the
people providing service and the processes
supporting service delivery.
• Consider using the product design and
development process approach for design-
ing service delivery processes (see clause
7.1 note 2 and clause 7.3).
• Find the vital few key performance indica-
tors for both services and service delivery
processes; it is better to measure and
analyze a few key indicators well, than
many poorly.

7.1 Planning of Product Realization 67
• Align the key process measures with the quality objec-

tives (see clause 5.4.1).
• Pay particular attention to records; they are evidence
of conformance, but can also be valuable to protect
intellectual property and to provide evidence of prudent
judgment if liability issues ever arise. Lack of required
records or inadequate records could create problems
for an organization for several reasons.

• Is there evidence of planning of service creation and
delivery processes?
• Does the planning extend beyond service delivery
processes to encompass all service realization
processes?
• Is the planning consistent with other elements of the
quality management system?
• Do objectives and measures for service realization
processes align with the quality objectives?
• Does service realization documentation exist?
• Are service realization resources and facilities defined
during the planning process, and do they appear to be
adequate?
• Does the planning define the records that must be
prepared to provide confidence in conformity of the
processes and resulting service?

7.1 Plan
7.2 7.3 7.4 7.5

Customers Design Purchasing Operations
7.6 Monitoring and measuring equipment
7.2.1 DETERMINATION OF REQUIREMENTS

RELATED TO THE PRODUCT

The organization needs to be sure there is a clear understand-
ing of the requirements specified by the customer (including
“soft” requirements for items such as delivery and postdeliv-
ery activities), any statutory or regulatory requirements that
apply (such as data or records), and any additional require-
ments included in the quality management system that are
related to customer orders or quotations.
The organization must also address service requirements
that have not been specified by the customer but are nec-
essary for the intended or specified use of the service. This
would include “requirements” that are “understood” for a par-
ticular product, for example, the careful handling of a package

7.2.1 Determination of Requirements Related to the Product 69
by a package delivery organization or courteous service by a

bank teller.
Why Do It?
• To be sure that the organization can meet customer
commitments
• To positively impact customer satisfaction
• To mitigate disputes with customers over what
services the customer thinks was ordered and what
services the organization thinks it promised to provide
• To resolve problems as early as possible
• To minimize the chance of an incomplete quote (for
example, missing costs)
Implementation Tips
• Hold face-to-face meetings to resolve issues and
anything that is not clear
• Attend pre-bid meetings
• Read quotes and contracts carefully and thoroughly
• Understand “marketplace standard” and “service
standard” unstated expectations
• Consider processes to observe customer behavior to
better understand customer requirements
• Keep up to date on regulatory and statutory requirements
by subscribing to an update service or by other means


• Does the organization determine customer require-
ments?
• Does the process include the determination of require-
ments needed but not specified?
• Are records available that provide evidence that cus-
tomer requirements have been determined?
7.2.2 REVIEW OF REQUIREMENTS

RELATED TO THE PRODUCT

Prior to making a commitment to supply a service to a cus-
tomer (for example, providing a quote, accepting a contract or
order, or accepting a change to an existing contract or order),
be sure you understand the customer’s requirements. This
includes resolving any contract or order requirements that
are different from previous agreements or previously issued
quotes. Also, be sure that defined requirements (for example,
the customer delivery requirement) can be met.
Records of the results of reviews and any actions taken as
a result of the review need to be maintained.
Where the customer provides no formal statement of
requirements, the organization needs to confirm what it intends
to supply, via phone, e-mail, or more preferably in writing.
When customer requirements change (for example, a
change order is issued by a customer), a process is needed

7.2.2 Review of Requirements Related to the Product 71
to ensure that relevant documents are amended and that per-

sonnel involved with an order are made aware of the changed
requirements.
Why Do It?
• To ensure that the conditions stated in the order or
quote or commitment to a customer can be met
• To provide the services included in the scope of the
quotation or tender
• To understand fully and comply with ancillary items
such as stated delivery dates and requirements of
applicable external standards
• To comply with the commercial terms and conditions
applicable to the order, contract, quote, or tender
Implementation Tips
• Balance the risks of noncompliance with the effort
expended in the review of a quotation or a contract
• Keep in mind that the purpose of the review is to
add value and not to create a bureaucratic review
process
• Have a process for reviewing oral orders
• Have a process for standardized services that are
provided in accordance with long-standing practices
• Have a very simple, brief, and effective contract-review
process for simple services

• Have a formal process for large, complex contracts

or quotations, which may require the involvement of
many organizational entities such as service devel-
opment, service delivery, legal, finance, and quality
assurance
• Consider how to review electronic orders, blanket
orders with periodic releases, unsolicited orders,
orders through distributors or representatives, faxed
orders, Internet orders, and any other type you may
receive
• Consider using quality function deployment (QFD)
and developing quality plans where appropriate (see
ISO 10005)
• If you have unique service requirements that occur
only rarely, note in a procedure that any such circum-
stances will be addressed using a specific quality
plan to be created when unique occasions arise

• Does a process exist that requires the review of identi-
fied customer requirements before commitment to
supply a service to the customer?
• Does a process exist that requires the review of quotes
and orders to ensure that requirements are adequately
defined?
• Is there a procedure for handling the review of orders
transmitted orally?

7.2.3 Customer Communication 73
• Is there a process documented to handle the resolution

of differences between quotations and orders?
• Does a process exist for handling changes to service
requirements?
• Are records maintained of the results of reviews and
actions taken?
7.2.3 CUSTOMER COMMUNICATION

“Arrangements” are required for communicating with custom-
ers on a variety of subjects. This is two-way communication.
You need to include information you provide to the customer
that is related to the services being provided.
Why Do It?
• To ensure customer satisfaction
• To solve problems quickly and early
• To increase business with customers by being in touch
on a regular basis
Implementation Tips
• Make the level and form of customer contact con-
sistent with the services provided and the volume of
business with a customer

• Tie the processes to meet this requirement to your pro-

cesses to address requirements in clause 8.2.1 relat-
ing to monitoring information on customer satisfaction
• Consider processes for contracts or order handling,
including changes, and any customer feedback regard-
ing your products or services, including customer
complaints

• Are there effective processes in place to communicate
with customers about product information, inquiries,
contracts, order handling (including amendments or
changes), and customer feedback, including customer
complaints?
• Have you linked the processes for communicating with
customers with those to monitor customer satisfaction?
7.3 DESIGN AND DEVELOPMENT

7.3.1 DESIGN AND DEVELOPMENT PLANNING

During design and development planning, the organization
needs to determine all the things it must do to complete the
design and development project. This includes identification
of at least (1) the design activities to be completed, (2) the
review, verification, and validation activities that are appro-
priate, and (3) the responsibilities and authorities for the
activities to be performed. Also, the approach for managing

7.3 Design and Development, 7.3.1 Design and Development Planning 75
the interfaces among the different groups involved with the

project needs to be identified to ensure effective communi-
cations. In other words, a detailed project plan needs to be
created.
Why Do It?
• To ensure that the service meets customer requirements
• To ensure that the service will meet customer
expectations
• To ensure compliance with any regulatory/statutory
requirements that apply to the service
• To maximize the probability that projects will be com-
pleted on time and within budget
Implementation Tips
• Generate some form of project flowchart that
1 incorporates the pertinent personnel, timing, and
interrelationship information
• Consider using Gantt charts
4
• Consider using project management software such
as Microsoft Project or Primavera
• Determine the project stages and how the project
will proceed from inception to completion
• Consider service delivery options during service
design; use concurrent design of the service
(clause 7.3) and development of the service deliv-
ery processes (clause 7.5.1)

• Use failure modes and effects analysis (FMEA) dur-

8 ing the design process to prevent problems
• Carefully plan the validation process, considering
how it will ensure that customer needs will be
satisfied under the actual conditions the customer
will experience

• Are the stages of the design and development project
defined? Where?
• Are verification and validation addressed? Are these
activities appropriate?
• Is it clear who is responsible for what?
• Are the communications channels defined? Is there
evidence that communication on projects is occurring
and that it is effective?
7.3.2 DESIGN AND

DEVELOPMENT INPUTS

This clause requires the organization to determine what input
information is pertinent to the service to be designed and
developed and to create a requirements specification or an
equivalent statement of the general and specific characteris-

7.3.2 Design and Development Inputs 77
tics of the service to be developed, including the suitability of

the service to meet marketplace and customer needs. Specifi-
cally, the organization needs to address:
• Functional and performance requirements
• Applicable statutory and regulatory requirements
• Where applicable, information derived from previous
similar designs
• Other requirements essential for design and
development
Why Do It?
• To maximize the probability that the project will meet
defined requirements
• To complete projects on time and within budget
Implementation Tips
Concurrence with the requirements document by all par-
ties is not explicitly required, but it should be considered to
avoid misunderstandings during project implementation. It is
especially worthwhile to obtain closure, where appropriate,
between marketing or sales and those who will be doing the
development work.
Examples of items to consider when addressing design
and development requirements for services include:
• Customer requirements, wants, and needs
• The function the service will perform

• Performance requirements such as timeliness, accu-

racy, and courtesy
• Information from previous similar service designs
• Competitive benchmark information
• Statutory or regulatory requirements
• Environmental considerations such as ISO 14001
• Industry standards
• National and international standards
• Organizational standards
• Safety regulations
• Cost
• Past experiences
• Contract commitments (for designing services that are
related to specific customer orders)
• Use of focus groups and quality function deployment
(QFD)

• Are the requirements for new services defined and
records maintained?
• Are the requirements complete?
• Are the requirements unambiguous?
• Are the requirements without conflict?

7.3.3 Design and Development Outputs 79
7.3.3 DESIGN AND DEVELOPMENT OUTPUTS

This provision of the standard requires that design and
development outputs meet defined requirements (as defined
in clause 7.3.2), and exists in a form that can be used for
subsequent verification. This generally means there must be
objective evidence that the design and development have
been executed in accordance with the requirements that were
defined at the inception of the project.
Why Do It?
• To provide the information needed to deliver the service
• To show that the design and development work has
been performed in accordance with requirements
Implementation Tips
• Assign responsibility for documentation of the
results of a development project to the person or
team performing the work on the project
• Use failure modes and effects analysis (FMEA) dur-
8 ing the design process to prevent problems
• Maintain development reports or logs that contain
data showing that the requirements have been
satisfied, where appropriate
• Provide appropriate information to facilitate the
delivery of the service to specified requirements

• Use appropriate statistical tools such as design of

experiments, hypothesis testing, regression and cor-
relation analysis, simulations, reliability analysis, and
statistical tolerancing
• Include in documentation clear criteria for acceptable
delivery of the service
• Include any information that relates to proper delivery
and safe use of the service
• Consider how to demonstrate that the service will not
do what it should not do
• Ensure that software or hardware provided with the
service meets requirements and will not interfere with
the delivery of the service
• Keep good records
• Ensure that the output is approved before the service is
released, which is typically achieved by the appropriate
management personnel signing off on it
• Consider carefully who should be responsible for deciding
on any design releases before completion of design and
development review, verification, and validation

• Is the output of design and development projects
in a form suitable for verification against input
requirements?
• Does the design and development output satisfy input
requirements (for example, as stated in a functional

7.3.4 Design and Development Review 81
requirements specification of the service offering to be

developed)?
• Does output provide, as appropriate, information for
service delivery operations?
• Are criteria for acceptable delivery of the service
clearly stated?
• Are safety and use characteristics identified?
• Is there an approval process for the release of services
from the design and development process?
7.3.4 DESIGN AND DEVELOPMENT REVIEW

Design review is a process step that requires evaluation of a
design by individuals in the organization who are concerned
with the design stage or stages being reviewed. It is intended
to evaluate the ability of the results of design and develop-
ment to meet requirements, and to identify any problem areas
and propose necessary actions.
It is intended to provide confidence that the spectrum of
internal and external customer needs has been considered as
early as possible and addressed with the aim of ultimately
ensuring external customer satisfaction.
Why Do It?
• To ensure the timely release of a new service that fully
meets requirements

• To find cost-reduction opportunities

• To ensure service will be reliable
• To make service easier to deliver
Implementation Tips
• Address the “abilities” associated with a new service,
including deliverability, availability, and reliability
• Address the “abilities” for hardware/software that may
accompany the service, including manufacturability,
deliverability, testability, inspectability, shipability,
serviceability, reparability, availability, and reliability
• Structure the design review process so that it will
not interfere with the creativity and innovation of the
designers or slow down the development process
• Determine the number and timing of design and
development reviews that should be conducted during
the design and development planning process and
modify this number, as appropriate, during the course
of a project
• Ensure that review timing allows for resolution of
issues as early in the design and development process
as possible
• Keep records of design and development reviews,
including issues noted and proposed actions
• Involve appropriate individuals in the reviews
• Identify issues, discuss possible resolutions, and deter-
mine appropriate follow-up

7.3.5 Design and Development Verification 83

• Are design and development reviews being performed?
• Are they indicated in the project planning documents?
• Who attends?
• Is the attendance appropriate?
• Are results documented?
• Are follow-up actions taken?
• Are appropriate records maintained?
7.3.5 DESIGN AND

DEVELOPMENT VERIFICATION

Verification is a requirement that ensures that the design and
development outputs meet the design and development input
requirements. There is also a requirement that records of
the results of the verification and any necessary actions be
maintained.
Why Do It?
• To ensure that the output of the project meets specified
requirements
• To ensure that objective evidence exists to demon-
strate the basis for this assertion

Implementation Tips
• Make a determination, by any reasonable means,
that the service does meet the stated requirements
• Consider using review and analysis of test data,
making alternative calculations, performing addi-
tional testing of the service or its components, or
any other means that the organization chooses
• Consider the use of statistical sampling when
9 designing tests
• Ensure that objective evidence exists to demon-
strate that validation has been completed
Design and development

Review, verification and validation
Verification
Customer Design Design and Design

needs inputs development output
Design Change
review control
Validation

7.3.6 Design and Development Validation 85

• Is a verification process in place?
• Is it effectively implemented?
• Are follow-up actions recorded?
• Are required records defined and maintained?
7.3.6 DESIGN AND DEVELOPMENT VALIDATION

It is necessary to ensure that the output from the design and
development process is capable of meeting the requirements
for the specified application or intended use, where known.
It is also necessary to complete validation before delivery or
release of the service where practicable and to keep records
of validation actions.
Why Do It?
• To ensure that the service will meet application
requirements for customers, in addition to meeting
specified requirements
• To contribute to minimizing product-liability exposure
• To reduce cost, especially when validation is completed
before a service is released for sale or delivered to a
customer, resolution of issues after service delivery
can be very expensive or perhaps impossible

Implementation Tips
• Often validation is performed after successful
design and development verification
• Record results and retain as records
• Perform validation in an environment that approxi-
mates as closely as possible the operating condi-
tions that will exist in actual use
• Complete the validation before release or delivery
to customers; if this is not possible, conduct
validation to the extent that is reasonable prior
to release and complete final validation when
appropriate
• Consider the use of design of experiments and
9 statistical sampling when designing tests

• Is design and development validation performed to
confirm that the service is capable of meeting the
requirements for intended use?
• Is validation completed prior to service delivery when
applicable?
• Is partial validation provided in cases where full valida-
tion cannot be performed prior to delivery?
• Are records of design and development validation
maintained?

