Cracking The Case ISO9001 2008 For Manufacturing

Cracking the Case of
ISO 9001:2008
for Manufacturing
1355_Cianfrani.indd i 11/11/09 1:17:54 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 Service

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.
1355_Cianfrani.indd ii 11/11/09 1:17:54 PM

Cracking the Case of
ISO 9001:2008
for Manufacturing
A Simple Guide to Implementing
Quality Management in
Manufacturing
Second Edition
Charles A. Cianfrani
and John E. (Jack) West
ASQ Quality Press

Milwaukee, Wisconsin
1355_Cianfrani.indd iii 11/11/09 1:17:54 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 manufacturing : a simple guide to
implementing quality management in manufacturing / Charles A. Cianfrani and John
E. (Jack) West. — 2nd ed.
p. cm.
Originally published under title: Cracking the case of ISO 9001:2000 for
manufacturing.
Includes bibliographical references and index.
ISBN 978-0-87389-761-7 (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 manufacturing. III. Title.
TS156.C72 2009
658.5’62—dc22
2009043601
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.
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800-248-1946. Visit our Web site at www.asq.org or http://www.asq.org/quality-press.
Printed on acid-free paper
1355_Cianfrani.indd iv 11/11/09 1:17:54 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
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vi 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 . . . . . . . . . . . . . . 78
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Contents vii
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 . . . . . . . . . . . . . . . . . 101
7.5.4 Customer Property . . . . . . . . . . . . . . . . . . . . . . . . . . 103
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
8.5 Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
8.5.1 Continual Improvement . . . . . . . . . . . . . . . . . . . . . . 131
8.5.2 Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
8.5.3 Preventive Action . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Chapter 4 Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Tools Discussed in This Section . . . . . . . . . . . . . . . . . . . . . 139
Tool 1: Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Tool 2: Process Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Tool 3: Brainstorming . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
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viii 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: Reliability Analysis . . . . . . . . . . . . . . . . . . . . . . . . . 165
Tool 10: Sampling Inspection . . . . . . . . . . . . . . . . . . . . . . 166
Tool 11: Process Capability Studies . . . . . . . . . . . . . . . . . . 173
Tool 12: Cause-and-Effect Diagram
(Fishbone/Ishikawa Diagram) . . . . . . . . . . . . . . . . . . . . 175
Tool 13: Problem Solving . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Tool 14: How to Conduct an Improvement Project . . . . . . . 181
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Additional Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
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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 bor-
ing 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
1355_Cianfrani.indd 1 11/11/09 1:17:54 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 management system that is designed to con-
tinually improve performance while addressing
the needs of all interested parties. Managing an
organization encompasses quality management
amongst other management disciplines.
5

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 (clause 5.5.2) ensuring 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 product related to customer require-
ments 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
management system needs to be composed of interrelated
processes. Clause 0.2 of ISO 9001:2008 describes this con-
cept 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 manag-
ing across the functional departments of the organi-
zation, 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.

1355_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 1:17:55 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
Process 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 requirements
(clauses 5.1, 5.2, and 5.5.2) and receive input on the effec-
tiveness 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 management
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. The role of top managers, supervi-
sors, and the management representative is to find ways to
get and keep everyone in the organization involved in the effi-
cient 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 ANSI/ISO/ASQ Q9001-2008.
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 of 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 edition 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 on 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 It is now clear that the
be the management management representa-
representative for an tive must be a member of
organization the management of the
organization
6.2.1 Clarifies the applicabil- A broader view that
ity of competence competence is required
requirements of personnel 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 ment to the customer
otherwise unsuitable
for use
7.6 Note added regarding Clearly states the need
software used in to confirm the ability of
calibration activities software to perform its
intend function
8.2.2 Clearer requirement for This change is a rewording
a procedure for plan- of the 2000 standard re-
ning and conducting quirements with emphasis
audits and the require- on the need for records
ment for audit records and the clarification that
and for correction and both correction and cor-
corrective action rective action are required
( Continued )

Clause
number Nature of change Comment
8.2.3 Note added to guide The note clarifies the con-
what to consider when cept of suitable methods
determining suitable
methods
8.3 Wording change to It is now clear that a
more clearly indicate documented procedure is
the requirement for a required, as well as taking
documented procedure, action after delivery of
and words added to nonconforming product
address taking 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
useful for demonstrating the ability of an organization to con-
sistently meet customer requirements for product. 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 permissible exclusions to the orga-
nization’s quality management system. It provides that where
any requirement of clause 7 in the standard cannot be applied
due to the nature of an organization and its product, this
requirement can be considered for exclusion. Where exclu-
sions are made, claims of conformity to this International Stan-
dard 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 product
that meets customer and applicable statutory and regulatory
requirements. 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 your 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 product?
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 of standards. When a term
defined in ISO 9000 is used in ISO 9001, the ISO 9000 defini-
tion 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 “product” as “the result of a
process.” Remember, if an organization provides services
or software along with manufactured goods, the services or
software provided should be considered part of the “prod-
uct” offering.
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 used in ISO 9001 is defined in ISO 9000,
the ISO 9000 definition is the official meaning of the
term
Question to Ask Yourself

• Have you obtained 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 manage,
operate, monitor, measure, analyze, and control the processes
must be determined. Resources must be made available to

4.1 General Requirements 25
operate, monitor, measure where applicable, and improve the

processes. “Where applicable” was added in ISO 9001:2008
to recognize that sometimes measurement may not apply. 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 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
• To understand and control the processes so that they
are managed effectively
Implementation Tips
• Identify your processes
• Identify inputs and outputs for each process
• Decide how to measure inputs, outputs, and/or
3 process parameters
2 • Create process maps for key processes

• Use relationship diagrams to show the interactions
of the processes

• Use a flowchart to show the processes

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 monitored and analyzed, with appro-
priate 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 product been identified?
• Has provision been made to ensure control of any
outsourced process that affects conformity of the
product?

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 required by the
various clauses of ISO 9001.
Why Do It?
• To ensure consistent performance of required
activities
• To provide a baseline for improvement of 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
2 • Use process maps


• Have the processes needed for quality management
been identified?
• Are the quality policy and quality objectives docu-
mented and controlled?
• Are 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
any exclusions from clause 7 that the organization has found
appropriate. The quality manual either includes or references
the documented procedures that describe the process of the
quality management 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 relationship diagrams in the quality manual 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

4.2.3 Control of Documents 31
reviewed and updated as necessary. In cases where obsolete

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 that 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 your 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 system
address the identification of records needed to provide evi-
dence of the effective operation of the quality management

4.2.4 Control of Records 33
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
contains requirements for their maintenance and disposition.
The quality management system must provide for control of
storage, protection, retention time, and disposition. Control of
records is one of the six processes for which a documented
procedure is required.
Why Do It?
• To provide evidence that your products conform to
requirements
• To provide evidence that your 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 products, processes, and the effectiveness of
the quality management system

Implementation Tips
• Define the types of records required for the quality
management system
• Make a matrix of record types, indicating the specific
controls necessary 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 manage-
ment system. There are 10 basic requirements described in
clause 5 of ISO 9001:2008 that are the direct responsibility 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 objectives 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 the
five additional activities that top man-
agers are required to accomplish:
(6) ensure that customer requirements
are determined and met (clause 5.2),
(7) ensure that the quality manage-
ment system is planned and its integ-
rity is maintained when changes are made (clause 5.4.2),
(8) ensure that responsibilities and authorities are defined
and communicated (clause 5.5.1), (9) appoint the manage-
ment representative (clause 5.5.2), (10) ensure that appropri-
ate internal communications processes are established and
that communication takes place on the effectiveness of the
quality management 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

