Guide To ISO 9001:2000

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HB90.12000
The Small Business Handbook
Guide to ISO 9001:2000
The Small Business Handbook

Guide to ISO 9001:2000
COPYRIGHT
Standards Australia International
All rights are reserved. No part of this work may be reproduced or copied in any form or by
any means, electronic or mechanical, including photocopying, without the written
permission of the publisher.
Published by Standards Australia International Ltd
GPO Box 5420, Sydney, NSW 2001, Australia
ISBN 0 7337 3697 1
HB 90.1 2000
PREFACE
This Handbook, designated HB 90.1, has been written to provide guidance to
small businesses on the interpretation and implementation of ISO 9001:2000.
It is both a revision of, and a replacement for, HB 66:1996 which was the
Australian adoption of the ISO Handbook ISO 9000 for Small Businesses
What to do Advice from ISO/TC 176. This ISO Handbook, in turn, was
based on the second edition of HB 66:1995, Quality Assurance Explained A
Handbook for small business, developed and published by Standards
Australia. (The initial version of HB 66 was published in 1994).
This Handbook also replaces the Interim version, published as
HB 66(Int):2000 and based on ISO/DIS 9001:2000, which was made
available to give some insight into the changes that were likely between the
1994 and 2000 versions of ISO 9001. The Convenor and Secretary of the
International Working Group which developed the ISO Handbook have
formed a team to bring you this up-to-date edition of HB 90.1.
Throughout this Handbook the terms the standard, the 2000 version and
the 2000 revision of ISO 9001 have been used to describe ISO 9001:2000.
HB 90.1 2000
CONTENTS
Page
ABOUT THIS HANDBOOK ........................................................................ 5
WHAT HAS CHANGED? ........................................................................... 7
QUALITY MANAGEMENT SYSTEMS ........................................................ 8
WHAT IS A QUALITY MANAGEMENT SYSTEM? ............................ 8
WHAT IS AN ISO 9000 QUALITY MANAGEMENT SYSTEM?........ 8
WHY HAVE ONE? ......................................................................... 9
STARTING ............................................................................................ 11
FIRST STEPS ............................................................................... 11
WHATS NEXT?.......................................................................... 11
GOING AHEAD ........................................................................... 12
DO IT YOURSELF ........................................................................ 13
USE OF A CONSULTANT .............................................................. 15
WHAT DOES CERTIFICATION/ REGISTRATION MEAN? ................. 16
GUIDANCE ON WHAT THE STANDARD MEANS ....................................... 18
EXPLANATION OF TERMS USED .................................................. 19
FOREWORD .......................................................................................... 23
INTRODUCTION .................................................................................... 25
0.1 GENERAL ............................................................................. 25
0.2 PROCESS APPROACH ............................................................ 28
0.3 RELATIONSHIP WITH ISO 9004 ............................................ 32
0.4 COMPATIBILITY WITH OTHER MANAGEMENT SYSTEMS ........ 33
1 SCOPE ............................................................................................... 34
1.1 GENERAL ............................................................................. 34
1.2 APPLICATION ....................................................................... 34
2 NORMATIVE REFERENCE ................................................................... 36
3 TERMS AND DEFINITIONS .................................................................. 37
4 QUALITY MANAGEMENT SYSTEM ...................................................... 38
4.1 GENERAL REQUIREMENTS .................................................... 38
4.2 DOCUMENTATION REQUIREMENTS ....................................... 40
5 MANAGEMENT RESPONSIBILITY ........................................................ 49
HB 90.1 2000
5.1 MANAGEMENT COMMITMENT .............................................. 49

5.2 CUSTOMER FOCUS ............................................................... 50

5.3 QUALITY POLICY ................................................................. 51
5.4 PLANNING............................................................................ 52
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION .......... 55
5.6 MANAGEMENT REVIEW ........................................................ 58
6 RESOURCE MANAGEMENT ................................................................. 61
6.1 PROVISION OF RESOURCES ................................................... 61
6.2 HUMAN RESOURCES ............................................................. 62
6.3 INFRASTRUCTURE ................................................................ 65
6.4 WORK ENVIRONMENT .......................................................... 65
7 PRODUCT REALIZATION .................................................................... 66
7.1 PLANNING OF PRODUCT REALIZATION .................................. 66
7.2 CUSTOMER-RELATED PROCESSES ......................................... 68
7.3 DESIGN AND DEVELOPMENT ................................................ 71
7.4 PURCHASING........................................................................ 83
7.5 PRODUCTION AND SERVICE PROVISION ................................ 87
7.6 CONTROL OF MONITORING AND MEASURING DEVICES .......... 97
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT .............................. 102
8.1 GENERAL ........................................................................... 102
8.2 MONITORING AND MEASUREMENT ..................................... 103
8.3 CONTROL OF NONCONFORMING PRODUCT .......................... 112
8.4 ANALYSIS OF DATA............................................................ 114
8.5 IMPROVEMENT ................................................................... 115
BIBLIOGRAPHY .................................................................................. 120
ANNEX A HOW ISO 9001:2000 AND ISO 14001:1996 COMPARE .... 121
ANNEX B CORRESPONDENCE BETWEEN ISO 9001:2000 AND ISO
9001:1994 ............................................................................... 128
ANNEX C STEPS TOWARD A QUALITY MANAGEMENT SYSTEM ........ 134
ANNEX D BRIEF OUTLINE OF CERTIFICATION/ REGISTRATION .......... 144
ANNEX E BRIEF OUTLINE OF STATISTICAL TECHNIQUES................... 146
HB 90.1 2000
About this Handbook