7.3.7 Control of Design and Development Changes 87
7.3.7 CONTROL OF DESIGN AND

DEVELOPMENT CHANGES

Any changes that occur in the design of a service, either dur-
ing the design and development process or during delivery of
the service, need to be identified and records of the changes
maintained. Further, changes should be subjected to appropri-
ate design review, verification, and validation processes and
should be approved before implementation.
This clause also requires evaluation of the effect of
changes on constituent parts of the service and on services
already delivered. Changes to service design can have unin-
tended effects since changes to one part of the service can
have an impact on other parts.
Why Do It?
• To make certain that changes do not introduce unfore-
seen adverse effects into the service or other related
services
• To ensure that design configuration is controlled
• To ensure cost-effective service delivery
Implementation Tips
• Include control of changes that occur during design
and development in the document or design control
process

• Review changes to ensure that they do not compro-

mise other aspects of the design
• Conduct design and development review, verification,
and/or validation in cases where appropriate
• Record and follow up on issues from the review of the
change

• Are design and development changes identified and
documented?
• Are design and development changes reviewed, veri-
fied, and validated as required?
• Does review of changes include evaluation of the effect
on constituent parts and delivered product?
• Are records of design and development changes
maintained?
7.4.1 PURCHASING PROCESS

Controls are required to ensure that products and services
purchased and included in the service delivered to customers
conform to specified requirements. There is flexibility regarding
how this is done. The approach should depend on the effect of
the purchased product or service on subsequent operations,
on the final services provided, and on the customers.

7.4.1 Purchasing Process 89
Suppliers need to be evaluated and selected based on

their ability to supply products or services in accordance
with requirements. Criteria need to be established for selec-
tion, evaluation, and reevaluation of suppliers. Records of the
results of evaluations and any actions taken as a result of the
evaluations must be kept.
Why Do It?
• To ensure that you get what you specify and pay for
• To ensure your own profitability in cases where
purchased material is a significant component of the
overall service cost
• To ensure that products and services conform to
specifications
• To ensure satisfaction of your customers
• To drive robust controls “upstream” as far as possible
to ensure the most economical control of product and
service quality, minimizing your total cost
• To ensure the ongoing ability of your suppliers to
continually provide conforming product and services at
optimal cost
Implementation Tips
• Understand the risk to your business if purchased
products or services do not meet requirements
• Consider rigorous controls in cases where the potential
impact of purchased product and service is great

• Consider reducing the controls in cases where impact

of purchased product and service is less
• If purchased material has little impact on the final
product or service delivered to customers, then mini-
mal control is needed
• Think about what makes sense from both a customer
and business perspective
• Focus more on obtaining conforming material and not
just on maintaining approved-supplier lists

• Have criteria for the selection and periodic evaluation
of suppliers been defined?
• Is there a process for selecting and evaluating
suppliers?
• Are the results of evaluations documented and retained
as records?
7.4.2 PURCHASING INFORMATION

The product or service to be purchased needs to be described
(typically with a purchase order), including any requirements
for special approvals of the purchased items, and any special
procedures, processes, or equipment that may be related to
the purchased product. If special qualification of personnel

7.4.2 Purchasing Information 91
or specific quality management system requirements apply

(for example, compliance with ISO 9001:2008), such require-
ments need to be included in the purchasing documents.
The adequacy of purchase requirements needs to be
checked prior to communicating them to the supplier.
Why Do It?
• To maximize the probability that you will receive what
you order, on time
• To minimize discussion with suppliers over what you
really want
• To forge a partnership mentality with your suppliers
Implementation Tips
• Communicate clearly to suppliers what your organiza-
tion wants to purchase
• Communicate clearly to suppliers your criteria for
accepting the purchased product
• Be creative when devising Web-based purchasing
approaches to ensure adequacy and control of pur-
chase documents
• Match the process to check the adequacy of your pur-
chase requirements to the importance of the items—
important items may require that several functions or
levels be involved in review and approval (for example,
for high-value purchased items); less important items
may require only a single level of review and approval


• Do purchasing documents adequately describe the
products or services being ordered?
• Do purchasing documents include, where appropriate,
requirements for approval or qualification of product
or service, procedures, processes, equipment, and
personnel?
• Do purchasing documents include, where applicable,
quality management system requirements?
• How does the organization ensure adequacy of speci-
fied purchase requirements prior to communication to
the supplier?
7.4.3 VERIFICATION OF PURCHASED PRODUCT

Processes are required to ensure that purchased product
meets the specified purchase requirements. This could be
inspection, but inspection is not required. There is flexibility
here to choose the most effective approach.
If verification is necessary at a supplier’s location, the
purchasing information must include this expectation and the
requirements for product release.
Why Do It?
• To ensure that material you put into your processes
meets specified requirements

7.4.3 Verification of Purchased Product 93
• To avoid costly recovery operations after services are

delivered
Implementation Tips
• Consider approaches such as:
■ Certifying suppliers (based on demonstrated
performance, supplier third-party certification, or
your own audit)
■ Certifying a specific supplier’s product or service
(based on demonstrated process capability)
■ Conventional or skip-lot incoming inspection for
9 attributes or variables using sampling plans
■ One hundred percent inspection (or more)
■ Verification at the supplier’s facility
■ Any combination of these or other approaches
• Consider performing verification activities at the sup-
plier’s premises if this makes sense
• This requirement often does not apply where service
is the primary end product (see clause 1.2)

• Has the organization defined a process for verifying
that purchased product or service conforms to defined
requirements?
• Is the process effectively implemented?

• Does objective evidence exist of product or service

acceptance?
• Is verification of purchased product or service
performed at the supplier’s premises? If so, are the
arrangements specified and does objective evidence
exist of effective implementation?
7.5.1 CONTROL OF PRODUCTION

AND SERVICE PROVISION

Production and service provision needs to be planned and
carried out under controlled conditions. Controlled conditions
include:
• Having information available that states the charac-
teristics of services—such as specifications, service
manuals, or a course syllabus
• Having suitable documentation available where
needed—such as procedures, work instructions,
specifications, forms, check sheets, and so on
• Knowing the criteria for service acceptability
• Knowing what controls are needed and where they
are needed, for example, what checks and inspections
need to be done and where in the process
• Using suitable equipment needed to deliver the service,
to monitor and/or measure the service performance
and/or the service delivery process

7.5.1 Control of Production and Service Provision 95
• Knowing and doing all the things that need to be done

before service is provided to a customer
• Knowing and doing all the things needed to meet both
delivery and postdelivery commitments, for example,
consideration of special materials, instructions, tools, or
equipment that may be required to provide the service
Why Do It?
• To ensure that what you are providing will meet both
internal and customer requirements
• To prevent service and process variability that may
exceed specification limits or cause high costs, rejects,
rework, scrap, and other forms of waste
Implementation Tips
• Review and understand specifications of
services
• Identify key processes
• Flowchart or process map the processes
1 2
• Define or clearly identify the outputs of all
processes at appropriate stages
• Establish clear criteria of acceptability
• Identify interrelationships between
operations
• Consider preparation of quality plans where
appropriate (see ISO 10005)

• Determine what procedures and working instruc-

tions are needed for the various processes
• Document processes in a manner suitable to the
organization’s method of operation
• Make sure process documentation is available
when and where needed
• Make sure that any related equipment is suitable
• Ensure ongoing suitability of related equipment by
planning maintenance activities
• Plan measuring and monitoring activities (see
clauses 7.6, 8.1, 8.2.3, and 8.2.4) in conjunction
with planning the controls
• Consider the use of statistical sampling
9
• Identify devices needed to monitor and measure
both the service and its processes
• Make sure that the needed monitoring and mea-
surement equipment is suitable
• Ensure that planning is compatible with the other
processes of the entire interconnected quality
management system

• Are specifications available that define quality charac-
teristic requirements of the service?
• Has the organization determined the criteria of
acceptability for demonstrating the suitability of

7.5.1 Control of Production and Service Provision 97
equipment for service operations to meet service

specifications?
• Has the organization demonstrated the suitability of
equipment for service operations to meet service
specifications?
• Has the organization defined all production and service
provision activities that require control, including those
that need ongoing monitoring, work instructions, or
special controls?
• Are work instructions available and adequate to permit
control of the appropriate operations so as to ensure
conformity of the service?
• Have the requirements for the work environment
needed to ensure the conformity of the service been
defined, and are these work environment requirements
being met (see clause 6.4)?
• Is suitable monitoring and measurement equipment
available when and where necessary to ensure confor-
mity of the service?
• Have monitoring and measurement activities been
planned and are they carried out as required?
• For related hardware, processed material, or software,
have suitable processes been implemented for release
of the service and for its delivery to the customer?
• Have suitable release mechanisms been put in place to
ensure that service conforms to requirements?

7.5.2 VALIDATION OF PROCESSES FOR

PRODUCTION AND SERVICE PROVISION

For processes where the output cannot be easily verified (that
is, where you cannot adequately inspect the service), the
organization needs to:
• Identify criteria for approval of the processes delivering
the service, and for related equipment and personnel
• Develop a process for reviewing and approving processes
• Provide evidence that processes can achieve planned
results
• Define and use appropriate methods and procedures
• Keep records of service delivery personnel and process
qualifications
• Determine if revalidation is required, and if so, estab-
lish a process for and perform revalidation
Controls are also required in cases where service verification
is not conducted because it would be inconvenient, take too
much time, or be too expensive. It is very common for service
processes to meet these criteria.
Why Do It?
• To ensure that services with hard-to-verify characteris-
tics meet customer requirements

7.5.2 Validation of Processes for Production and Service Provision 99
• To prevent service failures during use by your

customers
• To avoid the negative cost implications if service
processes do not produce expected results
Implementation Tips
• Consider processes like face-to-face interactions with
customers (for example, a bank teller, a store clerk) as
candidates for special controls
• Address the competence (see clause 6.2) of the people
who deliver the service
• Address the work environment (see clause 6.4) in
which the service is to be delivered, to ensure confor-
mity to service requirements
• Address the support processes and equipment
used in service delivery, to ensure competence and
capability
• Decide which records are necessary and have pro-
cesses to produce the records
• Use process monitoring and measurement to verify
ongoing control
• Develop a revalidation plan for processes that could go
out of control without warning
• Consider the cost of revalidation against the risk of
nonconforming service to determine revalidation
frequency


• Has the organization determined which service pro-
cesses require validation? Have these processes been
validated?
• Has the organization defined criteria for the review and
approval of service processes? Have the reviews and
approvals been performed?
• Has the organization determined which personnel need
to be qualified, and has it determined the qualification
criteria? Have these personnel been qualified?
• Does the organization use defined methodologies and
procedures to validate processes?
• Have the requirements for records of validated pro-
cesses been defined?
• Are records of validated processes maintained?
• Have the processes requiring revalidation been defined?
• Have processes, as required, been revalidated?
• Do adequate records exist to ensure that process
validation is effective?
7.5.3 IDENTIFICATION AND TRACEABILITY

The organization needs to identify appropriate aspects of ser-
vice throughout the realization process, wherever it is appropri-
ate. Methods to ensure that appropriate verifications have been

7.5.3 Identification and Traceability 101
performed also need to be addressed. When traceability is a

requirement (usually because it is included in specifications and/
or in a customer order), a method is required to maintain unique
identification at all appropriate stages and maintain records.
Why Do It?
• Identification:
■ Facilitates customers’ ability to know they have
received the correct service
■ Ensures that all service activities have been completed
• Traceability:
■ May be a regulatory or contractual requirement
■ For financial and other similar services, traceability
may be an integral element of the service realization
process
■ Can be an internal requirement in cases where you
wish to reduce the extent of potential data research
needed to resolve customer issues
Implementation Tips
• Consider identification by use of forms, check sheets,
bar codes, stamps on documents, reports, or any other
approach that makes sense to the organization
• Recording of traceability may include such items as
the identity of the individual performing the service,
customer identity, identity of replacement parts that
are used, and so on

• Consider using computerized identification systems

• Traceability is frequently considered for a possible
exclusion under clause 1.2 since these concepts are
either not applicable or addressed in other parts of
service realization

• Have identification requirements been addressed by
suitable means throughout service operations?
• Has the status of the service been identified at suitable
stages with respect to monitoring and measurement
requirements?
• Is traceability a requirement?
• Where traceability is a requirement, are the controls
defined and implemented?
7.5.4 CUSTOMER PROPERTY

The organization must protect and safeguard customer prop-
erty such as information or material that will be incorporated
into the final service. The controls apply while customer prop-
erty is under the control of or being used by the organization. If
customer property is lost or damaged, or if it becomes unsuit-
able for use for any reason, this needs to be reported to the
customer and documented.
The standard makes a special point to remind organizations
to pay attention to intellectual property of customers to which

7.5.4 Customer Property 103
the organization has access (for example, software, account

information) and to treat such customer property with care.
Why Do It?
• To meet implied obligations to take care of customer
property (in addition to all contractual obligations)
• To avoid the time and costs that would be required to
resolve any problems with the customer if you dam-
age, lose, or misuse customer property
Implementation Tips
• Consider a process to control items such as informa-
tion provided by the customer during the service
process, as well as customer material provided before
the service is delivered
• Make a brief quality plan specifically for the care and
handling of customer property

• Has the organization identified, verified, protected,
and maintained customer property that is provided for
incorporation into the service or to facilitate delivery of
the service?
• Does control extend to all customer property, including
intellectual property?
• Does the organization have records that indicate when
customer property has been lost, damaged, or other-
wise found to be unsuitable?

