SP6

SP65: 1998
HANDBOOK
ON
IS/IS0 9000 FOR SMALL BUSINESSES
ICS 03.120.10
0 BIS 1998
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9, BAHADUR SHAH ZAFAR MARG
NEW DELHI 110 002
December 1998 Price Rs 210.00
.t
--.
SP 65 : 1998
HANDBOOK
ON
IS/IS0 9000 FOR SMALL BUSINESSES
ICS 03.120.10
0 BIS 1998
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9, BAHADUR SHAH ZAFAR MARG
NEW DELHI 110 002
SP 65 : 1998
First Published December 1998
0 BUREAU OF INDIAN STANDARDS
ICS 03.120.10
ISBN 8 l-706 l-050-8
Price Rs 210.00
Published by Bureau of Indian Standards, New Delhi- 110002

Laserset by Paragon Enerprises, 1 Ansari Road, Daryaganj, New Delhi-l 10002
Printed by Printograph, 2966/40 Beadon Pura, Karol Bagh, New Delhi-l 10005
NATIONAL FOREWORD
This Special Publication which is identical with the ISO Handbook ‘IS0
9000 for Small Businesses, What to do-Advice from ISO/TC 176’ issued
by the International Organization for Standardization (ISO), was adopted
by the Bureau of Indian Standards on the recommendation of the Quality
Management Sectional Committee (MSD 2) and approval of the
Management and SystemsDivision Council.
The IS0 Handbook referred above has been prepared under the auspices of
ISOlTC 176 - Quality management and quality assurance technical
committee of ISO, which is responsible for developing and maintaining the
IS0 9000 family of International Standards. India has made significant
contribution in finalization of this Handbook.
This publication is not a normative document and is not, therefore, an
additional International Standard of the IS0 9000 family. The document is
informative in intent and status, and seeks to provide advic~e for small
businesses on the interpretation and application of the IS0 9000 quality
system standards.
This Handbook has been adopted as Special Publication in the light of
problems encountered by Indian Industry in small scale sector, while
implementing IS/IS0 9001,9002 and 9003. The guidance provided takes
into account constraints of small scale industry, for example, in terms of
cost, time and resources.
The text of this IS0 Handbook has been approved as suitable to be published
as Special Publication without deviations. Certain conventions arc,
however, not identical to those used in Indian Standards and Special
Publications. Attention is particularly drawn to the following:
Wherever the words ‘International Standard’ appear, they should be read

as ‘Indian/International Standard’.
In the adopted Handbook, normative references appear to certain

International Standards for which Indian Standards also exist. The
corresponding Indian Standard which is to be substituted in its place is given
below along with its degree of equivalence for the edition indicated:
3
International Corresponding Indian Standard Degree of
Standard Equivalence
IS0 8402 : 1994 IS/IS0 8402 : 1994 Quality Identical

management and quality assurance
- Vocabulary @rst revision)
In the adopted Handbook, informative references appear to certain

International Standards for which Indian Standards also exist. Each of these
standards has been adopted by BIS under dual numbering scheme in IS/IS0
9000 or IS/IS0 10000 series. The list of standards thus adopted is given
below:
IS0 9000-I : 1994 IS/IS0 9000-l : 1994 Quality Identical

standards - Part 1 : Guidelines for
selection and use (first revision)
IS0 9000-2 : 1993 IS/IS0 9000-2 : 1993 Quality do
standards - Part 2 : Ge~neric
guidelines for the application of IS0
900 I, 9002 and 9003
IS0 9000-3 : 1991 IS/IS0 9000-3 : 199 1 Quality do

standards - Part 3 : Guidelines for
the application of IS0 9001 to the
development, supply and
maintenance of software
IS0 9000 - 4 : 1993 IS/IS0 9000-4 : 1993 Quality do

standards - Part 4 : Guide to
dependability programme
management.
4
Standard Equivalencr
IS0 9001 : 1994 IS/IS0 9001 : 1994 Quality systems Identical

- Model for quality assurance in
design, development, production,
installation and servicing (first
revision)
IS0 9002 : 1994 IS/IS0 9002 : 1994 Quality systems do

- Model for quality assurance in
production, installation and servicing
(first revision)
IS0 9003 : 1994 IS/IS0 9003 : 1994 Quality systems - do

Model for quality assurance in final
inspection and test (first revision)
IS0 9004- 1 : 1994 ISO/ISO 9004-l : 1994 Quality do

management and quality system
elements - Part 1 : Guidelines
(fourth revision)
IS0 9004 -2 : 1991 IS/IS0 9004-2 : 1991 Quality do

elements - Part 2 : Guidelines for
services
IS0 9004-3 : 1993 IS/IS0 9004-3 : 1993 Quality do

elements - Part 3 : Guidelines for
processed materials
IS0 10005 : 1995 IS/IS0 10005 : 1995 Quality do

management - ~Guidelines for
quality plans
IS0 10007 : 1995 IS/IS0 10007 : 1995 Quality do

management - Guidelines for
configuration management
IS0 10011 - 1 : IS/IS0 1001 1- 1 : 1990 Guidelines for Identical

1990 auditing quality systems - Part 1 :
Auditing
IS0 10011 - 2 : IS/IS0 1001 l-2 : 1991 Guidelines for do

Qualification criteria for quality
systems auditors
IS0 10011 - 3 : IS/IS0 1001 l-3 : 1991 Guidelines for do

Management of audit programmes
IS0 10012-l : IS/IS0 10012-l : 1992 Quality do
1992 assurance requirements for
measuring equipment - Part 1 :
Metrological confirmation system for
measuring equipment
IS0 10013 : 199s IS/IS0 10013 : 1995 Guidelines for do
developing quality manuals
In Annex A of IS0 Handbook, under ~‘Guidance’, the designation of IS0

Standard, ‘IS0 9000-3 : 1987’ may be read as ‘IS0 9000-3 : 1991’.
In the adopted handbook, informative reference appears to ISO/TR
13425 : 1995 ‘Guidelines for the selection of statistical methods in
standardization and specification’. The concerned Sectional Committee
has reviewed the provisions of this technical report and has decided that it
is acceptable for use in conjunction with this handbook.
Table of contents
National Foreword ................................................................................... 3
About this Handbook ............................................................................... 9
Quality systems ....................................................................................... 11

, . ..........................................................................................
What are thevq 11
Why have one? ......................................................................................... II
What are the IS0 9000 standards?. .......................................................... 13
How to start.. ........ . .................................................................................. 15

First steps.. ............................................................................................... 15
What’s next?. ..................... . ..................................... .._.............................. 16
Going ahead ............................................................................................. 16
Do it yourself ........................................................................................... .17
Use of a consultant ................................................................................... 19
What does certification/registration mean?. ............................................. 21
Guidance on IS0 9001, IS0 9002 and IS0 9003.. .............................. .23
Introduction.. ....................................................................................... _... .25
Scope.. .................................................................................................... ..2 7
Normative reference ................................................................................ 30
Definitions ............................................................................................... 31
Quality system requirements.. .................................................................. 33
Manngement responsibility ...................................................................... 33
Quality system .......................................................................................... 39
Contract review .......................................................................... _........... .A6
Design control ......................................................................................... 48
Document and data control .... ................................................................. 59
Purchasing.. ............................................................................................. 64
Control of customer-supplied product ..................................................... 70
Product identification and traceability .................................................... 71
7
Process control.. ...................................................................................... .73
Inspection and testing.. ............................................................................. 78
Control of inspection, measuring and test equipment ............................. .84
Inspection and test status ....................................................................... .9 1
Control of nonconforming product.. ........................................................ 93
Corrective and preventive action.. ........................................................... 96
Handling, storage, packaging, preservation and delivery ..................... 10 I
Control qf quality records.. ..................................................................... 106
Internal quality audits. ......................................... ................................. .108
Trffining.. ................................................................................................ 112
Servicing.. .............................................................................................. .114
Statistical techniques.. ............................................................................ 115
Annex A Bibliography.. ......................................................................... 1I 9
Annex-I How the key quality system standards compare.. ................... .I27
Annex II Explanation of terms used .................................................... .I29
Annex III Steps towards a quality system ............................................ .135
Annex IV Brief outline of certification/registration .............................. 149
8
SP 65 : 1998
About this Handbook
Most businesses have some problems with putting a quality system in place.
In a small business these problems are potentially greater due to :
. minimal available resources,
l difficulty in understanding and applying the standard, and
. costs involved in setting up and maintaining a quality system.
This handbook gives guidance to a small business on putting an IS0 9000
quality system in place. It explains how quality system standards apply to
the-small business sector and also explains the requirements of such stand-
ards. However, this advice does not set any requirements, or add to, or
otherwise change the requirements of the standards.
For you, the small business manager, implementing a quality 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 introduc-
ing/developing your quality system will have a major influence in these
areas.
Avoiding mistakes at an early stage is essential and an aim of this Handbook
is to give you a better understanding of what you have to do and what you
don’t need to do.
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 can be simple and
more direct. Individuals are expected to undertake a wide varitety of tasks
9
sP65: 1998
within the~business. Decision making is confined to a few people (or even

one).
The advice given has been developed with the above features in mind. Much
of it will also be relevant to larger organizations. However, caution should
be exercised, since the features on which the advice is based may not exist
in larger organizations.
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 systems
This section gives an overview of what an IS0 9000 quality system is.
How to start
This gives some practical advice on different options, should you wish
to introduce a quality system into your business.
Guidance on IS0 9001, IS0 9002 and IS0 9003
This is a major part of the Handbook and includes the text of IS0 9001
itself. It provides guidance on the interpretation of the requirements,
together with extensive examples and suggestions of how these could be
met.
Annexes A, I, II, III and IV
The annexes are intended to supplement the main section. Annex III, in
particular, offers a practical step-by-step approach to implementing a
quality system.
Throughout the Handbook some words are shown in bold italics. These
have special meanings and are explained in Annex II, Explanation of terms
used.
Titles of standards, clauses and annexes are shown in italics but are also
accompanied by the standard, clause or annex number. They should not be
confused with special meaning words.
We hope you find this Handbook useful.
10
SP 65 : 1998
Quality Systems
What are All businesses, large and small, already have an established
they? way or system of doing business. In a small business, the
likelihood is that the system is quite effective, but informal
and probably not documented. Quality system standards
identify those features which can help a business consis-
tently meet its customers’ requirements. They are not about
imposing something totally new.
Quality 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 standards specify.
Why have Some customers in both the private and public sectors are
one? looking for the confidence that can be given by a business
having a quality~system.
While meeting these expectations is one reason for having
a quality system, there may be others, which could include
the following:
-0 Improvement of performance, coordination and produc-
tivity.
l Greater focus on your business objectives and your

customer’s expectations
11
SP 65 : 1998
. Achievement and maintenance of the quality of your

product’) to meet the customer’s stated and implied rieeds.
. Management confidence that the intended quality is
being achieved and maintained.
. Evidence to customers and potential customers of the
organization’s 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).
NOTE - A customer’s order does not always provide

all the requirements that need to be met. For example
when booking a room in a hotel, the customer expects,
on entering the room, that it will be clean, tidy and
properly made up. However, this requirement is seldom,
if ever, stated to the hotel.
While the quality system can help in achieving these ex-

pectations, don’t forget that it is only a means and cannot
take the place of the goals you set for your business. You
should regularly review and upgrade your quality system
to ensure that worthwhile and economically viable im-
provements are achieved. In the 1~994editions of the IS0
9000 standards there is a thread of quality improvement
requirements which can be used as a basis for improvement
programmes.
A quality system, on its own, will not automatically lead
to improvement of work processes or yourgroductquality.
I) Words in bold italics have special meanings and are explained in Annex II,
Explarratinnofterms used. However, to assist in gemeral understanding, the term
“products and services” is used where helpful in the context.
12
SP 65 : 1998
It won’t solve all your problems. It is a means for you to

take a more systematic approach to~your business.
Quality systems are not just for big companies. Since

quality 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.
Quality system standards should not be confused with

product standards. Most-organizations, new to the concepts
of quality systems and in particular the IS0 9000 series of
standards, confuse product quality with the concept of
quality management. The use of product standards, quality
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 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 system is built.
You may find that you are already carrying out many of
the requirements included in these standards 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.
What are The IS0 9000 series, which has gained international recog-
the nition and acceptance, is a set of standards some of which
IS0 9000 specify requirements for quality systems (IS0 9001, IS0
standards? 9002 and IS0 9003), and others which provide guidance
to aid in the interpretation and implementation of the
quality system (e.g. IS0 9000-2, IS0 9004-l).
13
SP65:1998
IS0 9001 sets out the requirements to be met where a

business is involved in design and development, produc-
tion, installation and servicing.
IS0 9002 gives the equivalent requirements where a busi-

ness does not undertake design and development.
IS0 9003 is the equivalent model where design control,

process control, purchasing or servicing are not required
and basically inspection and testing are used to ensure that
final products and services meet specified requirements.
IS0 9001 is not “higher” in level than either IS0 9002 or
IS0 9003. For each small business, one of the three
standards will be the most appropriate. The standard
selected should be the one that best suits your operations.
(See Annex III for more guidance.)
Other quality system standards which may be relevant are
listed in Annex A to IS0 9001 and a brief description of
their contents is given in the guidance to this part of the
standard.
Two standards, which may be of particular use are:

l IS0 9000- 1: 1994, Quali~ mnnagement and quality as-
surance standards - Part 1: Guidelines for selexztion
and use.
l IS0 9004-I : 1994, Quality management and quality sys-
tem elements - Part 1: Guidelines.
If your business is providing service, you may also find that
IS0 9004-2, Quality manugement and quality system
elements -Part 2: Guidelinesforservices, is a worthwhile
reference. You may find that a combination of this
Handbook and one of the guidance standards listed in
Annex A to IS0 9001 provides a sufficient basis for putting
a quality system in place.
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SP 65 : 1998
How to start
First step This Handbook is written particularly for a small business

wishing to put a quality system in place. The first step is to
use this Handbook to give yourself an understanding of
what quality systems are and what the requirements are.
Since it is not the purpose of the quality system standards
to impose a totally new way of managing your business,
the next step is to look at what is being done now. This does
not necessarily mean you having to change your business
activities or introduce new paperwork. You should look at
what is already being done and what documentation and
forms already exist. In many cases, minor modifications
can lift a current practice to a level that will satisfy the
requirements of the standard.
You will then need to decide what standard applies to your
business. Annex I lists the requirements given in each
quality system standard. IS0 9000-I also gives further
guidance on how to select the appropriate standard. The
guidance given under clause 1, Scope (in the section
“Guidance on IS0 9001, IS0 9002 and IS0 9003”), may
also help provide assistance to make this selection.
Having made this selection, you will need to see what

requirements of the standard your business is already meet-
ing and also those it is not yet meeting. An approach which
might prove helpful is given in Annex III.
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SP 65 : 1998
What’s Do you need more information? Some sources that you

next? may be able to use for advice are:
. industry or professional associations;
. government departments, particularly those specializ-
ing in small business affairs and business development
units;
. self-help groups;
l
Internet Web Pages;
.
other businesses putting in a quality system;
l
IS0 9000 News, published by IS0 Central Secretariat,
includes IS0 9000 case studies from different business
sectors around the world;
.
certification/registration bodies;
.
standard bodies which are members of ISO;
.
consultancies;
.
customers.
Ask your customers if they have any particular require-
ments that you might need to consider for inclusion in your
quality system.
Going After all this research, you should have some idea of how
ahead much work needs to be done to put a quality system in
place. 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.
16
SP 65 : 1998
You will need to establish what personnel and time resour-

ces you have available since this will determine~how much
assistance you are going to need.
Because most small businesses will not always have suffi-

cient 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 “what’s
next” (on previous page).
The key issue that you need to recognize in using external

assistance is that it is your business approach and quality
system that has to be developed. Be wary of off-the-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 system in place at the same time,
a step-by-step approach is often used.
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
additional clause requirements.
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. A grouping
of requirements given at the end of Annex III may be of
assistance for this purpose.
Do it The section entitled “Guidance on IS0 9001, IS0 9002

yourself and IS0 9003” 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
17
SP 65 : 1998
to further develop your quality system. Probably many of

the requirements are already being achieved or perhaps
partially achieved.
Sole traders or small partnerships may find that if !hey

write out all the things they do in running the husiness,
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 with one of your suppliers, you
already have some idea of that supplier’s 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 procedure, 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. These
activities should be generally written out as procedures,
instructions or whatever name you like to callthem. These
procedures are then evaluated against what the relevant
clauses of the standard require. Usually there is a need for
upgrading some of your practices to meet these
requirements. More detail is given in Annex III, Steps
towrds a quality system
There are many ways of preparing or presenting
procedures or instructions. You should use 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 procedures and instructions.
18
SP 65 : 1998
For a multi-cultural workforce, simple pictorial

representations may be a more appropriate way of
presenting procedures and instructions. If the costs can be
justified, you may even wish to consider the use of videos
or computer-generated graphics.
An important requirement is that, whichever way the

information is presented, it should be adequate to
describe how to perform the tasks covered by the
procedures or instructions.
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 quality system standards set out what needs to be
done. They require you to decide how you are going to do
it.
Use of-a If you decide to engage a consultant, it is essential that the

consultant work to be done is agreed by both parties and that a realistic
time-table is set. You might also want to ask the consultant
to carry out a survey or preliminary assessment of your
existing practices.
The following are some of the actions that should be

considered in engaging a consultant:
l Talk to several consultants.
l Choose your consultant carefully, check credentials,

experience and references.
l Ensure that the full scope of thebusiness’s activities and

objectives is understood by the consultant.
l Commit the necessary resources for the time needed as

agreed.
19
SP 65 : 1998
l Takea personal interest in what is being done; after all,

it is your quality system.
l Explain what your customers expect and why you are

seeking to implement a quality system.
When 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 system on to
someone else.
Effective use of a consultant requires two-way
communication between the consultant and yourself. The
consultant needs to work with you and your workforce to
build a quality system which is based on your business’s
activities and practices. If required, many consultants will
include training on the quality system for everyone
involved.
The consultant should work with the various individuals in

your business to ensure that the necessary procedures are
in place to meet the requirements of the relevant IS0 9000
standard. The consultant should be able to provide input
and guidance to ensure that these are simple, easily
understood and that they contribute to helping you and your
people do their job rather than create unnecessary
paperwork and documentation.
An effective quality 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 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 system that
meets your needs is subsequently developed.
20
SP 65 : 1998
When your personnel are involved with the development

land implementation of the quality system, they can develop
a sense of “ownership” and this may provide an easier
path to making the quality system work. it may be difficult
to inspire ownership with a quality 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
consllltant’s 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 system. It takes your time and
effort as well as the consultant’s. If the consultant is to write
procedures or instructions on your behalf, then you w~ill
need to be involved. Without your inputs, at best the
resulting procedures will be the consultant’s interpretation
of what makes your business run. In the worst case, they
will be a copy of somebody else’s procedures and
instructions which have nothing in common with what you
do.
What does Certification may be regal-ded as the formal recognition by