5.1 Management Commitment 37
• The quality policy should be one of the key policies of

any organization
• 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 distribution of the organization’s
resources
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 quality objectives with overall business
objectives
• Hold frequent, comprehensive management reviews

• 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?
• 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
(determination of requirements related to the product),
8.2.1 (customer satisfaction), 5.4 (planning), and 5.6
(management review)

5.3 Quality Policy 39
• Top managers must ensure that the needs and expec-

tations of the market and customers are captured in
customer requirements
• 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 your organization
• Use appropriate techniques such as brainstorming
3 to get ideas for policy development
• Use words, structure, and content that reflect the
culture of your organization
• Be sure to reflect in the policy the basic overall
direction of your organization relating to quality
• Think about how objectives can be structured from
policy so that policy and objectives will be in align-
ment across your organization
• Make it easy for people to describe the policy in
their own words without quoting it word for word

5.4.1 Quality Objectives 41

• 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
policy. The objectives necessary to meet requirements for the
product must be included. These objectives need to be estab-
lished 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 your quality objectives align with the qual-
ity policy
• Consider brainstorming to develop initial ideas
3 related to the objectives
• Avoid conflicting priorities by ensuring that 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 necessary to meet
requirements for the organization’s products, including
any services?
• Are the quality objectives consistent across the
organization?
• Are the quality objectives measurable?
• Are the quality objectives reviewed against the quality
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? Product- or 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 and interactions
defined and communicated to facilitate effective qual-
ity 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

5.5.2 Management Representative 47
representative to promote within the organization the aware-

ness of customer requirements.
Why Do It?
• To make certain that 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 the factory (products, material, percent defective,
production operations, schedules, and so on) and the
language of top managers (money, strategies, capital
plans, and so on)
• 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 communication
processes are established in the organization. These com-
munication processes need to be appropriate for the organi-

5.5.3 Internal Communication 49
zation. The effectiveness of the quality management 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,
for example, postings on bulletin boards, work group
meetings, all employee meetings, newsletters, and
e-mail
• 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 indicate

that the organization effectively communicates the
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-
tives, and the processes of the quality management system.

5.6 Management Review, 5.6.1 General 51
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 of the system 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 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 product performance, status of pre-
ventive and corrective actions, changes that could affect the
quality management system, and the results of audits. In addi-

5.6.2 Review Input 53
tion, 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,
product 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 improve-
ment? Are recommendations for improvement
included?
5.6.3 REVIEW OUTPUT

Management review outputs include actions to be taken and
decisions made for improving the quality management sys-
tem and its processes. In addition, it is often necessary to
improve the product itself when customer requirements are
not being fully met. Top managers need to allocate or real-
locate resources to make the improvements happen.
Why Do It?
• To make the management review efficient and
effective
• To focus the review on important issues

5.6.3 Review Output 55
• To provide data on which top managers can make

objective decisions
• To focus on action and getting results
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
• Product improvement 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 that does not
meet customer requirements?
• Do the outputs of management reviews address
resource needs?
• Are management review records maintained?
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
product quality, not just the resources needed to oper-
ate the “quality department”
• Consider short- and long-term resource needs; timing
may be critical
• 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 product that meets 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, to produce x quantity of con-
forming product per day)
• Address competency requirements for personnel who
assess customer satisfaction

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

• Are personnel who perform work affecting conformity

to product 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 product requirements is required.
Training or other action is required to fill any gaps between
the competency requirements and the actual education, train-
ing, skills, and experience of personnel. Effectiveness of these
actions has to be measured. Appropriate competency (educa-
tion, 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 perform-
ing activities affecting conformity to product require-
ments, 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 activi-
ties 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 buildings, workspace, and
associated utilities, process equipment, communications,
information systems, and services needed to achieve confor-
mity of products are required.
Why Do It?
• To ensure that the infrastructure is sufficient to ensure
conformity of product 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
• The list in clause 6.3 is not all-inclusive; consider all
physical resources needed to design and provide the
product to the customer, except people
• Go beyond production and service operations to
include all other activities and processes of your quality
management system
• Integrate resource needs with overall organizational
planning, including capital plans

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 product. The orga-
nization is also required to manage that work environment so
that it actually does achieve conformity.
Why Do It?
• To ensure that the environment is suitable for the
product during its realization
• To prevent product contamination, deterioration, or
other detrimental effects during product realization

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 product conformity
• 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 work 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 of product?

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
product, which processes and documents need to be estab-
lished, which specific resources are needed for each product,
and which verification, validation, measurement, monitoring,
inspection, and test activities are required. (The word “mea-
surement” was added in ISO 9001:2008 with no intended
change in the requirement.) The criteria for product accep-
tance need to be established. The organization also needs to
determine which records are required to provide evidence that

the realization processes and resulting product meet require-

ments (see clause 4.2.4).
Why Do It?
• To achieve customer satisfaction
• To thoroughly understand the processes and activities
that will result in products that conform to customer
and regulatory/statutory requirements
• To foster continual improvement
Implementation Tips
• Map or flowchart the processes necessary
1 2 to produce conforming products.
• Create quality plans for each product, if
appropriate.
• Consider using the product design and
development process approach for design-
ing processes. (See clause 7.1 note 2 and
clause 7.3.)
• Find the vital few key performance indica-
tors for both products and processes; it is
better to measure and analyze a few key
indicators well, than many poorly.
• Align the key process measures with your
quality objectives (see clause 5.4.1).

7.1 Planning of Product Realization 67
• 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.

• Is there evidence of planning of production
processes?
• Does the planning extend beyond production
processes to encompass all product realization
processes?
• Is the planning consistent with other elements of your
quality management system?
• Do objectives and measures for product realization
processes align with your quality objectives?
• Does product realization documentation exist?
• Are product 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 product?

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 product requirements
that have not been specified by the customer but are nec-
essary for the intended or specified use of the product. This
would include “requirements” that are “understood” for a par-

7.2.1 Determination of Requirements Related to the Product 69
ticular product, for example, the careful handling of a package

by a package delivery organization.
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 the
customer thinks was ordered and what the organiza-
tion 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 “industry standard” and “product stan-
dard” unstated expectations
• Keep up to date on regulatory and statutory require-
ments by subscribing to an update service or by
other means


• Does the organization determine customer
requirements?
• 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 product 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 products 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 off-the-shelf products
• Have a very simple, brief, and effective contract-review
process for simple products

• Have a more formal process for large, complex

contracts or quotations, which may require the
involvement of many organizational entities such as
engineering, manufacturing, 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 product 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 product 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 product
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.
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 products you sell and the volume of
business with a customer
• Tie the processes to meet this requirement to your
processes to address requirements in clause 8.2.1

relating 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 facilitate com-
munication with customers about product information,
inquiries, contracts, order handling (including amend-
ments or changes), and customer feedback, including
customer complaints?
• Have you linked the processes for communicating
with customers with those for monitoring 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 identifi-
cation of at least (1) the design activities to be completed,
(2) the review, verification, and validation activities that are

7.3 Design and Development, 7.3.1 Design and Development Planning 75
appropriate, and (3) the responsibilities and authorities for

the activities to be performed. Also, the approach for man-
aging the interfaces among the different groups involved with
the project needs to be identified to ensure effective com-
munications. In other words, a detailed project plan needs to
be created.
Why Do It?
• To ensure that the product meets customer and regu-
latory/statutory requirements
• 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 approaches such as Gantt charts, PERT
4 (program evaluation and review technique) charts,
or CPM (critical path method) charts
• 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
• Plan for the use of failure modes and effects analy-
8 sis (FMEA) during the design process to prevent
problems