• Is there evidence that the customer has been informed

when customer property has been lost, damaged,
or otherwise found to be unsuitable? Are records
maintained?
7.5.5 PRESERVATION OF PRODUCT

The organization must preserve the conformity of product during
internal processing and delivery to the intended destination. For
service providers, this requirement frequently does not apply,
except for materials that are associated with the service. For
example, if manuals were to be provided for a training service,
the manuals would need to be handled in a way that ensures
usability at the time when the training service is provided.
Why Do It?
• To prevent damage to tangible material related to a
service being provided; most services do not require
preservation, but services are often attached to other
product categories (for example, printing of photo-
graphs is a service, but the photograph itself is a
product that needs to be preserved)
• To ensure that perishable information or data that are
part of the service are preserved
• To ensure that everyone in the organization is aware of
the actions necessary to prevent damage to material
that may be related to a service being provided

7.5.5 Preservation of Product 105
Implementation Tips
• For the services provided:
■ Determine the aspects of the service, if any, that
require preservation
■ Consider perishable components of the service such
as data and information
• For hardware or other tangible product that may
accompany or be used in delivery of the services:
■ Develop processes to appropriately identify, handle,
package, store, and deliver any product related to a
service being provided to a customer
■ Include appropriate controls for the components of
these products during and between all processing
steps through to delivery
■ Consider procedures for segregating batches, stock
rotation, and expiration dates
■ Ensure that packaging, containers, wraps, and
pallets are appropriate and durable for protecting
product from damage
■ Consider both physical security of products and
protection from harmful environmental conditions
(for example, humidity)
■ Consider application to raw materials typically
stored outside (for example, cleaning supplies used
in conjunction with providing cleaning services)


• Does the organization uniquely identify material related
to services during internal processing and delivery?
• Does the organization protect appropriate aspects of
the service during internal processing and delivery so
as to preserve conformity to customer requirements?
• Does the organization package the material supplied
with or used in delivery of the service during internal
processing and delivery so as to preserve conformity to
requirements?
• Does the organization store the material supplied
requirements?
• Does the organization protect the material supplied
requirements?
7.6 CONTROL OF MONITORING

AND MEASURING DEVICES

Monitoring and measurement requirements need to be deter-
mined and device requirements identified to provide evidence
of conformity of product to requirements. For example, the
administering of drug tests, blood alcohol content determina-

7.6 Control of Monitoring and Measuring Devices 107
tion, or speed determination with a radar or laser gun require

certain measuring equipment.
Processes are required to ensure that monitoring and
measurement are carried out in a manner that is consistent
with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equip-
ment must be calibrated or verified at specified intervals, or
prior to use, against measurement standards traceable to
international or national measurement standards. Where no
such standards exist, the basis used for calibration or verifica-
tion needs to be recorded. Also, equipment must be adjusted
or readjusted as necessary and identified to enable the cali-
bration status to be determined. It must also be safeguarded
from adjustments that would invalidate the measurement
result and be protected from damage and deterioration during
handling, maintenance, and storage.
If measuring equipment is found to be nonconforming to
requirements, the validity of the previous measuring results
obtained by using the piece of equipment must be recorded.
Appropriate action must be taken on the equipment and any
product affected. Records of the results of calibration and
verification need to be maintained.
When used in the monitoring and measurement of speci-
fied requirements, the ability of computer software to satisfy
the intended application needs to be confirmed, both prior to
initial use and periodically, as appropriate.
Why Do It?
• To provide assurance that services meet customer and
internal requirements through adequate measurements

• To prevent the delivery of nonconforming services

because devices used to make measurements or to
monitor process performance or product conformance
are inappropriate for making the measurement, not
accurate, unstable, or damaged
Implementation Tips
• Many services may not require these measurement
controls, and clause 7.6 may be considered for exclu-
sion under clause 1.2
• Develop a process for control of measuring and
monitoring devices so that they are identified and their
custody or location is controlled
• Carefully analyze measurement needs, if any such
needs exist
• Where measurements are required (for example,
if actual values are determined and compared to a
specification either by people using the equipment or
automatically by the equipment itself), the equipment
used should normally be subject to calibration controls
• Develop or obtain procedures and instructions for
performing calibration on each model of measuring
equipment requiring calibration
• Have professional(s) who have a working knowledge
of metrology, including an understanding of accuracy,
precision, and measurement uncertainty, manage the
metrology activities

7.6 Control of Monitoring and Measuring Devices 109
• Consider outsourcing metrology activities (see

clause 4.1) if sufficient professional metrology
personnel are not available internally
• Consider using a calibration laboratory accredited to
ISO 17025 for outsourced calibration work
• Develop a process for handling a situation where mea-
suring equipment is found not to conform to require-
ments. Consider as a minimum:
■ Determining the validity of any measurements made
since the piece of equipment was last known to be
in conformity
■ Actions to be taken in the event the measurements
could have resulted in delivery of nonconforming
services
■ Actions to be taken to correct the measuring
equipment
• Consider the controls appropriate for simple devices
that do not become erroneous unless damaged (for
example, tape measures, fixed-power magnifying
glasses); controls may include:
■ Initial inspection against a known standard to
ensure acceptable measurement capability for the
application
■ Rules requiring simple visual inspection of the
device prior to and after each use to ensure continu-
ing adequacy
■ Mandatory turn-in of the device if damaged


• Has the organization identified the measurements to
be made?
• Has the organization identified the monitoring and
measurement devices required to ensure conformity of
services to specified requirements?
• Are monitoring and measurement carried out in a man-
ner consistent with the monitoring and measurement
requirements?
• Are monitoring and measurement devices calibrated
and adjusted periodically or before use against devices
traceable to international or national standards?
• Is the basis used for calibration recorded when trace-
ability to international or national standards cannot be
done, since no standards exist?
• Are monitoring and measurement devices safeguarded
from adjustments that would invalidate the calibration?
• Are monitoring and measurement devices protected
from damage and deterioration during handling, main-
tenance, and storage?
• Do monitoring and measurement devices have the
results of their calibration recorded?
• Does the organization have the validity of previous
results from monitoring and measurement devices
reassessed if they are subsequently found to be out of
calibration? Is corrective action taken?

8 Measurement, Analysis and Improvement, 8.1 General 111
• Is the software used for monitoring and measurement

of specified requirements confirmed as to its suitability
before use?
8.1 General
8.2 Monitoring and measurement
8. Measurement,
8.3 Control of nonconforming
analysis and
product
improvement
8.4 Analysis of data
8.5 Improvement
8 MEASUREMENT, ANALYSIS
AND IMPROVEMENT
8.1 GENERAL

The organization must plan and implement the monitoring,
measurement, analysis, and improvement processes that
demonstrate conformity of the service, to ensure conformity
of and to continually improve the effectiveness of the quality
management system.
This includes determination of the methods and tech-
niques to be used, including statistical techniques, and

where and to what extent such methods and techniques

should be used.
Why Do It?
• To ensure that necessary monitoring, measurement,
analysis, and improvement activities are planned and
implemented
• To obtain high return on the investment made in the
measurement, analysis, and improvement processes
• To have a quality management system that integrates
the concepts of clauses 8.1, 4.1, and 7.1 to achieve
customer satisfaction and continual improvement
Implementation Tips
• Think about the processes of the quality
management system (see clauses 4.1 and
5.4.2)
• Think about the measurement and control
needs for product realization processes (see
clause 7.1)
• Integrate measurement, analysis, and
1 2 improvement activities into maps and
flowcharts developed to support
clauses 4.1 and 7.1
• Decide what you need to know about pro-
cesses and services to ensure conformity of
service and to make certain you meet your
quality objectives

8 Measurement, Analysis and Improvement, 8.1 General 113
Management review (5.6)

t*OQVUT
Policy (5.3) t0VUQVUT
t.POJUPSQSPHSFTT
Objectives (5.4.1)
Corrective action (8.5.2)
Planning Preventive action (8.5.3)
Measures (8.2) 5.4.2, 8.1
t1SPEVDUBOEQSPDFTT
t$VTUPNFSTBUJTGBDUJPO
t"VEJUSFTVMUT
Identify opportunities (8.4 & 5.6)

Data collection (8.4)
Analysis of data (8.4)
• Define the key indicators of performance for the

services and processes that will help you under-
stand your progress toward reaching your quality
objectives
• Think through all the aspects of measurement,
ALL
analysis, and improvement activities; keep in mind
that you must cover both aspects related to service
conformity and aspects related to meeting your
quality objectives
• Think about the statistical and other tools that are
appropriate for your situation
• Be sure it is clear how you will accomplish the
analysis of the data you gather and how you will
use it for improvement of processes


• Has the organization identified the measurements to
be made?
• Is objective evidence available to demonstrate that the
organization has defined, planned, and implemented
the monitoring and measurement activities needed to
ensure conformity and achieve improvement?
• Is objective evidence available to demonstrate that
the organization has determined the need for and
use of applicable methodologies, including statistical
techniques?
• Does the organization have an ongoing process
to determine new measurement needs as service
delivery and process changes are developed and
implemented?
8.2 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION

As one of the measurements of the performance of the quality
management system, it is a requirement to monitor informa-
tion relating to customer perception as to whether the orga-
nization has met customer requirements. There is flexibility to
decide the methods to get this information, but methods must
be established.

8.2 Monitoring and Measurement, 8.2.1 Customer Satisfaction 115
Why Do It?
• To understand customers’ perceptions related to your
services so that you can take action to improve that
perception
• To understand actions needed to keep current
customers
• To understand actions needed to expand your business
or increase market share or grow your markets
Implementation Tips
• Decide what information you will monitor, how you will
get that information, and how you will use it
Examples of sources of customer

satisfaction Information
t$VTUPNFSDPNQMBJOUT t3FQPSUTGSPNDPOTVNFS
t3FUVSOT PSHBOJ[BUJPOT
t8BSSBOUZJOGPSNBUJPO t%JSFDUDVTUPNFS
DPNNVOJDBUJPO
t$VTUPNFSTBUJTGBDUJPO
TUVEJFT t#FODINBSLJOHEBUB
t3FTVMUTGSPNGPDVT t*OEVTUSZHSPVQ
HSPVQNFFUJOHT JOGPSNBUJPO
t$VTUPNFSUSBDLJOH t5SBEFBTTPDJBUJPO
TUVEJFT JOGPSNBUJPO
t2VFTUJPOOBJSFTBOE
TVSWFZT

• Consider that to demonstrate compliance in regulated

markets, it may be sufficient to monitor customer
reports of service deficiencies
• Consider using surveys of service users or focus
groups
• Consider face-to-face interviews with the individuals who
make key buying decisions in customer organizations
• Understand the distinction between monitoring and
measurement; monitoring usually provides less infor-
mation than measuring
Surveys
Active Focus groups
Personal interviews
Customer Complaints
satisfaction
data Receptive
Returns
Passive Supplier ratings
Consumer feedback
Indirect
Competitive analysis
News media
Multiple sources of customer data shown in tree diagram.

Source: Reprinted with permission from C. A. Cianfrani, J. J. Tsiakals, and J. E. West,
eds., The ASQ ISO 9000:2000 Handbook (Milwaukee, WI: ASQ Quality Press, 2002).

8.2.2 Internal Audit 117
• Keep the process dynamic and flexible; the results of

monitoring may indicate a need to gather more infor-
mation through measuring
• Include methods to understand what is important to
the customers, including price and delivery perfor-
mance, when deciding what to monitor and measure
• Consider using voice of the customer and quality func-
tion deployment (QFD) techniques
• Look around your organization for customer informa-
tion; there are typically 30 or more sources of such
data, most of which are not effectively used

• Is customer satisfaction information monitored?
• Are methods for gathering and using customer
information determined and deployed throughout the
organization?
8.2.2 INTERNAL AUDIT

Internal audits are required at planned intervals to determine
whether the quality management system conforms to the
requirements of this International Standard and to your quality
management system requirements, and to determine if it is
effectively implemented and maintained.
Internal audit planning needs to consider the status and
importance of the processes and areas to be audited as well

as the results of previous audits. The audit criteria, scope, fre-

quency, and methods all need to be defined.
The selection of auditors and conduct of audits need to be
done on a basis that ensures objectivity and impartiality of the
audit process. Auditors cannot audit their own work.
A documented procedure is required to describe the
responsibilities and requirements for planning and conducting
audits, and for reporting results and maintaining records.
Management of the area being audited is responsible for
ensuring that actions are taken without undue delay to elimi-
nate detected nonconformities and their causes. Follow-up
activities need to include the verification of the actions taken
and the reporting of verification results.
Why Do It?
• To provide confidence in the effective implementation
of the quality management system
• To identify opportunities for improvement in addition to
assessing compliance
• To keep everyone sharply focused on adhering to
processes, minimizing the natural tendency of “con-
formity drift”
Implementation Tips
• Use ANSI/ISO/ASQ QE19011S as a guide to set up your
audit processes; choose from its many guidance items
• Consider assigning organization, basic planning, and
documentation integrity for the internal audit process
to one area, such as the internal audit department or
the quality assurance department

8.2.2 Internal Audit 119
• Consider combining and integrating common aspects

of management system audits for quality, health and
safety, and the environment
• When evaluating the quality management system,
the following questions are typical of what should be
considered for every process being evaluated during
internal audits:
■ Is the process identified and appropriately described?
■ Are responsibilities assigned?
■ Are required processes implemented and maintained?
■ Is the process monitored and measured as
appropriate?
■ Is the process operated under controlled conditions?
■ Is the process effective in achieving the required
results?
■ Is the process continually improved?
• Ensure that internal audits consider the processes of
the quality management system, not just elements or
activities
• Select internal auditors carefully (individuals from
areas such as finance, engineering, or top manage-
ment often make excellent quality auditors) and
provide good training for them to ensure competence
• Consider both the status and importance of areas and
the results of prior audits when determining audit
frequency; audit the most critical areas most often

• Consider using the audit process to find opportunities

for improvement

• Does the organization conduct periodic audits of the
quality management system?
• Do the periodic audits evaluate the conformity of the
quality management system to the requirements of ISO
9001:2008?
• Do the periodic audits evaluate the degree to which
the quality management system has been effectively
implemented and maintained?
• Does the organization plan the audit program with
consideration of the status and importance of areas to
be audited?
• Does the organization plan the audit program with
consideration of the results of previous audits?
• Are the audit scope, frequency, and methodologies
defined?
• Do the audit process and auditor assignment ensure
objectivity and impartiality?
• Is there a documented procedure that includes the
responsibilities and requirements for planning and
conducting audits?
• Is there a process to ensure the objectivity and impar-
tiality of auditors?

8.2.3 Monitoring and Measurement of Processes 121
• Is there a documented procedure for reporting results

and maintaining records?
• Is timely corrective action taken on deficiencies found
during the audit?
• Do follow-up actions include the verification of the
implementation of corrective action?
• Do follow-up actions include the reporting of verifica-
tion results?
8.2.3 MONITORING AND

MEASUREMENT OF PROCESSES

Appropriate methods are required for monitoring and measur-
ing the quality management system processes. These methods
need to demonstrate the ability of the processes to achieve your
planned results. When planned results are not achieved, correc-
tion and corrective action need to be taken, as appropriate.
Why Do It?
• To ensure that all processes of the quality management
system are performing to expectations
• To ensure that processes critical to achieving quality
objectives are controlled and improved
• To ensure that processes for product realization are
controlled, improved, and provide service that meets

Implementation Tips
• Include, as appropriate, the management
responsibility processes, the resource
processes, and the measurement and
improvement processes, in addition to the
product realization processes
• Monitor processes of the quality man-
agement system; monitoring can range
from normal supervision to exacting
measurement
• Define the key processes needing measure-
ment, focusing on processes critical to
meeting quality objectives and providing
conforming service
• Choose carefully and wisely those
processes to be measured; don’t try to
measure everything
• Use data from histograms and statisti-
6 9 cal sampling to help determine which
processes have high inherent variation and
require measurement to maintain control
and which processes are both capable and
relatively stable
• Consider the use of statistical process control
(SPC), control charts, and Six Sigma tools
• Tie in the results from monitoring and mea-
suring to correction and corrective action
where appropriate

8.2.4 Monitoring and Measurement of Product 123

• Have the key quality management system processes
needed to meet planned results, especially the product
realization processes, been identified?
• Are suitable methods used to measure and monitor
these key processes?
• Can the key requirements for controlling service
delivery processes be determined from product
specifications?
• Are the monitoring and measurement methods for the
processes of the quality management system adequate
for confirming the continuing suitability of each
process to satisfy its intended purpose and achieve its
planned result?
8.2.4 MONITORING AND

MEASUREMENT OF PRODUCT

This requirement determines what, if anything, you need to
monitor and measure while preparing to deliver service, and
what must be monitored and measured to ensure that the
delivered service conforms to requirements. Evidence of con-
formity with the acceptance criteria is required. Records are
required to indicate who provided a service and, if applicable,
who authorized provision of the service.