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

of-implementing IS0 9001, IS0 9002 or IS0 9003, but may
SP 65 : 1998
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 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 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.
Before the actual certification/registration, it is essential to
have all aspects of the quality system in place and running
for several months. you can then see the quality system in
operation and have the opportunity to improve it. Any
improvements you can achieve at this stage can simplify
the certification/registration process. This can save you
time and money.
Certification/registration bodies do not operate on the

principle of “what is going to happen”. They want to see
what has happened. You will need sufficient records to
demonstrate that your quality system has become
established and effective.
. Annex IV briefly describes the certification/ registration
process and gives you some idea of what to expect.
22
SP65: 1998
Guidance on IS0 9001, IS0 9002

- and IS0 9003
Introduction
Whether you are using a consultant or putting a quality system in place
yourself, a good understanding of the detailed requirements for a quality
system is necessary. Many of the IS0 9000 series of standards provide
guidance in this respect, particularly IS0 9000-2 and IS0 9004-l. These
and other various guidance standards have been used as sources of input in
compiling this section of the Handbook, which is based around IS0 9001,
IS0 9002 and IS0 9003, since these are the standards that are most
frequently encountered by small businesses.
Advice on the interpretation and application of these three standards is given
by first listing the full text of each clause of IS0 9001 (in the shaded sections,
marked “Standard”) 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.
IS0 9001 and IS0 9002 are identical except for clause 4.4, Design control,
which does not apply to the latter. Some IS0 9003 clauses are less com-
prehensive and the guidance will give an indication of the nature and extent
of the difference. However, IS0 9003 should be referred to for the precise
details of the relevant clauses.
Examples have been used wherever possible as an aid to understanding.
These have been selected with a view to their suitability to small businesses
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
businesses is based on the existence of simple and effective communications
23
SP 65 : 1998
and famitiarity with all parts of the business. Accordingly, it may not always
be as appropriate to a larger organization.
When reading a quality system standard such as IS0 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:
Supplier Whenever this word is used in the standard, it means you,

the small business.
Subcontractor This means the individuals or organizations that you pur-

chase goods and services from and whom you normally
refer to as “your suppliers’ ’ .
Shall This means a requirement has to be followed whenever it

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

can course of action. They are never used to indicate a require-
ment that must be followed.
(as) Where these or similar terms occur, you need to decide how
(as) appropriate the requirements apply to your business, and in some cases,
(as) necessary how they may not.
(as) needed
24
SP 65 : 1998
Standard Introduction
This International Standard is one of three International
Standards dealing with quality system requirements that
can be used for external quality assurance ,purposes. The
quality assurance models, set out in the three International
Standards listed below, represent three distinct forms of quality
system requirements suitable for the purpose of a supplier
demonstrating its capability, and for the assessment of the
capability of a supplier by external parties.
a) IS0 9001, Quality systems - -Model for quality
assurance in design, development, production,
installation and servicing
- for use when conformance to specified requirements
is to be assured by the supplier during design,
development, production, installation and servicing.
b) IS0 9002, Quality systems - Model for quality
assurance in production, installation and servicing
- for use when conformance to specified
requirements is to be assured by the supplier during
production, installation and servicing.
c) IS0 9003, Quality systems -- Model for quality
assurance infinal inspection and test
- for use when conformance to specified
requirements is to be assured by the supplier solely
at final inspection and test.
It is emphasized that the quality system requirements

specified in this International Standard, IS0 9002 and IS0
9003 are complementary (not alternative) to the technical
(product) specified requirements. They specify require-
ments which determine what elements quality systems
have to encompass, but it is not the purpose of these
International Standards to enforce uniformity of quality
systems. They are generic and independent of any specific
industry or economic sector. The design and implementa-
25
SP 65 : 1998
tion of a quality system will be influenced by the varying

needs of an organization, its particular objectives, the
products and services supplied, and the processes and
specific practices employed.
It is intended that these International Standards will be
adopted in their present form, but on occassions they may
need to be tailored by adding or deleting certain quality
system requirements for specific contractual situations.
IS0 9000- 1 provides guidance on such tailoring as well as
on selection of the appropriate quality assurance model, i.e.
IS0 9001, IS0 9002 or IS0 9003.
Guidance The three quality system standards and their intended

application
Much of the above is self-explanatory. You will have to
choose which of the-standards is applicable to your busi-
ness and advice in this regard is given in the subsequent
pages. Clause 4 of each of standard describes the require-
ments which make up the quality system. You need to
decide whether all of these requirements are relevant to
your operations in light of the standard selected. This is
referred toas tailoring.
Tailoring is adding to or omitting the requirements of IS0
9001, IS0 9002 or IS0 9003 to reflect the particular cir-
cumstances of your business. Applicable requirements
should not be ignored or omitted. You cannot discard as
irrelevant a requirement of any of these standards just because
you do not want to do it. Just because you have not done it
before does~not mean that it is not applicable to your business.
If you question a requirement, ask yourself :
l What is the idea or principle behind this requirement?
l What kind of problem could be prevented by meeting
this requirement?
l Why would meeting the requirement give confidence to
the customer?
SP 65 : 1998
Scope
Standard 1 Scope
This International Standard specifies quality system
requirements for use where a supplier’s capability to
design and supply conforming product needs to be
demonstrated.
The requirements specified are aimed primarily at
achieving customer satisfaction by preventing
nonconformity eat all stages from design through to
servicing.
This International Standard is applicable in situations when
a>design is required and the product requirements are

stated principally in performance terms, or they need to
be established, and
b) confidence in product conformance can be attained by

adequate demonstration of a supplier’s capabilities in
design, development, production installation and
servicing.
NOTE 1 For informative references, see Annex A2)
Guidance Where the standard applies

The Scope requirements vary from IS0 9001 to IS0 9003.
The key differences between the three standards are the
quality system requirements described in clause 4 of each
2) This is Annex A to IS0 900 1 and appears on page I 19.
27
SP 65 : 1998
standard. Clause 4 contains 20 subclauses (4.1 to 4.20),

although the number of subclauses that apply is different
for each standard. The guidance given in this Handbook
highlights the major differences where they exist. Further
comparison of the differences between the three standards
is given in the table included in Annex I.
IS0 9001 : 1994 is titled Quality systems - Model for

quality assurance in design, development, production,
installation and servicing. All 20 subclauses apply.
If your need to carry out design and development in order

to meet yourcustomers’ requirements, then IS0 9001 is
the relevant standard for your business. This standard
provides for production, installation and servicing where
these operations are part of your business activities. It
apphes to those service-providing businesses whose
product is a design or could be described as intellectual
property, e.g. consultants, design engineers, architects and
similar professions.
Development is considered to be part of design control and

is covered by the guidance given in 4.4, production and
installation is covered under processs control in 4.9, and
servicing is covered in both 4.9 and 4.19. Installation
includes the situation where aproduct is produced at your
premises and is subsequently installed at a location
specified by the customer.
This could include, for example :
l a manufactured item to be installed in a customer’s

plant, e.g. a plastic shredder to be installedin arecycler’s
plant;
l a software programme to be installed in a customer’s

computer network;
l a training programme to be integrated into a customer’s
training system.
28
SP65:1998
IS0 9002 : 1994 is titled Quality systems - Model for

quality assurance in production, installation and
servicing. Only 19 subclauses (which are identical to those
in IS0 900 1) apply. It omits clause 4.4, Design control.
This standard is to be used where a small business is

producing goods and delivering services. It also applies
when instaliation and/or servicing are included as part of
the contract.
IS0 9003 : 1994 is titled Quality systems - Mod for

quulity assurance in fmal inspection and test. Only 16
subclauses apply, omitting clause 4.4, Design control,
clause 4.6, Purchasing, clause 4.9, Process control, and
Clause 4.19, Servicing. This standard is aimed primarily at
product conformance by final inspection and testing.
Consequently, some of the subclauses have a reduced
scope compared with the other two standards. Where this
situation arises, it will be indicated in the guidance on the
relevant clause.
This standard applies generally where the business is
supplyingproducts on the basis of established inspection
and test capabilities. These could include:
subcontract machining services;

photocopy/print shops;
secretarial services;
car valet services.
29
SP 65 : 1998
Normative reference
Standard 2 Normative reference
The following standard contains provisions which, through

reference in this text, constitute provisions of this
International Standard. At the time of publication, the
edition indicated was valid. All standards are subject to
revision, and parties to agreements baskd on this
international Standard are encouraged to investigate the
possibility of applyin, 0 the most recent edition of the
standard indicated below. Members of IEC and IS0
maintain registers of currently valid International
Standards.
IS0 8402: 1994, Quality marlngemerlt and quality

assurance - Vocabulary
Guidance Other references
The “normative reference” clause is ~included in all the

IS0 quality system standards so people will know which
standards are mentioned as references. This clause will
normally be of little concern of most small businesses.
The reference to IS0 8402 directs you to that standard as

a source of definitions for some of the quality terminology
used in IS0 9001, IS0 9002 and IS0 9003.
30
SP 65 : 1998
Definitions
Standard 3 Definitions
For the purposes of this International Standard, the

definitions given in IS0 8402 and the following definitions
apply.
3.1 product : Result of activities or processes.
NOTES
2 A product may include service, hardware, processed

materials, software or a combination thereof.
3 A product can be tangible (e.g. assemblies or processed

materials) or intangible (e.g. knowledge or concepts), or a
combination thereof.
4 For the purposes of this International Standard, the term

“product” applies to the intended product offering only
and not to unintended “by-products” affecting the en-
vironment. This differs from the definition given in
IS0 8402.
3.2 tender : Offer made by a supplier in response to an

invitation to satisfy a contract award to provide product.
3.3 contract : Agreed requirements between a supplier

and customer transmitted by any means.
31
SP 65 : 1998
Guidance Explanation of terms
This clause provides definitions of certain terms used in

IS0 9001, IS0 9002 and IS0 9003. The term “product”
is defined in IS0 8402, but one of the IS0 8402 notes is
slightly modified for the purposes of these standards.
Further explanation of-these and other terms used in this
Handbook as they relate to small businesses, are given in
Annex II, Explanation of terms used.
Whileproduct is used in this Handbook in the sense of the

above definition and includes service, to assist in general
understanding, the term “products and services” is used
where it is helpful in the context.
32
SP 65 : 1998
Quality system requirements
Management responsibility
Standard 4 Quality system requirements
4.1 Management responsibility

4.1.1 Quality policy
The supplier’s management with executive responsibility
shall define and document its policy for quality, including
objectives for quality and its commitment to quality. The
quality policy shall be relevant to the supplier’s
organizational goals and the expectations and needs~of its
customers. The supplier shall ensure that this pohcy is
understood, implemented and maintained at all levels of
the organization.
Guidance A commitment to quality
This clause requires the business toput its quality policy

in writing. The quality policy establishes:
a commitment to quality;
what the quality objectives are; and
how the objectives relate to your customers’ expectation$.
Your commitment to quality is written to describe your

overall vision of what quality means to your business and
your customers.
33
SP-65 : 1998
To make that commitment understandable, you will need

to identify overall quality goals for your business to
achieve, usually in a given time frame. It is important that
these goals are not vague but address what’s important to
you and your customer.
To do this successfully, you will need to establish what

your customer expects of you. This could involve:
l talking to your customers;
l carrying out market/customer surveys;
l access to industry reports; and

l identification of niche marketing opportunities.
Management commitment for quality should be visible and
active. For example, a publicly displayed copy of the
quality policy signed by the company’s owner is one
method which may be used to show that commitment to
both employees and customers.
All employees need to understand the quality policy, how
it affects them and their role in the quality system. The
manager should decide how this is to be achieved.
Standard 4.1.2 Organization
4.1.2.1 -Responsibility and authority

The responsibility, authority and the interrelation of
personnel who manage, perform and verify work affecting
quality shall be defined and documented, particularly for
personnel who need the organizational freedom and
authority to:
a) initiate action to prevent the occurrence of any

non-conformities relating to the product, process and
quality system;
34
SP 65 : 1998
b) identify and record any problems relating to the

product, process and quality system;
c) initiate, recommend or provide solutions through

designated channels;
d) verify the implementation of solutions;
e) control further processing, delivery or installatiottof

nonconforming product until the deficiency or
unsatisfactory condition has been corrected.
Guidance Who is responsible for what?
In a small business, as there is a limited number of people

available to carry out the tasks described in the clause, there
will frequently be a need to share duties and responsibilities
and for people to be able to do each other’s jobs. Everyone
should know what they are expected to do (responsibilities)
and allowed to do (authorities) and this needs to be written
down. The descriptions do not have to be elaborate or
complex. It is important that the descriptions clearly reflect
the “real life” situation and allow for flexibility.
One method of identifying and recording the
responsibilities and authorities is a job description. This
might be supplemented by a simple organization chart.
Other methods which suit your way of working are e~qually
satisfactory, provided the responsibilities and authorities
are defined.
The specific requirements listed in items a) to e) will need

to be addressed to the extent that they are relevant.
NOTE - In item c) of the clause, “designated channel”

means you and who you provide the information to;
“nonconformities” are covered in 4.13 and 4.14 and
explained in Annex II, Explanation of terms used.
35
SP 65 : 1998
IS0 9003 : 1994 has reduced requirements. Item a) refers

only to those “who conduct final inspection and tests”
while item b) refers to ensuring “that finished product~that
does not conform to specified requirements is prevented from
being used or delivered”. There are no items c), d) ore).
Standard 4.1.2.2 Resources
The supplier shall identify resource requirements and

provide adequate resources, including the assignment of
trained personnel (see 4.18), for management,
performance of work and verification activities including
internal quality audits.
Guidance What is needed?
The intent of this clause is to make sure you have the

resources needed to carry out the work required in the time
agreed with your customer.
These resources cover both~personnel and equipment. For
example, it may be necessary to:
l train or retrain personnel (4.18) to acquire the necessary

skills;
l seek additional personnel either on a temporary or per-

manent basis, to acquire the necessary skills;
l Jc\ elop new processes or new working methods;
l obtain additional equipment, which could be rented,
leased or purchased.
Alternatively, it may be more cost-effective to acquire~the

resources and skills through subcontracting.
It is probably a good idea to review resources on a regular

basis, perhaps in conjunction with the management review
(4. I .3). A review of resources may also be necessary when
a new tender or contract is being considered (4.3).
36
SP 65 : 1998
The requirements for internal auditing are discussed in 4.17

and these should also be considered in any resource review.
Standard 4.1.2.3 Management representative

shall appoint a member of the supplier’s own management
who, irrespective of other responsibilities, shall have
defined authority for
a) ensuiring that a quality system is established,

implemented and maintained in accordance with this
International Standard, and
b) reporting on the performance of the quality system to

the supplier’s management for review and as a basis for
improvement of the quality system.
NOTE 5 The responsibility of a management repre-

sentative may also include liaison with external parties on
matters relating to the supplier’s quality system
Guidance Who looks after the quality system?
The requirement is that you nominate someone with

management authority to take overall responsibility for the
quality system. This person can carry out other duties as
well, but must have the necessary authority within the
business to make sure the quality system is working
properly.
In a small business, it may be appropriate for the manager

to assume these duties. One of the key duties of the
management representative is to be aware of the perfor-
mance of the quality system and possibilities for improve-
ment. Where this job is not done by the manager, the
manager should be kept informed.
37
SP 65 : 1998
Standard 4.1.3 Management review

shall review the quality system at defined intervals
sufficient to ensure its continuing suitability and
effectiveness in satisfying the requirements of this
International Standard and the supplier’s stated quality
policy and objectives (see 4.1 .l). Records of such reviews
shall be maintained (see 4.16).
Guidance Is the quality system working?
You should review the quality system on a regular basis;

annually could be acceptable for an established quality
system. Where changes are planned or being implemented,
more frequent review periods may be needed.
To ensure that the entire quality system is covered, a
standard procedure or agenda should be followed. This
agenda should include:
l quality problems and actions taken;
l customer complaints;
l how the quality system is working and whether objec-
tives are being met;
l quality audit reports (both internal and external);
l areas for improvement/changes needed;
l outstanding actions;
l relevance of quality policy and objectives to current
needs.
Other items which may be helpful to consider include:

l training needs;
l supplier problems;
38
SP 65 : 1998
l equipment, working environment, and maintenance

problems.
Identifying the issues to go under these headings may allow

you to develop and revise your own quality, strategic and
business plans for future activities. For example, as
improvements are achieved and problems eliminated, you
may need to review -your inspection controls and other
controls adopted. Are they still essential or can some
savings be made since the cause of the problem has been
addressed?
Reviews and audits are not the same. This is best
understood from the fact that the results of audits are part
of the management review. (see also Annex II,
Explanation of terms used.)
Records of the review need to be kept which address all
points of the agenda together with any action points and
target dates allotted.
The records can be in any form that suits your business,
such as notes in a daybook, formal meeting minutes or
notes, produced, distributed and stored on a paper or
electronically (computer data.)
Quality system
Standard 4.2 Quality system
4.2.1 General
The supplier shall establish, document and maintain a

quality system as a means of ensuring that product con-
forms to specified requirements. The supplier shall prepare
a quality manual covering the requirements of this Interna-
tional Standard. The quality manual shall include or make
39
SP 65 : 1998
reference to the quality system procedures and outline the

structure of the documentation used in the quality system.
NOTE 6 Guidance on quality manuals is given in