This Handbook, which is a revision of the well known ISO Handbook,
ISO 9000 for Small Businesses What to do Advice from ISO/TC 176
gives guidance to a small business on putting a quality management system in
place, based on ISO 9001:2000. It is recognized that some readers will
already have a quality management system in place and will not need to
worry about the advice given in the section titled Starting. However this
Handbook explains how the quality management system standard applies to
the small business sector and also where the requirements of the 2000 version
differ significantly from the 1994 standards. This advice does not set any
requirements, or add to, or otherwise change the requirements of the standard,
and is simply intended to be helpful.
Most businesses have some problems with putting a quality management
system in place. In a small business these problems are potentially greater due
to
minimal available resources;
difficulty in understanding and applying the standards; and
costs involved in setting up and maintaining a quality management

system.
For the purposes of this Handbook, a small business is not a matter of the
number of employees, but rather a philosophy of the way the business is run.
With only a few people involved, communications in a small business can
often be simple and more direct. Individuals are expected to undertake a wide
variety of tasks within the business. Decision making is confined to a few
people (or even one). Much of the advice given in this Handbook will also be
relevant to larger organizations, which are often good at adapting techniques
and improvements developed successfully elsewhere. However, caution
should be exercised, since the features on which the advice is based may not
always be appropriate in larger organizations.
For you, the small business manager, implementing a quality management
system costs time and money and should be looked at in the same way as any
other investment you make. For it to be viable, you have to be able to achieve
a return for your time and effort, through improvements in marketability
and/or internal efficiency. Your decisions at the early stages of introducing/
developing your quality management system will have a major influence in
these areas.
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HB 90.1 2000
It is not expected that you will sit down and read this Handbook in one
sitting. It is broken up into sections to be read and used separately and
referred to as the need arises. The sections are:
Quality Management
System
This section gives an overview of what an

ISO 9001 quality management system is.
How to Start
This gives some practical advice on different

options, should you wish to introduce a quality
management system into your business.
NOTE: If you already have a quality management
system in place you may skip this Section.
Guidance on
ISO 9001
This is the major part of the Handbook and

includes the text of ISO 9001:2000 itself.
It provides guidance on the interpretation of the
requirements, together with extensive examples
and suggestions of how these could be met.
Bibliography
This gives details of standards which are

referenced in the standard, or may be useful to
consider in conjunction with the standard.
Annexes A, B, C, D, The Annexes are intended to supplement the main

and E
section. Annex C in particular offers a practical
step-by-step approach to implementing a quality
management system.
In this edition of the Handbook a new feature has been included to show
those clauses which feed into other clauses which, it is hoped, will assist
with tracing the various requirements of the standard. We would welcome any
suggestions for improvements to this Handbook which you feel might make it
even more useful.
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HB 90.1 2000
What has changed?

The major changes which have been made in ISO 9001:2000 (compared with
the 1994 version) include:
A totally new structure, which no longer uses the so called

20 elements, but now follows a process approach which is more
like the way most businesses operate.
A clearer understanding that production of conforming product

and/or delivery of conforming service is included in and is part of
the quality management system.
There is now only one management system requirement standard

i.e. ISO 9001, where previously there were three requirement
standards i.e. ISO 9001, ISO 9002 and ISO 9003. In clause 1.2,
provision has been made for those who previously used ISO 9002
or ISO 9003 by permitting, under certain conditions, some
requirements to be excluded.
A more logical use of terminology, particularly in the description

of the supply chain and the use of the terms:
supplier organization customer.
A clear linkage between the quality management system and the

supply of conforming products and/or services.
Greater focus on interaction between the organization and the

customer, before, during and after the product and/or service
delivery.
The need to link the various review and assessment activities to

ensure that the quality management system is continually improved.
Greater compatibility with the

Management System standards.
The need to ensure control over those processes which provide

outsourced product and/or processes.
The need to ensure that people are competent to perform their

assigned work.
A shift in emphasis in the 2000 version now requires your

organization to take responsibility for identifying and developing
the procedures you need for your business.
ISO 14000
Environmental
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HB 90.1 2000
Quality Management Systems

What is a
Quality
Management
System?
A quality management system is the way your organization

carries out business activities associated with quality. Broadly,
it consists of your organizational structure together with the
documentation, processes and resources you use to achieve
your quality objectives and to meet your customers
requirements.
Quality management systems are about evaluating how and
why things are done, writing down how things are done and
recording the results to show they were done. Many small
businesses will already be carrying out many of the operations
which the standard specifies.
What is an
ISO 9000
Quality
Management
System?
An ISO 9000 quality management system is one which is

built on the current version of the requirements standard, i.e.
ISO 9001:2000.
For the 2000 revisions, the ISO 9000 series of standards,
consists of
ISO 9000 which sets out the concepts, principles,
fundamentals and vocabulary of quality
management systems;
ISO 9001 which sets out the requirements to be met;
ISO 9004 which provide guidance for improving the
performance of the quality management system.
NOTES
1
For those who previously used ISO 9002:1994 or