• 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 product to be designed and
developed and to create a requirements specification or an
equivalent statement of the general and specific characteris-
tics of the product to be developed, including the suitability of
the product to meet marketplace and customer needs. Spe-
cifically, 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

7.3.2 Design and Development Inputs 77
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 include:
• Customer requirements, wants, and needs
• Functional requirements
• Performance requirements
• Information from previous similar designs
• Statutory or regulatory requirements
• Environmental considerations such as ISO 14000
• Industry standards
• National and international standards
• Organizational standards
• Safety regulations

• Cost
• Past experiences
• Contract commitments (for designs that are related to
specific customer orders)
• Use of focus groups and quality function deployment
(QFD)

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

7.3.3 Design and Development Outputs 79
Why Do It?
• To provide the information needed to produce the
product
• 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, as appropriate, mock-ups, models, or other
means to communicate the intent of the design
and development team
• 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 manu-
facture of the product to specified requirements
• Use appropriate statistical tools such as design of
experiments, hypothesis testing, regression and
correlation analysis, simulations, reliability analysis,
and statistical tolerancing
• Indicate clear product acceptance criteria in
documentation

• Include any information that relates to producing or

using the product safely and properly
• Consider how to demonstrate that the product will not
do what it should not do
• Ensure that software or hardware meets require-
ments and will not interfere with the operation of other
software
• Keep good records
• Ensure that the output is approved before the product
is released, which is typically achieved by the appro-
priate 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
requirements specification)?
• Does output provide, as appropriate, information for
production operations?
• Are product acceptance criteria clearly stated?

7.3.4 Design and Development Review 81
• Are product safety and product use characteristics

identified?
• Is there an approval process for the release of products
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 problems 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 product that fully
meets requirements
• To find cost-reduction opportunities
• To ensure that product will be reliable and durable
• To make products easier to produce

Implementation Tips
• Address the “abilities” associated with a new
9 product, including manufacturability, deliverability,
testability, inspectability, shipability, serviceability,
repairability, 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 is early enough to allow
for resolution of issues, and ensure that life-cycle
issues are addressed early in the design and
development process
• 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
determine appropriate follow-up

• Are design and development reviews being performed?
• Are they indicated in the project planning documents?

7.3.5 Design and Development Verification 83
• 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 product does meet the stated requirements

• Consider using review and analysis of test data,

making alternative calculations, performing addi-
tional testing of the product or its components, or
by any other means that the organization chooses
• Consider the use of statistical sampling and design
10 of experiments when designing tests
• Consider using the results of reliability analysis,
9 maintainability analysis, and produceability analy-
sis in the verification process
• Ensure that objective evidence exists to demon-
strate that validation has been completed
• Consider using maintainability analysis
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 product where practicable and to keep records
of validation actions.
Why Do It?
• To ensure that the product 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 com-
pleted before a product is released for sale or delivered
to a customer, resolution of issues after shipment is
usually very expensive

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 shipment
of product 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
10 statistical sampling when designing tests
• Consider using results of reliability analysis, main-
9 tainability analysis, and produceability analysis in
the validation process
• Consider validation of maintainability by actually
conducting maintenance on prototypes or pilot
production units under field conditions

• Is design and development validation performed to
confirm that the product is capable of meeting the
requirements for intended use?
• Is validation completed prior to delivery, when
applicable?

7.3.7 Control of Design and Development Changes 87
• 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

Any changes that occur in the design of a product, either dur-
ing the design and development process or after the delivery
of the product to a customer, need to be identified and records
of the changes maintained. Further, changes should be exer-
cised through the design review, verification, and validation
processes and should be approved before implementation.
This clause also now requires evaluation of the effect of
changes on constituent parts of the product and on product
already delivered.
Why Do It?
• To make certain that changes do not introduce unfore-
seen adverse effects into the product or other related
products or subsystems
• To ensure that design configuration is controlled
• To ensure cost-effective manufacturing and life-
cycle support, where applicable, after shipment to a
customer

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 purchased products con-
form to specified requirements. There is flexibility regarding
how this is done. The approach should depend on the effect of

7.4.1 Purchasing Process 89
the purchased product on subsequent product operations, on

the final product, and on the customers.
Suppliers need to be evaluated and selected based on
their ability to supply product in accordance with require-
ments. Criteria need to be established for selection, evalua-
tion, and reevaluation of suppliers. Records of the results of
evaluations and any actions taken as a result of the evalua-
tions 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 pur-
chased material is a significant component of the cost
of goods sold (CGS)
• To ensure that product conforms 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 qual-
ity, minimizing your total cost
• To ensure the ongoing ability of your suppliers to con-
tinually provide conforming products at optimal cost
Implementation Tips
• Understand the risk to your business if purchased
product does not meet your requirements
• Consider rigorous controls in cases where the potential
impact of purchased product is great

• Consider reducing the controls in cases where impact

of purchased product is less
• If purchased material has little impact on the final
product, then minimal 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 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 or specific quality

7.4.2 Purchasing Information 91
management system requirements apply (for example, com-

pliance with ISO 9001:2008), such requirements 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 being ordered?
• Do purchasing documents include, where appropriate,
requirements for approval or qualification of product,
procedures, processes, equipment, and personnel?
• Do purchasing documents include, where applicable,
quality management system requirements?
• Does the organization ensure adequacy of specified
purchase requirements prior to communication with
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 manufactur-
ing flow meets specified requirements

7.4.3 Verification of Purchased Product 93
• To avoid costly rework in subassembly or final assem-

bly or after a product is shipped
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 (based on
demonstrated process capability)
■ Conventional or skip-lot incoming inspection for
10 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

• Has the organization defined a process for verify-
ing that purchased product conforms to defined
requirements?
• Is the process effectively implemented?
• Does objective evidence exist of product
acceptance?

• Is verification of purchased product 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 character-
istics of products—such as specifications, drawings,
and so on
• Having suitable documentation available where
needed—such as procedures, work instructions, specifi-
cations, drawings, forms, check sheets, and so on
• Knowing the criteria for product acceptance
• Knowing what controls are needed and where they are
needed, for example, what tests and inspections need
to be done and where in the process
• Using suitable equipment to make, monitor, and/or
measure the product (or process)
• Knowing and doing all the things that need to be done
before product is delivered to a customer or moved to

7.5.1 Control of Production and Service Provision 95
the next operation—for example, reports, sign-offs,

and stamps
• Knowing and doing all the things needed to meet both
delivery and postdelivery commitments—for example,
is there special packaging or shipping instructions,
after-shipment start-up service, or ongoing service
obligations?
Why Do It?
• To ensure that what you are providing will meet both
internal and customer requirements
• To prevent product and process variability that may
exceed specification limits or cause high costs,
rejects, rework, scrap, and other forms of waste
Implementation Tips
• Understand specifications of products and
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
• Consider the use of statistical tolerancing
• Identify interrelationships between
operations

• Consider preparation of quality plans where appro-

priate (see ISO 10005)
• Determine what procedures and working instruc-
tions are needed for the various processes
• Document processes in a manner suitable to your
organization’s method of operation
• Make sure process documentation is available
when and where needed
• Consider establishing clear criteria for process
capability
• Ensure ongoing suitability of equipment by plan-
ning 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
10
• Identify devices needed to monitor and measure
both the product and its processes
• Make sure that the needed monitoring and mea-
surement equipment is suitable (see clause 7.6)
• Consider the use of process capability studies and
11 control charts
• Ensure that planning is compatible with the other
processes of the entire interconnected quality
management system

7.5.1 Control of Production and Service Provision 97

• Are specifications available that define quality charac-
teristic requirements of the product or service?
• Has the organization determined the criteria of accept-
ability for demonstrating the suitability of equipment
for production and service operations to meet product
or service specifications?
• Has the organization demonstrated the suitability of
equipment for production and service operations to
meet product or 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 product or service?
• Have the requirements for the work environment
needed to ensure the conformity of the product or
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 product or service?
• Have monitoring and measurement activities been
planned and are they carried out as required?