IS0 10013.
Guidance Write down what you do
Where this clause says “eatablish, document and

maintain”, it means having put the quality system in place,
write down what is done, and keep it up to date.
You will need to have a quality manual which either
includes your quality system procedures (4.2.2) or says
where they are located. The quality manual can also be used
to record the principal characteristics of your quality
system. As such, the quality-manual can be considered as
the “road-map” of the quality system. It is the place where
you might choose to document or reference the following:
l The quality policy.
l The activities of your business.
l How the documentation works and where people look
to find information on how to do things.
l An outline of the procedures which document each

relevant requirement as-it is performed.
l A definition of any terms having a unique meaning to
your business.
l Statements on responsibility and authority.
If any of the above are not included in the quality manual,

it is acceptable for the quality manual to indicate where
they may be found.
You are free to choose whichever format for the quality
manual you consider most appropriate for your business.
40
SP 65 : 1998
For example, it is equally acceptable for the quality manual

to follow your normal work processes rather than the clause
of the IS0 9000 series of standards. If you choose a format
that does not follow the clauses of the applicable IS0 9000
standard, it is advisable to create a cross-reference matrix
between your manual and the standard to ensure you have
not missed anything and to act as a signpost to others
reading your quality manual.
NOTE - Advise on writing a quality manual is given in
IS0 10013, Q ua l’ty
I manuals - Guide to preparation.
Additonally, you may tailor the quality system by only
including the clauses which actually apply to your
business’s operations. If, for example, one or more of the
clauses of the selected standard are not relevant to the
operations, the quality manual should indicate this. How-
ever, if the quality system is to be certified/registered, the
certification/registration body will need to see the reasons
why a particular clause was excluded.
You may also include additional material in your quality
manual if you choose. However, again for certified/
registered quality system, certification/ registration bodies
will check that you are actually doing what the quality
manual describes.
This means that the quality manual should be regarded as
a real working document and not just a show-piece to
impress customers.
IS0 9OQ3 : 1994 has a reduced requirement in that the
quality sy-stem relates to “theproduct on completion”.
Standard 4.2.2 Quality system procedures
The supplier shall

a) prepare documented procedures consistent with the
requirements of this International Standard and the
supplier’s stated quality policy, and
41
SP 65 : 1998
b) effectively implement the quality system and its

documented procedures.
For the purpose of this International Standard, the range

and detail of the procedures that form part of the quality
system shall be dependent upon the complexity of the
work, the methods used, and the skills and training needed
by personnel involved in carrying out the activity.
NOTE 7 Documented procedures may make reference to

work instructions that define how an activity is performed.
Guidance Having procedures and following them
Documented procedures are a written description of what

is being done. sometimes they will need to be very detailed.
Often they can be very simple, e.g. flowcharts. The form
they take may vary enormously: from separate formal
documents, to technical notes incorported into a drawing,
or to an equipment instruction manual.
You should examine the need for quality system
procedures to describe how your business operations are
performed. Existing documentation may be adequate and
can be simply referenced in the quality manual.
Procedures should indicate who does what, where, when,

why and how. Some organizations may prefer to describe
how in a different type of document, such as a work
instruction, or an operational manual referenced from the
procedure.
Many of the clauses in this standard have requirements for

documented procedures. However, this does not mean you
need to have a special procedure for each requirement.
The amount of detail your procedures and instructions

contain will depend largely on the methods used, the skills
needed, the training undertaken and the extent of
42
SP 65 : 1998
supervision required. Excessive detail does not necessarily

give you more control of the activity and should be avoided
where possible. Training may reduce the need for detailed
instructions, provided everybody has the information they
need to do their job correctly.
Where there are language difficulties, procedures or

instructions could be given in graphic form or on video.
Frequently, a simple set of pictures can convey the
requirement more accurately than a lengthy detailed
description.
Procedures and instructions should not be a “wish list” of
what you would like to happen in your business. They
should accurately reflect what really happens. To this
extent, they should be clear and cover all the requirements
to complete the differing tasks within your business.
The quality system and the writing of procedures needs to
involve all your personnel. It cannot be driven by one
person acting in isolation. The earlier, and the more people
involved, the better will be their understanding,
involvement and sense of “ownership”.
43
SP55 : 1998
Standard 4.2.3 Quality planning
The supplier shall define and document how the

requirements for quality will be met. Quality planning shall
be consistent with all other requirements of a supplier’s
quality system and shall be documented in a format to suit
the supplier’s method af operation.
The supplier shall give consideration to the following
activities, as appropriate, in meeting the specified require-
ments for products, projects or contracts:
a) the preparation of quality plans;
b) the identification and acquisition of any controls,
processes, -equipment (including inspection and test
equipment), fixtures, resources and skills that may be
needed to achieve the required quality;
c) ensuring the compatibility of the design, the production
process, installation, servicing, inspection and test
procedures and the applicable documentation;
d) the updating, as necessary of the quality control,
inspection and testing techniques, including the
development of new instrumentation;
e) the identification of any measurement requirement
involving capability that exceeds the known state of the
art, in sufficient time for the needed capability to be
developed;
f) the identification of suitable verification at appropriate
stages in the realization of product;
g) the clarification of standards of acceptability for all
features and requirements, including those which
contain a subjective element;
h) the identification and preparation of quality records
(see 4.16)
NOTE 8 The quality plans referred to [see 4.2.3 a)] may

be in the form of a reference to the appropriate documented
procedures that form an integral part of the supplier’s
quality system.
44
SP 65 : 1998
Guidance How are we going to do it?
The business needs to consider each of the requirements of

a) to h) above and decide what is the best way to address
them. This planning may be carried out at the time of
establishing the quality manual and procedures, and the
results will be reflected in their contents.
NOTE - Item g) refers to setting the basis for accepting

or rejecting aproduct.
For businesses whose product and service is routine and

highly repetitive, reference to the quality manual and
procedures may be sufficient to meet the quality planning
requirements, providing these documents are reviewed
periodically to ensure they are still adequate.
In some types of business, it may be necessary to repeat
this planning approach for each new order or project. For
others, it may only be appropriate where there are
non-routine products or activities. forthese businesses it
may be appropriate to draw up specific quality plans.
If, as part of your planning approach, you decide quality
plans are needed, they can be as brief as a check-list or
flowchart which may include references to existing
documents. For complex activities, quite detailed plans
may be more appropriate. (Reference could be made to IS0
10005: 1995, Quality munagement - Guidelines for
qualig plans, and IS0 9004- 1, Quality management and
quality system elements - Part 1: Guidelines.)
IS0 9003 : 1994 has reduced requirements in that quality
planning activities relate to ensuring “that the
requirements for quality of the finished product will be
met’ ’ .
45
SP65: 1998
Corztmct review
Standard 4.3 Contract review

4.3.1 General
The supplier shall establish and maintain documented pro-
cedures for contract review and for the coordination of
these activities.
4.3.2 Review
Before submission of a tender, or the acceptance of a
contract or order (statement of requirement), the tender,
contract or order shall be reviewed by the supplierto ensure
that:
a) the requirements are adequately defined and
documented; where no written statement of
requirement is available for an order received by verbal
means, the supplier shall ensure that the order
requirements are agreed before their acceptance.
b) any differences between the contract or order
requirements and those in the tender are resolved;
c) the supplier has the capability to meet the contract or
order requirements.
4.3.3 Amendment to a contract

The supplier shall identify how an amendment to a contract
is made and correctly transferred to the functions con-
cerned within the supplier’s organization.
4.3.4 Records
Records of contract reviews shall be maintained (see
4.1.6).
NOTE 9 Channels for communication and interfaces with

the customer’s organization in these contract matters
should be established.
46
SP 65 : 1998
Guidance Make sure you understand and can meet your

customers’ requirements
Contracts may vary in form and may be, for example, a

written order, a verbal agreement or a telephone order.
Contract review focuses mainly on theproduct or service

to be provided. However, do not forget that the “contract”
also may cover additional factors, such as delivery
schedules and conditions of payment. All parts of the
contract need to be reviewed to ensure that you can meet
your commitments.
One of the most common problems encountered is
misunderstanding what was ordered. Good
communication between you and your customer is
essential to resolve any misunderstandings.
Written orders, such as those received by mail or facsimile,
provide a permanent record of the order details.
Where telephone and direct computer link orders are
received, special provisions need to be made to record and
confirm the order. Methods of handling these could be as
follows:
l One approach to telephone orders is to provide a pad
(these could even be preprinted forms) for the order
receiver to record the details of the order and read it back
to the customer, asking for confirmation. Alternatively,
the details may be faxed back to the customer.
l Where electronic media are involved, two options exist:
either save permanently on disk or print out the details.
Contract review is the appropriate time to determine if

there are any design requirements in the order and whether
the requirements of 4.4, Design control, are to apply.
An appropriate person in the organization should review

the order to ensure that the requirements listed in 4.3.2 a)
47
SP65 : 1998
to c) can be met. In a small business, the appropriate person

is frequently the manager.
The record of the review can be as simple as a notation on

the order, confirming that it can be fulfilled, with the
signature of the reviewer and the date. Where a more
complex review is called for, how the review is recorded
is at your discretion.
When the situation arises that you are required to tender

for a contract, the same approach should be taken. When
differences between the tender offer and the contract occur,
these should be resolved before proceeding with the order.
NOTE - In some countries, a tender is referred to as a
proposal.
Where changes to an order or tender, or both, arise for
whatever reason, the changes should be reviewed and
agreed in exactly the same manner as the original
order/tender. If the changes are accepted, it is essential that
everyone in your business who is affected by the changes
is informed.
Any tenders and customers’ orders, and any amendments
to these, are quality records and should be handled in
accordance with the requirements of 4.16.
Design control
Standard 4.4 Design control
4.4.1 General
The supplier shall establish and maintain documented

procedures to control and verify the design of the product
in order to ensure that the specified requirements are met.
48
SP 65 : 1998
Guidance Providing a disciplined approach to design
This requirement is relevant to IS0 9001 only. It is

important to understand that this is intended to provide
controls for the design process and in no way attempts to
restrict the creativity of the designer.
The basic requirements of the clause are clearly stated, in

that you should have suitable documented procedures for
design control. The main aim of these procedures is to
establish a disciplined approach to the design process. This
should ensure that all aspects needing consideration are
identified and, where relevant, taken into account in the
design.
Design control and the corresponding procedures generally

cover the following:
l establishing the design aims, planning how the design is
to proceed, and who is to carry out the design (4.4.2 and
4.4.3);
l establishing what is needed to be known for the design
to proceed (4.4.4);
l establishing the form of the output from the design

(4.4.5);
l reviewing, on completion of the design, whether it has
achieved what was wanted (4;4.6,4.4.7 and 4.4.8);
l modifying the design to include changes, which may
occur at any stage of the process and for any reason
(4.4.9).
IS0 9002 : 1994 and IS0 9003 : 1994 contain this clause
only to maintain clause numbering uniformity between the
three standards. This requirement is therefore not relevant
to any IS0 9002 or IS0 9003 quality system.
49
SP 65 : 1998
Standard 4.4.2 Design and development planning
The supplier shall prepare plans for each design and

development activity. The plans shall describe or reference
these activities, and define responsibility for their
implementation, The design and development activities
shall be assigned to qualified personnel equipped with
adequate resources. The plans shall be updated as the
design evolves.
Guidance Who is going to do what?
You need to plan what is to be done and who is going to

do it in relation to the design. Responsibilities for design
should be clearly assigned and the methods for the
development and updating of the design plans should be
established.
It is not essential to identify whether an activity is design
or development since the standard treats these as part of the
same continuous process. Design control covers this entire
process from the initial concept through to final acceptance
of the resulting product and the control of subsequent
changes.
Frequently, in a small business, there may be only one
designer, unless the principal business activity is actually
design. However, where there is more than one designer
and/or the design lends itself to being broken into
identifiable stages, then the possibility exists of assigning
stages to different designers (who could be subcontractors
-see 4.6.2). When this happens, it should be shown in the
design plan and recorded.
Design plans do not have to be complex. They can be as

simple as a flowchart, showing the steps to be taken and
who is to do them.
50
SP 65 : 1998
As part of the requirements, you should also plan how the

design review (4.4.6) verification (4.4.7) and validation
(4.4.8) activities are to be carried out.
Standard 4.4.3 Organizational and technical interfaces
Organizational and technical interfaces between different

groups which input into the design process shall be defined
and the necessary information documented, transmitted
and regularly reviewed.
Guidance Who do we need to talk to?
In a large company, there are usually lots of people and

departments involved in the design process. Control of the
relationships and communications between them is
obviously important.
Most small companies will not encounter this situation.
However, even if the small business designer is the sole
designer, there are some relationships and communications
with other parties which are important. Thesecould include
customers, regulatory bodies, subcontractors and similar.
You will need to establish which of these are critical to the
design and decide how to establish good communication
with these parties. It is important that the design records
show what information has passed between you and the
other parties and that it has been reviewed and acted upon.
Standard 4.4.4 Design input
Design input requirements relating to the product,

including applicable statutory and regulatory
requirements, shall be identified, documented and their
selection reviewed by the supplier for adequacy.
Incomplete, ambiguous or conflicting requirements shall
51
SP 65 : 1998
be resolved with those responsible for imposing these

requirements.
Design input shall take into consideration the results of any

contract review activities.
Guidance What do we need to consider?
All the things to be taken into account in producing the

design should be carefully considered and written down.
There needs to be a check to make sure that none of these
requirements conflict.
A major consideration is the customer’s needs, which may
not always be clearly stated. It is often just as important to
be aware of the customer’s unstated expectation, which
may be even more critical to the design. For example, a
client’s specification to an architect on the type of house to
be built may not include any statements regarding the
structural soundness of the house or the need to comply
with any statutory or legal requirements. These may be
considered as “unstated requirements”, which will be a
major consideration in the design.
The review may result in additional information to be
considered. Other factors that may be considered and
documented include the following:
l statutory and regulatory requirements, such as health
and safety requirements and environmental considera-
tion;
l other legal requirements;
l market surveys;
l industry practice and standard;
l past experience.
52
SP 65 : 1998
Standard 4.4.5 Design output
Design output shall be documented and expressed in terms

that can be verified and validated against design input
requirements.
Design output shall:
a) meet the design input requirements;
b) contain or make reference to acceptance criteria;
c) identify those characteristics of the design that are

crucial to the safe and proper functioning of the product
(e.g. operating, storage, handling, maintenance and
disposal requirements).
Design output documents shall be reviewed before release.
Guidance What have we done?
You need to ensure, after spending the time and money on

the design process, that the results meet the intended
requirements.
The design output may take a number of forms, for

example:
l an engineering design would generally take the form of
drawings and calculations;
l a fashion design would be in the form of sketches and a
specification relating to material to be used;
l a graphics art design could take the form of a particular
layout to be used in a publication;
l a food product design might be in the form of a recipe;

or
l an advertising agency design could be in the form of a

plan for the marketing campaign.
53
SP 65 : 1998
The design ~plan should describe what form your output

should be and how you intend to check that the
requirements have been met. In deciding what form your
output should take, you will need to consider who is going
to make use of it and in what circumstances. For example,
a regulatory authority may have a specific format,-which
needs to be complied with.
In some cases, the design output may be the actualproduct

of the business. Architects, design engineers and graphic
artists are all examples of professions or businesses where
the design can be the actualproduct.
Design output documents must be reviewed prior to issue
and controlled (4.5 and 4.16).
Standa-rd 4.4.6 Design review

At appropriate stages of design, forma1 documented
reviews of the design results shall be planned and
conducted. Participants at each design review shall include
representatives of all functions concered with the design
stage being reviewed, as well as other specialist personnel,
as required. Records of such reviews shall be maintained
(see 4.16).
Guidance Are we on track?
Design review is the forma1 checking of the design to

confirm its adequacy to meet the customer’s needs and
other design inputs, to identify problems and to develop
solutions. Design review can take place at any stage. For
relatively simple designs one review may be sufficient. For
complex designs, several reviews may be required. In the
design of software, there may need to be frequent reviews
throughout the design involving consultation with the
customer. In the design of a simple heating and ventilation
54
SP 65 : 1998
air- conditioning system, review may be needed only once

as part of design completion.
In deciding how many reviews you will need, you need to

consider:
l Are there obvious phases or natural breaks in the design?
l If something is going wrong, which is not detected until

a much later stage, what are the likely consequences?
l The time scale of the design.
Other people should be included in the design review. Not

only just the person who did the design but also the key
people who will be involved in making the product or
delivering the service. This should include not only people
within the business but, where relevant, those outside such
as the customer and any subcontractors involved.
You need to keep records of such reviews using an
appropriate recording method. For example, a complex
design may be reviewed in a formal meeting, and the
minutes of such a meeting would constitute the record. The
review for a simple design may be less formal, and the
record might consist of a notation on the plan, confirming
that the review has been carried out, signed off by the
reviewer and dated.
While the aims of design review (4.4.6), design verification
(4.4.7) and design validation (4.4.8) are different, there
may be considerable overlap and interrelation between
them. In many instances an activity will be relevant to all
three requirements, e.g. prototype testing and evaluation of
test results make a major contribution to all three.
Figure 1 is a diagrammatic representation of the

relationship between review, verification and validation
and is presented to aid in the understanding of the
connection between these three.
SP 65 : 1998
Verification
j[*
FIGURE I
Simplified diagram of the relationship between design
review, design verification and design validation
Standard 4.4.7 Design verification

At appropriate stages of design, design verification shall
be performed to ensure that the design stage output meets
the design stage input requirements. The design
verification measures shall be recorded. (see 4.16).
NOTE 10 In addition to conducting design, reviews (see
4.4.6), design verification may include activities such as
- performing alternative calculations,
-comparing the new design with a similar proven design,
if available,
- undertaking tests and demonstrations, and
- reviewing the design stage documents before release.
Guidance Have we got it right?