Before providing a service it is necessary to ensure com-

pletion of all service delivery process planning and qualifica-
tion, including training and qualification of personnel who will
deliver the service.
If service is provided before all the requirements have
been met, approval by a relevant authority is required (that
means a member of the management of the organization and,
where appropriate, by the customer).
Why Do It?
• To ensure that your services conform to specified
requirements
• To maximize your probability of having satisfied, or
even delighted, customers
• To minimize or eliminate the need to redo the service

8.2.4 Monitoring and Measurement of Product 125
Implementation Tips
• Consider all measurement activities that may be
needed during the various aspects of product
realization, including design verification and valida-
tion, and qualification of purchased parts/material,
as well as activities related to all service delivery
processes
• Consider using statistical sampling
9
• Consider the use of statistical process control
(SPC), control charts, and Six Sigma tools
• Involve people working in the various affected
areas (including both customer contact personnel
and “back office” personnel who affect the ability
to meet requirements) in the planning
• Address service measurement during design
review(s) to ensure that problems are resolved
before a service is released for delivery to
customers

• Does the organization monitor and measure service
characteristics to verify that service requirements
are met?
• Does the organization monitor and measure service
characteristics at appropriate stages of the product
realization process?

• Is there objective evidence that acceptance criteria for

service have been met?
• Do records identify the person authorizing release of
the service?
• Are all specified activities performed before service
release and service delivery?
• If there are instances in which all specified activities
have not been performed before service release or
service delivery, has a relevant authority or, as appro-
priate, the customer been informed, and has approval
of the action been obtained?
8.3 CONTROL OF
NONCONFORMING PRODUCT

A documented procedure is required to describe the controls
and related responsibilities and authorities for dealing with
nonconforming service. For hardware, processed material,
and software, this requirement is intended to ensure that
product that does not conform to requirements is identi-
fied and controlled to prevent its unintended use or delivery.
For services, this type of control may be impossible—if the
service is nonconforming at the time it is provided to the
customer, there just may be no nonconforming product to
control. For example, once a bank teller provides incorrect

8.3 Control of Nonconforming Product 127
information to a customer, there is no way to capture and

control the words leading to the nonconforming service.
Nonconforming service can be addressed by taking action
to eliminate or correct the detected nonconformity or by recov-
ery action to ensure that the customer ultimately receives
what is required. Subsequent to correction or recovery, the
corrective action process (clause 8.5.2) may be appropriate.
Records of the nature of nonconformities and any subse-
quent actions taken, including concessions obtained, need to
be maintained.
The requirement for reverification of corrected nonconform-
ing product often does not apply to the service sector. Each
organization should consider the nature of its services and
develop and implement processes that ensure control of non-
conformity, correction, and reverification, if applicable, under
controlled conditions (see clause 7.5.1). Such an approach
would be effective in meeting the intent of clause 8.3, which
has its origins in the hardware world and still retains distinctly
hardware-focused requirements.
When nonconforming service is detected after delivery
or after use has started, action appropriate to the effects, or
potential effects, of the nonconformity needs to be taken.
Why Do It?
• To prevent unintended delivery of service that does not
conform to requirements
• To ensure an appropriate process is in place to address
control of nonconforming service delivery, if and where
such controls are necessary

Implementation Tips
• If disposition of nonconforming service is possible,
define who (by job function) has the authority for
approval of the actions.
• Keep records of nonconformities, the action taken to
resolve them, and any required internal or external
approvals. These records may be needed in the future
(for example, to resolve a customer dispute).

• Is there a documented procedure to ensure that, if
and where possible, service that does not conform to
requirements is identified and controlled to prevent
unintended use or delivery?
• Is there evidence of appropriate action being taken
when nonconforming service has been detected after
delivery or after use has started, or a process that con-
siders correction or corrective action, as appropriate?
• Is it required that any proposed rectification of non-
conforming service be reported for concession to the
customer, the end user, or a regulatory body?
• Is there objective evidence of appropriate communica-
tion with a customer when the organization proposes
rectification of nonconforming service?
• Are concessions obtained from customers as
appropriate?

8.4 Analysis of Data 129
Measuring
Customer
Monitoring satisfaction Analyzing
data
Improving
Define how data are used
8.4 ANALYSIS OF DATA

Determination, collection, and analysis of appropriate data are
required to demonstrate the suitability and effectiveness of
the quality management system and to evaluate where con-
tinual improvement can be made. This includes data gener-
ated as a result of monitoring and measurement and from
other relevant sources.
The analysis of data needs to address and provide infor-
mation relating to customer satisfaction (see clause 8.2.1);
conformity to service requirements (see clause 7.2.1); char-
acteristics and trends of processes and services, including
opportunities for preventive action (this includes virtually
every process in the quality management system and in
product realization); and information relating to suppliers.

Why Do It?
• To determine the suitability and effectiveness of the
quality management system
• To identify improvements that can be made to quality
management system effectiveness
• To encourage decision making based on fact
• To obtain value from the investment made to collect data
Implementation Tips
• Determine during planning how the data will
be used
• Consider the relative importance of the data
to be analyzed and scale the analysis effort
to the relative importance of the data
• View the requirements of clauses 5, 6, 7,
and 8 as linked in the sense that the orga-
nization should function on a closed-loop
basis, and data analysis should consider all
characteristics of processes
• Use information from the analysis of data as
part of the management review process
• Consider use of commercially available
software to alleviate the tedious aspects of
data analysis
• Focus data analysis on things important to
5 7 achieving the quality objectives; use trend
and Pareto charts

8.4 Analysis of Data 131
• Understand the information contained in the data; for

example:
■ Customers may be delighted even though the
service is nonconforming
■ Customers can be highly dissatisfied with service
that fully conforms to requirements
■ Identifying the things important to the customer
and causes of dissatisfaction offers an opportunity
to change requirements to reflect actual customer
needs
■ Understand the effects of variation; consider using
6 histograms
■ Don’t overlook the simple techniques

• Has the organization determined the appropriate data
to be collected?
• Does the organization analyze the appropriate data to
determine the suitability and effectiveness of the qual-
ity management system?
identify improvements that can be made?
provide information on customer satisfaction?
• Does the organization analyze the appropriate data
to provide information on conformance to service
requirements?


provide information on characteristics of processes,
services, and their trends?
provide information on suppliers?
8.5 IMPROVEMENT
8.5.1 CONTINUAL IMPROVEMENT

Continual improvement of the effectiveness of the quality
management system is required through the use of the quality
policy, quality objectives, audit results, analysis of data, cor-
rective and preventive actions, and management review.
Why Do It?
• To become more competitive
• To survive
• To operate more effectively
• To improve your ability to meet customer requirements
Implementation Tips
• Include in the quality policy a commitment to
12 continual improvement and teach everyone in the
organization the basics of improvement
• Set quality objectives with improvement in mind

8.5.2 Corrective Action 133
• Ensure that top management uses management

reviews to identify opportunities to improve the quality
management system and its processes
• Incorporate an improvement mentality into the internal
audit process
• Use corrective and preventive action as tools for
improvement of processes and services

• Does the organization plan and manage the processes
necessary for the continual improvement of the quality
management system and consider appropriate actions
related to improvement of services?
• Does the organization use quality policy, quality
objectives, and data analysis to facilitate the continual
improvement of the quality management system?
• Does the organization use audit results, corrective
action, and preventive action to facilitate the continual
improvement of the quality management system?
8.5.2 CORRECTIVE ACTION

Action is required to eliminate the causes of nonconformities
in order to prevent recurrence. This action is called corrective
action. Corrective actions should be appropriate for the effects
of the nonconformities encountered.

A documented procedure is required to define requirements

for reviewing nonconformities (including customer complaints),
determining the causes of nonconformities, evaluating the need
for action to ensure that nonconformities do not recur, deter-
mining and implementing action needed, recording the results
of action taken, and reviewing corrective action taken.
Why Do It?
• To learn from errors and mistakes that cause noncon-
formity, waste, or customer dissatisfaction
• To continually improve your quality management sys-
tem’s effectiveness in meeting customer requirements
and, where appropriate, your service offerings
• To avoid the costs that would be incurred if nonconfor-
mities continue
Implementation Tips
• Process mapping, Pareto analysis, brain-
1 2 storming, and flowcharting can be useful in
identifying problems that impact on meeting
3 7 quality objectives
• Evaluate the need to take corrective action
so that resources are devoted to the most
important problems; if the nonconformity is
minor and an isolated condition, the risks
or cost associated with taking corrective
action may not be justified; use Pareto
charts to help with establishing priorities

8.5.2 Corrective Action 135
• In some cases, action may be neither required nor

appropriate
• Use problem-solving techniques
11
• Use cause-and-effect diagrams or other tools to
10 determine causes
• Strive to “institutionalize” corrective action using
appropriate training, changes to documents,
follow-up, and internal audit
• Balance corrective actions taken with the nature of
the problem

• Does the organization take corrective action to elimi-
nate the causes of nonconformities?
• Is the corrective action taken appropriate to the impact
of the problems encountered?
• Do the documented procedures for corrective action
provide for identifying nonconformities, determining
causes, evaluating the need for actions to prevent
recurrence, determining the corrective action needed,
and implementing the needed corrective action?
provide for recording the results of corrective actions
taken?
provide for reviewing the corrective action taken?

8.5.3 PREVENTIVE ACTION

Action is required to eliminate the possible causes of poten-
tial nonconformities in order to prevent their occurrence. This
action is called preventive action.
Preventive action needs to be appropriate to the effects of
the potential problems.
A documented procedure is required to define require-
ments for how the organization will proceed to determine
potential nonconformities and their causes, to evaluate the
need for action to prevent occurrence of such potential non-
conformities, to determine and implement action needed, to
keep records of results of action taken, and to review the
effectiveness of the preventive action taken.
Why Do It?
• To identify the potential causes of problems so they
can be avoided rather than fixing them after they
happen
• To manage the risk of things going wrong
• To prevent potential problems that could have serious
consequences for you or your customers
Implementation Tips
• Make a sharp distinction in your system between cor-
rective action and preventive action

8.5.3 Preventive Action 137
• Process mapping and flowcharting can be

1 2 useful in identifying potential problems that
could impact on meeting quality objectives
• Identify those areas that the organization
will consider for preventive action
• Consider performing failure modes and
8 effects analysis (FMEA) in the design stage
for new services and new processes
• Consider fault tree analyses and potential
problem analysis
• Consider data analysis of other areas of the
organization to identify problems in one area
that may become problems elsewhere
• Review corrective actions to determine if
there is potential to apply lessons learned
from one nonconformity to prevent other
potential similar situations; ask “where else”
could a similar problem occur
• Use preventive action where it is most effec-
tive: during service and process design and
development

• Does the organization identify preventive actions
needed to eliminate the potential causes of possible
nonconformities?
• Is the preventive action taken appropriate to the impact
of potential problems?

• Do the documented procedures for preventive action

provide for identifying potential nonconformities and
their probable causes?
provide for determining the need for preventive action
and the implementation of the preventive action
needed?
provide for recording the results of the preventive
actions taken?
provide for reviewing the preventive action taken?

Chapter 4
Tools
TOOLS DISCUSSED IN THIS SECTION

This chapter outlines a limited number of tools commonly
used in the application of ISO 9001:2008 requirements to ser-
vice processes. The amount of detail included in the descrip-
tion of each tool is intentionally limited. For most of the tools
included, entire books are available that describe the tools
and their application in great detail. Our intent is to provide
an overview of (1) what it is, (2) where it is used, (3) how it
is done, and (4) cautions to be considered when using the
tool. Where appropriate, examples of the use of the tool are
also given. The user should consult appropriate texts for more
detailed information to ensure correct application in specific
situations.
139

140 Chapter Four Tools
The following tools are included in this section:
Tool Used with

number Tool ISO 9001:2008 clauses
1 Flowchart 4.1, 5.4.2, 7.1, 7.3.1,
7.5.1, 8.1, 8.5.2
2 Process mapping 4.1, 4.2.1, 5.4.2, 7.1, 8.1,
8.5.2, 8.5.3
3 Brainstorming 4.1, 5.3, 5.4.1, 8.5.2
4 Gantt chart 5.5.1, 7.3.1
5 Run or trend chart 5.6.2, 8.4
6 Histogram 5.6.2, 8.4
7 Pareto chart 5.6.2, 8.4, 8.5.2
8 Failure modes and effects 7.3.1, 7.3.3, 8.5.3
analysis
9 Sampling inspection 7.3.5, 7.3.6, 7.4.3, 7.5.1,
8.2.3, 8.2.4
10 Cause-and-effect diagram 8.5.2
11 Problem solving 8.5.2
12 How to conduct an All clauses
improvement project
TOOL 1: FLOWCHART
What Is It?
A flowchart is a picture of the actual flow or sequence of
events that occur in a process. Flowcharts can be at a “high

Tool 1: Flowchart 141
level,” showing only the major elements of a process or sys-

tem. They can also be very detailed, for example, showing the
specific steps in delivering a service to a customer.
An accurate flowchart can also be used to identify oppor-
tunities for improvements in processes.
Flowcharts typically use the following symbols:
Oval—begins or ends the process
Rectangle—activity or a step in the process
Diamond—decision point
Wait or delay symbol—hold or wait point

in the process
Flow line or arrow—shows the direction

of flow
Document—shows the need to create

a document or record
Note: Other symbols are often used for added clarity.
Where Is It Used?
Anywhere that processes exist, flowcharts can be considered
as a tool to understand the elements of the processes. Flow-
charts can be used to:
• Identify the interactions of the overall processes of the
quality management system (clause 4.1)

• Represent the steps in the service realization pro-

cesses of an organization (clause 7.5.1)
• Aid in developing plans for monitoring and measuring
(clause 8.1)
How Is It Done?
• Decide on the process to be flowcharted
• Identify the steps of the process (for example, use
brainstorming)
• Place the steps in order
• Draw the flowchart using the appropriate symbols (as
given earlier)
• Consider using the tools in Microsoft Word or Power-
Point to create flowcharts
• Connect the steps with arrows
• Verify the accuracy of the flowchart
• Validate the flowchart with individuals familiar with the
process
Cautions
Flowcharts can be made so complex (or so simple) that they are
useless. Care must be exercised when selecting the scope of
the process to be flowcharted—not too simple, not too complex,
not too much detail, not too little. Also, it is beneficial to involve
individuals with intimate knowledge of the process being flow-
charted to ensure that an accurate picture is created.