ISO 9003:1994, allowance has been made in the 2000
version for permissible exclusions to permit similar
coverage to these two superseded standards (see clause 1.2
page 34).
Other standards which may be relevant are listed in the

Bibliography to ISO 9001:2000.
Even though the above three standards have been substantially

revised compared with the 1994 versions, and there are some
new requirements in the 2000 version of ISO 9001, they are
still not about imposing something totally new.
If you are adopting ISO 9001 for the first time, it is likely that
your system is quite effective, but informal and probably not
documented.
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HB 90.1 2000
If your system is already based on ISO 9001:1994, your

system should be well documented but it will need to be
updated to the 2000 version.
In both cases, the advice given in this Handbook is relevant.
Why have
one?
Some customers in both the private and public sectors are

looking for the confidence that can be provided by a business
having a quality management system.
While meeting these expectations is one reason for having a
quality management system, there may be others, which could
include the following:
Improvement of performance, coordination and
productivity.
Greater focus on your business objectives and your
customers expectations.
Achievement and maintenance of the quality of your
product and/or service to meet the customers stated
and implied needs.
Achievement of customer satisfaction.
Management confidence that the intended quality is
being achieved and maintained.
Evidence to customers and potential customers of
your organizations capabilities.
Opening up new market opportunities or to maintain
market share.
Certification/Registration.
Opportunity to compete on the same basis as larger
organizations (e.g. ability to tender or submit price
quotations).
While a quality management system can help in achieving
these expectations, you need to remember that it is only a
means and cannot take the place of the goals you set for your
business. A quality management system, on its own, will not
lead to an automatic improvement of work processes or your
product and/or service quality. It wont solve all your
problems. It is a means for you to take a more systematic
approach to your business.
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HB 90.1 2000
You should regularly review and upgrade your quality

management system to ensure that worthwhile and
economically viable improvements are achieved.
In ISO 9001:2000, there is a major new requirement of quality
improvement which you should use to improve the way your
business operates.
Quality management systems are not just for big companies.
Since quality management systems are about how the
business is managed, they can be applied to all sizes of
companies and to all aspects of management, such as
marketing, sales and finance, as well as the basic business. It
is up to you to decide the extent of application. (The 2000
version emphasizes that the standard is applicable to all sizes
and types of companies and organizations.)
Quality management system standards should not be confused
with product standards. Most organizations, new to the
concepts of quality management systems and in particular the
ISO 9000 series of standards, confuse product and/or service
quality with the concept of quality management.
The use of product standards, quality management system
standards and quality improvement approaches are all means
of improving your customers satisfaction and the
competitiveness of your business and they are not exclusive of
each other.
Quality management systems should not result in excessive
bureaucracy or paperwork or lack of flexibility. Remember all
businesses already have a management structure and this
should be the basis on which the quality management system
is built. You may find that you are already carrying out many
of the requirements included in the standard but have not
recorded how.
Changes or additions should be made only if they are
necessary to meet the requirements of the standard or are
otherwise helpful to the business. The proposed 2000 versions
of the ISO 9000 standards emphasize that it is not necessary to
rewrite existing documentation to meet the structure of the
new version (see clause 0.1 page 25).
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HB 90.1 2000
Starting
First steps
This Handbook is written particularly for a small business

wishing to put a quality management system in place. The
first step is to use this Handbook to give yourself an
understanding of what quality management systems are
and what the requirements are.
The Handbook is also applicable to organizations which
might have already implemented a quality management
system in accordance with the 1994 versions of ISO 9001,
ISO 9002 or ISO 9003, but now need to know what changes
are necessary to meet the requirements of the 2000 version of
ISO 9001. If you are thinking either of doing it yourself or
using a consultant, then you should read this section before
starting.
Since it is not the purpose of the 2000 version of ISO 9001 to
impose a totally new way of managing your business, the next
step is to look at what you are doing now. This does not
necessarily mean you have to change your business activities
or introduce new paperwork. You should look at what is
already being done and what documentation already exist. In
many cases, minor modifications can lift a current practice to
a level that will satisfy the requirements of the revised
standard.
Having made this selection, you will need to see what
requirements of the standard your business is already meeting
and also those it is not yet meeting. An approach which might
prove helpful is given in Annex C.
Whats next? Do you need more information? Some sources that you may
be able to use for advice are:
Industry or professional associations.
Government departments, particularly those that
specialize in small business affairs and business
development units.
Self help groups.
Internet Web Pages.
Other businesses putting in a quality management
system.
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HB 90.1 2000
Certification/registration bodies;
Standards bodies.
Consultancies.
Customers.
Suppliers.
Ask your customers if they have any particular requirements

that you might need to consider for inclusion in your quality
management system.
Going ahead
After discussions with some of these sources, you should have

