I So Guidebook

T
T
h
h
e
e

I
I
S
S
O
O
9
9
0
0
0
0
1
1
:
:
2
2
0
0
0
0
0
0
G
G
u
u
i
i
d
d
e
e
b
b
o
o
o
o
k
k
R Ro oa ad dm ma ap p t to o W Wo or rl ld d- -C Cl la as ss s Q Qu ua al li it ty y
TM
The ISO 9001:2000 Guidebook

Rev 06/02. 2002 CONTRACT ASSEMBLY SOLUTIONS Division of P & M COMPANIES, INC. Page 2 of 12

The New and Improved ISO 9001 Standard

The dust has settled and copies of the newly revised ISO 9001 standard have landed on the
desks of management and quality professionals around the globe.

For those of us who lived through the earlier 1994 revision, it is apparent that the conversion to
the 2000 revision will not be as straightforward for organizations and auditors alike. Gone are
the good old days of merely ticking off the questions on the list and being satisfied that there is
a check mark in every box. Some quality professionals, organizations, and auditors will simply
not survive this conversion.

The new ISO 9001:2000 emphasizes a process approach. A process-based quality system
model, shown schematically below, has replaced the old familiar 20 element structure of the
1994 revision:

Measurement,
Analysis,
Improvement
Resource
Management
Product
Realization
Input
Output
Continual Improvement of the
Quality Management System
Customers
and other
Interested
Parties
Management
Responsibility
5
6 8
4
7
Product
Value-Adding Activities Information
Satisfaction
Requirements
Customers
and other
Interested
Parties
8
Measurement,
Analysis,
Improvement
Measurement,
Analysis,
Improvement
Resource
Management
Resource
Management
Product
Realization
Input
Output
Continual Improvement of the
Quality Management System
Customers
and other
Interested
Parties
Management
Responsibility
Management
Responsibility
5
6 8
4
7
Product Product
Value-Adding Activities Information
Satisfaction
Requirements
Customers
and other
Interested
Parties
8
The Process Approach


Within the context of ISO 9001:2000, the process approach includes the processes needed for
product realization, internal audit process, management review process, data analysis, and the
resource management process, among others. Requirements for these processes are stated in
Sections 4 (Quality Management System), 5 (Management Responsibility), 6 (Resource
Management), 7 (Product Realization) and 8 (Measurement, Analysis, and Improvement).

This process approach includes:

Identifying the processes necessary for the effective implementation of the quality
management system
Understanding the interactions between these processes
Documenting the processes to the extent necessary to assure their effective operation
and control

Clause 3.4.1 defines a process as a set of interrelated or interacting activities, which transforms
inputs into outputs. Inputs and outputs may be tangible and/or intangible. To perform activities
within the process, appropriate resources (equipment, personnel, materials, energy, information,
etc.) have to be allocated by management. A measurement system can be used to gather
information and data to analyze process performance and identify areas needing continual
improvement. The schematic below represents a process.

PROCEDURE*
(Specified way to carry out an activity or a
process - may be documented or not)
PRODUCT
(Result of a
process)
MONITORING AND
MEASUREMENT OPPORTUNITIES
(Before, during and after the process)
Output
Input
PROCESS
(Set of interrelated
or interacting activities)
EFFECTIVENESS
OF PROCESS =
Ability to achieve
desired results
(Focus of ISO
9001:2000)
EFFECTIVENESS
OF PROCESS =
Ability to achieve
desired results
(Focus of ISO
9001:2000)
EFFICIENCY OF
PROCESS =
Results achieved
vs resources used
(Focus of ISO
9004:2000)
EFFICIENCY OF
PROCESS =
Results achieved
vs resources used
(Focus of ISO
9004:2000)
(Includes
Resources)
* Note This is the definition of procedure given in ISO 9000:2000.
This does not necessarily mean one of the 6
documented procedures required by ISO 9001:2000


The standard has been reorganized to increase the emphasis in the following areas:

Planning
Customer satisfaction
Measurement and analysis of system effectiveness
Continual improvement

This is good news for those organizations that attempted to implement reality based quality
management systems that reflect and build upon actual business configurations and resources.
This is bad news for those who still cling to the approach that maintains a separation between
actual business practices and all of this stuff done to keep the certificate of registration hanging
in the lobby. The difficulty of your conversion will depend on which approach you have been
following.