Verification is checking that the results at the end of the
design process meet the requirements identified as
necessary at the beginning of the design process. For larger
projects, the design process is often broken into stages and
56
SP 65 : 1998
design verification may be carried out on a stage-by-stage

basis.
The design plan should identify the verification method to

be used, including who is to carry it out, how it is to be
performed and what records are to be kept. There are many
ways to verify the design (some of which amgiven in Note
10 of 4.4.7) and you should determine which are
appropriate and effective. Sometimes, regulatory agencies
will describe the means required to verify the design.
The customer may need to be involved in the verification
process.
Standard 4.4.8 Design validation

Design validation shall be performed to ensure that product
conforms to defined user needs and/or requirements.
NOTES
11 Design validation follows successful design
verification (see 4.4.7).
12 Validation is normally performed under defined
operating conditions.
13 Validation is normally performed on the final product,
but may be necessary in earlier stages prior to product
completion.
14 Multiple validations may be performed if there are
different intended uses.
Guidance Does it work?
Validation is the process of checking that the finalproduct

will be capable of meeting or does meet the customer’s
needs in use.
57
SP 65 : 1998
This may include marketing trials or operational testing. It

is the final stage in the design process and is an important
opportunity to prevent serious financial loss by failure to
supply acceptable product. The results of the verification
and validation processes can be fed back into each stage of
the design p_rocess, leading to modifications and
improvements or even the next design revision or product
generation.
For many products, validation is a relatively simple

process. An example could be a new design of garden
furniture, which could be validated by testing of the
prototype, followed by test marketing.
For other types of products, the validation of the total
performance range cannot be achieved until the actual
conditions occur. For example, the performance of an
air-conditioning system under the extremes of maximum
and minimum external design temperatures cannot be
validated until those extremes actually occur. If these are
based on once-in-l 00 years occurrence, the performance
at the extremities of the design range may never be
validated.
In some cases, the product is the design itself. Take the
example of an architect who may not necessarily validate
the final construction, but can check that the plans, sketches
and specifications describe the construction that the
customer asked for in the contract. The architect might also
use a scale model or models, or might use a virtual reality
computer programme to validate that the product, i.e. the
design, meets the customer’s requirements. Validation at
this stage is consistent with Note 13 of 4.4.8.
It is also acceptable for the customer to perform the

validation and to provide feedback of the results to the
designer. Many software projects are validated-in this way.
58
SP 65 : 1998
Standard 4.4.9 Design changes

All design changes and modifications shall be identified,
documented, reviewed and approved by authorized
personnel before their implementation.
Guidance Controlling changes

For a small business, change is a way of life. Design
changes occurring due to the customer, market, design
review, verficstion or validation activities must be
recorded, reviewed and approved. The extent to which the
design needs to be modified as a result of the changes needs
to be considered. It may be necessary to carry out the steps
described in 4.4.2 to 4.4.8 to the extent required as a result
of these changes.
The quality system has formal requirements for document
and change control which must be followed.
Design changes may also require you to reconsider the
contract review with your customer (4.3).
The design change control process may need to be no more
complicated than the system described in 4.5 to control
other documents. In other situations, the controls may need
to be more complex, e.g. those involved in software design
may have to be involved in configuration management.
Further advice on this specialization can be obtained in IS0
10007, Quality management - Guidelines for configura-
tion tnanagemetzt.
Document and data control

Standard 4.5 Document and data control
4.51 General
procedures to control all documents and data that relate to
59
SP 65 : 1998
the requirements of this International Standard including,

to the extent applicable, documents of external origin such
as standards and customer’s drawings.
NOTE 15 Documents and data can be in the form of any

type of media such as hard copy or electronic media.
4.5.2 Document and data approval and issue
The documents and data shall be reviewed and approved

for adequacy by authorized personnel prior to issue. A
master list or equivalent document control procedure
identifying the current revision status of documents shall
be established and be readily available to preclude the use
of invalid and/or obsoletedocuments.
-This control shall ensure that:
a) the pertinent issues of appropriate documents are

available at all locations where operations essential to
the effective functioning of the quality system are
performed.
b) invalid and/or obsolete documents are promptly

removed from all points of issue or use, or otherwise
assured against unintended use;
c) any obsolete documents retained for legal and/or

knowledge-preservation purposes are suitably
identified.
4.5.3 Document and data changes

Changes to documents and data shall be reviewed and
approved by the same functions/organizations that
performed the original review and approval, unless
specifically designated otherwise. The designated
functions/organizations shall have access to pertinent
background information upon which to base their review
and approval.
60
SP 65 : 1998
Where practicable, the nature of the change shall be

identified in the document or the appropriate attachments.
Guidance Providing people with the information they need
Document control is basically about making sure that the

document which is in use is the “right” document,
approved as necessary. That is, it is the applicable
document (normally the latest issue) for the work being
done. This is important if people are to have the
information they need in order to do the job.
The term ‘ ‘document” is employed in the context of

whatever means are used to contain the information and,
for example, could include written documents; documents
held on computer hard disks, diskettes or CD-ROM, video,
audio tapes or graphic posters.
Essentially, documents are used to describe or control how
things are to be done and are capable of being revised to
reflect changing circumstances.
These could include internal documents, such as drawings,
procedures and instructions, and external documents, such
as statutory regulations, standards, codes and
specifications.
These should not be confused with records. Records are
generated as a result of some activity and are a statement
of facts existing at the time and cannot be revised.
Superseded documents (or revised documents) can
become records.
This clause describes document control; record control is

covered by 4.16.
You should always try to keep the number of copies of

these documents to an absolute minimum. Access to
common documentation is much simpler in a small
61
SP 65 : 1998
business where there is less formality, fewer potential users

and smaller, often single, sites. If everybody has easy
access to a central copy, the need for complex controls may
be eliminated and arrangements for controlling changes
simplified.
Your procedure should ~describe how control is exercised

on those documents for which it is considered necessary.
You should try to avoid finishing up with complex
arrangements -for updating and retrieval. The standard
requires information to be up to date, but does not specify
how this should be done. By taking advantage of the
flexibility allowed in the clause and adopting the simplest
and most practical methods, some of the bureaucracy and
costs associated with implementing a quality system can
be avoided.
Where there are relatively few employees, a list could be
kept of who has what documents. If there is a change, one
person could be assigned to collect the old document and
issue the new one. A suitable note to this effect could be
made in an appropriate logbook or computer record.
Before any documents are issued, they should be reviewed

and approved by an appropriate person to ensure that they
are suitable for their intended purpose. The document
control procedure should identify who conducts the
review. In a small business, it would probably be the
manager. On the other hand, the manager may authorize
someone to carry out the review and approval of
documents.
A further requirement is that any changes to controlled

documents should be approved by an appropriate person.
Again, in a small business this will probably be the
manager. Signatures on written documents are only one
way of indicating approval.
62
SP 65 : 1998
In the case of documents on computer, the use of

password-controlled access, combined with date of
approval, is also a way of indicating approval.
It is recognized that sometimes superseded documents are

retained for a variety of reasons. (Retention for legal or
reference purposes are the two examples given.) If this is
the case, you will need to have a method to identify such
documents (to prevent their accidental use in place of the
current documents), and record the reasons for, and the
period of retention.
The standard also refers to data. Data is information which
may be stored in any form. Where failure to keep data up
to date would adversely affect quality, it needs to be
controlled in accordance with the requirements of this
standard. The type of data that would be controlled under
this clause is revisable data, such as:
l supplier listings -- including name, address, telephone
and facsimile numbers, contacts andproducts approved
for supply;
l customer listings - including name, address, delivery
address( delivery restrictions, telephone and facsi-
mile numbers, contacts and contracts, orders or
products purchased;
l stock information - such as inventory of stock or
products held.
Controllable data is distinguished by its ability to be

revised, updated and re-issued. In the above examples,
telephone numbers and contacts are likely to change
relatively frequently.
Non-controllable data is usually a record, i.e. not revisable.

For example, the quantity delivered on a given day is data
but it is not revisable. If you delivered 100 items last
63
SP 65 : 1998
Tuesday, you cannot go back and change the record to say

that 200 items were delivered.
IS0 9003 : 1994 has a less demanding requirement for

document control. While the wording of the clause is
identical to that of IS0 9001, since the quality system is
related to product on completion, the extent of documents
that may need to~be controlled is reduced accordingly.
Purchasing
Standard 4.6 Purchasing
4.6.1 General
procedures to ensure that purchased product (see 3.1)
conforms to specified requirements.
Guidance Avoiding bought-in problems
Remember that the term “supplier” means you. This

should not be confused with the people you purchase from.
They are referred to in the standard as subcontractors (see
Annex II, Explanation of terms used).
The intent of this clause is to ensure that when you buy

something, you get what you want. The risks of your
business and your customer not getting what was wanted
will be increased by any failure to state your requirements
fully and accurately and the use of unsatisfactory
subcontractors.
IS0 9003 : 1994 contains this clause only to maintain

clause numbering uniformity between the three standards
and it is therefore not relevant to any IS0 9003 quality
system.
64
SP 65 : 1998
Standard 4.6.2 Evaluation of subcontractors
The supplier shall:
evaluate and select subcontractors on the basis of their

ability to meet subcontract requirements including the
quality system and any specific quality assurance
requirements;
define the type and extent of control exercised by the

supplier over subcontractors. This shall be dependent
upon the type of product, the impact of subcontracted
product on the quality of final product and, where
applicable, on the quality audit reports and/or quality
records of the previously demonstrated capability and
performance of subcontractors;
establish and maintain quality records of acceptable

sub-contractors (see 4.16).
Guidance Who do we get it from?
You will need to identify those materials and services that

you buy which can affect the quality of yourproducts. You
will then need to select from subcontractors who can
supply these materials and services, those you intend to
use. Remember that subcontracted services such as design,
transport and delivery, calibration services, etc, may affect
quality and may need to be considered.
Most businesses usually have a number -of reasons why

they deal with a particular subcontractor. You can continue
to use existing subcontractors when developing your
quality system. The standard simply requires that selection
be carried out in a controlled manner.
When you decide why a particular subcontractor is to be

used, you should write down the criteria and basis for the
65
SP 65 : 1998
selection. Questions you may wish to ask in selecting

subcontractors may include one or more of the following:
l How reliable are they’?
l Can they supply what you want?
l Do they have the necessary resources, e.g. equipment

and personnel?
l Is the quoted delivery time and price acceptable?

1
l Do they have a quality system?
l Have you used them before successfully‘?
l Have they a good business reputation?
Where a proprietary or brand name product is to be
purchased, an obvious source may be a wholesale or retail
outlet offering an off-the-shelf or self-selection service. A
wide range of products are available from such sources,
such as electrical supplies, plumbing supplies, general
engineering supplies, food for catering services, etc.
In these circumstances, the criteria for subcontractor
selection and the associated records may be minimal.
You may wish to consider buying for a trial period, with a
review at the end of the period to establish the acceptability
of the supplied product or the supplier.
As well as maintaining records of approved subcontractors
and basis of approval, you should also regularly monitor
the performance of those subcontractors to ensure that they
still meet the selection criteria. However, as a small
business, you need to be aware that your purchasing power
is limited, and threats to~remove subcontractors from your
supplier approval system may be ineffectual. This is
particularly true where you are obtainingprodcts from very
large national or international organizations. Your quality
manual needs to reflect the real life situation.
66
SP 65 : 1998
The extent to which you monitor subcontractor’s

performance depends on how critical the product being
supplied is to the quality of yourproduct.
For example, in a printing business, the paper quality could

be very critical. A travel agency might use normal,
commercial stationery, which would not need any
quality-related purchasing controls.
The printing business may monitor the performance of its

paper suppliers very closely to ensure that the quality of its
printedproduct remains at the expected level.
Standard 4.6.3 Purchasing data

Purchasing documents shall contain dataclearly describing
the product ordered, including where applicable:
a) the type, class, grade or other precise identification;
b) the title or other positive identification, and applicable

issues of specifications, drawings, process
requirements, inspection instructions and other relevant
technical data, including requirements for approval or
qualification of product, procedures, process
equipment and personnel;
c) the title, number and issue of the quality system

standard to be applied.
The supplier shall review and approve purchasing
documents for adequacy of the specified requirements
prior to release.
Guidance Stating purchasing requirements
In order to get what you need, the purchase instructions

should leave no doubt about what it is you want.
Instructions are preferably given as a written order.
67
SP-65 : 1998
Remember that phone instructions are open to

misunderstanding by your subcontractor and you may
need to take additional precautions to ensure that your
instructions are understood. Irrespective of ~whether the
order is written or verbal, you will need to keep a record of
what was ordered so you can confirm that you got what you
asked for.
This part of the purchasing requirement deals with the

details that you should include, as appropriate, in advising
your purchase requirements. The extent to which the
details listed in items a) to c) apply depends on the extent
that the goods and services being ordered affect the main
business and the quality of yourproduct.
It is essential that all relevant details of the items or services
wanted are clearly stated at the time of ordering. These may
include drawing, catalogue or model numbers and required
delivery date and place. In some cases, the complete
description may be covered by a catalogue number, or a
part number. While it is essential to fully describe what you
want, unnecessary detail can lead to misunderstanding and
incorrect delivery.
The written purchase order should be checked prior to
issue. In a small business, it would probably be the person
who does the buying who would do the checking for
adequacy. This may simply involve reading the order,
initialling and dating it.
Standard 4.6.4 Verification of purchased product
4.6.4.1 Supplier verification at subcontractor’s premises
Where the supplier proposes to verify purchased product

at the subcontractor’s premises the supplier shall specify
verification arrangements and the method ~of product
release in the purchasing documents.
68
SP 65 : 1998
Guidance Ensuring your access to subcontractor’s premises
If you order goods or services, or both, from a

subcontractor, and wish to inspect the goods or services, or
both, at the subcontractor’s premises, the arrangements for
such an inspection need to be agreed and included in your
order to the subcontractor. Some examples of this
requirement are:
l an interior decorator viewing curtain fabrics before

taking delivery;
l do-it-yourselfpurchasing at wholesale or retail outlets;
l monitoring employees being trained at a training
organization
Standard 4.6.4.2 Customer verification of subcontracted

product
Where specified in the contract, the supplier’s customer or
the customer’s representative shall be afforded the right to
verify at the subcontractor’s premises and the supplier’s
premises that subcontracted product conforms to specified
requirements. Such verification shall not be used by the
supplier as evidence of effective control of quality by the
subcontractor.
Verification by the customer shall not absolve the supplier

of the responsibilty to provide acceptable product, nor shall
it preclude subsequent rejection by the customer.
Guidance Ensuring your customer’s access to subcontractor’s

premises
If your customer wants to visit your subcontractor’s

premises to check the product, this needs to be stated in
69
SP 65 : 1998
both the customer’s order to you and in your order to the

subcontractor.
Whether or not the customer actually does this, you are still
responsible for ensuring that all theproducts obtained from
subcontractors meet the requirement of the customer’s
order.
Control of c~uytomer-supplied product
Standard 4.7 Control of customer-supplied product

procedures for the control of verification, storage and
maintenance of customer-supplied product provided for
incorporation into the supplies or for related activities. Any
such product that is lost, damaged or is otherwise
unsuitable for use shall be recorded and reported to the
customer (see 4.16).
-Vt-rification by the supplier does not absolve the customer
ot the responsibility to provide acceptable product.
Guidance Lonkirq after what your customer gives you
Occ,lsions may arise where the customer gives you

matensl or equipment to be used in prodacing the items or
delivering the service. Examples could include:
l a dressmaker being provided with material the customer

wants made up into a dress;
e a roll of film provided for a film processor to develop

and provtde prints;
* a landscape gardener being provided with the stone

flagging which is to form the pathways;
70
SP 65 : 1998
l instruments provided by the customer for measurement

purposes;
l tools;
l a training room provided by the customer;
l a motor vehicle left for service or repair;
l a domestic appliance, e.g. a washing-machine, left for

repair.
The relevant procedure should describe how a
customer-supplied product is identified and how it is cared
for. The-procedure could simply reference other in-house
procedures you use, such as incoming inspection (4.10)
and handling, storage, packing, preservation and delivery
(4.15).
If the customer-supplied goods are damaged, lost or
otherwise unsuitable for use, you should tell the customer.
IS0 YO03 : 1994 requirements cover customer-supplied
product as it relates to “incorporation into the finished
product”. Otherwise the requirements are identical to the
above.
Product identij?cation md traceabiiiry
Standard 4.8 Product identification and traceability
Where appropriate, the supplier shall establish and

maintain documented procedures for identifying the
product by suitable means from receipt and during all
stages of product, delivery and installation.
Where and to the extent that traceability i(; a specified

requirement, the supplier shall establish and mamtain
documented procedures for unique identification of
71
SP 65 : 1998
individual product or batches. This identification shall be

recorded (see 4.16).
Guidance Keeping track of what you’ve got
Identification is knowing what the product is. Where you

need to identify product, the methods used and the records
to be kept need to be defined. The recording of part
numbers, job numbers, bar-codes, colour-codes or the
revision status and version number of a software package
being developed are just some examples of identification.
Traceability is knowing where the product came from and
where it is now. Most businesses, irrespective of size, will
have a need in some stage of their operations to keep track
of what goes where. Where traceability is a requirement,
typical methods used include:
l job card entries;
l tagging;
l computer tracking.
Some of the above techniques may also be used for
identification. You need to be aware that the requirements
for traceability ~may result in additional paperwork and
costs.
Reasons for having identification and traceability are
varied; some applications are found:
l in the clothing industry, where materials from the same
dye lot are usually processed as a batch to avoid colour
mis-match problems;
l in a courier service, where there is a need to keep track

of items being picked up and delivered to maintain
delivel;jl commitment and schedules.
72
SP 65 : 1998
You need to establish what your internal requirements are

and documented them.
In some industries, identification and traceability are

specified requirements either by regulation or contract.
Pressure vessel manufacture and boatbuilding are two
good examples where activities in these industries are
frequently carried out under subcontract arrangements to a
small business. For example, in pressure vessel
manufacture, it is common for the identification of a given
material to be recorded and traced through all
manufacturing stages. Thus the end component can be
traced to the original material certificate. Here, the
identification and traceability requirements should be
notified in the customer’s order and should have been taken
into account during contract review (4.3).
Records which provide the traceability (including the
customer’s order) should be retained (4.16).
EGO 9003 : 1994 has a reduced requirement in that only
the second paragraph of the clause applies.
Process Control
Standard 4.9 Process control
The supplier shall indentify and plan the production,

installlation and servicing processes which directly affect
quality and shall ensure that these processes are carried out
under controlled conditions. Controlled conditions shall
include the following:
a) documented procedures defining the manner of

production, installation and servicing, where the
absence of such procedures could adversely affect
quality;
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SP 65 : 1998
b) use of suitable production, installation and servicing

equipment, and a suitable working~environment;
c) compliance with reference standards/codes, quality

plans and/or documented procedures;
d) monitoring and control of suitable process parameters

and product characteristics;
ej the approval of processes and equipment, as

appropriate;
f) criteria for workmanship, which shall be stipulated in

the clearest practical manner (e.g. written standards,
representative samples or illustrations);
g) suitable maintenance or equipment to ensure

continuing process capability.
Where the results of processes cannot be fully verified by
subsequent inspection and testing of the product and
where, for example, processing deficiencies may become
apparent only after the product is in use, the processes shall
be carried out by qualified operators and/or shall require
continuous monitoring and control of process parameters
to ensure that the specified requirements are met.
The requirements for any qualification of process
operations, including associated equipment and personnel
(uee 4. I S), shall be specified.
NOTE 16 Such processes requiring pm-qualification of

their process capability are frequently referred to as special
processes.
Records shall be maintained for qualified processes,

equipment and personnel, as appropriate (see 4.16).
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SP 65 : 1998
Guidance Controlling what you do