some idea of what needs to be done to put a quality
management system in place and what benefits your
organization and your customers can expect. The important
decision you need to reach now is whether you are going to go
ahead.
If the decision is yes, the next question is How much can I do
myself? If you feel you are going to need assistance, the list
above can be used to identify possible sources and associated
costs.
You will need to establish what personnel and time resources
you have available since this will determine how much
assistance you are going to need.
Because most small businesses will not always have sufficient
resources, they may need to consider using external
assistance. There are many sources of assistance available,
such as training courses, seminars, computer packages and
financial support as well as those described under Whats
next (see page 11).
The key issue that you need to recognize in using external
assistance is that it is your business approach and your quality
management system that has to be developed. Be wary of offthe-shelf solutions that cannot be tailored to your business,
whether these are offered by a computer package or a
consultant.
If you have some resources available but not sufficient to put
all aspects of a quality management system in place at the
same time, a step-by-step approach is often used.
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HB 90.1 2000
Depending on the nature and activities of your business, it

may be appropriate to take the requirements of one or two
clauses and fully implement these and then move on to the
requirements of a further two or three clauses.
The order in which the clauses are selected for
implementation is a matter for you to decide, but the most
effective approach would be to first put in place those which
have the greatest benefit to the business.
Do it yourself The section entitled Guidance on what the standard means

will prove helpful here. You can use this section to identify
what the standard requires and how these requirements relate
to what your business actually does. This comparison should
identify the areas where you need to further develop your
quality management system. Probably many of the
requirements are already being met or perhaps partially met.
Sole traders or small partnerships may find that if they write
out all the things they do in running the business, including
the ones not commonly thought about, the significance of the
requirements of the various clauses becomes more relevant.
For example, when placing job advertisements for personnel,
you are, in a sense, writing a job description. When placing an
order on one of your suppliers, you already have some idea of
that suppliers capability to supply what you ordered. When
you write down an instruction on how you want something
done, you are creating what might be a process control
document, a quality plan or a check list.
Having determined how the requirements of the standard
apply to your business, the next step is to look at your
activities and record what is actually being done.
The standard requires you to have six quality management
system procedures, (called documented procedures, in the
standard) which are shown in the Guidance to clause 4.2
Documentation requirements (see page 40).
The standard identifies these six procedures as documented
procedures. Additionally the standard recognizes that you
will need to have some documents which show how you
control your process activities. In this context, both
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HB 90.1 2000
documented procedures and documents are procedures.

You do not have to maintain any real distinction between
them unless you choose to do so. For the purposes of this
Handbook the term procedures will be used to describe both.
What you call these documents is up to you. Terms
commonly used are
procedures;
instructions (including work instructions,
process instructions);
practices; or
methods.
Procedures are what your people need to do their job. You can
prepare or present procedures in whatever method, style,
layout or format that is most suitable for you. This may range
from a formal style, to a note-like approach listing the relevant
points, to a flowchart. The main thing is to keep them as
simple as possible and avoid writing unnecessary documents.
If you have a multi-cultural workforce, simple pictorial
representations may be a more appropriate way of presenting
your procedures. If the costs can be justified, you may even
consider using videos or computer generated graphics.
However the information is presented, it should be adequate
to describe how to perform the tasks covered by the
procedures.
The extent of documentation could be very simple for a sole
trader, or a partnership, but may need to be more detailed
where more employees are involved.
Also, it is important to realize that there should be no reason
for you to substantially change the way your business is run.
The standard set out what needs to be done, but you have to
decide how you are going to implement it.
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Use of a
consultant
HB 90.1 2000
If you decide to engage a consultant, it is absolutely essential

that the work to be done is agreed by both parties and that a
realistic timetable is set. You might also want to ask the
consultant to carry out a survey or preliminary assessment of
your existing practices.
If a consultant has been selected, it is a good idea to establish
what the consultant is expected to do and what you are
expected to do or provide. The use of a consultant should not
be regarded as an exercise in pushing the responsibility of
establishing a quality management system onto someone else.
An effective quality management system is one that is written
about the way your business operates. Small businesses are
advised to be careful of any consultant offering to put a ready
made quality management system in place. This is unlikely to
succeed, other than for a short time, and much time and effort
will have been wasted until a quality management system that
meets your needs is subsequently developed.
The following are some of the actions that should be
considered if you are considering engaging a consultant:
Talk to several consultants.
Choose your consultant carefully, check credentials,
experience and references.
Ensure the full scope of the businesss activities and
objectives is understood by the consultant.
Commit the necessary resources for the time needed
as agreed.
Take a personal interest in what is being done; after
all, it is your quality management system.
Explain what your customers expect and why you
are seeking to implement a quality management
system.
Effective use of a consultant requires two-way
communication between the consultant and yourself. The
consultant should work with the various individuals in your
business to ensure that the necessary procedures are in place
to meet both the requirements of ISO 9001:2000 and your
business needs. The consultant should be able to provide input
and guidance to ensure these are simple, easily understood
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HB 90.1 2000
and that they contribute to helping you and your people to do