The ISO (International Organization for Standardization), the governing body for the ISO
standards, is requiring all ISO-certified organizations to upgrade their quality management
systems to ISO 9001:2000 by December 15, 2003. Otherwise, certification may be withdrawn.
All new certifications are to the 2000 revision. In April 2002, ISO estimated that only 5% to 10%
of the more than 400,000 certified organizations had completed the upgrade to the 2000
revision.

For most organizations, the implementation deadline is achievable if they embark on a well-
organized project plan based on a thorough understanding of the standards requirements. The
effort necessary to effect the transition varies significantly from one organization to another.

So whats new? Lets look at the major changes in the 2000 revision.

Section 5 - Customer Processes

With regard to customer processes, the new standard requires management to:

Ensure customer needs and expectations are identified and converted into specific
requirements
Demonstrate its commitment to creating awareness of the importance of fulfilling
customer requirements, needs and expectations
Make employees aware of the importance of meeting customer requirements
Establish process(es) for customer communication
Implement a system for obtaining and using information on customer satisfaction

Together, these requirements demand that organizations expand their quality systems to all
departments and functions that deal with and represent customers. Typically, these departments
would include marketing, sales, customer service, billing and servicing.

New Emphasis Areas


Sections 5 and 8 - Continual Improvement

In the area of continual improvement, many of the elements supporting the continual
improvement cycle were already required in the previous editions of the standard. However,
now there is a new, stronger linkage among these elements and some new requirements as well:

Establish quality objectives and plan activities and resources needed to achieve these
objectives
Provide a framework for the development and periodic review of the quality objectives
Ensure managements commitment to meeting requirements and reviewing the quality
system on an ongoing basis
Collect and analyze data to determine effectiveness of the quality system
Establish a procedure for the use of the quality policy, objectives and quality-related
data and information to facilitate continual improvement

ISO 9001:2000 also includes new requirements pertaining to process control, measuring and
monitoring devices, training and awareness, internal communication, work environment, and
legal/regulatory requirements. Rather than being group into specific additional clauses, these
new requirements are spread throughout the standard and are often restated and expanded upon
under multiple sections. For example, requirements pertaining to process control are first
introduced in Section 5, are developed in two separate clauses of Section 7, and the restated in
Section 8.

What Happened to ISO 9002 and ISO 9003?

In the 2000 revision, ISO 9002 and ISO 9003 have been eliminated and their requirements
folded into ISO 9001. There will be no new certificates issued to ISO 9002 or ISO 9003 as the
December 15, 2003 implementation deadline draws near.

The newly revised ISO 9004:2000 still serves as an internal guide to the ISO 9001 requirement.
It is recommended that organizations spend the time to read ISO 9004. ISO 9004 uses the
same clause structure as ISO 9001 and provides insight into possible practices that can be
employed to meet the standards requirements. Remember, however, that your quality
management system will be assessed to ISO 9001, not ISO 9004.
With the elimination of ISO 9002 and ISO 9003, it now falls to your organization to
determine the applicability of the various requirements of ISO 9001:2000 to your
operations. Per Section 1.2, your exclusions are limited to requirements of Section 7
(Product Realization) and must be substantiated. Any exclusion may not affect your
organizations ability or responsibility to provide products that meet the requirements of
your customer(s) or applicable regulations.

Other Changes


ISO 9001:2000 has significantly reduced the documentation requirements as compared with the
1994 revision. It also allows much more flexibility in the way in which an organization chooses to
document its quality management system, thus permitting the minimal amount of documentation
needed in order to demonstrate the effective planning, operation, control and continual
improvement of its processes.

What is a document? In ISOs view, the primary objectives of an organizations documentation
is:

Communication of information,
Evidence of conformance, and
Knowledge sharing.