This requirement is about controlling those operations
within your ~business which affect the quality of the
product. In many companies, the requirement for planning
is usually addressed through drawings, production
schedules, internal orders, service specifications, operator
instructions, etc.
The requirement for written procedures and work instruc-

tions applies only where their absence would affect quality.
One of the key issues h&e is that it is not necessary to write
a procedure with all the details which a competent operator
would be expected to know. For example, it is not con-
sidered necessary to describe to a trained forklift driver
how to operate a forklift. If the operator cannot operate the
forklift, the answer is not written instructions but training
(4.18). However, the procedure might detail the stacking
arrangements, handling restrictions and routine main-
tenance.
Control of operations will require you to ensure that your
equipment is fit for purpose and that there are no problems
due to the work area, e.g. in a bakery, the ovens should be
capable of producing an evenly cooked product and the
working areas should not constitute a risk to hygiene.
Many of the requirements for equipment control and work-

ing environment may be specified by your customer or~by
regulation and will need to be reflected in your own proce-
dures.
These procedures should also include how the process
condition or the product itself is to be monitored, e.g. the
baker may monitor the oven temperature or the colour of
the loaves or both. To assist, there may be charts or
photographs available to indicate the acceptable oven
temperature range, or the preferred colour and shape of the
loaves.
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SP 65 : 1998
When product quality is dependent on avoiding any

deterioration of the condition of process equipment, you
need to establish arrangements for maintenance of that
equipment, e.g. spot welding equipment may-only continue
to produce good welds if there is periodic maintenance of
electrode conditions.
Some processes require that operators have extra training

or be specially qualified, or the process itself have specific
approval. Records of these need to be kept.
An example of a personal qualification is welding, where

test techniques for soundness of the weld metal give no
information on weld strength. The welder is required to be
trained and “qualified” to perform the weld according to
a weld procedure in order to provide the assurance of weld
strengths.
An example of a pre-qualified process is the pouring of a
concrete slab. The properties of the concrete are not known
at the time of pouring. To get the required strength, the
amount of cement, aggregate and water needs to be
accurately controlled, the mixing and delivery phases
controlled, and the pouring and working needs to be carried
out by trained people. Concrete does not gain its full
strength for several weeks.
For many service industries, the service provided is

instantaneous, which does not readily allow inspection
before delivery of that service. A typical example might be
a small travel agency providing advice on travel
arrangements, flight tickets or train times. Failure by the
individual giving advice to access and interpret
information correctly or to take account ofpotcntial delays
are only likely to be discovered by the c’ustomer after
having attempted to travel.
In such circumstances, the extratraining of individuals, the

availability of up-to-date databases and following
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SP 65 : T998
systematic procedures are critical to consistent customer

satisfaction. This situation exists whenever customer order
and service delivery are simultaneous and is a common
feature in many retail service businesses.

clause ~numbering uniformity among the three standards.
This clause is therefore not relevant to any IS0 9003
quality system.
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SP 65 : 1998
Inspection clml festing
Standard 4.10 Inspection and testing
4.10.1 General
procedures for inspection and testing activities in order to
verify that the specified requirements for the product are
met. The required inspection and testing, and the records
to be established, shall be detailed in the quality plan or
4.10.2 Receiving inspection and testing
4.102.1 The supplier shall ensure that incoming product
is not used or processed (except in the circumstances
described in 4.10.2.3) until it has been inspected or other-
wise verified as conforming to specified requirements.
Verification of conformance to the specified requirements
shall be in accordance with the quality plan and/or docu-
mented procedures.
4.10.2.2 In determining the amount and nature of receiv-
ing inspection, consideration shall be given to the amount
of control exercised at the subcontractor’s premises and the
recorded evidence of conformance provided.
4.10.2.3 Where incoming product is released for urgent
production purposes prior to verification, it shall be posi-
tively identified and recorded (see 4.16) in order to permit
immediate recall and replacement in the event of noncon-
formity to specified requirements.
4.10.3 In-process inspection and testing
The supplier shall:
a) inspect and test the product as required by the quality
plan and/or documented procedures;
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SP 65 : 1998
b) hold product until the required inspection and tests have

been completed or necessary reports have been
received and verified, except when product is released
under positive-recall procedures (see4.10.2.3). Release
under positive-recall procedures shall not preclude the
activities outlined in 4.10.3a).
4.10.4 Final inspection and testing
The cupplier shall carry out all final inspection and testing
in accordance with the quality plan and/or documented
i*r!>cedures to complete the evidence ofconf ormancc of the
t’lnished product to the specified requirements.
The quality plan and/or documented procedures for final

inspection and testin g shall require that all specified
inspection and tests, including those specified either on
receipt of product or in-process, have been carried out and
that the results meet specified requirements.
No product shall bc dispatched until all the activities
specified in the quality plan and/or documented procedures
have been satisfactorily completed and the associated data
and documentation are available and authorized.
4.10.5 Inspection and test records
The supplier shall ectablish and maintain records which
pro\,ide evidence that the product has been inspectrd
and/or tested. These records shall show c tearly whether the
product has passed or failed the inspections and/or tests
according to defined acceptance criteria. Where the
product fails to pass any inspection and/or test, the
procedures for control of nonconforming product shall
apply (see 4.13).
Records shall identify the inspection authority responsible

for the release of the product (see 4.16).
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SP 65 : 1998
Guidance Checking things are right
The requirements on inspection and testing break this

operation into the following three inspection and testing
phases:
l Receiving inspection and testing.
l In-process inspection and testing.
l Final inspection and testing.
The distinction between these three phases is not always

clearcut and the general requirements are very similar.
Inspection and testing are used as terms to cover any type
of operation which basically determines whether
something is acceptable. Some examples include:
l measuring dimensions;
l proofreading publications;
l tasting sauces;
l matching colours;
. carrying out chemical analyses; and
l looking at things anddeciding if they are what was asked
for.
You need to decide what your inspection and testing
requirements and how they are to be carried out. People
inspecting and testing need to be trained for w~hatthey are
doing.
You also need to decide and record who has the authority
to say a job is finished and the product can be delivered.
Individuals may check their own work, without secondary

checking by another person. Such flexibility is essential in
a small business where excessive duplication of effort
should-be avoided.
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SP 65 : 1998
Verification, i.e. examining something to see if it meets

requirements, is also an inspection and testing operation.
In some industries, such as the book publishing industry,
visual verification may be the main form of inspection and
testing carried out.
Most businesses have some form of incoming inspection,

even if it is simply an employee checking the delivery
docket and signing it to confirm that goods were delivered.
A further check is that goods are what was ordered.
However, you need to decide whether the goods and
services you receive should be inspected, by whom and
how.
Where a subcontractor has a quality system in place, it may

be possible to reduce the extent of inspection and test.
The extent of inspection and test also depends on the nature
of the goods being received; e.g. the inspection of office
supplies may be simply a verification that the quantity
ordered was delivered. The delivery docket, signed by the
employee, may be all the documentation required.
The reputation of a restaurant depends on the quality of the
food and the service it provides. Inspection of the
ingredients it purchases is vital to the continued success of
the business. In fact, the restaurant typifies the need, not
only for inspection of incoming foods but also for
inspection during the “in-process” phase and for final
inspection.
Inspections durin g the food processing and preparation

stages could include not only the quality of the food but
also cleanliness and hygiene considerations. There are
various regulations which apply to restaurants and the
inspection and testing procedures should take these into
account.
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SP 45 : 1998
Before the meal or course is served to the customer a check

should be made that the course is, in fact, what the customer
ordered, and that the course has been prepared and
presented to the standard the restaurant has set. This check
may be made~by the chef or even by the waiter.
Somebody has to be responsible for the actual inspection

and testing. The person does not have to have a staff or
managerial status. For example, in small machine shops
with only a few employees, it is common practice for
machine operators to inspect their own work before
passing it on to the next machining station. A job card
usually follows the ‘work, and the operator signs off the
work performed on the job card. This works well because
the work of the next operator down the line is affected if
the “incoming” work is not correct.
The final inspection phase includes not only checking the
finished product or service, but that all inspections and
tests that ought to have been done, have in fact been done
and that if any paperwork is to go with the product or
service, that it has been prepared and is satisfactory. In
other words, if you were the customer these are all the
things you would like to know have happened before you
took delivery of the-product.
The inspections and tests to be carried out may be listed in
a number of ways, such as:
l a quality plan;
l a sampling plan;
l an inspection and test plan;
l a procedure;
l an instruction;
l the customer’s order.

SP 65 : 1998
There needs to be aconsistent method ofrecording that the

inspections and tests are carried out. The person servicing
the rooms in a hotel could note that rooms have been
serviced and sign them off. The foreman could sign off a
job card to show all the inspections have taken place.
A more formal method could involve a prepared check-list

and the results of inspections and tests recorded; e.g.
dimensions, temperature, physical properties andchemical
analysis.
Sometimes it is difficult to determine at which point final

inspection takes place. For example, in a restaurant a head
waiter may check with the customer on leaving that both
the meal and service were satisfactory. However, this could
be considered to be after the event with respect to the meal
(but not the overall service) and is usually dealt with by the
head waiter monitoring the activities in the restaurant to
ensure effective service delivery.
It can happen that you have product that has to be

dispatched before inspection is complete, e.g. at the
customer’s request. An example is, before the results of
tests can be available, food items must be delivered to the
customer’s cold storage to prevent deterioration. If this
happens, your quality system should be capable of
identifying the job and include a procedure to recall the job
if the item subsequently proves defective.
You need to have a system for keeping the necessary
testing and inspection records or have other means of
showing that the inspections have taken place. (Records
are discussed further in 4.16.)
Your records of inspection and testing should indicate

whether any failures occurred and the proposed action.
Inspection and test failures should not be confused with

normal processing activities to bring the product within
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SP 65 : 1998
specification before it is released as good to the next stage

of operations. The former will be required to be dealt with
by the procedures for the control of nonconforming
product (see 4.13), whereas the latter will be addressed
within the normal process control requirements.
A typical example might be an air-conditioning engineer

who measures, adjusts and readjusts fan speeds and air
flows until the requked performance is achieved. Such an
iterative approach does not constitute an inspection failure.
However, if the engineer signs the system off as meeting
specification, and it is subsquently found to be outside
specification, this is a nonconformance and 4.13 applied.
IS0 9003 : 1994 requirements for inspection and testing

are limited to ensuring that “specified requirements for
finishedproduct are met”.
Control of inspection, measuring and test equipment
Standard 4.11 Control of inspection, measuring and test equip-

ment
4.11.1 General
procedures to control, calibrate and maintain inspection,
measuring and test equipment (including test software)
used by the supplier to demonstrate the conformance of
product to the specified requirements. Inspection,
measuring and test equipment shall be used in a manner
which ensures that the measurement uncertainty is
known and is consistent with the required measurement
capability.
Where test software or comparative references such as test
hardware are used as suitable forms of inspection, they
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SP 65 : 1998
shall be checked to prove that they are capable of verifying

the acceptability of product, prior of release for use during
production, installation or servicing, and shall be
rechecked at prescribed intervals. The supplier shall
establish the extent and frequency of such checks and shall
maintain records as evidence of control (see 4.16).
Where the availability of technical data pertaining to the

inspection, measurin g and test equipment is a specified
requirement, such data shall be made available, when
required by the customer or customer’s representative, for
verification that the inspection, measuring and test
equipment is functionally adequate.
NOTE 17 For the purposes of this International Standard,
the term “ measuring equipment ” includes measurement
devices.
4.11.2 Control procedure
The supplier shall:
a) determine the measurement to be made and the

accuracy required, and select the appropriate
inspection, measuring and test equipment that is
capable of the necessary accuracy and precision;
b) identify all inspection, measuring and test equipment

that can affect product quality, and calibrate and adjust
them at prescribed intervals, or prior to use, against
certified equipment having a known valid relationship
to internationally or nationally recognized standards.
Where no such standards exist, the basis for calibration
shall be documented;
c) define the process employed for the calibration of

inspection, measurin g and test equipment, including
details of equipment type, unique identification,
location, frequency of checks, check method,
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SP 65 : 1998
acceptance criteria and the action to be taken when

results are unsatisfactory;
d) identify inspection, measuring and test equipment with

a suitable indicator or approved identification record to
show the calibration status;
e) Maintain calibration records for inspection, measuirng

and test equipment (see 4.16);
f) assess and document the validity of previous inspection

and test results when inspection, measuring or test
equipment is found to be out of calibration;
g) ensure that the environmental conditions are suitable

for the calibrations, inspections, measurements and
tests being carried out;
h) ensure that the handling, preservation and storage of

inspection, measuring and test equipment is such that
the accuracy and fitness for use are maintained;
i) safeguard inspection, measuring and test facilities,

including both test hardware and test software, from
adjustments which would invalidate the calibration
setting.
NOTE 18 The metrological confirmation system for
measuring equipment given in IS010012 may be used for
guidance.
Guidance Having confidence in the equipment used to check your

work
This clause is only applicable to those industries or

businesses where measuring or testing equipment
(including test software) is used to check that what you are
providing meets your customer’s requirements. If, for
example, your inspection method is visual inspection, you
86
SP 65 : 1998
may not need to have any measuring equipment or

instruments and this clause does not apply.
However, if use is made of measuring and testing

equipment for checking compliance with your customer’s
requirements. You will need to consider how it is
controlled, stored, used and its accuracy maintained at the
level needed.
It should be emphasized that the requirement applies only

to equipment which can affect quality. If you are using
measuring and test equipment for indication purposes only,
it does not necessarily have to be calibrated. The key
message here is do not automatically calibrate everything.
Calibration is the process of periodically comparing your
equipment against a reference standard to determine how
accurate it is and whether or not it is still capable of meeting
the accuracy required for the measurements made with it.
Periodically can be on a time basis (monthly, annually) or
a usage basis (before each use or after a number of times
used).
The reference standard may have been provided with the
equipment. For example, a paint thickness meter is
normally supplied with a set of thickness standards. In
other instances, you may have to have access to a suitable
reference standard by buying one or using a subcontractor.
For a reference standard to have validity, it needs to be
traceable back to an appropriate recognized accurate
source. This will normally be ~anational or international
standard. There are cases where a national standard does
not exist. In these cases, the sources or frame reference
need to be described. An example is chemical analysis of
samples used in “round robin” laboratory testing forming
the basis for calibration.
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SP 65 : 1998
You also need to take into account just how accurate the
measurements need to be. How accurate your equipment
needs to be will depend upon how much tolerance is
permissible in what you are measuring. A measuring
device usually has to be capable of measuring to a much
closer tolerance than the tolerance specified for the item
being measured. However, there is no point in having
measuring devices calibrated to unnecessarily high
precision if you do not need that precision for your
operations. Allied with these factors is how skilled the
personnel need to be to use the equipment.
For example, a motor mechanic setting clearances in an
engine may need to measure to an accuracy of one tenth of
a millimetre (+ 0.1 mm), a dressmaker may require an
accuracy of one milhmetre (4 1 mm) and a road builder
may have a tolerance of + 50 mm on the width of a road.
To make sure the measuri-ng equipment operates
effectively and gives reliable results, you need to:
l Make sure it is looked after, regularly calibrated and
adjusted as needed.
l Describe how this will be done so that records are
available which show calibration is traceable to national
or international standards.
l Make sure it is possible to identify which equipment has

been calibrated and that it is suitable for use (e.g. label
the equipment)
If equipment is found to be faulty, you need to find out at

what stage it went wrong. You need to decide whether you
need to do anything about product you have passed using
that equipment. The results of any review may indicate that
no action is required or that a product recall is required.
Other possible courses of action are listed in 4.13.1 and
4.14.2.
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SP 65 : 1998
Test software needs to be subject to some form of

validation to make sure that it can perform the required
measurements. One way is to ensure that this software can
accurately and reliably identifyprodtccts with a known set
of faults and deficiencies. The details of how the test
software is validated should be documented.
Unlike hardware test equipment, test software does not

experience “drift” or ageing, so periodic revalidation may
not appear to be necessary. However, software can be
subject to unintended errors. Therefore the purpose of
revalidating test software is to ensure its continuing ability
to perform the required measurements.
Some type of secure write protection should be used, in the
same manner as seals are used on hardware calibration
adjustments, to minimize inadvertent adjustments.
Small businesses are usually faced with the choice of
carrying out the calibration themselves or having someone
else do it for them.
If you decide to carry out your own calibrations, you will
need to have procedures for calibrating each type of
equipment you use.
If you decide to use a subcontractor, in addition to the
points raised in 4.6.2, some additional points you will need
to consider are:
l Ideally, the organization should be endorsed as a
calibrating service by a suitable certifying body.
l The organization should issue a certificate of calibra-

tion, which states the uncertainty of measurement. (This
is another way of stating just how accurately the instru-
ment can measure.)
l The certificate should indicate that the organization can

trace your calibration back to a national or international
standard.
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SP 65 : 1998
You are free to use an organization which has not been

endorsed as described above to carry out your own
calibration if this is practical, e.g. original equipment
manufacturer or neighbouring company. However, the
resulting records must confirm that the reference standards
used for calibration are of known accuracy, normally
traceable to a national or international standard.
It may be possible, if you have several measuring instru-
ments of a similar type, for the most accurate of these to be
calibrated by a subcontractor, then used as the basis for
calibration of the others. For example, an accurately
calibrated digital thermometer may be suitable as a refer-
ence standard for other less accurate temperature measur-
ing equipment.
Calibration is an expensive operation. For a small business,
the costs of calibration can be considerable. You should
ensure, therefore, that you know the difference between
checking that process control equipment is fit for purpose
and calibrating equipment which is required to give con-
fidence in your inspection and test measurements.
You need to make sure that the calibration frequency, and
standards of accuracy specified are appropriate to the ac-
tual equipment usage and not excessive. Once having
determined the initial calibration procedure it does not have
to remain fixed forever; it can be adjusted in light of
experience.
In some industries, it is common practice for employees to
use their own persona1 measuring equipment; steel tapes,
micromometers and Vernier callipers are typical examples.
When this occurs, it does not absolve the business from
ensuring That such measuring equipment is calibrated
where it is used for release ofproduct. The solutions are to
either ban the use of employee measuring equipment or to
calibrate it. The employee should be asked to consent for
calibration of the equipment.
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SP 65 : 1998
In addition to calibrating equipment, records need to be

kept to show:
l When the equipment was last calibrated, who did it, the
calibration procedure, the acceptance criteria, what the
result was, its acceptability and how this affects the
equipment suitability (calibration status); and
l when the next calibration is due-the period is depend-

ent on the type of_equipment,~its usage and how critical
the measurements are to the process.
Measuring equipment needs to be suitably stored when not

in use, toprotect it from damage or deterioration. It should
also be suitable for use in the proposed operating
environment. These precautions apply even more so to any
‘ ‘master’ ’ measuring equipment or reference standards
used for calibration purposes.
IS0 9003 : 1994 includes a requirement for this which is
confined to equipment (including software) used for final
inspection and testing.
Inspection and test status
Standard 4.12 Inspection and test status