Tool 1: Flowchart 143
System-level corrective action

Review
Identification of Exceptions
measures that NO
nonconformance noted?
show exceptions
Review
YES process ends
NO
Document
Action review of
required? contract
YES measures
Corrective
action plan Corrective
developed and plan recorded
implemented
Review Keep
corrective records
action
Has corrective
action plan addressed
the cause of non- NO
YES conformance?
Document that Loop back

corrective action to review step
as taken has
addressed the
occurrence of
nonconformance
and archive

TOOL 2: PROCESS MAPPING
What Is It?
A process map describes a process in detail, considering the out-
puts from the process and the inputs to the process. It also visually
displays the value-adding steps in the process that convert the
inputs to the desired outputs. Process mapping is the flowchart-
ing of a work process in detail, including key measurements.
Process mapping
Flowchart + Measures
Process flowchart
Inputs Outputs
Identify: Identify:
tøSuppliers tøCustomers
tMeasures tMeasures
tTargets tTargets
Where Is It Used?
Process mapping is a tool to make certain that key processes
are designed in such a way that they focus on achieving the
desired outputs and objectives of the organization. The process
approach of ISO 9001:2008 includes the requirement to identify
and manage the processes of the quality management system
(see clauses 4.1 and 5.4.2). This includes focusing on the pro-
cesses that are most important to achieving the organization’s
quality objectives (see clauses 5.4.1 and 5.4.2). These key pro-

Tool 2: Process Mapping 145
cesses should not only be monitored by normal activities such

as supervision and audits but should also be measured.
How Is It Done?
For each key process:
Define Outputs and Inputs

• Identify customers and outputs of the process
• Identify the key measures of outputs and under-
stand how they align with the organization’s quality
objectives
• Identify the suppliers to the process
• Identify the key measures of inputs
• For each measure of input or output:
■ Determine current performance
■ Determine the goal or target
Flowchart the Process

Use the flowchart tool (see tool 1) to show the process as it is.
Do not make changes. It is very important to understand the
current process to understand the causes of gaps between
the target and current results. Add the inputs, outputs, and
measures to the flowchart.
Analyze the Flowchart

Once an accurate as-is representation of the process is cre-
ated, study the flowchart to determine areas to consider for

improvement. Focus on changes that will improve the pro-

cess performance relative to targets and quality objectives.
Examples of things to look for include:
• Obvious process disconnects such as outputs that
go to the wrong place, obvious missing processing
steps, or obvious redundancies. For example, work
instructions are routinely misrouted because the
distribution list has an error. Consider actions to
address issues, for example, changing the routing
of misdirected outputs, introducing needed new
steps, eliminating redundant steps, and reallocating
resources. In this example, the only action needed
may be to correct the distribution list and provide a
means to keep it up to date.
• Process has individual activities with problems, so the
overall process does not meet targets, is not effective
in meeting quality objectives, or is not efficient—for
example, an auto service process that requires the
service person to wait for delivery of service parts
from the parts department. For such a circumstance,
one could identify problems and root causes, develop
and implement actions to correct the causes, and
measure improvements. If necessary, gather, record,
and analyze data on these activities. In this example
you may need to analyze the response time from
when a part is requested by a service mechanic to
when the part is provided.
• Process fails to meet target, but results are stable with
no clear problems. For example, the process is stable
and most activities seem OK, but the results do not

Tool 2: Process Mapping 147
meet the target or the process has never met expecta-

tions. For example, the completion of a change to the
benefits selection in a benefits process may have a
cycle time of several weeks due to time required to
perform multiple eligibility cross-checks. If the pro-
cess exhibits characteristics such as these, consider
reengineering the process using a “clean sheet”
approach with out-of-the-box thinking or the applica-
tion of new technology. In this example, perhaps a
new computer program could be created.
• Opportunities for preventive action. In investigat-
ing opportunities for preventive action, one could
ask, “what could go wrong?” and apply preventive
measures as appropriate. For example, you could
prevent customer service representatives from provid-
ing erroneous information by including answers in the
customer service computer system.
Revise the Process Map, Implement, and Audit

The next step is to revise the map and its flowchart. Ensure
that those involved in the process are aware of the changes.
Audit the process to ensure ongoing implementation of the
changes.
Cautions
Be careful to identify the key processes when constructing a
process map, and to focus the most effort on improving those
areas that are important to meeting your objectives. Flex-
ibility is also important; remember that processes that were
unimportant yesterday may be critical to success tomorrow.

TOOL 3: BRAINSTORMING
What Is It?
Brainstorming is a disciplined process used with small groups
of people to get ideas. It is often combined with other tech-
niques to accomplish limited analysis of the ideas generated
and to achieve group consensus. One extension of the brain-
storming concept is often called the nominal group technique,
which was developed in the 1960s by André P. J. Delbecq and
Andrew H. Van de Ven.
Where Is It Used?
The technique is used in small groups when it is desired to
generate a number of ideas that can be used to achieve the
group’s objectives. Some examples of situations where a
group may wish to use the technique include:
• Determining and prioritizing objectives
• Defining potential problems when looking for preven-
tive action opportunities
• Identifying potential causes of known or potential
problems
• Defining potential corrective or preventive actions
How Is It Done?
The technique is often performed with the aid of a facilitator
to keep the group on track and to ensure that the discipline
of the process is maintained. It may be considered to have

Tool 3: Brainstorming 149
five phases: defining the issue, listing alternatives, sorting and

combining, clarifying, and developing consensus on priorities.
Phase Activities
Defining the 1. Prepare a clear written description of the
issue issue
Listing 1. Each group member silently lists the alter-
alternatives natives he or she can think of
2. Go around the group and list one item from
each participant; continue until all items are
listed; list each item without challenge
Sorting and 1. Combine items where appropriate
combining 2. If the number of items is large, sort them
into logical groups
Clarifying 1. Discuss the items and ensure each is clear
2. Write a concise description of each item or
group of items
Developing 1. Each group member ranks the items
consensus 2. Rankings are tabulated
3. Results are summarized and reviewed by
the group, with emphasis on items where
there is strong consensus
Cautions
It is important that the objective of the session be clear to all
participants. Lack of clarity may cause the process to get off
subject. During the development of alternatives, each member
of the group must be permitted to list items without discus-
sion or challenge. Discussion needs to be deferred until the
clarification phase. The most timidly presented idea may well
be the most important.

TOOL 4: GANTT CHART
What Is It?
A Gantt chart is a tool for scheduling a series of tasks or
events. It lists tasks to be completed on the vertical axis and
time on the horizontal axis. It is a tool for clearly illustrating
project or program elements or tasks and the amount of time
anticipated for completing each. Gantt charts are named for
Henry Gantt, an American engineer and social scientist, who
developed this tool for use in production management.
Where Is It Used?
Gantt charts are used in many places in the development,
deployment, and operation of a quality management system.
Some examples include:
• Planning the transition to ISO 9001:2008
• Monitoring and controlling an internal audit program
• Structuring an improvement project
• Managing corrective action projects
• Coordinating and tracking the activities of a new
service design and development project
How Is It Done?
A Gantt chart is constructed with a horizontal axis represent-
ing time and a vertical axis showing the tasks or events or
activities associated with the project or program. Horizontal

Responsibility Task to be completed Month
1 2 3 4 5 6 7 8 9 10 11 12
Top management team 1 Define/clarify organizational
responsibilities and interfaces
Top management team 2 Define objectives and quality
policy
Implementation team 3 Conduct gap analysis against
ISO 9001:2008
Implementation team 4 Identify processes of the QMS
Implementation team 5 Map processes and draft
necessary procedures
Management 6 Circulate draft copy of proce-
representative dures for review/comment
Implementation team 7 Finalize procedures after staff
agreement
Tool 4: Gantt Chart
Gantt chart to achieve ISO 9001 compliance. (Continued )

151
11/11/09 12:59:55 PM
152
Responsibility Task to be completed Month
Management 8 Release ISO 9001:2008–
representative compliant QA documentation
Chapter Four Tools
As assigned 9 Implement system throughout

organization
QA manager 10 Internal audit of implementa-
tion effectiveness
Implementation team 11 Corrective action including final-
ization of QA documentation
QA manager 12 Pre-audit
Registrar 13 ISO certification audit
Gantt chart to achieve ISO 9001 compliance (continued).
11/11/09 12:59:55 PM
Tool 5: Run or Trend Chart 153
bars are drawn beside each task (event/activity), representing

the sequence and time span for each task. The spans of the
bars may overlap if one or more tasks are expected to occur
at the same time. Some Gantt charts become elaborate via
adding secondary bars and arrows to denote progress, partial
completion, and reporting dates.
Cautions
Gantt charts do not indicate task interdependencies. One can-
not tell from a Gantt chart the impact of a delay in one task
on other tasks. To address such issues, tools such as program
evaluation and review technique (PERT) charts or the critical
path method (CPM) could be used.
TOOL 5: RUN OR TREND CHART
What Is It?
A run or trend chart is a graphical method for displaying data
to show changes over time.
Success %
protocol “A”
Up is good
Trend
Time
Run chart for treatment success in a hospital

Order to delivery
Down is good
in minutes
Trend
Time
Run chart for meal delivery time in a restaurant
Where Is It Used?
Run charts are often used to track trends in service character-
istics such as time, customer reactions, or problems encoun-
tered. They can be used anytime it is desirable to visualize
trends over time. Some common uses include:
• Trending time to accomplish service tasks
• Trending nonconformities in performing services
• Trending service process performance
• Trending supplier performance
How Is It Done?
Any single set of data may be charted over time.
• Select the time period (hour, day, week, month, and so
on). This is the horizontal axis of your chart.
• Select a scale for the vertical axis.
• Collect the data for each time period and plot.

Run chart for call length in sequence of calls received
Length of calls in order answered – CSR #83
Run chart
No. of Length of call
occurrences (minutes)
0 17.384
0 17.383
1 17.382 X
3 17.381 X X X
4 17.38 X X X X
7 17.379 X XX X X X X
10 17.378 X X X X XXX X X X
8 17.377 X X X X XX X X
6 17.376 X X X X X X
5 17.375 X X X X X
4 17.374 X X X X
2 17.373 X X
0 17.372
Tool 5: Run or Trend Chart
0 17.371
155
11/11/09 12:59:56 PM
Run charts are easy to prepare using the graphical tools of most
spreadsheet software programs. Run charts are often combined
with Pareto charts and histograms for analytical purposes. For
example, a run chart may be used to show a trend in service
nonconformities or customer dissatisfaction, and an associated
Pareto chart may show the types of service problems encoun-
tered. The data from a run chart of service measurement data
(such as call length) may be analyzed using a histogram. The
same data from the example of the run chart for call length are
used in the illustration of the histogram tool (tool 6).
Cautions
Be careful in selecting the time period and vertical scales. Too
small a vertical scale can give the appearance of big changes
in otherwise stable results. Too large a vertical scale can hide
significant changes. If the time interval is selected incorrectly,
similar distortions may occur.
TOOL 6: HISTOGRAM
What Is It?
A histogram is a graphical display of the pattern of variation
of a set of data.
Where Is It Used?
Histograms can be used to develop theories about a process.
They can also be used to determine whether improvements
have occurred in process performance after corrective action
was implemented. In addition, they can provide a picture of

Tool 6: Histogram 157
Histogram
20
Number of occurrences
16
12
0
5–6 7–8 9–10 11–12 13–14 15–16 >16
Call length
Note: The data in this example are the same as were used in the run
chart tool example.
the degree of dispersion of the elements or events occurring

in a process. They can be excellent tools to perform root cause
analysis.
How Is It Done?
Assuming a set of data exists, a histogram can be constructed
according to the following general methodology:
• Determine the number of data points in the set of data
• Determine the range of the data (the highest value in
the set minus the lowest value)
• Construct a worksheet to tally the data, marking an X
for each occurrence of each value (the example shown
uses the data from the run chart tool example)

158
Worksheet
Target range Number of calls Cell Histogram worksheet

Number of occurrences
Chapter Four Tools
12
16 X
4
15 X X X
14 X X X X
11
13 X X X X X X X
12 X X X X X X X X X X
18
11 X X X X X X X X
Minutes
9
10 X X X X X X
11
9 X X X X X
8 X X X X
6
7 X X
11/11/09 12:59:56 PM
Tool 6: Histogram 159
• Decide on the number of cells or classes of data you

desire in the histogram; Joseph M. Juran developed
guidelines for cells vs. data points as follows:
■ 40–50: 6 cells
■ 51–100: 7 cells
■ 101–200: 8 cells
■ 201–500: 9 cells
■ 501 and up: 10 cells
• Determine the size or width of each cell by dividing
the range by the number of cells and rounding to a
convenient number; be sure that every data point falls
into only one cell
• Mark the cell boundaries on the worksheet, starting with
a cell that will include the smallest data point and finish-
ing with a cell that will include the largest data point
• Determine the number of data points in each cell by
counting the number of X marks on your worksheet
• Plot the data on graph paper by indicating the cell
width on one axis and the number of data points in
each cell on the other axis
• Label the horizontal and vertical axes, and place a title
on the histogram
Cautions
Be sure that the sample size is adequate to characterize
the process (that is, do not make decisions on a set of data

that is too small) and that the data points are represen-
tative of steady-state process performance. Also, become
familiar with the patterns of variation that can be observed
in histograms (normal, skewed, truncated, bimodal, and so
on) and the implications of such patterns. It is also gener-
ally true that histograms will not detect small differences
in variability.
TOOL 7: PARETO CHART
What Is It?
The Pareto chart is used to show the frequency of occurrence
of related sets of data.
70
60
Number of problems
50
40
30
20 A B C D E F
10
0
Types of call center problems (March)
A Put caller on hold D Call longer than 20 minutes
B Problem not resolved E Abandoned
C Had to call back F Caller redirected

Tool 7: Pareto Chart 161
Where Is It Used?
Pareto charts are often used for analytical purposes to identify
the most important or most frequently occurring problems or
opportunities for improvement. They are also useful in display-
ing data so that others can understand priorities. Examples of
uses for the Pareto chart include:
• Analysis of the types of problems found in a service
activity over a given period of time
• Analysis of causes of a particular problem
• Analysis of the cost of various problems
• Prioritization of opportunities to improve a process
How Is It Done?
The Pareto chart is based on the idea that in many cases, a
small number of causes account for a large fraction of the
problems (sometimes called the 80-20 rule, meaning that
80% of the nonconformities come from 20% of the causes of
the nonconformities).
To prepare the chart, simply define the appropriate cate-
gories (for example, types of problems) and count the number
of each for the period or activity under consideration. Select
a scale for the vertical axis of the graph that will best display
the data.
Cautions
Use care in selecting the types of problems and how you
quantify them. In using the data to make decisions, remember

that a Pareto chart that gives frequency of occurrence does

not show criticality or cost. If cost or criticality is more impor-
tant than frequency of occurrence, a second Pareto chart with,
for example, the cost data can be prepared to bring that per-
spective to the decision-making process.
TOOL 8: FAILURE MODES AND