Documents your company employs in its quality management system may be in any form or type
of medium, including but not limited to:

Paper
Magnetic
Electronic or optical computer disc
Photograph
Master sample

ISO 9001:2000 Quality Management System documentation

is generally composed of four key
elements:

Quality Manual,
Standard Operating Procedures (SOPs),
Work Instructions (WIs), and
Forms/Records.

The Quality Manual is the "roadmap" to your quality management system and addresses every
ISO 9001 requirement. Standard Operating Procedures (SOPs) that form Level 2 of your
companys quality system pyramid describes specific steps to comply with the standards primary
requirements. Level 3 consists of Work Instructions (drawings, test procedures, assembly
instructions, etc.), which describe in detail how a particular task is performed. Forms/Records
are the basis for documenting the activity of your companys quality management system.

For ease of use, the Quality Manual is generally organized into eight major sections following the
structure of the current ISO standard. Individual SOPs describe specific steps your company
must perform to comply with the ISO 9001 standard. ISO 9001:2000 specifically requires only
six (6) documented procedures. Your company may elect to have many other procedures
depending on its size, process complexity or personnel competence. Detailed Work Instructions
form the basis of your companys day-to-day operations and will likely account for most of the
documents in your quality management system. ISO 9001 does not specifically mandate any set
of Work Instructions. Forms/records document specific activities, which take place. ISO
9001:2000 specifically requires twenty one (21) records.

ISO 9001 Documentation Basics


The following table serves as starting point to illustrate the documents generally employed for
ISO 9001 compliance. Note: your company may not use all of the documents cited or may need
to use additional documents. Documents highlighted in red are specifically required by the
standard.

Quality Manual Specifically Required by
ISO 9001:2000
Quality Manual ?

SOPs
Document Description

Quality Management System - General
Quality System Documentation
Reserved for future use
Control of Documents ?
Control of Records ?
Management Commitment
Customer Focus
Quality Policy
Quality Objectives
Quality Management System Planning
Responsibility & Authority
Management Representative
Internal Communication
Management Review
Resource Management
Training
Infrastructure
Work Environment
Product Realization Planning
Contract Review
Customer Communication
Design Control
Purchasing
Verification of Purchased Parts
Process Controls
Process Validation
Identification and Traceability
Customer Property
Preservation of Product
Control of Monitoring & Measuring Devices
Customer Satisfaction Monitoring
Internal Audits ?
Process Monitoring & Measurement
Product Monitoring & Measurement
Control of Nonconforming Product ?
Data Analysis
Continuous Improvement
Corrective Action ?
Preventive Action ?



ISO 9001:2000 poses significant challenges and advantages with respect to implementation.

If you are planning a new quality system implementation, the newly revised standard provides
an excellent framework upon which to build an effective QMS. The reduce documentation
requirements, as compared with the 1994 revision, will likely translate into fewer overall
documents to author, maintain and control. And without the existing infrastructure built around
the previous standard, you do not have the confusion associated with a conversion.

Organizations already certified to ISO 9000:1994 face a more difficult task of upgrading their
existing systems and processes to meet the new standard. Here are ten tips to help you
navigate from the old standard to the new one without getting lost along the way:

1. Under st and t he new and c hanged r equi r ement s

Obtain copies of the ISO 9000:2000 family of standards. These include ISO 9001:2000, ISO
9000:2000, and ISO 9004:2000. Before opening ISO 9001:2000, review the quality concepts
found in ISO 9000:2000. Look up any terms you are unsure of in Section 3 of ISO 9000:2000.

Next, read through ISO 9004:2000, which provides guidance on performance improvements
beyond the basic requirements of ISO 9001. The ISO 9001 requirements are highlighted for
ease of identification in ISO 9004. This is a good place to gain a better understanding of the
requirements by seeing possible practices.

Next, refer to Annex B of ISO 9001 to see the clause correlation between the 2000 revision and
the 1994 revision.