their job rather than create unnecessary paperwork and
documentation. If required, many consultants will include
training on the quality management system for everyone
involved.
When your personnel are involved with the development and
implementation of the quality management system, they can
develop a sense of ownership and this may provide an easier
path to making the quality management system work. It may
be difficult to inspire ownership with a quality management
system developed by a consultant working in isolation.
Cost is an important consideration. In deciding to engage a
consultant, you should explain your needs and expectations
and you may ask the consultant to set these out in a proposal
or specification. You may also wish to get proposals from
other consultants. It is not only the consultants costs that must
be considered when you are making your final choice. The
consultant should spend time with you and time observing the
business operations. The effect of these time costs on your
business will also need to be taken into account.
There is no short way to the development and documentation
of a quality management system. It takes your time and effort
as well as the consultants. If the consultant is to write
procedures on your behalf, then you will need to be involved.
Without your input, at best the resulting documentation will
be the consultants interpretation of what makes your business
run. In the worst case, they will be a copy of somebody elses
documentation which have nothing in common with what you
do.
What does
Certification/
Registration
mean?
Certification may be regarded as the formal recognition by

others of your quality management system. In some countries,
certified quality management systems are considered to be
registered and the term registration is used instead of
certification.
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Certification/registration is not a mandatory requirement of

implementing ISO 9001, but may be required of you by some
of your customers. Your decision regarding certification/
registration may also be influenced by your competitors or by
regulatory or statutory requirements.
If you are considering this option, your first step is to contact
several certification/registration bodies to find out what is
offered, what the likely costs are, the period for which the
certification/registration will apply and how frequently they
will want to look at your quality management system. Some
bodies may include an initial pre-assessment in their offer.
This can be of major benefit in finding out what needs to be
done.
Annex D briefly describes the process of certification/
registration and gives you some idea of what to expect.
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18
Guidance on what the standard means

Whether you are using a consultant or putting a quality management system
in place yourself, a good understanding of the detailed requirements for a
quality management system is necessary. There are a number of sources for
information that you can use, in addition to this Handbook. ISO has issued a
number of publications (see Bibliography page 120) which give guidance on
various aspect of ISO 9001:20001.
Advice on the interpretation and application of ISO 9001:2000 is given by
first listing the full text of each clause, followed by relevant guidance. You
should read the guidance in conjunction with the clause, since in cases where
the text of the clause is clear, only limited advice is given.
Examples have been used wherever possible as an aid to understanding.
These have been selected with a view to their suitability to small business and
to reflect that many small businesses are service providers rather than
manufacturers. Much of the guidance given may also be relevant to a larger
business. It should be noted, however, that specific advice relating to small
business is based on the existence of simple and effective communications
and familiarity with all parts of the business. Accordingly, it may not always
be as appropriate to a larger organization.
One of the great features of the 2000 version is the increased use of feedback
as a powerful management tool: one that will underpin your business if you
are not already using this technique in your management system. Feedback
employs some form of monitoring or measurement to detect when things
require attention. This is used to alert the operator or management to do
something to bring things back to normality. Indeed, without such
mechanisms, waste will be higher and morale lower, both of which will affect
the bottom line.
The Handbook 90 series, available from http://www.9000-2000.com provides sector

specific advice on the application of ISO 9001:2000. These and other various guidance
standards have been used as sources of input in compiling this section of the Handbook.
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HB 90.1 2000
When reading a standard such as ISO 9001, you should note that certain
words and phrases have particular significance or meaning. Some explanation
of the more important of these is given below:
Shall
This means a requirement has to be followed whenever it

occurs in the standard.
Should/may/can
These terms are normally used to suggest or recommend a

course of action. They are never used to indicate a
requirement that must be followed.
Appropriate
Where this or a similar term occurs, you need to decide how

the requirements apply to your business, and in some cases
they may not.
Explanation of terms used

The explanations of some of the terms used in this Handbook, as they relate
to either the standard and/or small business, are given below. They should not
be confused with the formal definitions given in ISO 9000:2000.
Audit (quality)
(see also Review)
This term is defined in ISO 9000:2000 and may be

considered as the systematic examination to find out if
the planned quality activities and associated results are
in line with those expected or planned for.
Contract
This term applies to all transactions between a customer

and small business. It may be verbal or documented.
Examples include the following:
Continual
Improvement
A purchase order.
A telephone order.
A verbal order in a restaurant.
This term is used in the Handbook to indicate that where

you find the opportunity to improve any part of your
quality management system, and there is justification
for the improvement and the necessary resources are
available, you should do it. It does not mean that you
should improve simply for the sake of improving.
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Top Management
This term is defined in ISO 9000:2000 as the person or

group of people who directs and controls an
organization at the highest level.
It is used in this Handbook to emphasize that, on the
occasions where it used in ISO 9001:2000, it is intended
to mean, as appropriate, any of the following:
Manager
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Chief Executive Officer.
Managing Director.
Chairman.
Board of Directors.
Executive Directors.
Managing Partner(s).
Single Owner.
Partner(s)
This term is used in the Handbook to describe, as

appropriate in the context, the person who exercises
authority, takes responsibilities, makes decisions and
fulfils similar managerial functions on behalf of the
business. It includes, as appropriate, any of the
following:
Single Owner.
Partner.
Managing Director.
Director.
General Manager.
Manager.
Senior Executive.
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Nonconformity
This term is defined in ISO 9000:2000 and is used to