• For hardware, processed material, and software, have

suitable processes been implemented for release of
the product and for its delivery to the customer?
• Have suitable release mechanisms been put in place
to ensure that products and services conform 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 the product cannot be adequately tested or
inspected without making it nonconforming), the organization
needs to:
• Identify criteria for approval of the process, its equip-
ment, and its 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 operator and process qualifications
• Determine if revalidation is required, and if so, estab-
lish a process for and perform revalidation

7.5.2 Validation of Processes for Production and Service Provision 99
These controls are also required in cases where product

verification is not conducted because it would be inconve-
nient, take too much time, be too expensive, or destroy the
product.
Why Do It?
• To ensure that products with hard-to-verify character-
istics meet customer requirements
• To prevent product failures during later production
processes or during use by your customers
• To avoid the negative cost implications when pro-
cesses do not produce expected results
Implementation Tips
• Consider processes like welding, heat treating, and
soldering as candidates for special controls
• Address both people and equipment, to ensure
competence and capability
• Decide what records are necessary and have
processes to produce those records
• Use process monitoring and measurement to verify
ongoing control
• Consider using process capability studies
11
• Develop a revalidation plan for processes that
could go out of control without warning

• Consider the cost of revalidation against the risk of

nonconforming product to determine revalidation
frequency

• Has the organization determined which production
or service processes require validation? Have these
processes been validated?
• Has the organization defined criteria for the review and
approval of production or 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 process revalidation criteria been established?
• Have processes, as required, been revalidated?
• Do adequate records exist to ensure that process
validation is effective?

7.5.3 Identification and Traceability 101
7.5.3 IDENTIFICATION AND TRACEABILITY

The organization needs to identify product throughout the
realization process, wherever it is appropriate. Inspection and
test status 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 control
unique identification at all appropriate stages. Records are
required.
Why Do It?
• Identification of product (including material, parts,
components, assemblies, and finished goods):
■ Ensures that the status of material will be known at
all stages so there is no guesswork about whether
a lot, subassembly, or final product has been
inspected or tested, or has completed a product
realization step
■ Reduces the risk of product failure due to use of the
incorrect material, part, or component in production
or assembly
■ Facilitates easier material control during storage,
in-process operations, assembly, and shipment
■ Facilitates customers’ ability to know that they have
received the correct product

• Traceability:
■ Ensures that you can meet any compelling customer
need to trace a product back to its component ele-
ments in case a problem occurs later
■ Is commonly required in industries such as aerospace,
automotive, medical devices, oil and gas, and nuclear
power for products that are related to health and safety
■ Can be an internal requirement in cases where you
wish to reduce the size of potential recalls if prob-
lems are found with delivered product
Implementation Tips
• Consider identification by use of traveler cards with
lots of materials, bar codes, color codes (especially for
machine shop stock), inspection, test, or other stamps;
special containers for subassemblies; placement in a
specific location; or any other approach that makes
sense to the organization
• Recording of traceability may include heat, lot, batch,
or serial numbers
• Consider using computerized identification systems
utilizing bar coding on product labels or radio fre-
quency identification (RFID) tags that gives verification
status, item identity, and traceability data

• Has the product been identified by suitable means
throughout production and service operations?

7.5.4 Customer Property 103
• Has the status of the product been identified at suitable

stages with respect to monitoring and measurement
requirements?
• Is traceability a requirement?
• Where traceability is a requirement, is the unique iden-
tification of the product recorded and controlled?
7.5.4 CUSTOMER PROPERTY

The organization must protect and safeguard customer prop-
erty (for example, a subassembly that will be incorporated into
the final product). These controls apply while the property is
under control of or being used by the organization. If customer
property is lost or damaged, or if it becomes unsuitable for
use for any reason, this needs to be reported to the customer
and documented.
The standard makes a special point to remind organiza-
tions to pay attention to intellectual property of customers to
which the organization has access—for example, software—
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 tooling,
information, test equipment and software, and shipping
containers
• 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 product?
• 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

Conformity of product must be preserved during internal pro-
cessing and delivery to the intended destination, usually an

7.5.5 Preservation of Product 105
end customer, a storeroom, or a distribution point. This pres-

ervation needs to include the identification, handling, packag-
ing, storage, and protection of the product. Preservation also
applies to the constituent parts of a product.
Why Do It?
• To prevent damage to product and constituent parts
• To ensure that everyone in the organization is aware of
the actions necessary to prevent damage to product
Implementation Tips
• Develop processes to appropriately identify, handle,
package, store, protect, and deliver the product
• Include appropriate controls for the components of
the product 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 preservation of raw materials typically stored
outside (rust on steel plate may be OK for some appli-
cations, but it may need to be prevented for others)


• Does the organization uniquely identify the product
during internal processing and delivery?
• Does the organization handle the product during
internal processing and delivery so as to preserve
conformity to customer requirements?
• Does the organization package the product during
conformity to requirements?
• Does the organization store the product during internal
processing and delivery so as to preserve conformity to
requirements?
• Does the organization protect the product during
conformity to 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.
Processes are required to ensure that monitoring and
measurement are carried out in a manner that is consistent
with the monitoring and measurement requirements.

7.6 Control of Monitoring and Measuring Devices 107
Where necessary to ensure valid results, measuring

equipment must be calibrated or verified at specified inter-
vals, or prior to use, against measurement standards trace-
able to international or national measurement standards.
Where no such standards exist, the basis used for calibration
or verification needs to be established and recorded. Also,
equipment must be adjusted or readjusted as necessary and
identified to enable the calibration 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, it must be assessed and 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 products meet customer and
internal requirements through adequate measurements
• To prevent the acceptance of nonconforming product
because devices used to make measurements or

monitor process performance or product conformance

are inappropriate for making the measurement, not
accurate, unstable, or damaged
Implementation Tips
• 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
• Where there are measurements (for example, if actual
values are determined and compared to a specification
either by people using the equipment or automati-
cally by the equipment itself), the equipment 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
• Consider outsourcing metrology activities (see
clause 4.1) if sufficient professional metrology
personnel are not available internally
• Consider using a calibration laboratory that operates in
conformity to ISO 10012 or ISO 17025 for outsourced
calibration work

7.6 Control of Monitoring and Measuring Devices 109
• 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 acceptance of nonconforming
product
■ Actions to be taken to correct the measuring
equipment
• Consider the controls appropriate for simple devices
that normally 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
product to specified requirements?
• Are monitoring and measurement devices used to
ensure measurement capability?
• 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 is not
possible, since no standards exist?
• Are monitoring and measurement devices safe-
guarded 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?
• Is the software used for monitoring and measurement
of specified requirements confirmed as to its suitability
before use?