2. Det er mi ne t he QMS sc ope and any ex c l usi ons

ISO 9001:2000 is intended to be generic (applicable to all organizations regardless of size,
product/service type, etc). However, ISO recognizes that not all requirements will be applicable
to all organizations under all circumstances. Thus, you can take exclusions if you can justify
them. These exclusions are limited to requirements in Section 7, Product Realization. [This is
precisely the advantage ISO 9002:1994 offered to organizations without design control
activities.]

Defining your systems scope involves deciding on which products and sites will be included in
your registration. If you analyze what your organization does and find that you cannot apply a
product realization requirement from Section 7, you may define and justify an exclusion in your
quality manual. Remember that you cannot avoid the requirements of Section 7 by simply
outsourcing your design activities to an outside organization.

3. Adopt t he pr oc ess appr oac h

Implementation Tips


The process approach promoted by ISO 9001:2000 systematically identifies and manages the
processes that make your quality system work and their interactions. This process model is
based on the Plan-Do-Check-Act cycle (PDCA) which can be applied to all processes. A
schematic of the PDCA cycle applied to a QMS is shown below:

Remember that your QMS must describe these interacting processes. Many companies have
already migrated to the use of process maps to define and document these interactions.
Although process maps are not required by the standard, you are encouraged to investigate their
use and applicability to your QMS documentation approach.

4. Revi se/c r eat e your syst em doc ument at i on

Documentation for a conforming QMS must include the quality policy, quality objectives, quality
manual, required procedures and any other documented deemed necessary for the effective
operation of the quality management system. These may include work instructions, records,
forms, manuals, etc.

You may already have most of the required documentation in place for the new standard,
whether you have ever looked at ISO 9001 or not, particularly if you have been working to a
military quality requirement, an FDA requirement, or just following industry best practices.
Organizations already registered to an industry-specific standard such as TL9000 or QS9000
may find that many of the new requirements in ISO 001:2000 are already addressed in their
documentation.

What ISO 9001:2000 does not tell you is how to all your systems information should be
documented. In one respect, this is preferred, as it allows variation in documentation methods
between organizations based on existing practices, industry-specific norms, product types,
processes, and the like. On the other hand, it leaves the documentation method open to much
Plan
What to do?
How to do it?
Do
Do what was
planned
Check
Did things happen
according to plan?
Act
How to improve
next time?
Establish the
objectives and
processes
necessary to
deliver results in
accordance with
customer
requirements and
the organization's
policies.
Implement the
process(es).
Monitor
and measure
processes and
product against
policies,
objectives and
requirements
and report the
results.
Take actions to
continually
improve
process
performance.


interpretation and concern. As a general rule, avoid creating overly complex documents which
will be hard to maintain and control later in actual practice. Use the implementation/conversion
effort as an opportunity to examine your present documentation for the right level of detail,
useable formats and overall business value.

As you review your existing documents, consider the use of electronic media for easier, more
widespread access and better document control. Process mapping will also help to identify the
truly critical documentation for your system.

5. Foc us on management s ex panded r ol e

ISO 9001:2000 defines top management as the person (or group of people) who directs and
controls an organization at the highest level. Obviously, their commitment, leadership and
active participation are crucial to implementing an effective QMS. And ISO 9001:2000
recognizes this fact through an increase emphasis on top managements role.

Review the new (and existing) duties with your top management and explain the expected
benefits for the organization. You must stress that top managers must be willing to actively
participate in the implementation/revision process if it is to be successful.

6. Est abl i sh measur abl e qual i t y obj ec t i ves

Your organization needs to define key quality measures for evaluating the performance of the
QMS. First, use the quality policy statement as a framework for establishing your process and
product goals. Then, set specific, measurable targets on the path to attaining these goals.

Product objectives will be largely determined by your product specifications. Focus first on the
process objectives and the methods you will use to measure process performance. See Clause
5.4.1 on quality objectives.

Provide the necessary resources to collect the product and process data. Analyze the data, as
called for in Clause 8.4, and use the facts for continual improvement efforts and better decision-
making. Remember that while an efficient system is desirable, the standard only requires an
effective system. Keep this subtle point in mind as you set your quality objectives.