The inspection and test status of product shall be identified
by suitable means which indicate the conformance or
nonconformance of product with regrad to inspection and
tests performed. The identification of inspection and test
status shall be maintained, as defined in the quality plan
and/or documented procedures, throughout production,
installation and servicing of the product to ensure that only
product that has passed the required inspections and tests
[or released under an authorized concession (see 4.13.2)]
is dispatched, used or installed.
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SP 65 : 1998
Guidance Knowing what’s ready to go
Most businesses have some method which shows them

what’s been done and what has still to be completed.
For example, in a hotel, as each room is made up after the

preceding guests have departed, the room status is changed
from “not ready” to “ready”. The room service personnel
normally ring the reception desk to give this advice, which
is noted by some suitable method.
In servicing a car, the status of each operation on the service

check-list is changed from “to be done” to “done” by
ticking off each operation on completion.
In a phone-answering service, the status of messages taken
is initially “message received”. On passing the message
on to the client, the status changes to “message delivered”.
The phone answering service would have some suitable
means of identifying the status.
All of these are different forms of inspection and test status.
Methods that are frequently used to identify inspection and
test status of manufactured goods include:
l the use of markings, tags, labels or similar;
l the use of routing cards, inspection records, job cards
and similar;
l the use of a physical location.
A status tag or use of a physical location could be used to

show, for example, that aproduct:
l is awaiting inspection;
l has been inspected and accepted:
l has been inspected, rejected and put on hold until a

decision is made regarding future action;
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SP 65 : 1998
- has been inspected and released under authorized

concession;
l has been inspected and rejected.
The method(s) you adopt as being most suited to your

business should be described (e.g. in your procedures) so
that everybody knows how it works.
IS0 9003 : 1994 requirements are related to final

inspection only, to ensure that only conformingproduct is
delivered.
Control of nonconforming product
Standard 4.13 Control of nonconforming product
4.13.1 General
procedures to ensure that product that does not conform to
specified requirements is prevented from unintended use
or installation. This control shall provide for identification,
documentation, evaluation, segregation (when practical),
disposition of nonconforming product, and for notification
to the functions concerned.
4.13.2 Review and disposition of nonconforming
proudct
The responsibility for review and authority for the
disposition of nonconforming product shall be defined.
Nonconforming produet shall be reviewed in accordance

with documented procedures. it may be:
a) reworked to meet the specified requirements,
b) accepted with or without repair by concession,
c) regraded for alternative applications, or
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SP 65 : 1998
d) rejected or scrapped.
Where required by the contract, the proposed use or repair

of product [see 4.13.2 b)] which does not conform to
specified requirements shall be reported for concession to
the customer or customer’s representative. The description
of the nonconformity that has been accepted, and of repairs,
shall be recorded to denote the actual condition (see 4.16).
Repaired and/or reworked product shall be reinspected in

accordance with the quality plan and/or documented
procedures.
Guidance Sorting out your product problems

In the course of business, problems will occur. You will
need to decide what to do about them. The standard
requires you to have ways to identify the product
nonconformity3), deciding what to do about it and, where
possible, keeping it separate from acceptable product. You
also need to keep records as you deal with it that show what
happened along the way and any decisions made.
Everybody affected by the problems needs to be kept
informed of what happened.
The method of recording the information is up to you.
Daybook notes may be adequate. Be wary of any~approach
that requires the issue of several forms to control any
nonconformity.
In a quality system, process control (4.9) and inspection

and testing (4.10) are the most likely internal sources to
show up problems with your products. Customer
complaints and warranty claims are the most common
external indications, which will enable you to target where
attention is needed.
3) Nonconformity is a term used to describe any form of problem and is explained

further in Annex II, Explunufion c~~fermsused.
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SP 65 : 1998
Depending on the nature of the nonconformingproduct, it

should be isolated pending a decision on what to do (see
4.13.2). Techniques such as tags or physical location
preferred An 4.12 will be useful in controlling
nonconformingproduct.
When anonconformingproductis detected, there are some
options on what could be done; 4.~13.2a) to d) lists them.
Your management representative .(see Guidance on
4.1.2.3) or some other person, having the necessary
authority, has to decide which of these four options will be
applicable to each instance of a nonconforming product.
Some customers may require notification of any
nonconformingproduct and approve what steps should be
taken. If this is the case, it will be necessary to notify the
customer following detection of the nonconforming
product. You may wish to include the steps you propose
taking along with the notification.
Records will need to be kept of any decision made,
approval given by the customer, any rework or repair
proeedure, and the results of the inspection and testing on
any rework or repair.
If, for example, a catering company discovers that it has
inadvertently used processed meat which was well past its
“use-by date” (or shelf-life) to make sandwiches for
contract customers (retail chain storesj, a number of
actions might be required to fix the problem:
l investigation to find out the extent of the problem:
l segregation and quarantine of the remaining processed
meat from that consignment;
l segregation and quarantine of affected sandwiches
awaiting delivery to the retail outlets;
l recall from the retail outlets those sandwiches likely to
be similarly affected.
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Depending on the potential risks, there may be a need to

involve regulatory authorities and to make the public aware
of the problem.
IS0 9003 : 1994 has reduced requirements for control of

nonconforming product relating generally to finished
product.
Corrective m&preventive action
Standard 4.14 Corrective and preventive action
4.14.1 General
procedures for implementing corrective and preventive
action.
Any corrective or preventive action taken to eliminate the
causes of actual or potential nonconformities shall be to a
degree appropriate to the magnitude of problems and
commensurate with the risks encountered.
The supplier shall implement and record any changes to
the documented procedures resulting from corrective and
preventive action.
Guidance Fixing the causes of problems

Both corrective and preventive action can be seen as steps
in a quality improvement cycle. The need for corrective
action can arise when an internal nonconformity @roduct
or quality system) occurs, or from external sources such as
a customer complaint or warranty claim, or problems
encountered with a subcontractor.
Corrective action involves finding the cause of the

particular problem and then putting in place the necesssary
actions to prevent the problem recurring.
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Preventive action starts with considering and analysing all

the incidences of nonconformities, all the customer
complaints, all the warranty claims, al&he problems with
subcontractors as well as any other sources of problems to
find out if any trend is occuring.
Where this analysis shows that the potential for problems

exists, preventive action then involves putting in place the
necessary steps to eliminate these potential causes.
The procedures for both corrective and preventive actions

should define the responsibilities and authorities for these
activities.
IS0 9003 : 1994 has reduced requirements. The clause is
titled “4.14 Corrective action”. It relates to corrective
action only, based on final inspection and test reports and
customer complaints.
Standard 4.14.2 Corrective action
The procedures for corrective action shall include:
a) the effective ~handling of customer complaints and

reports of product nonconformities;
b) investigation ofthe cause of nonconformities relating

to product, process and quality system, and recording
the results of the investigation (see 4.16);
c) determination of the corrective action needed to

eliminate the cause of nonconformities;
d) application of controls to ensure that corrective action

is taken and that it is effective.
Guidance Fixing the cause of known problems
There is a difference between carrying out corrective

action and fixing a nononformity. Fixing a nonconformity
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SP 65 : 1998
(the standard calls it “disposition”) is about making good

the problem either by reworking, replacing or any of the
other activities described in 4.13. A corrective action is
concerned with finding out why the nonconformity
occurred and making sure that the problem does not occur
again.
The need for corrective action could be indicated by a

number of factors, some of which could be:
l customer complaints;
l nonconformances;
l rework of repairs;
l audit reports (see also guidance on 4.17 for internal audit
reports).
Analysis of the causes may suggest some solutions such as
retaining employees or amending an operating procedure.
The action taken should be in line with the size of the
problem and the likely risks associated with not
implementing any corrective action.
If corrective action is taken, it should be documented and

followed up within a reasonable period to find out whether
it has worked. It may be necessary to change the quality
manual, procedures, instructions and any other relevant
documentation. Changes should be made in accordance
with the provisions of 4.5, Document control.
In the case of the catering company with the processed

meat past its use-by date, the investigation of the cause may
show that there was a stock rotation problem, either in the
caterer’s storage or the subcontractor’s storage. Another
cause that might be found is a lack of operator awareness
of the meaning of use-by dates. The actions to be taken
would depend on the actual cause(s) found.
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Records of the problem and the action taken should be

made. You should follow up the action after a suitable
period to make sure that it has been effective.
Standard 4.14.3 Preventive action
The procedures for preventive action shall include:
a) the use of appropriate sources of information such as

processes and work operations which affect product
quality, concessions, audit results, equality records,
service reports and customer complaints to detect,
analyse and eliminate potential causes of
nonconformities;
b) determination of the steps needed to deal with any

problems requiring preventive’ action;
-c>initiation of preventive action and application of

controls to ensure that it is effective:
4 ensuring that relevant information on actions taken is

submitted for management review (see 4.1.3).
Guidance Fixing the causeof potential problems
You should use yourrecords to see if any trends exist which

show a potential problem could arise. Typical examples of
where information might be found and used for such
~analysis are from such sources as:
difficulties with suppliers or subcontractors;
in-process problems, rework rates, wastage levels;
final inspection failures;
customer complaints and customer surveys;
warranty claims;
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SP 65 : 1998
l service reports;
l the need for concessions.
Other sources might include market surveys, sales figures,

audit reports and quality records. Where a potential
problem is identified, a course of action may need to be
developed and put in place to reduce or eliminate the risk
of the problem.
If preventive action is found to be necessary, it should be

documented and followed up within a reasonable period to
find out whether it has worked. As a result of preventive
action, the quality manual, procedures, instructions and
any other relevant documentation may need to be changed.
Changes should be made in accordance with the provisions
of 4.5.
Examples of where preventive action may be applied
include:
l identifying possible hazardous situations and im-
plementing working practices to prevent product
damage;
l review of sales figures may indicate customer dissatis-
faction with existing levels of service;
l feedback from personnel may indicate a more efficient
process; and
l re-assessment of tools and materials.
In a small business, there is little justification in separating
management review arrangements from long-term
corrective and preventive action. Where there are few
personnel and the same people are involved in both
activities, an artificial separation may result in duplication
of effort. If this approach is taken, it should be included in
the quality manual.
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SP 65 : 1998
The catering firm, as a result of the processed meat

problem, may undertake an analysis of delivery times,
storage conditions and “use-by-dates” to find if potential
problems exist with other fillings it handles, and adopt the
necessary actions to avoid these potential problems.
Handling, storage, packaging, preservation and delivery
Standard 4.15 Handling, storage, packaging, preservation and

delivery
4.151 General
procedures for handling, storage, packaging, preservation
and delivery of product.
Guidance Looking wafter the product
Depending on the nature of the business, some or all of the

requirements of this clause may apply. Where they do
apply, the arrangements for handling, storage, packaging,
preservation and delivery should be recorded in
procedures. The requirements for each of these processes
are given in 4.15.2 to 4.15.5, inclusive.
The requirements of this clause could also apply to
customer supplied product (4.7). For example, this clause
could be applied to the autompbile left at a service centre
by a customer for servicing.
IS0 9003 : 1994 has very simplified requirements, limited
to the completed product after final inspection and test and
this appliesfrom 4.15.1 to 4.15.6 inclusive.
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Standard 4.152 Handling
The supplier shall provide methods of handling product

that prevent damage or deterioration.
Guidance Handlingproducts properly
There are a number of areas of materials handling where

problems affecting the quality of the product can arise.
Some examples are found the following areas:
l Stacking of materials using forklifts, where incorrect

operating procedures can cause damage; exceeding the
recommended stack heights can result in crushing.
l ~Mostcopper-based metals, e.g. copper, brass and bronze

are susecptible to corrosion from finger-marks. Where
corrosion may affect performance, such as in printed
circuit boards or decorative applications, gloves need to
be worn to prevent such marking.
l Liquids handling, where washing out of liquid-carrying
tankers, prior to filling with a different liquid, is neces-
sary to prevent contamination.
l Food handling, where cleaning of utensils after use is a
very necessary requirement in food handling for health
reasons.
l Electrical and electronic equipment, where safe
handling practices are required to avoid damage from
electrostatic discharges.
These. are some common examples of where special
handling techniques are required for a particular industry.
You will need to examine your operations to determine to
what extent specific handling procedures are needed and
to document them.
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Standard 4.15.3 Storage
The supplier shall use designated storage areas or stock

rooms to prevent damage or deterioration of product,
pending use or delivery. Appropriate methods for
authorizing receipt to and dispatch from such areas shall
be stipulated.
In order to detect deterioration, the condition of product in

stock shall be assessed at appropriate intervals.
Guidance Using the right storage conditions
Like handling, the storage requirements vary from industry

to industry. Examples of storage conditions include:
l cold storage of food;
l segregation of corrosive substances (such as acids and
caustic materials) from other materials; and
l storage of magnetic media (such as video tapes, audio
tapes and computer disks) in a non-magnetic environ-
ment;
Consideration should be given to the effect of stack height,
light, temperature, humidity, vibration, etc, which may
affect the product.
In many instances, there can be a requirement that the stock
is turned over on a regular basis or that it has a limited
shelf-life. An example is food which frequently carries a
“use-by date’ ‘. The term “first in, first out” is often used
to describe the approach.
For financial reasons, most businesses already have a stock

control system. During stocktaking it is usually possible to
check the condition of products. You need to identify the
storage requirements for your products and assign
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SP 65 : 1998
appropriate storage areas. Each product does not

necessarily require a separate storage area.
A periodic check of the condition of the product in stock

is also a requirement. The frequency is dependent on the
nature of the product, with robust types requiring a less
frequent check than perishable or fragile products.
Standard 4.15.4 Packaging
The supplier shall control packing, packaging and marking

processes (including materials used) to the extent
necessary to ensure conformance to specified
requirements.
Guidance Use suitable packaging

Packing should be appropriate for the materials. In many
cases, little or no packaging will be required. Bulk
materials, such as sand, gravel, coal, wheat, sugar and
timber, are examples where packing consists simply of
filling the carrying container. Even for such bulk transport,
there needs to be a check that the container is suitable and
does not contaminate the product.
Large fabricated components may be simply loaded onto
a truck and strapped down. Other materials may have
minimal packing, such as strapping to a pallet or bulk
delivery in open drums.
You should make sure that where packaging and marking
materials are used, they are compatible with the products
being packaged or ~marked. Marking materials can cause
corrosion or otherwise damage products and should be
selected with care.
Packaging should be appropriate for the product, the

intended transport and the end use. The likelihood of
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SP 65 : 1998
contact of the packaging with, for example, water, should

be assessed and the packaging selected accordingly.
Additionally, you should be aware if any regulations exist
regarding packaging. These could require “use-by dates”,
handling instructions or specific information regarding the
contents to be displayed on the package.
Standard 4.15.5 Preservation
The supplier shall apply appropriate methods for

preservation and segregation of product when the product
is under the supplier’s control.
Guidance Avoid deterioration
Preservation is essentially using the necessary practices to

ensure that the product does not spoil, deteriorate or
become contaminated while under your control.
Aspects of product preservation have already been
discussed in the guidance to 4.15.3 and 4.15.4.
If packaging is used, it can also be used to provide
identification, preservation and segregation.
If there are further preservation requirements, then you
need to identify what they are and develop the necessary
procedures. For products, there may be regulatory -and
legislative requirements or the preservation system may be
specified in the customer’s order.
Standard 4.156 Delivery
The supplier shall arrange for the protection of the quality

of product after final inspection and test. Where
contractually specified, this protection shall be extended to
include delivery to destination.
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SP~65: 1998
Guidance Getting theproduct to your customer