describe any instance of failure to meet a specified
requirement. It may be a non-fulfilment of a customers
requirement, a problem with a product and/or service, a
deficiency in the quality management system or any
other situation where what happened was not what was
required or expected.
Objective evidence
This term is defined in ISO 9000:2000 and may be

considered as information which can be proved true,
based on facts obtained through observation,
measurement, test or other means.
Documented
procedures
There are six clauses where the standard requires a

documented procedure and they are:
Product and/or
service
4.2.3 Control of documents.
4.2.4 Control of records.
8.2.2 Internal audit.
8.3
8.5.2 Corrective action.
8.5.3 Preventive action.
Control of nonconforming product.
This term is used in a generic fashion in this Handbook

to describe the following:
Physical products.
Provision of services.
Design output.
Computer software.
Any other form by which a business can

provide a saleable commodity or service.
Standards Australia
HB 90.1 2000
Review
22
This term is used in three situations: management

review, contract review and design review.
In each context, it can be taken to mean the broad
overview of the activities relevant to that situation.
Small business
For the purposes of this Handbook, a small business is

not a matter of the number of employees, but rather a
philosophy of the way the business is run. A small
business is usually managed by a very small number of
people. The single owner, two or three people in
partnership, a company with three or four executives are
typical examples.
This explanation should not deter any business from
using the guidance given here, if it is appropriate to the
businesss situation.
Standards Australia
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HB 90.1 2000
FOREWORD
STANDARD
Foreword
ISO (the International Organization for Standardization) is a
worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International
Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for
which a technical committee has been established has the
right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison
with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
International Standards are drafted in accordance with the
rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical
committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by
at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements
of this International Standard may be the subject of patent
rights. ISO shall not be held responsible for identifying any or
all such patent rights.
International Standard ISO 9001 was prepared by Technical
Committee ISO/TC 176, Quality management and quality
assurance, Subcommittee SC 2, Quality systems.
This third edition of ISO 9001 cancels and replaces the
second edition (ISO 9001:1994) together with ISO 9002:1994
and ISO 9003:1994. It constitutes a technical revsion of these
documents. Those organizations which have used ISO
9002:1994 and ISO 9003:1994 in the past may use this
International Standard by excluding certain requirements in
accordance with 1.2.
The title of ISO 9001 has been revised in this edition and no
longer includes the term Quality assurance. This reflects the
fact that the quality management system requirements
specified in this edition of ISO 9001, in addition to quality
assurance of product, also aim to enhance customer
satisfaction.
Annexes A and B of this International Standard are for
information only.
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HB 90.1 2000
GUIDANCE
Besides listing technical details about the standards writing and
approval processes of ISO, the Foreword states that the quality
management system has two major aims, viz.
achieving quality assurance of the product; and
enhancement of customer satisfaction.
Standards Australia
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HB 90.1 2000
INTRODUCTION
STANDARD
Introduction
0.1 General
The adoption of a quality management system should be a
strategic decision of an organization. The design and
implementation of an organizations quality management
system is influenced by varying needs, particular objectives,
the products provided, the processes employed and the size
and structure of the organization. It is not the intent of this
International Standard to imply uniformity in the structure of
quality management systems or uniformity of documentation.
The quality management system requirements specified in
this International Standard are complementary to
requirements for products. Information marked "NOTE" is for
guidance in understanding or clarifying the associated
requirement.
This International Standard can be used by internal and
external parties, including certification bodies, to assess the
organizations ability to meet customer, regulatory and the
organizations own requirements.
The quality management principles stated in ISO 9000 and
ISO 9004 have been taken into consideration during the
development of this International Standard.
GUIDANCE
The standard is about the specification for an internationally
recognized way of running a business. It specifies a minimum
standard; i.e. in any implementation you should regard its
provisions as only minimal requirements. This quality
management system may be assessed and may result in
certification or registration by a recognized body. A customer
may ask for it as a requirement for its suppliers on critical
products and/or services.
It aims to give confidence to your customers that your business is
well run. It requires you to prove your ability to meet your
customers and any associated regulatory requirements. Records
that show how well you have performed in the past can provide a
basis for prospective customers having a high degree of
confidence in your capabilities.
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HB 90.1 2000
The quality management system complements the technical