EFFECTS ANALYSIS
What Is It?
Failure modes and effects analysis (FMEA) is a technique for
studying the causes and effects of failures before they occur.
There are two common variations of FMEA: FMEA for products
or services provided, and FMEA for the processes that cre-
ate the product or deliver the services. It is very common to
include not only an analysis of the potential failure modes and
their effects but also the criticality of potential failure modes.
When criticality is included, the process is normally termed
FMECA—failure mode, effects, and criticality analysis.
Where Is It Used?
This technique is usually performed during product design
and development (clause 7.3) and during process develop-
ment (clause 7.5.1). Since FMEA is one of the most important
tools for preventing failures from occurring, its use should be
an element of the preventive action process (clause 8.5.3).
FMEA is most often applied to hardware products and
systems, but the concept can be effectively applied to ser-
vice, especially during the design phase of a new service. The

Function Cause(s) of
Part/ of part/ Potential potential
Severity
Probability of
occurrence
Detectability
Risk priority
process process failure mode Effect failure Action to be taken
Driver Find Cannot find Irate No maps or 9 5 10 450 Provide maps, GPS,
stranded motorist customer GPS; poor and computer with
motorist operator map program
within one training
hour
Truck Full towing Equipment Cannot tow Failure of 8 4 9 288 Preventive mainte-
capability failure car hydraulics or nance schedule
mechanical
systems
Equipment Meters, Air compres- Cannot No PM; no 7 3 7 147 Individual “throw-
hand tools, sor test repair flat periodic away” air canisters;
air com- equipment tire checks equipment
pressor malfunction checklist
Supplies Gas, lug No gas on Cannot Operator does 6 3 6 108 Prepare a checklist
nuts truck; no solve not check sup- for use at beginning
spare fuses; problem plies before of each call
Tool 8: Failure Modes and Effects Analysis
no aspirin each call
New 24-hour road service FMEA.

163
11/11/09 12:59:56 PM
thought process is the same whether addressing hardware

or service.
How Is It Done?
Typically during the design phase of a product development
project, a designer or a team examines the service or system
being designed and considers all the ways that failure could
occur. Block diagrams are frequently used. During develop-
ment of new processes, process engineers often use a similar
thought process. In either case, each potential failure is listed
in an FMEA table and analyzed:
• For each potential failure, the possible failure modes
are listed
• For each failure mode, a description is developed for
each potential effect that such a failure could have
• For each potential failure, an estimate (on a scale of
1 to 10, with 10 being the worst) is made of severity,
probability (or frequency) of occurrence, and detect-
ability (ability to detect the potential cause and prevent
the failure)
• The rankings are multiplied to give a risk priority
number (RPN) that can be used to prioritize preventive
actions
Usually an evaluation is made of the potential failure modes,
and actions are considered to prevent the occurrence or to
minimize the impact of potential failures with the highest
priority.

Tool 9: Sampling Inspection 165
Cautions
FMEAs can become very cumbersome if every single element
of large systems or subsystems is considered. Care must be
taken to control the scope of the FMEA while retaining its
integrity. Also, information from an FMEA can often be useful
to other activities in an organization. FMEA outputs should be
shared with organizations performing related duties. Process
FMEA results should be shared with organizations that will
operate and maintain the processes.
TOOL 9: SAMPLING INSPECTION
What Is It?
Sampling inspection is defined in ANSI/ISO/ASQ A3534-2-2006
as “inspection of selected items in the group under consider-
ation” (as distinct from 100% inspection).
The table on the following page lists several International
Standards that describe general sampling concepts and the
terminology involved.
Where Is It Used?
Sampling inspection may be used for many purposes when
delivering services. Examples include:
• Sampling of file content where many files are
processed by several workers and files are required
to contain numerous documents (for example, birth
certificates, proof of employment)

Topic Document Document title

Introduction ANSI/ASQ S2- Introduction to Attribute
to sampling 1995 Sampling
Selection ISO/TR 8550- Guidance on the selection
and use of 1:2007 and usage of acceptance
sampling sampling systems for in-
standards spection of discrete items
in lots—Part 1: Acceptance
sampling
ISO/TR 8550- Guidance on the selection
2:2007 and usage of acceptance
sampling systems for
inspection of discrete items
in lots—Part 2: Sampling by
attributes
ISO/TR 8550- Guidance on the selection
3:2007 and usage of acceptance
sampling systems for
inspection of discrete items
in lots—Part 3: Sampling by
variables
Sampling ISO 3534-1:2006 Statistics—Vocabulary and
terminology Symbols—Part 1: General
statistical terms and terms
used in probability
ISO 3534-2:2006 Statistics—Vocabulary and
Symbols—Part 2: Applied
statistics
ISO documents explaining selection and terminology related

to statistical sampling.

• Sampling of employer satisfaction for a personnel

placement organization
• Sampling of customers to assess customer satisfaction
or salesperson effectiveness
How Is It Done?
There are many documents available that provide instruc-
tions for sampling inspection. There has been a wide variety
of sampling plans developed that can be used when working
with the numerous conditions found in actual application.
The table on pages 168–171 lists some of the national
standards and International Standards available. The most
commonly used sampling plans are those from ANSI/ASQ Z1.4
and Z1.9 (and their international counterparts, the ISO 2859
series and the ISO 3951 series).
The ANSI/ASQ documents are available from ASQ Quality
Press (http://www.asq.org/quality-press). A number of the ISO
documents are available in U.S. adoption form (designated
ANSI/ISO/ASQ), also available from Quality Press. Quality Press
also sells some of the ISO versions, or they may be ordered
from ANSI (http://www.ansi.org) or ISO (http://www.iso.org).
Where there are contractual, regulatory, or other require-
ments giving sampling inspection requirements, these must
be followed. Where there are no such requirements, refer-
ence to national standards or International Standards may be
appropriate. There are a number of different sampling strate-
gies, and selecting among them depends on application.
The table showing ISO statistical sampling standards
gives some of the simplest options available in national

Type of
sampling Document Document title
Attributes ANSI/ASQ Z1.4-2008 Sampling Procedures and
sampling Tables for Inspection by
Attributes
ISO 2859-1:1999 with Sampling procedures for
Corrigendum 1:2001 inspection by attributes—
Part 1: Sampling schemes
indexed by acceptance
quality limit (AQL) for lot-
by-lot inspection
ISO 2859-2:1985 Sampling procedures for
inspection by attributes—
Part 2: Sampling plans
indexed by limiting
quality (LQ) for isolated lot
inspection
Part 3: Skip-lot sampling
procedures
Part 4: Procedures for
assessment of declared
quality levels
Replaces Annex A of Part 5: System of
ISO 8422:1991 sequential sampling plans
indexed by acceptance
quality limit (AQL) for lot-
by-lot inspection
Some of the ISO statistical sampling standards.


Part 10: Introduction to
the ISO 2859 series of
standards for sampling for
inspection by attributes
Attributes ISO 13448-1:2005 Acceptance sampling
sampling procedures based on the
(allocation allocation of priorities
of priorities) principles (APP)—
Part 1: Guidelines to the
APP approach
ISO 13448-2:2004 Acceptance sampling
procedures based on the
allocation of priorities
principles (APP)—Part 2:
Coordinated single sam-
pling plans for acceptance
sampling by attributes
Attributes ISO 14560:2004 Acceptance sampling
sampling procedures by attributes—
(PPM) Specified quality levels in
nonconforming items per
million
Attributes ISO 18414:2006 Acceptance sampling
sampling procedures by attributes—
(accept Accept-zero sampling
zero) system based on credit
principle for controlling
outgoing quality
ISO 21247:2005 Combined accept-zero
sampling systems and pro-
cess control procedures for
product acceptance
( Continued )

Type of
sampling Document Document title
Attributes ISO 8422:2006 Sequential sampling plans
sampling for inspection by attributes
(sequential)
Variables ANSI/ASQ Z1.9- Sampling Procedures
sampling 2008 and Tables for Inspection
by Variables for Percent
Nonconforming
ISO 3951-1:2005 Sampling procedure for in-
spection by variables—Part
1: Specification for single
sampling plans indexed
by acceptance quality
limit (AQL) for lot-by-lot
inspection for a single
quality characteristic and a
single AQL
ISO 3951-2:2006 Sampling procedures for in-
and 3951-2/PRF spection by variables—Part
and 1 2: General specification for
single sampling plans in-
dexed by acceptance qual-
ity limit (AQL) for lot-by-lot
inspection of independent
quality characteristics
inspection by variables—
Part 3: Double sampling
schemes indexed by ac-
ceptance quality limit (AQL)
for lot-by-lot inspection
Some of the ISO statistical sampling standards (continued).

ISO/WD 3951-4 Sampling procedures for

(Working draft avail- inspection by variables—
able from ISO) Part 4: Procedures for
assessment of declared
quality levels
inspection by variables—
Part 5: Sequential
sampling plans indexed by
acceptance quality limit
(AQL) for inspection by
variables (known standard
deviation)
Variables ISO 8423:2008 Sequential sampling plans
sampling for inspection by variables
(sequential) for percent nonconform-
ing (known standard
deviation)
Sampling 11648-1:2003 Statistical aspects of sam-
of bulk pling for bulk materials—
materials Part 1: General principles
11648-2:2001 Statistical aspects of sam-
pling for bulk materials—
Part 2: Sampling of
particulate materials

standards and International Standards. Many other sources

of sampling plans exist. The required standard for sampling
on a project or contract may be specified in a purchase order
or in a contract.
Cautions
If you work under contracts or regulations, be certain to check
those documents for applicable requirements. In addition,
there are many specialized applications, and care should
always be exercised in the selection and use of sampling
plans to ensure that the plan selected is appropriate for the
circumstances.
TOOL 10: CAUSE-AND-EFFECT DIAGRAM

(FISHBONE/ISHIKAWA DIAGRAM)
What Is It?
A cause-and-effect diagram shows the relationship between
a characteristic or an effect of a process and its potential
cause factors. The cause factors are organized into categories
and displayed on a diagram. The purpose of the diagram is to
facilitate the thinking about a process and how to control the
significant cause factors so that the desired effect or result
is obtained.
The cause-and-effect diagram was created by Dr. Kaoru
Ishikawa and is sometimes called an Ishikawa diagram. It is
also sometimes called a fishbone diagram since, when it is
drawn, it resembles the skeleton of a fish.

Materials Machines Methods
System slow
Database Must use No performance measures
not updated several
System down
screens to
Answers not available get answers Effect
to customer rep Obsolete software
Callers get
wrong answers
Data not broken down Training to questions
by type of problem
Too few supervisory checks Experience
Measurements Man
Tool 10: Cause-and-Effect Diagram (Fishbone/Ishikawa Diagram)
173
11/11/09 12:59:56 PM
Where Is It Used?
Cause-and-effect diagrams are frequently used in problem
solving. They can be used anywhere it is desired to under-
stand the cause factors or characteristics that influence the
outcome of a process. For example, they could be used when
performing corrective action when a service delivery process
is causing customer dissatisfaction, when trying to under-
stand the root cause of a customer complaint, or when refin-
ing a service delivery process to improve efficiency.
How Is It Done?
• Step 1: Clearly identify the effect or characteristic of
the process you desire to study, or in other words,
what is the problem you desire to analyze?
• Step 2: Identify the major cause factors that contribute
to or influence the effect; in a “classic” cause-and-
effect diagram, the major cause factors are catego-
rized as:
■ Materials
■ Machines
■ Measurements
■ Methods
■ Man (that is, the people working in the process)
• Step 3: Construct the diagram by positioning the
effect in a box on the right side of a piece of paper
or on a computer screen and drawing a horizontal

Tool 10: Cause-and-Effect Diagram (Fishbone/Ishikawa Diagram) 175
arrow from the left to this box. Then insert branches

above and below the horizontal arrow that feed into
the horizontal arrow (see earlier figure) to indicate
significant cause factors in the categories indicated
in step 2.
• Step 4: Develop the diagram by thinking through the
significant cause factors for each category in step 2
and adding or modifying the cause factors.
• Step 5: Discuss the possible cause factors and decide
what actions are appropriate to improve process
performance.
• Step 6: Implement appropriate corrective or preventive
actions and perform follow-up evaluations to ensure
that results are compatible with expectations.
• Step 7: Institutionalize process improvements via
documentation, training, and audit.
Cautions
The quality of the analysis of causes is only as good as the
thinking of the individuals doing the analysis, so it is impor-
tant to involve all the individuals who can contribute to the
identification of potential causes. In the call center example
given earlier, for example, it may be appropriate to have cus-
tomer service representatives, a quality facilitator, information
technology personnel, telephone system personnel, and call
center supervisors involved in an analysis of possible causes
of the problem.