7. Pr epar e t he t r ansi t i on pl an

To form the transition plan, assess the current system against the requirements of the new
standard using a gap analysis. This gap analysis will help to identify any missing processes,
practices, and/or documentation. From this effort, it will be easier to determine the amount and
type of resources necessary to complete the missing deliverables. The elapsed time to complete
these efforts can also be determined.

You will need to coordinate the assessment of your revised QMS with your registrar. [If this is a
new implementation, this is good time to start looking into selecting an appropriate registrar.]
You may elect to have your revised system assessed by the registrar all at one time or phase it
in over several assessment visits to minimize its impact and possible reduce your registrar costs.
Registrars will want to see several months of operation under your new system before
conducting a certification audit. You will need to collect records as evidence that your system is
operating effectively and as planned.



If you are already registered to the 1994 standard, you will need to maintain conformity during
the transition period to keep your current certificate in effect. Therefore, you cannot drop any
existing practices not required by ISO 9001:2000 until after you obtain your new registration.
Your entire transition planning effort is covered under Clause 5.4.2 of ISO 9001:2000 and is
therefore subject to audit by the registrar, so be sure to have objective evidence of your planning
available.

8. I nf or m t he or gani zat i on of c hanges and pl ans

Communicate, communicate, communicate! It is vitally important to keep everyone in your
organization informed of your plans and your progress. Clause 5.5.3 of ISO 9001:2000 requires
the establishment of internal communication channels to share information about your QMS
effectiveness.

Providing this information will involve all employees in helping to improve performance and
meet established objectives for their areas. Remember to actively encourage feedback.

9. Updat e t he i nt er nal audi t pr ogr am

Your internal audit program (whether new or revised) should focus on the areas with new and
changed practices. In addition, the audit procedure must be updated to comply with the
requirements of Clause 8.2.2.

Do not overlook the need to train your internal auditors to the new standard. They need to
understand how the new clause structure and requirements will affect their audit plans. Instead
of auditing by clause, your organization may decide to audit by process or functional area.

Auditors need to consider the new audit trails demanded by the new standard and begin to
anticipate the expect evidence that documents conformance with requirements. You can contact
the Registrar Accreditation Board (RAB) for approved training courses for certified auditors.

10. I dent i f y ar eas f or c ont i nual i mpr ovement

According to Clause 8.5.1, your organization must continually improve the effectiveness of its
quality management system through its quality policy, quality objectives, audit results, data
analysis, corrective and preventive actions, and management review.

Management should continually seek to improve process effectiveness rather than wait for
problems to reveal opportunities for improvement. When a problem does occur, the root
cause(s) must be determined and a corrective action taken to prevent its recurrence.


CAS-Contract Assembly Solutions is a manufacturing services provider
specializing in process consulting, production services and outsourcing
strategies.
Our ISO 9001 services include:
New system design and implementation
Upgrades from 1994 to 2000 revision
Internal auditor training
Continuous process improvement training
Statistical process control training
Root cause analysis, problem solving and corrective action training

CAS can provide a complete custom quality management system or work
with your internal team on a consulting basis to guide them through the
necessary steps.

With over 20 years of quality management systems experience, look to
CAS to put your organization on the road to world-class quality.

Contact CAS today. Visit our website at www.pandmco.com or call
724.625.4667 or e-mail us at cas@pandmco.com.

2002 by CONTRACT ASSEMBLY SOLUTIONS Division of P & M COMPANIES, INC.
All rights reserved. No part of this manuscript may be reproduced in any form or by any means,
electronic, mechanical, photocopying, recording, or otherwise, without prior permission.
About Contract Assembly Solutions

I So Guidebook

Încărcat de

Informații document

Descriere originală:

Titlu original

Drepturi de autor

Formate disponibile

Partajați acest document

Partajați sau inserați document

Opțiuni de partajare

Vi se pare util acest document?

Este necorespunzător acest conținut?

Drepturi de autor:

Formate disponibile

I So Guidebook

Încărcat de

Drepturi de autor:

Formate disponibile

T

S-ar putea să vă placă și