If you have met the requirements of 4.15.4 and 4.15.5, the
first part of the requirements of this clause would normally
be met. The key issue is that if it is part of the customer’s
order, the protection of quality of the product after final
inspection and test extends to include delivery to
destination. You may need to carry out a subcontractor
assessment as required by 4.6.2.
This may involve you in taking responsibility for the

transport. In such cases, you would need to be aware of any
legislation or regulations which might apply.
Control of quality records
Standard 4.16 Control of quality records

procedures for identification, collection, indexing, access,
filing, storage, maintenance and disposition of quality
records.
Quality records shall be maintained to demonstrate
conformance to specified requirements and the effective
operation of the quality system. Pertinent quality records
from the subcontractor shall be an element of these data.
All quality records shall be legible and shall be stored and
retained in such a way that they are readily retrievable in
facilities that provide a suitable environment to prevent
damage or deterioration and to prevent loss. Retention
times of quality records shall be established and recorded.
Where agreed contractually, quality records shall be made
available for evaluation by the customer or the customer’s
representative for an agreed period.
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NOTE 19 Records may be in the form of any type of media

such as hard copy or electronic media.
Guidance Managing your records

Records exist in all companies. These records can provide
you with information to help you manage your business
effectively. Throughout the standard there are references
to the need for records. You will need to show that you
have actually done something, recorded certain
information or met a particular requirement. These are
known as quality records. This clause deals with how you
manage those records.
It is important that a small business does not burden itself
with piles of paper that serve no purpose. You should
decide what quality records are required in relation to your
business. You should identify how long each type of record
needs to be kept, where it will be found and how it is to be
disposed of. Only keep what needs to be kept. These should
not be kept just to satisfy an auditor.
In some instances, the retention period may be dictated by
statutory or regulatory requirements, financial
requirements or by customers’ specifications. These
details should be recorded in the documented procedure.
A number of clauses throughout IS0 9001 make reference

to records and~to this clause (4.16). Some examples of what
might constitute quality records are:
l design-files, calculations;
l customers’ orders, contract reviews;
l meeting notes (e.g. management review);
l internal audit reports;
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SP 65 : 1998
. nonconformance records (service failure reports, war-

ranty claims, customer complaints), corrective action
records;
. files on suppliers and subcontractors (evaluation of sub-
contractors, subcontractor performance history);
process control records;
inspection and testing repcrts;
training records; and

records of goods received and delivered.
Records, indexing and filing can be in any appropriate
form; hard copy or electronic. Storage needs to be
appropriate for the medium and should be such that the risk
of deterioration, damage or loss is minimized.
You also need to identify and document who has access to
the quality records and decide how readily available they
need to be.
If you use computer techniques to store records, be aware
that developments and evolution of software programmes
can result in difficulties in reading records made several
years ago. It may be necessary to keep old software
programmes to access these older records.
IS0 9003 : 1994 has reduced requirements which relate
only to records of finished product conformance and the
operation of the quality system.
Internal quality audits
Standard 4.17 Internal quality audits

procedures for planning and implementing internal quality
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SP 65 : 1998
audits to verify whether quality activities and related

results comply with planned arrangements and to
determine the effectiveness of the quality system.
Internal quality audits shall be scheduled on the basis of

the status and importance of the activity to be audited and
shall be carried out by personnel independent of those
having direct responsibility for the activity being audited.
The results of the audits shall be recorded (see 4.16) and

brought to the attention of the personnel having
responsibility in the area audited. The management
personnel responsible for the area shall take timely
corrective action on deficiencies found during the audit.
Follow-up audit activities shall verify and record the
implementation and effectiveness of the corrective action
taken (see 4.16).
NOTES
20 The results of internal quality audits form an integral
part of the input to management review activities (see
4.1.3).
21 Guidance on quality system audits is given in
IS0 10011.
Guidance Are you doing what you said you would do and does it
work?
Audits are about getting information, in a planned way,
from a variety of sources and comparing it all to confirm
that things are being done propei.ly. The steps of gathering
this information should include:
l reading the procedures;
l observing the procedures being carried out;
l talking to the people carrying out the procedures; and
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SP 65 : 1998
l looking at the records.
All these need to tell the same story; i.e. that you are doing
things right, the way you said you would.
Even for a small business, where familiarity with the

day-to-day activities is the norm, a properly conducted
‘audit can be beneficial. You should use audits to stand back
and look at your business objectively to confirm that the
quality system is helping you do what you want to do and
what you need to do. The information from internal audits
should be used as part of your management review. The
better your audit, the more useful your management review
will be (4.1.3).
Where an internal quality audit shows up

nonconformances and inconsistencies, you need to
develop the necessary corrective actions (4.1.4) and then
put them in place.
These may be as simple as:

l writing or revising a procedure;
l redesigning a form to incorporate more information; and
l arranging foremployee retraining.
Audits should be scheduled to cover all the quality-related
activities you undertake and all the requirements of IS0
9001, IS0 9002 or IS0 9003 as appropriate. In deciding
how to manage the audit schedule and how often any
particular aspect should be audited, the following factors
may be considered:
l Are there any complex procedures or processes which

would justify individual audits?
l Are there any aspects or areas which have a history of

problems?
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SP 65 : 1998
l Does your “hands-on” approach indicate aneed for less

frequent audits?
A report or summary of each audit should be made out,

listing the findings and what action if any is to be taken.
The record need not necessarily be complex. For example
a simple entry in a daybook may be sufficient. If the
previous audit recommended orrequired actionto be taken,
the current audit should check how effective the change
was and this should be recorded.
There is a requirement that an audit be carried out by

‘ ‘personnel independent of those having direct
responsibility for the work being performed”. For
example, it is acceptable for the office personnel to audit
the production/service activities and vice versa. This can
provide benefits in developing an understanding of each
other’s problems.
In a small business where there may be only one or two
people in the entire management structure, this
requirement may not be achievable. It is suggested that in
such cases, the manager, carrying out the duties of an
auditor tries to step back from direct involvement in the
business operations and be very objective about the audit.
Another approach would be to seek the cooperation of
another small business and each provide the internal
quality audit facility for the other. This may prove
attractive if there are good relations between the two
businesses.
Effective use of internal quality audits is an area which you

may use to minimize the ongoing costs of certification/
registration. If the auditor from the certification/
registration body can see that internal quality audits are
being used to effectively monitor and control the quality
system, the auditor does not need to spend as much time
verifying the quality system operation. What the auditor
111
SY 65 : 1998
will be seeking is objective evidence with respect to

internal quality audits.
IS0 9003 : 1994 has similar requirements for internal

audits but does not have specific requirements for audit
procedures.
Training
Standard 4.18 Training

procedures for identifying training needs and provide for
the training of all personnel performing activities affecting
quality. Personnel performing specific assigned tasks shall
be qualified on the basis of appropriate education, training
and/or experience, as required. Appropriate records of
training shall be maintained (see 4.16).
Guidance Training yourself and your people
You need to regularly review the experience,

qualifications, capabilities and abilities of yourself and
yourpeople relative to the skills and qualifications needed
by the business for current and foreseeable activities.
Based on this review, you should establish what training
needs to be carried out and over what period.
Management review (4.1.3), corrective action (4.14) and
internal quality audit (4.17) are all likely to identify areas
which may indicate a lack of training.
The resource review (4.1.2.2) is one activity where training

needs are required to be considered. Considerations of
skills and aptitudes required under process control (4.9)
may also indicate additional training needs.
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SP 65 : 1998
Even for a small business it may be appropriate to have

simple introductory training for new starters (including
temporary and part-time employees as well as full-time
employees). This could cover:
l the nature of the business;
l the health and safety regulations;
l the quality policy; and
l the role of the new employee.

Training may be carried out in stages, consisting of a
training period followed by a period of familiarization
followed by further training and familiarization.
Training in internal quality auditing is highly desirable,
almost essential if full advantage is to be taken of the
potential that rnternal auditing offers as a management tool.
Training may be at the actual workplace, in-house or at
some external location. Depending on the topics, attending
a seminar can also provide worthwhile training.
You need to maintain records to show what training an
employee has received. The records that demonstrate
successful completion of a training programme can be as
simple or complex as you like to make them. At their
simplest, the records may consist of “sign-off” to confirm
that personnel can now use certain equipment, carry out
specific processes or follow certain procedures.
Training should be carried out by personnel with

appropriate skills, qualifications and experience. You
should maintain records to show the qualifications of
personnel used for training purposes.
IS0 9003 : 1994 requirements for training refer to the need

for personnel carrying out final inspection and testing to be
appropriately qualified or experienced or to receive
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SP 65 : 1998
adequate training. There is no specific requirement for

Servicing
Standard 4.19 Servicing
Where servicing is a specified requirement, the supplier

shall establish and maintain documented.procedures for
performing, verifying and reporting that the servicing
meets the specified requirements.
Guidance Associated maintenance and support services
Many goods and services are sold with a commitment to

provide associated maintenance and support as part of the
overall contract. This clause applies in such instances.
Remember that commitments made as part of a warranty
also form part of the contract and again this clause is
relevant.
A typical example might be an air-conditioning engineer
who, as a condition of the original contract, agrees to come
back to check and adjust the system after it has run for a
period. Another example might be a small software
developer who, as part of the contract, has agreed to
provide user help or an update service.
In dealing with servicing activities, you will need

documented procedures which address the following
aspects:
l general provisions of a servicing programme;
l planning the servicing activities;
l personnel needed and any training requirements;
114
SP 65 : 1998
l spare parts management;
l preparation of servicing instructions;
l records of servicing activities.
When providing servicing, it is important to remember that

any product nonconformances should be fed into the
corrective action system so that the reason for the failure
can be identified. Remember, if warranty repairs were
required, the product did~not perform as intended and this
is a form of nonconformance.
The small business whose sole activity is the provision of

a maintenance and support service must note that this
clause is not the only one applicable to their business. The
entire standard, with the probable exception of clause 4.4,
Design control, would normally be applicable to their
business.
numbering uniformity between the three standards. This
requirement is therefore not relevant to any IS0 9003
quality system.
Statistical techniques
Standard 4.20 Statistical techniques
4.20.1 Identification of need

The supplier shall identify the need for statistical
techniques required for establishing, controlling and
verifying process capability and product characteristics.
4.20.2 Procedures
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SP 65 : 1998

procedures to implement and control the application of the
statistical techniques identified in 4.20.1.
Guidance Choosing and using statistical techniques
The requirement is that you identify whether you need to

use any statistical techniques. If there is no such need, then
4.20.2 does not apply.
Statistical techniques may be beneficial, even in the

smallest business. If you need to use such techniques to
collect and analyse data as part of your arrangements for
design or process control, or to confirm that your product
is satisfactory, you need to describe the techniques used in
procedures. The successful use of statistical techniques
depends on the selection of the right technique for your
needs. You may wish to seek specialist advice in this area.
Your procedures need to cover how each technique is
effectively applied in practice; e.g. there is no point in using
complicated double sampling plans when no one is sure
how to use a sampling plan.
Some of the statistical techniques that may be used include:
l graphical methods which help diagnose problems, e.g.
Pareto charts or scatter plots;
l control charts for monitoring production, e.g. average
and range charts;
l sampling plans;
l regression analysis;
l failure mode analysis.
Statistical techniques may be used singly or in combination

to measure and control process capability and may be
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SP 65 : 1998
referred to under the name of statistical process control

(SPC).
Other areas where statistical techniques could be used are:
l analysis of market research;
l stock control; and
l design of experiments.
Sampling plans are used when the nature of the product

precludes the use of 100% testing. There are many
products made where a sampling procedure is used and the
batch passed or re_jected on the basis of the sample. The
detection of nonconforming product does not necessarily
mean the sampling procedure is incorrect.
However, a continuing and perhaps higher than expected
level of nonconformances may suggest that the sampling
plan or procedure, or both, may need investigating.
Alternatively, if your samples are indicating a satisfactory
product, and you are receiving a high level of customer
complaints, your sampling plan may well be inappropriate
and need investigating.
IS0 9004-4 : 1593 contains a number of examples of
statistical techniques and may provide a useful reference.
IS0 9003 : 1994 has reduced requirements, applying to
product characteristics only, and omitting process
capability. The requirement to establish and maintain
documented procedures has also been omitted.
117
As in the Original Standard, this Page is Intentionally Left Blank
SP 65 : 1998
Annex A
Bibliography
Standard Annex A
(informative)
Bibliography
[ 11 IS0 9000- 1: 1994, Quality management and quality

assurance standards - Part 1 : Guidelines for
selection and use.
[2] IS0 9000-2:1993, Qdity management and quality

ossuronce standards - Part 2 : Genericguidelinesfor
the npplic~ltion of IS0 9001, IS0 9002 and IS0 9003.
p] IS0 9000-3: 199 1, Quality management and quality

assurance standards - Part 3: Guidelines for the
upplication of IS0 9001 to the development, supply
und maintenance of software.
[4] IS0 9002: 1994, Quality systems - Model for quality

assurance in production, installation and servicing.
[5] IS0 9003: 1994, Quality systems - Modelfor quality

assurance infinal inspection and test.
[6] IS0 1001 1-1: 1990, Guidelines for auditing quality

systems - Part 1 : Auditing.
[7] IS0 1001 1-2: 199 1, Guidelines for auditing quality

systems - Part 2 : Qualification criteria for quality
systems auditors.
119
SP 65 : 1998
PI IS0 100 1l-3 : 199 1, Guidelines for auditing quality

systems - Part 3: Management of audit programmes.
[91 IS0 10012- 1 : 1992, Quality assurance requirements

,for measuring equipment - Part 1: Metrological
cor@wzation system for measuring equipment.
[ 101IS0 100 13 : 1995, Guidelines for developing quality

manuals.
[ 1 I ] ISO/TR 13425 : 1995, Guidelines for the selection of

statistical methods in standardization and
specification.
Guidance References listed in IS0 9001:1994
The above Annex is part of IS0 9001 (updated to include

subsequent publication dates)and lists the references in the
standard. The following text gives some additional details
about the standards listed and also some others that may
prove useful. These standards are often referred to as the
IS0 9000 family.
The terms “normative” and “informative” are often used
to describe annexes. A “normative” annex is an integral
part of the standard, whereas an “informative” annex is
only for information and guidance.
In this Handbook the annexes are informative.

Standard Title Brief description of
contents
ISO9000-1 : 1994 Quality management and Provides guidance for the
quality assurance standards selection and use of IS0
- Part 1 : Guidelines for 9000 family of International
selection aild use Standards on quality
management and quality
assurance. Clarifies the
principal quality-related
120
SP 65 : 1998
Title Brief description of

contents
concepts needed for
effective understanding and
application of the standards,
and the distinctions and
interrelationships between
them.
ISO9000-2:1993 Quality management and Provides guidelines to
quality assurance standards enable users to have
- Part 2 : Generic guidelines improved consistency,
,for the application of IS0 precision, clarity and
9001, IS0 YOO2and IS0 9003 understanding when
applying the requirements
of the IS0 9000 series of
standards.
IS0 9000-3:1991 Quality management and Provides guidelines to
quality assurance standards software developers,
- Part 3 :Guidelines for the suppliers and maintainers
application of IS0 9001 to the and to purchasers in the
development, supply and specification and
maintenance of software implementation of IS0
9001 quality system
requirements as applied to
software.
1s09001:1994 Quality systems - Model for Specifies quality system

quality assurance in design, requirements for use when
development, production, conformance to specified
irlsrallatiorl and servicing requirements is to be
assured during design,
development, production,
delivery and servicing. It
provides a quality assurance
model for demonstration by
a supplier of its capability
and for assessment by
external parties.
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contents
IS0 9002: 1994 Quality sytems - Model for Specifies quality system
qualit) assurance in requirements for use when
production, installation arld conformance to specified
servicing requirements is to be assured
by the supplier during
production, installation and
servicing. It provides a quality
assurance model for
demonstration by a supplier of
its capability and for
assessment by external parties.
IS0 9003: 1994 Quality systems - Model for Specifies quality system
quality assurance in final requirements and a quality
inspection and test assurance model for use
where a supplier’s capabilty
to detect and control the
disposition of any product
nonconformity during final
inspection and test needs to
be demonstrated.
IS0 9004-l: 1994 Quality management and Provides guidelines on
qualiq spsrem elements - quality management for use
Part 1 : Guidelines within an organization in the
development and
implementation of a
comprehensive and
effective system designed to
satisfy customers’ needs
and expectations while
servicing to protect the
organization’s interests.
ISO9004-2:1991 Quality management arzd Provides guidelines for the
quality system elements - establisment of a quality
Part 2 : Guidelines for system for services with the
services primary objective of
preventing unsatisfactory
services.
122
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contents
ISO9004-3:1993 Quality management and Provides a guide to quality
qualip system elements - system elements applicable
Part 3: Guidelines for to processed materials, such
processed materials as bulk products, and
discusses means of ensuring
effective quality
management.
IS0 9004-4:1993 Quality management and Provides a set of

quality system elements - management guidelines for
Part 4 : Guidelinesfor qualiv implementing continuous
improvement quality improvement within
an organization. Describes
tools and techniques for a
quality improvement
methodology based on data
collection and analysis.
IS0 looo5:1995 Quality management - Provides guidance to assist

Guidelines for quality plans suppliers in the preparation,
review, acceptance and
revision of quality plans,
which~provide a mechanism
to tie specific requirements
of a product, project or
contract to existing quality
system procedures.
IS0 10007: 1995 Quality management - Provides guidelines for

Guidelines for configuration configuration manage-
management ment. This is a management
discipline that is applied
over the life cycle of a
product to provide visibility
and control of its
functionality and physical
characteristics. The
activities described are a
way of satisfying certain
123
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contents
requirements found in other
International Standards in
the IS0 9000 family.
IS0 1001 l-l:1990 Guidelines for auditing Provides guidelines for
qualify systems - Part 1: establishing, planning,
Auditing carrying out and
documenting audits of
quality systems as well as
providing basic audit
principles, criteria and
practices. It allows users to
adjust the guidelines to suit
their own needs.
IS0 1001 l-2:1991 Guidelines for auditing Sets out qualification
quality sytems - Part 2: criteria for the selection of
Qualification criteria for auditors to perform quality
qualiq systems auditors systems audits in
accordance with IS0
1001 l-l.
IS0 1001 l-3:1991 Guidelines for auditing Provides basic guidelines
quality systems - Part 3: for managing quality system
Management of audit audit programmes. These
programmes guidelines can be used to
establish and maintain an
audit programme function
when performing quality
system audits in accordance
with IS0 1001 l-l and IS0
1001 l-2.
IS0 10012-1:1992 Qualit) assurance Specifies quality assurance

requirements for measuring requirements for a supplier
equipment - Part 1: to ensure that measurements
Metrological co@rmation are made with the intended
system for measuring accuracy, and contains
equipment guidance on implemen-
tation; also specifies the
124
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contents
main features of the
confirmation system for
measuring equipment.
IS0 10013:1995 Guidelines for developing This standard provides
qualit? nurnl~als guidelines for the
development, preparation
and control of quality
manuals which will reflect
documented quality system
procedures, as required by
the IS0 9000 family of
standards, and which can be
tailored to suit the specific
needs of suppliers of goods
and services.
125
As in the Original Standard, this Page is Intentionally Left Blank
SP 65 : 1998
Annex I
How the key quality system standards compare
IS0 9000-2 provides guidance on all of the subclauses of IS0 9001 and has
been utilized in the preparation of thisHandbook. IS0 9004-l provides
guidance on quality management, much of which is relevantto the quality
assurance requirements of IS0 9001 and this also has been considered in
the preparation of this Handbook. Should readers wish to consult IS0
9004- 1, the comparison table below may be of assistance.
Corresponding clause numbers
Title Requirements Guidance
IS0 9001 IS0 9002 IS0 9003 IS0 9004-I
Management responsibility 4.1 . 4.1 . 4.1 0 4