8 Measurement, Analysis and Improvement, 8.1 General 111
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 product, to ensure conformity
of and to continually improve the effectiveness of the quality
management system.
This includes determination of the methods and techniques
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 man-
agement system (see clauses 4.1 and 5.4.2)
• Think about the measurement and control
needs for product realization processes (see
clause 7.1)
• Use process mapping and flowcharting
1 2 to integrate measurement, analysis, and
improvement activities into flowcharts devel-
oped to support clauses 4.1 and 7.1
• Decide what you need to know about pro-
cesses and products to ensure conformity of
product and to make certain you meet your
quality objectives
• Define the key indicators of performance for
the products and processes that will help
you understand your progress toward reach-
ing 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 product conformity and aspects related to
meeting your quality objectives

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

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Analysis of data (8.4)
• 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 product 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 what methods will be used to get this information, but
methods must be established.
Why Do It?
• To understand customers’ perceptions related to your
products 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

8.2 Monitoring and Measurement, 8.2.1 Customer Satisfaction 115
Examples of sources of customer

satisfaction Information
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Implementation Tips
• Decide what information you will monitor, how you will
get that information, and how you will use it
• Consider that to demonstrate compliance in regulated
markets, it may be sufficient to monitor customer
reports of product deficiencies
• Consider using focus groups and surveys of product
users
• If you manufacture products for other companies,
consider face-to-face interviews with the individu-
als who make key buying decisions in customer
organizations

• Understand the distinction between monitoring and

measurement; monitoring usually provides less infor-
mation than measuring
• 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 quality function deployment (QFD) and
voice of the customer techniques
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

• 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
• 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?

8.2.2 Internal Audit 119
■ Are required processes implemented, controlled,

maintained, and improved?
■ 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
• 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
regard to the status and importance of areas to be
audited?
• Does the organization plan the audit program with
regard to 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 audits and auditors?
• 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 121
8.2.3 MONITORING AND

MEASUREMENT OF PROCESSES

Appropriate methods are required for monitoring and mea-
suring 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, correction and corrective action need to be taken,
as appropriate.
Why Do It?
• To ensure that all processes of the quality manage-
ment system are performing to expectations
• To ensure that processes critical to achieving quality
objectives are controlled and improved
• To ensure that processes are controlled and
improved, and provide product that meets customer
requirements
Implementation Tips
• Include, as appropriate, the management responsibility
processes, the resource processes, and the measure-
ment 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; focus on processes critical to meeting
quality objectives and providing conforming
product
• Choose carefully and wisely those
processes to be measured; don’t try to
measure everything
• Use data from histograms, statistical sam-
6 10 pling, and process capability studies, where
it is available, to help determine which
11 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
• When product realization process problems
or upsets occur, take action to ensure that
product requirements are met until process
capability is restored
• 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 monitor and measure
these key processes?
• Can the key requirements for controlling pro-
duction 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

The characteristics of the product must be monitored and
measured to verify that product requirements have been met.
This needs to be carried out at appropriate stages of the prod-
uct realization process in accordance with the arrangements
defined during planning required in clause 7.1.
Evidence of conformity with the acceptance criteria needs
to be retained. Also, records need to indicate the person(s)

authorizing release of product, that is, who authorizes ship-

ment of the product.
Product release to the customer is contingent on the
completion of all planned arrangements, unless otherwise
approved by a relevant authority and, where applicable, by
the customer.
Why Do It?
• To ensure that products conform to specified
requirements
• To maximize the probability of having satisfied, or even
delighted, customers
• To minimize or eliminate internal scrap and rework
Implementation Tips
• Consider all measurement activities that may be
needed during the various aspects of product realiza-
tion, including design verification and validation, and
qualification of purchased parts/material, as well as
activities related to all production processes

8.2.4 Monitoring and Measurement of Product 125
• Consider using statistical sampling and

10 11 process capability studies
• Consider the use of statistical process
control (SPC), control charts, and Six Sigma
tools
• Involve people working in the various
affected areas (including test engineers,
design engineers, production engineers,
quality engineers, production employees,
and so on) in the planning
• Address product measurement during
design review(s) to ensure that problems
are resolved before production starts

• Does the organization monitor and measure product char-
acteristics to verify that product requirements are met?
• Does the organization monitor and measure product
characteristics at appropriate stages of the product
realization process?
• Is there objective evidence that acceptance criteria for
product have been met?
• Do records identify the person authorizing release of
the product?
• Are all specified activities performed before product
release and service delivery?

• If there are instances in which all specified activi-

ties have not been performed before product release
or service delivery, has a relevant authority or, as
appropriate, the customer been informed and approved
of the action?
8.3 CONTROL OF NONCONFORMING PRODUCT

A documented procedure is required to describe the controls
and related responsibilities and authorities for dealing with
nonconforming product. This procedure is intended to ensure
that product that does not conform to requirements is identi-
fied and controlled to prevent its unintended use or delivery.
Disposition of nonconforming product can include elimi-
nating the detected nonconformity or authorizing its use,
release, or acceptance under concession by a relevant author-
ity and, where applicable, by the customer, or taking action to
preclude its original intended use or application. When non-
conforming product is detected after delivery or after use has
started, action appropriate to the effects, or potential effects,
of the nonconformity needs to be taken.
When nonconforming product is corrected, it needs to
be subject to reverification to demonstrate conformity to the
original requirements.
Records of the nature of nonconformities and any subse-
quent actions taken, including concessions obtained, need to
be maintained.

8.3 Control of Nonconforming Product 127
Why Do It?
• To prevent unintended use or delivery of product that
does not conform to requirements
• To ensure that there is an appropriate review of
nonconforming material so that decisions about its
disposition are made and documented
Implementation Tips
• Consider how nonconforming product can be pre-
vented from inadvertent use by identification, segrega-
tion, location, or other methods.
• Define who (by job function) has the authority for
approval of each type of disposition; for example:
■ A “use as is” disposition might be approved only by the
engineering manager (since such a decision is effec-
tively a “change in design” with liability implications).
■ A rework or scrap disposition may be approved by
manufacturing management.
• 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, in case of product failure or customer dispute).

• Is there a documented procedure to ensure that prod-
uct 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 product has been detected after
delivery or after use has started?
• Is it required that any proposed rectification of non-
conforming product 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 product?
• Are concessions obtained from customers as
appropriate?
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-

8.4 Analysis of Data 129
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 product requirements (see clause 8.2.4); char-
acteristics and trends of processes and products, including
opportunities for preventive action (see clauses 8.2.3 and
8.2.4); and information relating to suppliers (see clause 7.4).
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 organization should func-
tion 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 the use of commercially available
software to alleviate the tedious aspects of
data analysis
• Focus data analysis on areas important to
5 7 achieving the quality objectives; use trend
and Pareto charts
• Understand the information contained in the
data; for example:
■ Customers may be delighted even though
the product is nonconforming
■ Customers can be highly dissatisfied
with product that fully conforms to
requirements
■ Identifying the things important to the
customer that are causes of dissatisfaction
offers an opportunity to change require-
ments to reflect actual customer needs
■ Understand the effects of variation;
6 11 consider using histograms and process
capability studies
■ Consider using statistical process control
(SPC), control charts, hypothesis testing,
regression analysis, and other statistical
tools

8.5 Improvement, 8.5.1 Continual Improvement 131

• 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 product
requirements?
provide information on characteristics of processes,
products, and their trends?
provide information on suppliers?
8.5 IMPROVEMENT
8.5.1 CONTINUAL IMPROVEMENT

Continual improvement of the effectiveness of the qual-
ity management system is required through the use of the

quality policy, quality objectives, audit results, analysis of

data, corrective and preventive actions, and management
review.
Why Do It?
• To become more competitive
• To survive
• To operate more effectively
• To improve the ability to meet customer
requirements
Implementation Tips
• Include in the quality policy a commitment to
14 continual improvement and teach everyone in the
organization the basics of improvement
• Set quality objectives with improvement in mind
• Ensure that top management uses manage-
ment 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