TOOL 11: PROBLEM SOLVING
What Is It?
Defining and solving problems is a key component of con-
tinual improvement. A problem can be broadly defined as “any
undesired state.” With regard to ISO 9001:2008 requirements,
it is useful to consider the direct link between the concepts of
corrective action (correcting the causes of nonconformities)
and problem solving (correcting the causes of problems).
Where Is It Used?
Problem-solving techniques are generally appropriate:
• To correct causes of nonconformities in service delivery
• To address and correct causes of customer complaints
• To address and correct situations that dissatisfy
customers
• To address issues that negatively impact internal
customers
• To improve processes
How Is It Done?
Perhaps the most important step in problem solving is to
address the correct problems. You should first prioritize the
problems you face (Pareto charts may help).
Once a high-priority problem has been identified, use a
disciplined approach to solve it. The problem-solving con-
cept can be described in many ways. It can be generalized as
shown in the following table:

Tool 11: Problem Solving 177
Analysis • Identify and define the problem

• Develop measurements or obtain data to under-
stand the current situation and for later use in
determining the extent to which the problem has
been solved (trend charts may be of use in track-
ing progress)
• Perform analysis to identify causes of the prob-
lem; tools such as run charts, scatter plots, and
cause-and-effect diagrams may be useful
• Prioritize potential causes—problems often have
more than one cause (Pareto analysis may help)
• Develop potential solutions of the important
cause(s)
• Develop and analyze potential solutions and
select the one(s) most likely to solve or reduce
the problem
Action • Implement the solution(s)
• Implementing solutions means change—manage
the change properly
• If the change is large, consider a pilot implemen-
tation
Measure • Consider the feasibility of determining if you can
results “turn the problem off and back on” by alternately
applying and withdrawing the solution(s)
• Measure the results to determine how much
progress has been made
Institution- • If the problem has been solved or sufficient
alize progress made, take action to ensure the solution
is permanent:
—Change the documentation
—Train personnel
—Audit to ensure ongoing effectiveness of the
solution
• If the problem is still significant, return to analysis

Cautions
Problems come in many forms, and it may be appropriate
to use tools and problem-solving sequences different from
those described here. Organizations should consider provid-
ing training and facilitation for the process. The first and last
steps are often the most important but the least often done
well. Clearly defining the important problems and institution-
alizing the changes required for effective solution are critical
elements of effective problem solving.
TOOL 12: HOW TO CONDUCT AN

IMPROVEMENT PROJECT
What Is It?
When an organization is implementing a quality manage-
ment system in conformity with ISO 9001:2008, it is diffi-
cult not to be directed to improvement of the organization’s
processes, products, and services. In spite of the continual
need for improvement, it is not uncommon for organizations
to have no defined methodology for addressing improvement
opportunities.
There are several forms of improvement an organization
should consider, ranging from systemwide improvement of the
overall quality management system or any of its processes to
local improvement of individual processes that are producing
results that do not meet requirements.
This tool is focused on providing a simple model to guide
the improvement of individual processes for which the results

Tool 12: How to Conduct an Improvement Project 179
are not meeting requirements or expectations. This tool is

intended for use by anyone in an organization.
Where Is It Used?
Improvement projects can be initiated in virtually any area of
an organization.
Typical examples include projects to:
• Eliminate waste
• Improve customer satisfaction
• Eliminate billing errors
• Reduce customer complaints
• Increase customer service rate
• Improve acceptance rate of purchased material
How Is It Done?
This tool requires no special training other than a willingness
to invest energy into addressing each of the seven simple
activities. It provides a structure for addressing a wide variety
of conditions where improvement is needed. It also encour-
ages pursuit of meaningful corrective action rather than reac-
tive correction of undesirable conditions. This model provides
an opportunity to use many of the other tools presented in
this chapter. It is not the only model that an organization can
adopt to guide improvement initiatives, but if no other model
or procedure exists, this is a good starting point.

The activities we propose are as follows:

• Activity 1: Determine project charter or project defini-
tion (that is, what you are going to do)
• Activity 2: Describe current state
• Activity 3: Determine root causes
• Activity 4: Consider possible solution options and select
the most promising for implementation
• Activity 5: Implement solutions
• Activity 6: Evaluate solutions
• Activity 7: Standardize solutions
Current Root Develop

Charter
state causes solutions
Implement Evaluate Standardize

solutions solutions solutions
Let us consider application of this model in an example.

Situation: The placement staff of a personnel agency
has a goal to achieve 20 job placements each week
for its clients. For the last several months, the
agency staff has been averaging 14 job placements
each week. Management wants to improve place-
ment performance.

Tool 12: How to Conduct an Improvement Project 181
The model can be applied to this issue as follows:

• Activity 1: Determine project charter. This could be
as simple as stating that an improvement team will
identify and deploy actions to increase the weekly
placement average to 20 from the current level of 14.
• Activity 2: Describe current state. Currently, perfor-
mance has been steady at 14 per week for the past
several months, and the agreed goal is 20 placements
per week.
• Activity 3: Determine root causes. After analysis of
placement data for the past six months, the improve-
ment team agreed that there were three primary
issues negatively impacting placement rate—issue A,
issue B, and issue C.
• Activity 4: Develop solutions. After brainstorming many
possible actions to address the root causes of the
lower than goal level of placements, it was decided to
implement three new processes to attempt to improve
placement performance—process E, process F, and
process G, along with a measurement system to track
the effectiveness of the newly implemented processes.
• Activity 5: Implement solutions. Introduction of new
or modified processes should include consideration
of appropriate documentation and training to ensure
competent and consistent implementation.
• Activity 6: Evaluate solutions. After three months
of implementation, the effectiveness of the newly

implemented processes is evaluated and measured by

review of the graphs of actual placements compared
with the goal and the performance during the preced-
ing time period. In addition to graphs of the overall
group performance, the improvement team can review
the performance of each individual.
• Activity 7: Standardize solutions. After evaluation of
the effectiveness of the newly implemented processes,
the processes that have had a favorable impact are
“institutionalized” by providing the documentation and
training needed to ensure consistent implementation in
the organization.
This is a simplified example of how a systematic approach
to improvement can be applied to many of the product or
service-delivery-related processes in an organization.
Cautions
When organizations encounter processes that are not yielding
expected results, it is not uncommon to leap into attempting
to correct the perceived issues without understanding if the
process is capable of meeting requirements or determining
the root causes of deviation from requirements or expec-
tations. Such correction attempts may yield a “quick fix”
but typically do not result in sustainable improvement. The
approach described earlier is designed to yield sustainable
improvement.

Glossary
The terms in italic are direct quotations from ANSI/ISO/ASQ

Q9000-2005. Used with permission.
A
analytical thinking: breaking down a problem or situation
into discrete parts to understand how each part contrib-
utes to the whole.
AS9100: a standard for the aeronautics industry embracing
the ISO 9001 standard.
assignable cause: (see special causes).
audit: systematic, independent and documented process for
obtaining audit evidence and evaluating it objectively to
determine the extent to which audit criteria are fulfilled.
audit criteria: set of policies, procedures or requirements.
audit evidence: records, statements of fact or other informa-
tion which are relevant to the audit criteria and verifiable.
183

184 Glossary
audit team: one or more auditors conducting an audit, sup-

ported if needed by technical experts.
auditor: person with the demonstrated personal attributes
and competence to conduct an audit.
B
balanced scorecard: translates an organization’s mission
and strategy into a comprehensive set of performance
measures to provide a basis for strategic measurement
and management, utilizing four balanced views: financial,
customer, internal business processes, and learning and
growth.
benchmarking: an improvement process in which a company
measures its performance against that of best-in-class
companies (or others that are good performers), deter-
mines how those companies achieved their performance
levels, and uses the information to improve its own per-
formance. Areas that can be benchmarked include strate-
gies, operations, processes, and procedures.
brainstorming: a problem-solving tool that teams use to
generate as many ideas as possible that are related to
a particular subject. Team members begin by offering all
their ideas; the ideas are not discussed or reviewed until
after the brainstorming session.
breakthrough: a method of solving chronic problems that
result from the effective execution of a strategy designed
to reach the next level of quality. Such change often requires
a paradigm shift within the organization.

Glossary 185
C
checklist: a tool used to ensure that all important steps or
actions in an operation have been taken. Checklists con-
tain items that are important or relevant to an issue or
situation. Checklists are often confused with check sheets
and data sheets.
competence: (audit) demonstrated personal attributes and
demonstrated ability to apply knowledge and skills.
conformity: fulfillment of a requirement.
continual improvement: recurring activity to increase the
ability to fulfill requirements.
contract review: systematic activities carried out by an
organization before agreeing to a contract, to ensure
that requirements for quality are adequately defined, free
from ambiguity, documented, and can be realized by the
supplier.
control plan: a document that may include the characteris-
tics for quality of a product or service, measurements, and
methods of control.
correction: action to eliminate a detected nonconformity.
corrective action: action to eliminate the cause of a detected
nonconformity or other undesirable situation.
customer: organization or person that receives a product.
customer relationship management (CRM): refers to an
organization’s knowledge of its customers’ unique require-
ments and expectations, and using the information to

186 Glossary
develop a closer and more profitable link to business pro-

cesses and strategies.
customer satisfaction: customer’s perception of the degree
to which the customer’s requirements have been fulfilled.
customer service: the activities of dealing with customer
questions; also sometimes the department that takes cus-
tomer orders or provides postdelivery services.
customer value: the market-perceived quality adjusted for
the relative price of a product.
D
data: facts presented in descriptive, numeric, or graphic form.
deployment: (to spread around) the activities associated with
preparing to implement plans or take action.
design and development: set of processes that transforms
requirements into specified characteristics or into the
specification of a product, process or system.
design of experiments (DOE): a branch of applied statistics
dealing with planning, conducting, analyzing, and inter-
preting controlled tests to evaluate the factors that control
the value of a parameter or group of parameters.
disposition of nonconformity: action taken to deal with an
existing nonconformity; action may include repair, rework,
regrade, scrap, obtain a concession, or amendment of a
requirement. (See also correction.)

Glossary 187
dissatisfiers: those features or functions that the customer or

employee has come to expect, and if they were no longer
present, customer dissatisfaction would result.
document: information and its supporting medium.
E
effectiveness: extent to which planned activities are realized
and planned results achieved.
efficiency: relationship between the result achieved and the
resources used.
eighty-twenty (80-20) rule: a term referring to the Pareto
principle, which suggests that most effects come from
relatively few causes; that is, 80 percent of the effects
come from 20 percent of the possible causes.
F
force-field analysis: a technique for analyzing the forces that
aid or hinder an organization in reaching an objective.
G
gage repeatability and reproducibility (GR&R): the evalu-
ation of a gauging instrument’s accuracy by determining
whether the measurements taken with it are repeatable
(that is, there is close agreement among a number of
consecutive measurements of the output for the same
value of the input under the same operating conditions)

188 Glossary
and reproducible (that is, there is close agreement among

repeated measurements of the output for the same value
of input made under the same operating conditions over
a period of time).
gap analysis: a technique that compares a company’s exist-
ing state with its desired state (as expressed by its long-
term plans) to help determine what needs to be done to
remove or minimize the gap.
I
information: meaningful data.
infrastructure: system of facilities, equipment and services
needed for the operation of an organization.
M
management system: system to establish policy and objec-
tives and to achieve those objectives.
materials review board (MRB): a quality control commit-
tee or team, usually employed in manufacturing or other
materials-processing installations, that has the responsibil-
ity and authority to deal with items or materials that do
not conform to fitness-for-use specifications. An equiva-
lent error review board is sometimes used in software
development.
mean: a measure of central tendency; it is the arithmetic
average of all measurements in a data set.
metric: a standard of measurement.

Glossary 189
metrology: science and practice of measurements.

mission statement: an explanation of purpose or reasons for
existing as an organization; it provides the focus for the
organization and defines its scope of business.
N
nonconformity: non-fulfillment of a requirement.
non-value-added: refers to tasks or activities that can be elim-
inated with no deterioration in product or service function-
ality, performance, or quality in the eyes of the customer.
normal distribution: a bell-shaped distribution for continu-
ous data where most of the data are concentrated around
the average, and it is equally likely that an observation will
occur above or below the average.
O
objective: something toward which effort is directed; quality
objectives need to be measurable.
objective evidence: data supporting the existence or verity
of something.
organization: group of people and facilities with an arrange-
ment of responsibilities, authorities and relationships.
outsourcing: a strategy to relieve an organization of processes
and tasks in order to reduce costs, improve quality, reduce
cycle time (for example, by parallel processing), reduce
the need for specialized skills, and increase efficiency.

190 Glossary
P
Pareto chart: a basic tool used to graphically rank causes
from most significant to least significant. It utilizes a ver-
tical bar graph in which the bar height reflects the fre-
quency or impact of causes.
plan-do-check-act (PDCA) cycle: a four-step process for
quality improvement. In the first step (plan), a plan to
effect improvement is developed. In the second step (do),
the plan is carried out, preferably on a small scale. In the
third step (check), the effects of the plan are observed.
In the last step (act), the results are studied to determine
what was learned and what can be predicted. The plan-do-
check-act cycle is sometimes referred to as the Shewhart
cycle because Walter A. Shewhart discussed the concept
in his book Statistical Method from the Viewpoint of Qual-
ity Control and as the Deming cycle because W. Edwards
Deming introduced the concept in Japan. The Japanese
subsequently called it the Deming cycle.
ppm: parts per million.
preventive action: action to eliminate the cause of a potential
nonconformity or other undesirable potential situation.
problem solving: a rational process for identifying, describ-
ing, analyzing, and resolving undesirable situations.
procedure: specified way to carry out an activity or a process.
process: set of interrelated or interacting activities which
transforms inputs into outputs.

Glossary 191
process management: the collection of practices used to

implement and improve process effectiveness; it focuses
on holding the gains achieved through process improve-
ment and ensuring process integrity.
process mapping: the flowcharting of a work process in
detail, including key measurements.
process owner: the manager or leader responsible for ensur-
ing that the total process is effective and efficient.
product: result of a process.
Q
quality: degree to which a set of inherent characteristics ful-
fills requirements.
quality council: (sometimes called “quality steering commit-
tee”) the group driving the quality improvement effort and
usually having oversight responsibility for the implementa-
tion and maintenance of the quality management system.
quality function deployment (QFD): a structured method in
which customer requirements are translated into appro-
priate technical requirements for each stage of product
development and production. The quality function deploy-
ment process is often referred to as listening to the voice
of the customer.
quality loop: conceptual model of interacting activities that
influence quality at the various stages ranging from the
identification of needs to the assessment of whether those
needs are satisfied.

192 Glossary
quality management system: management system to direct

and control an organization with regard to quality.
quality manual: document specifying the quality manage-
ment system of an organization.
quality objective: something sought, or aimed for, related to
quality.
quality plan: the document setting out the specific quality
practices, resources, and sequence of activities relevant
to a particular product, project, or contract.
quality policy: overall intentions and direction of an orga-
nization related to quality as formally expressed by top
management.
R
radar chart: a visual method to show in graphic form the size
of gaps among a number of current organization perfor-
mance areas and ideal performance areas; the resulting
chart resembles a radar screen.
range: measure of dispersion; highest value minus lowest value.
record: document stating results achieved or providing evi-
dence of activities performed.
reengineering: completely redesigning or restructuring a
whole organization, an organizational component, or a
complete process. It’s a “start over from the beginning”
approach, sometimes called a “breakthrough.” In terms
of improvement approaches, reengineering is contrasted
with incremental improvement (kaizen).

Glossary 193
Registrar Accreditation Board (RAB) U.S.: an organization that

evaluates the competency and reliability of registrars (orga-
nizations that assess and register companies to ISO 9001).
registration to standards: a process in which an accredited,
independent third-party organization conducts an on-site
audit of a company’s operations against the requirements
of the standard to which the company wants to be regis-
tered. Upon successful completion of the audit, the com-
pany receives a certificate indicating that it has met the
standard requirements.
repeatability and reproducibility (R&R): a measurement
validation process to determine how much variation exists
in the measurement system (including the gage used to
measure and the individuals using the gage).
requirement: need or expectation that is stated, generally
implied or obligatory.
risk assessment/management: the process of determining
what risks are present in a situation (for example, proj-
ect plan) and what actions might be taken to eliminate or
mediate them.
root cause analysis: a quality tool used to distinguish the
source of defects or problems. It is a structured approach
that focuses on the decisive or original cause of a problem
or condition.
run chart: a line graph showing data collected during a run or
an uninterrupted sequence of events. A trend is indicated
when the series of collected data points head up or down.