aspects of your products and/or services. It encourages you to
build a commercially viable system. The way you run your
business is probably unique. This standard gives you a
framework for good management practice that you can apply to
your business. It specifies a set of things that need to be included,
but does not say how you do them. Hence there is considerable
freedom in meeting the standard. You need to build your
management around your existing system what you currently
do. Only in the parts where you do not meet the requirements
should you need to improve your methods.
This section makes it clear that it is not necessary to rewrite an
existing quality management system to meet the revised standard.
For example, if you had a system that met the 1994 edition of
ISO 9001 or ISO 9002, it should be relatively simple to upgrade
it to meet this new version. While some parts may need to be
rewritten to address new features of the 2000 revision of
ISO 9001, most of the quality management system you have in
place should still be applicable. (Do not believe anyone who tries
to tell you that the whole thing needs revising because the
standard has changed.)
Whilst the standard puts emphasis on the customer, it also brings
out the importance of other interested parties, the shareholder, the
salaried manager and the employees, all of whom expect to gain
from an enterprise.
In the quality movement, emphasis on the customer is important
because satisfaction is a customer right. Dissatisfied customers
can lead to lost sales and that can affect those working for the
company as well as those who provided the capital for it.
The employees including managers have an important part to
play in helping ensure that the quality management system is
totally practical and non-bureaucratic.
The required quality management system has the concept of
continual improvement at its heart. Continual improvement is
seen as important because if you are not making improvements
you will be losing ground to your competition. The standard
takes a holistic approach starting with initial discussions with the
potential customer through to final delivery of the product and/or
service and then monitoring customer satisfaction.
Standards Australia
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HB 90.1 2000
Support services, such as reception, accounts and secretarial

support, do not normally feature in a quality management system,
because they are not considered to be a direct part of the main
money-making process for the business.
If any of these or similar functions are important to the quality of
the product and/or service that the customer receives, then they
should be included. For example, accounting in a firm of
accountants is clearly important and needs to feature as a service
provided to customers. A telemarketing person is important if
that is the way the organization gains most of its orders.
Standards Australia
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HB 90.1 2000
STANDARD
0.2 Process approach

This International Standard promotes the adoption of a
process approach when developing, implementing and
improving the effectiveness of a quality management system,
to enhance customer satisfaction by meeting customer
requirements.
For an organization to function effectively, it has to identify and
manage numerous linked activities. An activity using
resources, and managed in order to enable the transformation
of inputs into outputs, can be considered as a process. Often
the output from one process directly forms the input to the
next.
The application of a system of processes within an
organization, together with the identification and interactions of
these processes, and their management, can be referred to as
the "process approach".
An advantage of the process approach is the ongoing control
that it provides over the linkage between the individual
processes within the system of processes, as well as over
their combination and interaction.
When used within a quality management system, such an
approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and
effectiveness, and
d) continual improvement of processes based on objective
measurement.
The model of a process-based quality management system
shown in Figure 1 illustrates the process linkages presented in
clauses 4 to 8. This illustration shows that customers play a
significant role in defining requirements as inputs. Monitoring
of customer satisfaction requires the evaluation of information
relating to customer perception as to whether the organization
has met the customer requirements. The model shown in
Figure 1 covers all the requirements of this International
Standard, but does not show processes at a detailed level.
NOTE In addition, the methodology known as Plan-DoCheck-Act (PDCA) can be applied to all processes. PDCA
can be briefly described as follows.
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HB 90.1 2000
Plan:
establish the objectives and processes necessary to

deliver results in accordance with customer
requirements and the organizations policies.
Do:
implement the processes.
Check: monitor and measure processes and product against

policies, objectives and requirements for the product
and report the results.
Act:
take actions to continually improve process

performance.
Figure 1 Model of a process-based quality management

system
GUIDANCE
At the heart of this standard is a conceptual model, Figure 1, that
is important for you to understand. The standard refers to this as a
model of a process-based quality management system because
it highlights the main processes that are integral to this standard.
Also, these processes are likely to already exist in your
organization, although you may not have looked at it in this
particular way before.
Standards Australia
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HB 90.1 2000
This model takes the view that everything to do with quality

starts and ends with the customer. So the model is customer
driven. In the diagram, the customer is shown on both the left and
right. Most often it will be the same customer, but it could be a
different one.
The model picks up with the discussions and specification from
your customer what your customer wants. This becomes an
input to your quality management system (shown in the diagram
as the circle). This input feeds into the product and/or service
planning and into its production or service provision.
The main process flow that enables the product and/or service to
emerge is shown across the lower part of the figure, as Product
realization.
This box covers the various activities that your business needs to
do to make your product and/or provide your service. It becomes
the output from your business in the form of a product and/or
service.
The model highlights the importance of obtaining information on
customer satisfaction (the dotted arrow on the right points back to
measurement, analysis and improvement). This and other
measurements and evaluations become vital feedback on your
organizations performance. These measurement systems are
shown as the box titled Measurement, analysis and
improvement.
The rest of the model depicts activities that are considered
fundamental to the smooth operation of your process of product
and/or service realization. In other words they are ancillary but
necessary activities that help assure the product as it is made
and/or the service is delivered.
You need to study these concepts and act on them. The results
may be good but equally may be poor. Either way, you are in a
stronger position with this information than without it. You can
now act by adjusting its resources in the light of the information,
which then improves the performance of the product and/or
service realization. The Management responsibility box is there
to emphazise the need for management to study the results of the
feedback and other information.
Standards Australia
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HB 90.1 2000
Management responsibility also covers the need for managers to