8.5.2 Corrective Action 133

• Does the organization plan and manage the processes
necessary for the continual improvement of the quality
management system?
• 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 correc-
tive action. Corrective actions should be appropriate for the
effects of the nonconformities encountered.
A documented procedure is required to define require-
ments for reviewing nonconformities (including customer
complaints), determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities
do not recur, determining 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 or customer dissatisfaction
• To continually improve your quality management sys-
tem’s effectiveness in meeting customer requirements
• To avoid the costs that would be incurred if nonconfor-
mities continue
Implementation Tips
• Process mapping and flowcharting can be
1 2 useful in identifying problems that impact
on meeting quality objectives
• Evaluate the need to take corrective action
7 so that resources are devoted to the most
important problems; if a 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
• In some cases, action may be neither
required nor appropriate
13 • Use problem-solving techniques

• Use cause-and-effect diagrams or other
12 tools to determine causes
• Strive to “institutionalize” corrective action
using appropriate training, changes to docu-
ments, follow-up, and internal audit

8.5.3 Preventive Action 135
• 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 very
serious consequences
Implementation Tips
• Make a sharp distinction in your system
between corrective action and preventive
action
• Flowcharting and process mapping 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

8.5.3 Preventive Action 137
• Consider performing failure modes and effects

8 analysis (FMEA) in the design stage for new prod-
ucts, new processes, and new equipment
• Consider performing reliability analyses to make
9 component reliability tradeoffs
• Consider fault tree analyses, availability analysis,
and potential problem analysis
• Consider data analysis of other areas of the orga-
nization 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 noncon-
formity to prevent other potential similar situations;
ask “where else” could a similar problem occur
• Use preventive action where it is most effec-
tive: during product 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
manufacturing processes. The amount of detail included in
the description 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 ISO 9001:2008
number Tool clause reference
1 Flowchart 4.1, 5.4.2, 7.1, 7.3.1,
7.5.1, 8.1, 8.5.2, 8.5.3
2 Process mapping 4.1, 4.2.1, 5.4.2, 7.1,
7.5.1, 8.1, 8.5.2, 8.5.3
3 Brainstorming 4.1, 5.3, 5.4.1
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 Reliability analysis 7.3.1, 7.3.4, 7.3.5, 7.3.6
10 Sampling inspection 7.3.5, 7.3.6, 7.4.3, 7.5.1,
8.2.3, 8.2.4
11 Process capability studies 7.5.1, 7.5.2, 8.2.3, 8.2.4, 8.4
12 Cause-and-effect diagram 8.5.2
13 Problem solving 8.5.2
14 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 manufacturing a subassembly.
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 product 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 ben-
eficial to involve individuals with intimate knowledge of the
process being flowcharted 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
outputs 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 flowcharting 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. Show which function or depart-
ment is responsible for each step in the process.
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 process-
ing 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 assembly process where installation of
one component is difficult. 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 variation of the mating
parts to understand how to eliminate the assembly
difficulty.
• 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

Tool 2: Process Mapping 147
do not meet the target or the process has never met

expectations. For example, the production of an engine
part may have a cycle time of several weeks due to the
time required to correct defects at many stages in the
process. If the process exhibits characteristics such
as these, consider reengineering the process using a
“clean sheet” approach with out-of-the-box thinking
or the application of new technology. In this example, a
capital project may be developed to apply new produc-
tion technologies that reduce defects to near zero and
cut cycle time to a few hours.
• Opportunities for preventive action. In investigating
opportunities for preventive action, one could ask,
“what could go wrong?” and apply preventive mea-
sures as appropriate. For example, look for opportuni-
ties to prevent major equipment failures that could
cause costly defects or downtime.
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. Flexibility
is also important; remember that processes that were unim-
portant 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 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 1:18:04 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 1:18:04 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.
Yield %
Up is good
Trend
Time
Run chart for process yield

Percent rejected
Down is good
Trend
Time
Run chart for percent rejected
Where Is It Used?
Run charts are often used to track trends in process yields or
defects. They are used anytime it is useful to visualize trends
over time. Some common uses include:
• Trending percent defective or rejected
• Trending parts per million defective or rejected
• Trending capability of a process
• 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 diameters of parts in production sequence
Diameters of part no. 12-734
Run chart
No. of
occurrences Measured diameter
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 1:18:05 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 percent
defective for a product, and an associated Pareto chart may
show the defect types. The data from a run chart of product
measurement may be analyzed using a histogram. The same
data from the example of the run chart for diameters of a part
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. They can be excellent tools to perform root
cause analysis.

Tool 6: Histogram 157
Histogram
20
Number of occurrences
16
12
0
17.371– 17.373– 17.375– 17.377– 17.379– 17.381– 17.383–
17.372 17.374 17.376 17.378 17.380 17.382 17.384
Diameters for part no. 12-734
Note: The data in this example are the same as were used in the run chart tool
example.
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, mark-
ing an X for each occurrence of each value (the
example shown uses the data from the run chart
tool example)

158
Worksheet
Histogram worksheet
Tolerance No. of occurrences Cell Number of occurrences
Chapter Four Tools
17.383–17.384
17.382
X
4 X X X
17.381–17.382
X X X X
11 X X X X X X X
17.379–17.380
X X X X X X X X X X
18 X X X X X X X X
17.377–17.378
Diameter
17.377
X X X X X X
11 X X X X X
17.375–17.376
X X X X
6 X X
17.373–17.374
17.371–17.372
11/11/09 1:18:05 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 defects
50
40
30
20 A B C D E F
10
0
Types of defects (March)
A Too long D Wrong thickness
B Too short E Wrong marking
C Burrs F Wrong label

Tool 7: Pareto Chart 161
Where Is It Used?
Pareto charts are often used for analytical purposes to identify
the most frequently occurring defects or the most important
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 defects found in a product over
a given period of time
• Analysis of potential causes of a particular problem
• Analysis of the cost of various problems or defect types
• 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 non-
conformities. To prepare the chart, simply define the appro-
priate categories (for example, types of defects) and count
the number of each for the period under consideration. Plot
the data for each category in order of frequency. Select a
scale for the vertical axis of the graph that will best display
the data.
Cautions
In using the data to make decisions, remember that a Pareto
chart of defect types 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: product FMEA and
process FMEA. It is also 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).
How Is It Done?
Typically during the design phase of a product development
project, a designer or a team examines the product or system
or subassembly being designed and considers all the ways
that failure could occur. Schematics and block diagrams are

Cause(s)
Function Potential of
Part/ of part/ failure potential Action to be
Severity
Probability of
occurrence
Detectability
Risk priority
process process mode Effect failure taken
Thermo- Deter- Loses System Corrosion 9 3 9 243 High tempera-
couple mines continu- continually ture cutoff
(product) tempera- ity (open calls for heat
ture circuit)
Battery Provides Loss of Shuts off Degrades 9 9 9 729 Weak battery
(product) power power heat alert signal
Contacts Closes/ Fails to Erratic Corrosion 5 5 8 200 Gold plate
(product) opens close or temperature contacts
heating open circuit reading
circuit
Wall Holds Falls off Thermostat Corrosion 1 1 9 9 None
screws thermostat wall falls off wall
(product) on wall
Tool 8: Failure Modes and Effects Analysis
Home thermostat FMEA.