194 Glossary
S
self-assessment: a carefully considered evaluation resulting
in an opinion or judgment of the effectiveness and effi-
ciency of the organization and the maturity of the quality
management system (see ISO 9004:2000 annex A).
seven basic tools of quality: tools that help organizations
understand their processes in order to improve them. The
tools are the cause-and-effect diagram, check sheet, con-
trol chart, flowchart, histogram, Pareto chart, and scatter
diagram.
seven management tools of quality: the tools used pri-
marily for planning and managing are activity network
diagram (AND) or arrow diagram, affinity diagram (KJ
method), interrelationship digraph, matrix diagram, pri-
orities matrix, process decision program chart (PDPC),
and tree diagram.
Six Sigma approach: a quality philosophy; a collection of
techniques and tools for use in reducing variation; a pro-
gram of improvement.
Six Sigma quality: a term used generally to indicate that a
process is well controlled, that is, process limits ±3 sigma
from the centerline in a control chart, and requirements/
tolerance limits ±6 sigma from the centerline. The term
was initiated by Motorola.
statistical process control (SPC): the application of statisti-
cal techniques to control a process.

Glossary 195
statistical thinking: a philosophy of learning and action

based on fundamental principles:
• All work occurs in a system of interconnected processes
• Variation exists in all processes
• Understanding and reducing variation is vital to
improvement
strategic planning: a process to set an organization’s long-
range goals and identify the actions needed to reach the
goals.
supplier: organization or person that provides a product.
system: set of interrelated or interacting elements.
T
team: a number of people with complementary skills who are
committed to a common purpose.
technical expert: (audit) person who provides specific knowl-
edge or expertise to the audit team.
TL 9000: handbooks pertaining to the quality management
system for telecommunication suppliers; ISO 9001 is
embedded in TL 9000.
tolerance: the variability of a parameter permitted and toler-
ated above or below a nominal value.
top management: person or group of people who directs and
controls an organization at the highest level.

196 Glossary
total quality management (TQM): a term initially coined by the

Naval Air Systems Command to describe its management
approach to quality improvement. Total quality manage-
ment (TQM) has taken on many meanings. Simply put, total
quality management is a management approach to long-
term success through customer satisfaction. Total quality
management is based on the participation of all members
of an organization in improving processes, products, ser-
vices, and the culture they work in. Total quality man-
agement benefits all organization members and society.
The methods for implementing this approach are found
in the teachings of such quality leaders as Philip B.
Crosby, W. Edwards Deming, Armand V. Feigenbaum,
Kaoru Ishikawa, J. M. Juran, and others.
traceability: ability to trace the history, application or location
of that which is under consideration.
trend: consecutive points that show a nonrandom pattern.
trend analysis: refers to the charting of data over time to
identify a tendency or direction.
V
validation: confirmation, through the provision of objective
evidence that the requirements for a specific intended use
or application have been fulfilled.
variation: a change in data, a characteristic, or a function that
is caused by one of four factors: special causes, common
causes, tampering, or structural variation.

Glossary 197
verification: confirmation, through the provision of objective

evidence that specified requirements have been fulfilled.
vision: a statement that explains what the company wants to
become and what it hopes to achieve.
vital few/useful many: a term used by J. M. Juran to describe
his use of the Pareto principle, which he first defined in
1950. (The principle was used much earlier in economics
and inventory control methodologies.) The principle sug-
gests that most effects come from relatively few causes;
that is, 80 percent of the effects come from 20 percent of
the possible causes. The 20 percent of the possible causes
is referred to as the “vital few”; the remaining causes are
referred to as the “useful many.” When Juran first defined
this principle, he referred to the remaining causes as the
“trivial many,” but realizing that no problems are trivial in
quality assurance, he changed it to “useful many.”
voice of the customer: an organization’s efforts to under-
stand the customers’ needs and expectations (“voice”)
and to provide products and services that truly meet such
needs and expectations.
W
work environment: set of conditions under which work is
performed.
work instruction: a document that answers the question:
How is the work to be done?

198 Glossary
world-class quality: a term used to indicate a standard of

excellence: best of the best.
Y
yield: ratio between salable goods produced and the quantity
of raw materials and/or components put in at the begin-
ning of the process.

Additional Reading
The following books and standards publications can

be used for more in-depth coverage of the ISO 9000
standards:
ANSI/ISO/ASQ Q9004-2000: Quality management systems—Guidelines
for performance improvement. Milwaukee, WI: ASQ Quality Press.
Arter, D. R., J. E. West, and C. A. Cianfrani. 2003. How to Audit the
Process-Based QMS. Milwaukee, WI: ASQ Quality Press.
Cianfrani, C. A., J. J. Tsiakals, and J. E. West, eds. 2000. The ASQ ISO
9000:2000 Handbook. Milwaukee, WI: ASQ Quality Press.
Cianfrani, C. A., J. E. West, and J. J. Tsiakals. 2009. ISO 9001:2008
Explained. Third edition. Milwaukee, WI: ASQ Quality Press.
West, J. E., and C. A. Cianfrani. 2005. Unlocking the Power of Your QMS.
Milwaukee, WI: ASQ Quality Press.
For additional information on quality management systems

and quality tools, including sampling:
ANSI/ASQ Z1.4-2008: Sampling Procedures and Tables for Inspection by
Attributes. Milwaukee, WI: ASQ Quality Press.
ANSI/ASQ Z1.9-2008: Sampling Procedures and Tables for Inspection by
Variables for Percent Nonconforming. Milwaukee, WI: ASQ Quality
Press.
199

200 Additional Reading
ANSI/ISO/ASQC A3534-2-2006: Statistics—Vocabulary and Symbols—

Applied Statistics. Milwaukee, WI: ASQ Quality Press.
Delbecq, A. L., H. H. Van de Ven, and D. H. Gustafson. 1975. Group
Techniques for Program Planning: A Guide to Nominal Group and
Delphi Processes. Glenview, IL: Scott, Foresman and Company.
ISO/TR 10017:2003: Guidance on Statistical Techniques for ISO
9001:2000. Geneva, Switzerland: ISO.
Juran, J. M., and A. B. Godfrey. 1998. Juran’s Quality Handbook. Fifth edition.
New York: McGraw-Hill Professional Publishing.
Tague, N. R. 2005. The Quality Toolbox. Second edition. Milwaukee, WI:
ASQ Quality Press.

Index
A continual improvement, 13–14,

132–33
alignment, 12–13 controls
analysis for documents, 30–32
of data, 129–32 for records, 32–35
planning and implementing corrective actions, for nonconform-
processes for, 111–14 ing products, 133–35
audits, internal, 117–21 customer communication, 73–74
authority, defining, top managers customer focus, 7–9, 38–39
and, 45–46 customer property, protecting and
safeguarding, 102–4
B customer requirements, top manag-
brainstorming, 148–49 ers and, 38–39
C D
cause-and-effect diagrams, 172–75 data analysis, 129–32
cells, determining number of, 159 data points, determining number of,
commitment, top managers and, 157–59
35–38 design and development
communication control of changes in, 87–88
customer, 73–74 inputs, 76–78
internal, 48–50 outputs, 79–81
communication processes, 48–50 planning, 74–76
competency, determining, 60–61 reviews, 81–83
201

202 Index
design and development (continued ) improvements

validation, 85–87 continual, 132–33
verification, 83–85 corrective actions, 133–35
documentation planning and implementing
controls, 30–32 processes for, 111–14
quality manuals, 27–29 preventive actions, 136–38
of quality policies, 39–41 infrastructure, determining and
record controls, 32–35 providing necessary, 62–63
requirements, 29–30 internal audits, 117–21
internal communication, 48–50
E Ishikawa diagrams, 172–75
ISO 9000:2005, 23–26
employees. See workers ISO 9001:2000, 18–20
ISO 9001:2008
F changes in, from ISO 9001:2000,
18–20
failure modes and effects analysis
general requirements of,
(FMEA), 137, 162–65
24–26
fishbone diagrams, 172–75
normative reference in, 23–24
flowcharts, 140–43
reasons for embracing, 1–4
symbols for, 141
scope of, 21–23
G
L
Gantt charts, 150–53
leadership, 15–16
H
M
histograms, 156–60
human resources management, systems approach
determining competency and, to, 9–12
60–61 management representatives, 16,
general requirements for, 58–60 46–48
training and, 60–61 management reviews
inputs for, 52–54
outputs for, 54–56
I of quality management systems,
identification, 100–102 50–52
improvement projects, conducting, managers. See middle managers;
178–82 top managers

Index 203
measurement determining requirements related

for customer satisfaction, 114–17 to, 68–70
planning and implementing measuring, 123–26
processes for, 111–14 monitoring, 123–26
of processes, 121–23 nonconforming, controlling,
of product, 123–26 126–29
measuring devices, control of, 106–11 planning realization, 65–68
middle managers, benefits of ISO preservation of, 104–6
9001:2008 for, 2–3. See also purchasing information for, 90–92
top managers purchasing processes for, 88–90
monitoring reviewing requirements related
customer satisfaction, 114–17 to, 70–73
planning and implementing validating processes for provision
processes for, 111–14 of, 98–100
of product, 123–26 verifying purchased, 92–94
of quality management system property, customer, safeguarding,
processes, 121–23 103–4
monitoring devices, control of, 106–11 purchasing
information, 90–92
N processes, 88–90
nonconforming products
controlling, 126–29
Q
corrective actions for, 133–35 quality management principles, 5–7
normative reference, 23–24 quality management systems, 11
involvement in, 16
P monitoring and measuring
processes of, 121–23
Pareto charts, 160–62 planning, 43–45
personnel. See workers reviewing, 50–52
preventive actions, 136–38 quality manuals, 27–29
problem solving, 176–78 quality objectives, top managers
process approach, 9–12 and, 41–43
process controls, 14–15 quality policies, top managers and,
process mapping, 144–47 39–41
products
controlling conditions for provi-
sion of, 94–97
R
controlling monitoring and mea- records, control of, 32–35
suring devices for, 106–11 resources, provision of, 56–58

204 Index
responsibilities, defining, top manag- defining roles of personnel and,

ers and, 45–46 45–46
reviews, quality management internal communication and,
system, 50–52 48–50
run charts, 153–56 planning quality management
systems and, 43–45
S quality management system
reviews and, 50–52
sampling inspections, 165–72 quality objectives and, 41–43
scope, of ISO 9001:2008, 21–23 quality policies and, 39–41
services. See also products responsibilities of, 15–16
controlling conditions for provi- traceability, of products, 100–102
sion of, 94–97 training, determining requirements
validating processes for provision for, 60–61
of, 98–100 trend charts, 153–56
symbols, flowchart, 141
systems approach to management,
9–12
W
work environments, determining,
T 63–65
workers
top managers. See also middle benefits of ISO 9001:2008 for,
managers 1–2
benefits of ISO 9001:2008 for, 3–4 defining roles for, 45–46
commitment and, 35–38 roles of, 16
customer requirements and, 8,
38–39

Cracking The Case of ISO 90012008 For Service PDF

Încărcat de

Informații document

Titlu original

Drepturi de autor

Formate disponibile

Partajați acest document

Partajați sau inserați document

Opțiuni de partajare

Vi se pare util acest document?

Este necorespunzător acest conținut?

Drepturi de autor:

Formate disponibile

Cracking The Case of ISO 90012008 For Service PDF

Încărcat de

Drepturi de autor:

Formate disponibile

Cracking the Case of

1356_Cianfrani.indd i 11/11/09 12:59:46 PM

ISO 9001:2008 Explained, Third Edition

ISO 9001:2008 Explained, Third Edition (Spanish)

Cracking the Case of ISO 9001:2008 for Manufacturing

The ASQ ISO 9000:2000 Handbook

How to Audit the Process-Based QMS

Unlocking the Power of Your QMS: Keys to Business Performance Improvement

The ASQ Auditing Handbook, Third Edition

Quality Audits for Improved Performance, Third Edition

The Quality Toolbox, Second Edition

Mapping Work Processes, Second Edition

Lean Kaizen: A Simplified Approach to Process Improvements

Root Cause Analysis: Simplified Tools and Techniques, Second Edition

The Certified Manager of Quality/Organizational Excellence Handbook, Third Edition

To request a complimentary catalog of ASQ Quality Press publications, call 800-248-

1356_Cianfrani.indd iii 11/11/09 12:59:47 PM

ASQ Quality Press

1356_Cianfrani.indd v 11/11/09 12:59:47 PM

Library of Congress Cataloging-in-Publication Data

1356_Cianfrani.indd vi 11/11/09 12:59:47 PM

Chapter 1 Why Do ISO 9001:2008? . . . . . . . . . . . . . . . . . . . 1

1356_Cianfrani.indd vii 11/11/09 12:59:47 PM

4.1 General Requirements . . . . . . . . . . . . . . . . . . . . . . . . 24

1356_Cianfrani.indd viii 11/11/09 12:59:47 PM

7.3.4 Design and Development Review . . . . . . . . . . . . . . . 81

1356_Cianfrani.indd ix 11/11/09 12:59:47 PM

Tool 4: Gantt Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

1356_Cianfrani.indd x 11/11/09 12:59:47 PM

1356_Cianfrani.indd 1 11/11/09 12:59:47 PM

• The ability to adjust processes when results are not

1356_Cianfrani.indd 2 11/11/09 12:59:47 PM

1356_Cianfrani.indd 3 11/11/09 12:59:47 PM

Perhaps the most important reason for doing ISO 9001 is

1356_Cianfrani.indd 4 11/11/09 12:59:47 PM

QUALITY MANAGEMENT PRINCIPLES

To lead and operate an organization success-

1356_Cianfrani.indd 5 11/11/09 12:59:47 PM

Eight quality management principles have been

1356_Cianfrani.indd 6 11/11/09 12:59:47 PM

mance should be a permanent objective of

1356_Cianfrani.indd 7 11/11/09 12:59:47 PM

and preventing nonconformities have been fundamental to

1356_Cianfrani.indd 8 11/11/09 12:59:47 PM

(clause 7.2.1) and review (clause 7.2.2) those cus-

1356_Cianfrani.indd 9 11/11/09 12:59:47 PM

The system approach to management is basic to ISO

1356_Cianfrani.indd 10 11/11/09 12:59:47 PM

Quality management system

In summary, the process approach is very generic and applicable

ALIGNMENT—QUALITY OBJECTIVES, PROCESS

1356_Cianfrani.indd 12 11/11/09 12:59:48 PM

Clause 5.4.2 requires that the quality management system

1356_Cianfrani.indd 13 11/11/09 12:59:48 PM

• Establishing and deploying measurable objectives at

PROCESS CONTROL TO FACILITATE LEARNING,

1356_Cianfrani.indd 14 11/11/09 12:59:48 PM

controls are properly integrated into the organization’s pro-

LEADERSHIP AND INVOLVEMENT

1356_Cianfrani.indd 15 11/11/09 12:59:48 PM

• Ensure that the quality management system is planned

All People in the Organization

1356_Cianfrani.indd 16 11/11/09 12:59:48 PM