set policy, objectives and targets. Following from these there is a
need for proper planning. Planning includes the study of your
processes and ensuring that they are adequately documented.
These documents need to spell out the standard way that you
want your processes to be done.
Management needs to evaluate resources, which is addressed as
the fourth area of activity in your quality management system.
You need to ensure that you have adequate resources to assure
the quality of your product and/or service. Resources include
workspace, equipment, materials and people. You need to ensure
that people are trained and are competent to do the tasks that you
ask of them.
The data and analysis activities, shown in the box on the right,
titled measurement, analysis and improvement, may suggest
improvements to the quality management system, indicated as
the arrow pointing to the box at the top, titled continual
improvement of the quality management system.
At the initiative of top management, potential improvements
should also be investigated and appropriately implemented, and
this is yet another example of feedback.
So there are two mechanisms for making improvements:
As part of the quality management system (depicted
by the arrows of the inner loop). This includes
nonconformity rectification, corrective action and
preventive action.
Review processes, and in particular management
review, which look critically at the whole quality
management system and make improvements to it.
Hence the process model in Figure 1 ties together the concepts of
quality assurance to continual improvement and total quality
management. (Indeed, Figure 1 is an example of the continuous
improvement cycle commonly referred to as the as the Deming
Cycle, after the man who popularized it, and first suggested by
Walter Shewhart in the early part of the twentieth century.)
If you are interested in looking further into these concepts, you
should also read ISO 9004:2000, which is consistent with
ISO 9001:2000, e.g. the main clause headings are the same.
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HB 90.1 2000
STANDARD
0.3 Relationship with ISO 9004
The present editions of ISO 9001 and ISO 9004 have been
developed as a consistent pair of quality management system
standards which have been designed to complement each
other, but can also be used independently. Although the two
International Standards have different scopes, they have
similar structures in order to assist their application as a
consistent pair.
ISO 9001 specifies requirements for a quality management
system that can be used for internal application by
organizations, or for certification, or for contractual purposes. It
focuses on the effectiveness of the quality management
system in meeting customer requirements.
ISO 9004 gives guidance on a wider range of objectives of a
quality management system than does ISO 9001, particularly
for the continual improvement of an organizations overall
performance and efficiency, as well as its effectiveness.
ISO 9004 is recommended as a guide for organizations
whose top management wishes to move beyond the
requirements of ISO 9001, in pursuit of continual improvement
of performance. However, it is not intended for certification or
for contractual purposes.
GUIDANCE
This clause is self explanatory and needs little additional

guidance. The key point is that the 2000 versions of ISO 9001
and ISO 9004 now have a common main clause structure, which
simplifies using the two standards in conjunction with each other.
You should also note that ISO 9004 is a quality management
system in its own right and is not a guide to the implementation
of ISO 9001.
Standards Australia
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STANDARD
HB 90.1 2000
0.4 Compatibility with other management systems

This International Standard has been aligned with
ISO 14001:1996 in order to enhance the compatibility of the
two standards for the benefit of the user community.
This International Standard does not include requirements
specific to other management systems, such as those
particular to environmental management, occupational health
and safety management, financial management or risk
management. However, this International Standard enables
an organization to align or integrate its own quality
management system with related management system
requirements. It is possible for an organization to adapt its
existing management system(s) in order to establish a quality
management system that complies with the requirements of
this International Standard.
GUIDANCE
If you are contemplating having a management system that
includes other aspects, such as health, safety and environment,
you will be pleased to know that this new version has been
written with a view to facilitating alignment with ISO 14001.
If you have experience with ISO 9001:1994 or ISO 9002:1994,
you may wish to take this extra step and revise your quality
management system and integrate it with an environmental
management system. The effort in achieving this will pay off in a
simpler more efficient system for running your business.2
The occupational health and safety requirement standard, AS 4801:2000, uses the
ISO 14001 model, which is very similar in concept to the model shown in Figure 1,
section 0.2, above. You could use this standard as a basis for an OH&S management
system. For assistance with integration see AS 4581:1999, Management system
integrationGuidance to business, government and community organizations, and
HB 139:2000, Step by Step Guidance on Integrating Management Systems Health and
Safety, Environment, Quality, also available from http://www.9000-2000.com or
http://www.standards.com.au
Standards Australia
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HB 90.1 2000
1 SCOPE
STANDARD
1 Scope
1.1 General
This International Standard specifies requirements for a
quality management system where an organization
a) needs to demonstrate its ability to consistently provide
product that meets customer and applicable regulatory
requirements, and
b) aims to enhance customer satisfaction through the
effective application of the system, including processes
for continual improvement of the system and the
assurance of conformity to customer and applicable
regulatory requirements.
NOTE In this International Standard, the term product
applies only to the product intended for, or required by, a
customer.
1.2 Application
All requirements of this International Standard are generic and
are intended to be applicable to all organizations, regardless
of type, size and product provided.
Where any requirement(s) of this International Standard
cannot be applied due to the nature of an organization and its
product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this
International Standard are not acceptable unless these
exclusions are limited to requirements within clause 7, and
such exclusions do not affect the organizations ability, or
responsibility, to provide product that meets customer and
applicable regulatory requirements.
GUIDANCE
WHERE THE STANDARD APPLIES

ISO 9001 now covers the range of standards previously provided
in the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
Clause 1.2 Application provides the necessary flexibility to cater
for those who had an ISO 9002 or ISO 9003 quality management
system.
Standards Australia
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