163
11/11/09 1:18:05 PM
frequently used. During development of new processes, pro-

cess engineers often use a similar thought process. In either
case, each potential failure is listed in an FMEA table and ana-
lyzed as follows:
• 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 mini-
mize the impact of potential failures with the highest priority.
Cautions
FMEAs can become very cumbersome if every single compo-
nent 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 use-
ful to other activities in an organization. Product FMEA out-
puts should be shared with organizations performing product
safety, maintainability, and serviceability related duties. Pro-

Tool 9: Reliability Analysis 165
cess FMEA results should be shared with organizations that

will operate and maintain the processes.
TOOL 9: RELIABILITY ANALYSIS
What Is It?
Reliability analysis is the study of how a component, sub-
assembly, assembly, product, or system will perform under
stated conditions over time.
Where Is It Used?
Reliability analysis is used primarily in the design phase of the
product life cycle and in the analysis of the failure of products
shipped to customers. It can also be used as a tool to improve
product performance after product release, as an element of
supplier selection, and as a tool to measure product perfor-
mance during manufacture (for example, environmental test-
ing of products at the extremes of specified temperature prior
to shipment).
How Is It Done?
There are many excellent books that address the field of reli-
ability analysis. The tools and techniques are many and varied,
for analysis of both electronic and mechanical subassemblies,
assemblies, products, or systems. Reliability analysis is usu-
ally conducted by reliability engineers specially trained in this
field. The purpose of this description of reliability analysis is
to direct the reader to one of the many reference sources for

reliability (see, for example, Patrick O’Connor, Practical Reli-

ability Engineering, fourth edition [Chichester, West Sussex,
England: John Wiley and Sons, Ltd., 2002] or M. L. Shooman,
Probabilistic Reliability—An Engineering Approach [New York:
McGraw-Hill, 1965]) or to recommend that a reliability engi-
neer be involved in analysis of problems or issues related to
the performance of products over time.
Cautions
Reliability analysis is certainly a science, but there are many
assumptions that typically must be made that can dramatically
influence the outcome of any analysis. Assumptions must be
made cautiously. Also, reliability decisions are not made in a
vacuum. There are usually cost and performance trade-offs
to be made, and such trade-offs need to be evaluated in the
context of the objectives of the organization, considering the
inputs from all concerned functions, including manufacturing,
sales, service, marketing, finance, test, and purchasing, in
addition to engineering and quality.
TOOL 10: 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 following table lists several International Standards
that describe general sampling concepts and the terminology
involved.

Tool 10: Sampling Inspection 167
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.

Where Is It Used?
Sampling inspection may be used for many purposes during
hardware procurement, production, and delivery. Examples
include:
• Sampling of incoming product
• Sampling during in-process inspection
• Sampling to ensure conformity of the final product
How Is It Done?
There are many documents available that provide instructions
for sampling inspection. There is a wide variety of sampling
plans developed to suit numerous conditions found in actual
application. The table on pages 169–172 lists some of the
national and International Standards available. The most com-
monly 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.

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. ( Continued )

Type of
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 pro-
cedures based on the alloca-
tion of priorities principles
(APP)—Part 2: Coordinated
single sampling 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
Some of the ISO statistical sampling standards (continued).

ISO 21247:2005 Combined accept-zero

sampling systems and pro-
cess control procedures for
product acceptance
Attributes ISO 8422:2006 Sequential sampling plans
sampling for inspection by attributes
(sequential)
Variables ANSI/ASQ Z1.9- Sampling Procedures and
sampling 2008 Tables for Inspection by
Variables for Percent Non-
conforming
ISO 3951-1:2005 Sampling procedure for
inspection 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
and 3951-2/PRF inspection by variables—
and 1 Part 2: General specification
for single sampling plans
indexed by acceptance qual-
ity limit (AQL) for lot-by-lot
inspection of independent
quality characteristics
Part 3: Double sampling
schemes indexed by ac-
ceptance quality limit (AQL)
for lot-by-lot inspection
( Continued )

Type of
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
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
Some of the ISO statistical sampling standards (continued).

Tool 11: Process Capability Studies 173
This table gives some of the simplest options available

in national standards and International Standards, but many
other sources of sampling plans exist. The required standard
for sampling may be specified by 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 11: PROCESS CAPABILITY STUDIES
What Is It?
A process capability study is a statistical technique for deter-
mining the behavior of a process, including the people involved,
the machines, the materials, and the methods used. Process
capability studies can be performed on simple processes—
for example, the manufacture of a machined part or an entire
assembly, or even on an entire production operation, such as
the manufacturing of an automobile—although the common
application is on a part, a subassembly, or an assembly. The
objective of a process capability study is to determine the
natural behavior of a process and to understand what, if any-
thing, needs to be changed to achieve the desired results. For
example, if a process capability study indicates that a milling
machine is capable of holding a tolerance of ⫾.003 inches but
the specified tolerance is ⫾.002 inches, then corrective action

of some kind is needed (such as changing the tolerance or the

machine used or both, or other creative actions).
Where Is It Used?
Process capability studies can be used to address many dif-
ferent kinds of problems in manufacturing, inspection, testing,
management, or engineering. Such studies can be used just
about anywhere it is important to understand the nature and
behavior of the distribution of the output of a process.
How Is It Done?
Entire books have been written to describe how to perform
process capability studies. Here we can provide only a very
general and brief overview. Performing a process capabil-
ity study typically follows the scientific method: (1) conduct
an experiment to gather data from the process; (2) make a
hypothesis about the process from the data gathered, for
example, that the data exhibit only natural variation; (3) test
the hypothesis by using statistical techniques to interpret
the data (for example, plot the data on a control chart) to
understand and separate normal variation and special cause
variation; (4) change the process if necessary, based on the
interpretation of data, and continue performing experiments
until the process is operating in a way that consistently pro-
duces parts within specification at an acceptable cost.
This treatment of process capability studies is intended
only to expose the fact that there are a variety of techniques
available to perform capability studies of processes that can
be powerful tools in achieving conformance to requirements,
customer satisfaction, and cost control. Further study would

Tool 12: Cause-and-Effect Diagram (Fishbone/Ishikawa Diagram) 175
be necessary to effectively apply such techniques in a manu-

facturing environment.
Cautions
Gathering and interpreting the data obtained when conduct-
ing a process capability study can be tricky. Care needs to be
taken in measuring; the data collected must be representative
of the process performance (for example, different shifts, dif-
ferent operators); control chart construction can be tedious;
patterns of variation can be difficult to discern. If one is new to
the art and science of conducting process capability studies, it
is advisable to solicit advice and counsel from an experienced
practitioner in the organization, who can typically be found in
QA or engineering.
TOOL 12: CAUSE-AND-EFFECT DIAGRAM

(FISHBONE/ISHIKAWA DIAGRAM)
What Is It?
A cause-and-effect diagram shows the relationship between a
characteristic or an output of a process and its potential cause
factors. The cause factors are organized into categories and dis-
played 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.

176
Materials Machines Methods
Worn tooling
Bar stock
Chapter Four Tools
Machine No control charts

quality PM schedule settings
Material handling Machine capability NC program Effect

Milling machine
Gages out of parts out of spec
Training
calibration
Not enough checks Experience
Measurements Man
11/11/09 1:18:06 PM
Tool 12: Cause-and-Effect Diagram (Fishbone/Ishikawa Diagram) 177
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. They are commonly used when per-
forming corrective action when a process is producing out-
of-specification product, when trying to understand the root
cause of a customer complaint, or when refining a manufac-
turing process to improve throughput.
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 for manufacturing processes, the major
cause factors are categorized 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

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 important
to involve all the individuals who can contribute to the iden-
tification of potential causes. In the milling machine example
given earlier, it may be appropriate to have manufacturing
engineers, machine operators, quality assurance engineers,
purchasing agents, materials engineers, and production
supervisors involved in an analysis of possible causes of the
problem.

Tool 13: Problem Solving 179
TOOL 13: 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,
problem solving is a critical tool for achieving effective cor-
rective action.
Where Is It Used?
Problem-solving techniques are generally appropriate:
• To correct causes of nonconformities in product
• To address and correct causes of customer complaints
• To address and correct situations that dissatisfy
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:

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 or its impact is large, consider a
pilot implementation
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

Tool 14: How to Conduct an Improvement Project 181
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. Following these steps, clearly defining the important
problems, and institutionalizing the changes required for
effective solutions are critical elements of effective problem
solving.
TOOL 14: 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
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
• Reduce defectives in a manufacturing process
• 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 placement
performance.

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 measure-
ment system to track the effectiveness of the newly
implemented process.
• 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 measure-

ment of effectiveness by review of the graphs of
actual placements compared with the goal and the
performance during the preceding 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.
187

188 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 189
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

190 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 191
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)

192 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 responsi-
bility 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 193
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.

194 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 195
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.

196 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 improve-

Glossary 197
ment approaches, reengineering is contrasted with incre-

mental improvement (kaizen).
Registrar Accreditation Board (RAB) U.S.: an organization
that evaluates the competency and reliability of regis-
trars (organizations 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.

198 Glossary
run chart: a line graph showing data collected during a run

or an uninterrupted sequence of events. A trend is indi-
cated when the series of collected data points head up
or down.
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 primarily
for planning and managing are activity network diagram
(AND) or arrow diagram, affinity diagram (KJ method), inter-
relationship digraph, matrix diagram, priorities matrix, pro-
cess 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.

Glossary 199
statistical process control (SPC): the application of statisti-

cal techniques to control a process.
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.

200 Glossary
top management: person or group of people who directs and

controls an organization at the highest level.
total quality management (TQM): a term initially coined by
the Naval Air Systems Command to describe its manage-
ment approach to quality improvement. Total quality man-
agement (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, prod-
ucts, services, and the culture they work in. Total quality
management benefits all organization members and soci-
ety. 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 201
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 suggests 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?

202 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.
203

204 Additional Reading
ANSI/ISO/ASQC A3534-2-1993: Statistics—Vocabulary and Symbols—

Statistical Quality Control. Milwaukee, WI: ASQC 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 controls
of documents, 30–32
alignment, 12–13 of records, 32–35
analysis corrective actions, for nonconform-
of data, 128–31 ing products, 133–35
planning and implementing, customer communication, 73–74
111–14 customer focus, 7–9, 38–39
audits, internal, 117–20 customer property, safeguarding,
authority, defining, top managers 103–4
and, 45–46 customer service, monitoring and
measuring, 114–17
B
brainstorming, 148–49 D
data analysis, 128–31
C datapoints, determining number of,
cause-and-effect diagrams, 175–78 157–59
cells, determining number of, 159 design and development
commitment, management, 35–38 control of changes in, 87–88
communication inputs, 76–78
customer, 73–74 outputs, 78–81
internal, 48–50 planning, 74–76
competency, determining, 60–61 review, 81–83
continual improvement, 13–14, validation, 85–87
131–33 verification, 83–85
205

206 Index
documentation planning and implementing

controls, 30–32 process for, 111–14
quality manuals, 29–30 preventive actions, 136–38
of quality policies, 39–41 infrastructure, determining and
record controls, 32–35 providing necessary, 62–63
requirements, 27–28 internal audits, 117–20
internal communication, 8, 48–50
E Ishikawa diagrams, 175–78
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), 162–65
24–26
fishbone diagrams, 175–78
normative reference in, 23–24
flowcharts, 140–43
purpose of, 7–8
symbols for, 141
reasons for embracing, 1–4
scope of, 21–23
G
Gantt charts, 150–53 L
leadership, 15–16
H
histograms, 156–60 M
human resources
determining competencies of, management, systems approach
60–61 to, 9–11
requirement overview of, 58–60 management commitment, 35–38
training and, 60–61 management representatives, 16,
46–48
management review
I inputs for, 52–54
identification of products, 101–3 outputs, 54–56
improvement projects, conducting, requirement overview of, 50–52
181–85 managers. See middle managers;
improvements top managers
continual, 131–33 measurement
corrective actions, 133–35 for customer services, 114–17

Index 207
planning and implementing, validation of processes for,

111–14 98–100
of products, 123–26 products. See also nonconforming
of quality management system products
processes, 121–23 determining requirements related
measuring devices, control of, to, 68–70
106–11 identification of, 101–3
middle managers, benefits of ISO monitoring and measuring,
9001 system for, 2–3. See 123–26
also top managers planning realization of, 65–68
monitoring preservation of, 104–6
customer satisfaction, 114–17 purchasing information for,
planning and implementing 90–92
processes for, 111–14 reviewing requirements related
of products, 123–26 to, 70–73
for quality management system traceability of, 101–3
processes, 121–23 verification of purchased, 92–94
monitoring devices, control of, 106–10 property, customer, safeguarding,
103–4
N purchasing
information, for products,
nonconforming products. See also 90–92
products processes, controls for, 88–90
control of, 126–28
corrective actions for, 133–35
normative reference, 23–24
Q
quality management principles, 5–7
P quality management system, 11
involvement in, 16
Pareto charts, 160–62 quality management system plan-
personnel. See workers ning, 43–45
preventive actions, 135–38 quality management system
problem solving, 179–81 processes, monitoring and
process approach, 9–12 measuring, 121–23
process capability studies, 173–75 quality manuals, 29–30
process controls, 14–15 quality objectives, top managers
process mapping, 144–47 and, 41–43
production provision quality policies, top managers and,
control of, 94–98 39–41

208 Index
R commitment of, 35–38

customer requirements and, 8,
records, control of, 32–35 38–39
reliability analysis, 165–66 defining roles of personnel and,
resources, provision of, 56–58 45–46
responsibilities, defining, top internal communication and, 8,
managers and, 45–46 48–50
reviews, quality management planning quality management
system, 50–52 systems and, 43–45
run charts, 153–56 quality management system
reviews and, 50–52
S quality objectives and, 41–43
sampling inspections, 166–73 quality policies and, 39–41
scope, of ISO 9001:2008, 21–23 responsibilities of, 15–16
service provision. See also produc- traceability of products, 101–3
tion provision training, determining requirements
controlling conditions for provi- for, 60–61
sion of, 94–98 trend charts, 153–56
validation of processes for provi-
sion of, 98–100 W
symbols, flowchart, 141 work environments, determining,
system approach to management, 63–65
10–12 workers
benefits of ISO 9001 system
T for, 1–2
top managers. See also middle defining roles for, 45–46
managers roles of, 16
benefits of ISO 9001 system
for, 3–4

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Cracking the Case of ISO 9001:2008 for Service

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-

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ASQ Quality Press

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Library of Congress Cataloging-in-Publication Data

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

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

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

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

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• The ability to adjust processes when results are not

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Perhaps the most important reason for doing ISO 9001 is

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QUALITY MANAGEMENT PRINCIPLES

To lead and operate an organization success-

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Eight quality management principles have been

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mance should be a permanent objective of

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and preventing nonconformities have been fundamental to

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

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The system approach to management is basic to ISO

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Quality management system

In summary, the process approach is very generic and applicable

ALIGNMENT—QUALITY OBJECTIVES, PROCESS

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Clause 5.4.2 requires that the quality management system

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• Establishing and deploying measurable objectives at

PROCESS CONTROL TO FACILITATE LEARNING,

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controls are properly integrated into the organization’s pro-

LEADERSHIP AND INVOLVEMENT

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• Ensure that the quality management system is planned

All People in the Organization

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