Quality system requirements 4.2 l 4.2 l 4.2 o 5
Gontract review 4.3 l 4.3 g 4.3 ’ -
Design control 4.4 g 4.4 - 4.4 - 8
Document and data control 4.5 l 4.5 . 4.5 l 5.3;11.5
Purchasing 4.6 . 4.6 l 4.6 - 9
Control of customer-supplied
product 4.7 l 4.7 l 4.7 g -
Product identification and
trace ability 4.8 l 4.8 l 4.8 o 11.2
Equivalent requirements in IS0 9001, IS0 9002 and IS0 9003 are shown by ...................l
Where IS0 9003 has a different requirement to IS0 9001, this is shown by ..................... 0
For IS0 9001, IS0 9002 and IS0 9003, where there is no requirement, this is shown by ....... -
Since IS0 9004 I provides guidance, the clause number indicates its presence;
absence is indicated by ........................................................................................................ -
127
SP 65 : 1998
Corresponding clause numbers
Title Requirements Guidance

IS0 9001 IS0 9002 IS0 9003 IS0 9004-l
Process control 4.9 * 4.9 l 4.9 - IO;1 1
Inspection and testing 4.10 l 4.10 l 4.10 0 12

Control of inspection, measuring
and testing equipment 4.11 l 4.11 ~* 4.11 . 13
Inspection and test status 4.12 . 4.12 . 4.12 . 11.7
Control of nonconforming product 4.13 l 4.13 l 4.13 0 14
Corrective and preventive action 4.14 l 4.14 l 4.~140 15
Handling, storage, packaging, 4.15 l 4.15 . 4.15 l 10.4;16.1:

preservation and delivery 16.2
Control of quality records 4.16 . 4.16 . 4.16 o 5.3;17.2;

17.3
Internal quality audits 4.17 l 4.17 . 4.17 0 5.4
Training 4.18 l 4.18 . 4.18 o 18.1
Servicing 4.19 l 4.19 l 4.19 - 16.4
Statistical techniques 4.20 l 4.20 . 4.20 o 20

Quality economics - 6
Product safety - 19
Marketing - - 7
Equivalent requirements in IS0 9001, IS0 9002 and IS0 9003 are shown by .. .... .... ... .. ... . l
Where IS0 9003 has a different requirement to IS0 9001, this is shown by . .. .. .. .... .... ... ... 0
For IS0 9001. IS0 9002 and IS0 9003, where there is no requirement, this is shown by . .. .... .. .. -
Since IS0 9004-l provides guidance, the clause number indicates its presence;
absence is indicated by . .._.._....___........................................................................................... -
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Annex II
Explanation of terms used
This Annex contains explanations of some commonly used terms in this

Handbook as they relate ro small businesses. they should not be confused
with the formal definitions given in IS0 8402: 1994. (where there is a formal
definition given in IS0 8402 or IS0 900 1, it is shown under the explanation
in snlnll italic rypcr. Note that when clause numbers are given in IS0 8402
or IS0 9001 text, these ~Cer to the clause numbers in those standards.)
Audit Thib t~:r!il may bc considered as a systematic examination

(Qidity) (90t to find OUI ii‘ the actual quality activities and associated
also Review) results XC in line with those expected or planned for.
IS0 8402:1994 Clause 4.9 quality audit - systematic crnd

independent cxtmination to dertermine whether quuliq
(2. I) trc*Gritic.yand related results comply with planned
arru,lgements rrrd whether these crrrcrngements are
irnljirrrlc~rlrllil t:@cri\Jrly and are suitable to achieve
ol?jectives.
I The ~/ui!lity audit typically applies to, but is not limited

lo, L~,!rrarity .cystem (3.6) or elements thereoi to processes
(1.2) or ICYservices (1.5). Such u&its are often called
“clutrlitr s?lstem LlLtLlit”, “process quality audit”,
“product c@ity audit’ ’ or “service quality audit’ ‘.
129
SP 65 : 19%
2 (zuillity edits are carried out by stajfnot havirly direct

responsibility in the areas being audited but, prejkmbly,
L~~orkingin cooperation with the relevant personnel.
3 OIW I3urpose ofa quality audit is to evaluate the rleedfor

improvemerzt or corrective action (4.14). An alrdit shorrld
riot be confused with quality surveillance (4.7) or
insprctioll (2.15) ncti\Gties performed for the purposes oj
process c.o~lftd or product acceptance.
4 Qucrlity adits can be corducteclfor itzternal or exterd

purposes.
Contract This term applies to all transactions between a customer

and small business. It may be verbal or documented.
Examples include the following:
0 a purchase order;
. a telephone order;
l a verbal order in a restaurant.
IS0 9001:1994 Clause 3.3 contract - agreed
requirements between supplier and customer transmitted
by any means.
Manager This term is used in the Handbook to describe, as ap-

propriate in the context, the person who is exercising
authority, taking responsibilities, making decisions and
fulfilling similar managerial functions on behalf of the
business. It includes, as appropriate, any of thcfollowing:
0 single owner;
l partner;
l managing director;
l director;
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* general manager;
l manager;
l senior executive.
Non- This term is used to describe any instance of failure to meet

conformity a specified requirement. It may be failing to meet a
customer’s requirement, a problem with aproduct or ser-
vice, a deficiency in the quality system or any other situa-
~tion where what happened was not what was required.
IS0 8402:1994 Clause 2.10 nonconformity -

nonfulfilment of a specified requirement.
Objective IS0 8402:1994 objective evidence - information which

evidence can be proved true, based on facts obtained through
observation, measurement, test or other means.
Procedures This term is used generically to describe by whom, with

what, when, where and how processes are carried out. they
can include, as appropriate, any of the following:
l quality system procedures;
l manufacturing procedures;
l service delivery procedures;
l work instructions;
l maintenance procedures.
IS0 8402:1994%lause 1.3 procedure - specified way to

pe$orm an activity.
NOTES
I Irl many cases, procedures are documented [e.g. quality

systern(3.6)procedures].
131
This term is used throughout this Handbook to describe any
form by which a business can provide a saleable outcome
of its activities to meet a customer’s requirements. for
L3ample:
u physical products, either as assemblies or processed
material;
e provision of services;
a design output,
* computer software;
e raw materials.
dSla 8402:1994 Clause 1.4product -- rcsrrlt qfactivities
I ri^pi”;/<‘:‘.i,i’l’s ( 1.2).
:vo I-Es
? A ptw!llc:t may include service, hurdware, processed

motcrinls, st~fl \vare or a combinatiori thrreof:
2 A prOc/iicT mu be tatcllgible(e.g. assemblies or processed

r?ltrtcricrl.\)
or i/l:angihle (e.g. krzobvledge or concepts), or a
corilbirlaiior~thei.eojI
3 A product call be either intended [e.g. ojjfering to

customers (l.Y)] or unintended (e.g. pollutant or unwanted
eflect,s).
NOTE ~- 111
IS0 9001:1994 Clause 3.1, unintended product is
~xcl~rded from tlut Starzdmd.
§I’ 65 : 1998
Review (SW This term is used in three situations; management review,

also Audit) contract review and design review.
In each context. it can be taken to mean the broad overview

of the activities relevant to that situation.
IS0 8402: 1994 Clause 3.9 management review --fort&

evcllrtcrtion by top management of the status and adeq~r~~~
of‘the yucrli[y syslern (3.6) in relution to quality poiicy /_?.I)
and objectives.
NOTES
I Management review may inch& review of- lJv qiiullt\,l
policy.
IS0 8402:199-I Clause 3.10-contract review - SyStel?it7Pi(:

acti\Gtio.s carried out by the supplier h@re signing tJrl
contract to ensure thut requirements,for quality (2..? 1arc
ndcqucltely defined, free from ambiguity, docurnrtzlcd nrrd
cat1 be realked by the supplier (1. IOj.
I 771~
contract review is the responsibility qf’the supplier
brtt ccm be curried out jointly with the customer { 1.9).
2 A contruct review may be repeated at di$zrent phnses

of the contract as needed.
ISO8402:1994Clause3.11 design review-documented,

comprehensive and systematic examination of LIdesigl:IIto
evclllmte its capnbili5 to fulfl the requiretnents for qucrlitj,
(2.3), identify problems, if nrzy, ~rld propose til:-’
development ofsolutions.
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NOTE - A design review can be conducted at any stage

of the design process (1.2) but should in any case be
conducted at the completion of this process.
Small For the purposes of this Handbook, a small business is not

business 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 com-
pany with three or four executives are typical examples.
This explanation should not deter anybusiness from using
the guidance given here,~if it is appropriate to the business’s
situation.
Sub- This term is used in quality system standards and in this

contractor Handbook to describe any organization from which a small
business purchases products or services, or both. It
includes such commonly used terms as supplier or vendor.
IS0 8402:1994 Clause 1.13 - organization (1.7) that
provides a product (1.4) to a supplier (1.10).
NOTES
1 in English, the subcontractor may also be called the
“subsupplier”.
2 In French, the “sous-contractant” may also be called,
as appropriate, ‘ ‘sous-traitant ’ ’ or ‘ ‘sous- commandier ’ ‘.
Tailoring This term describes the selection of the applicable require-

ments from the standard which are relevant to the small
business. Sometimes, not everyrequirement or part of any
given requirement is appropriate to the -activities being
carried out by the small business.
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Annex III _- __._..~_
Steps towards a quality system
Introduction There are many ways a small business may go about

implementing a quality system. This Annex is intended to
provide one such example of implementation by 2%<mail
business.
NOTE - It is provided solely as an example :i~i.t L,i-i<>nid
not be regarded as the only method of implernentarton not
the best method of irnplementatiort.
The approach given consists of three stages as foilowz:
l considering what happens in your business;
0 implementing the quality system;
l improving the quality system.
These stages are achieved via a number of steps, as follows:
Considering 1 Consider your main business activities, i.e. the different

what happens flows of work through your business, and list them.
in your 2 With this list in mind, choose the quality system stand-
business ard most appropriate to your business activities.
Implementing 3 Get people involved by writing down what tht:ir,i~~~h~

the quality cover.
system 4 Collate this together in sequences relevant list of main
business activity you made earlier.
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5 Identify where the standards and this list of your main

business activities link together.
6 Apply the standard and the quality system.
7 Keep the quality system simple and functional, i.e.

relevant to the business operations.
Improving 8 Consider the feedback of information from the quality

the quality system to lead to improvement in activities.
system
9 Monitorand~measure the changes so you know what you
have gained by it all!
NOTE - In some instances, in providing guidance on .

implementation, some of the advice is specific to particular
sectors, such as manufacturing or service industries.
Considering Now that you have determined that you would like to
what happens analyse your business and would like to work in a more
in your efficient manner, where do you start?
business
‘Thestages and their associated steps hxqe already been
olltlines, so let’s walk through them.
Step 1 + Consider what your main business activities are and list
them
You and, if appropriate, your partner or business associates

should discuss and jot down what your main business
activities are.
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SP 65 : 1998
Depending on the type of industry sector you belong to,

this may vary and some examples are shown below.
Mmufacturing:
l If you are a manufacturer, you may have a single

product or you may have a range of products you
manufacture.
l You may warehouse and distribute.
Stockist/distribuior/agent:
l You may carry a single product or aproduct range.
l You may purchase components and repackage them or

assemble them into varied lots to satisfy customers’
needs.
l You may supply an information service on the
use of the goods to clients; so as well as being a
provider of raw materials, you are also a consultancy
service.
l You may be buying aproduct or warehousingproducts

manufactureed by somebody else.
l You may carry arange ofproducts which are perishable
and need to be monitored and rotated regularly.
l You may provide a transport/distribution service for the

goods.
Repair or after sales service agency:
l You may perhaps service a range of products but you

need to consider if your servicing is conducted different-
ly for different clients.
l You may also provide equipment and parts and

participate in the actual delivery of the service.
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Professional consultancy:
l You may provide initial research for clients.
l You may actually design the concepts and develop the

project plan.
l You may also provide project management and provide

ongoing consultancy services throughout the life of the
project.
All of the above industries or service business may

subcontract out components of their activities or use
subcontract labour. This needs to be identified and noted
against the relevant process areas when jotting down your
main business activities as the standard requires you to
manage your subcontract suppliers.
Further into the development of your quality system, you
will apply specific treatment to the management of
subcontractors supplying your raw components.
Step 2 * Now you are ready to use the IS0 9000 quality system
standards most appropriate to your business activities
Look at the list of main business activities you have jotted
down. Do any of the activities require you to do design
work?
Design means taking raw ideas or concepts and, either

through design drawing, computer design or academic
thought processes, developing a product or service design
or project plan to suit the needs of your customer.
If you do, you will need to address:
l IS0 9001, Quality systems - Model for quality

assurance in design, development, production, installa-
tion and servicing.
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SP 65 : 1998
If you don’t design and the manufacturing activities or

service delivery is done against tried and previously
developed standards or specifications, then you will need
to address:

assurance in production, installation and servicing.
If you provide a very simple service or product with no

intricate components or activities and the product can be
fully verified by completing some simple tests or final
visual inspection, then you would address:
assurance infinal inspection and test.
Implement- To achieve the next step, you need to keep the list of main
ing the business activities you initially thought through, firmly
quality fixed in your mind.
system
It may help at this stage to take each of the main business
activities you listed originally and produce them in the
form of a flowchart.
Display this in your office or at home for easy reference
and look at it regularly to remind you what it is you are
attempting to develop a quality system around.
The purpose of setting out your business activities like this
is so you can:
l identify the different components of your business and

decide if they all fit together well, or if, in fact, you need
to change something to make the whole process work
better; and
l identify where and if~the elements of the standard are

covered in your business activities.
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SP 65 : 1998
NOTE - Do not make the changes yet. This is covered

later in Step 5.
Note for service industries
a) Before attempting to do this activity, you need to stop,

think - question: what is my product, i.e. what services
do I deliver? For example, is it:
legal advice;
property advice;
educational and/or training;

public relations;
media placement;
graphic design;
specialist electronic design; or
individual specialist consultancy services?
b) Remember that:
The idea of a quality system is not to inhibit the
academic/intellectual or creative processes involved in
any of the above services.
Rather, the idea is to think about the framework and
structure within which your business operates and to
ensure all activities are known and repeatable. This will
allow you to provide consistent goods or services each
time you deliver to your customers.
Step 3 -9 Getpeople involved by writing down what their-jobs cover
Now is the time to get everyone concerned involved in

writing down how they carry out the parts of the business
activities they are responsible for, stating:
140
SP 65 : 4998
l who is responsible for performing and checking

activities;
l where the activity takes place;
l when it will happen; and
l what happens, that is, how the activity is performed.
Some important points you will need to think about are:
a) If it is a job done by a trained apprentice or specialist,

it may well be that you will only need to reference the
type of person and the qualifications, rather than a
detailed description of the job; for example, graphic
designer/welder/visiting professional consultant.
b) If, however, the work is done by casual labour, or there

are specific in-house requirements, more detail may be
required.
cj The sequence of the activities may still need to be

defined, for example:
* How the initial enquiry is recorded.
l How a file is initiated.

l How does the work get started?
l Who monitors the progress?
l How is the work processed and inspected?
l Who decides when the work is finished?
* How is delivery made?
l What follow-up action is needed and who does it?
l What records are kept and who keeps them?
If your organization already has its details written down as

operating or work instructions, your job is already half
done. Don’t rewrite what is already documented, make a
141
SP 65 : 1998
note of the name and title of the document so it can be

controlled and if necessary referenced in other quality
system documentation at a later date.
d) Most important . .. . Keep written documentations

SIMPLE!
Step 4 -9 Collate this together in sequences relevant to the list of

business activities (Step I)
Once everyone has written down, or collected previously

written, work instructions relevant to his or her part of the
activity or particular job responsibilities, you as manager
should take time out with someone else from the business
to look at:
l what has been written;
l satisfy yourself that it all fits together; and
l deal with any gaps or inconsistencies.
By appointing someone to assist you, you have basically

appointed a quality representative, or if you are doing most
of this yourself as manager, you have assumed the role of
management representative. You have now addressed one
of the first requirements of the standard.
By collalting all these documents, you now have a
procedures manual, which is another requirement of the
standard. Yotrmay wish to adopt aconsistent style for these
documents which you and your people are comfortable
with. This may provide an opportunity to review and
improve the procedures themselves.
Step 5 + Zdentify where the standards and this list ofyour business
activities link together
You or your quality representative need to go through the

documented procedures with a copy of the standard beside
142
SP 65 : 1998
~you and determine if the requirements of the standard have

been covered.
If you identify an area of the standard you have not

addressed, you will need to consider how your business
covers that particular requirement. You may need to add
some detail to one of the existing procedures to ensure the
requirement is met. It may require some additional
documentation, but be careful, make sure it is relevant to
your organization.
You may have to use external documents in your business

activities. Some examples are dealers’ manuals,
maintenance manuals and installation manuals. It is not
necessary to rewrite these to include them in your quality
system. All that is needed is to make an appropriate
reference to the procedure in your manual.
Step 6 * Apply the standard and the quality system

If you continue to involve others in your organization, they
are more likely to grow with the quality system and have
input. The quality system will then reflect reality rather
than become irrelevant paperwork. The following points
shoud be noted:
l Do not unnecessarily create paperwork, forms, and the
like. Look at what is currently done and write your
procedures to show how the job is done, not how you
wish it was done or should be done.
l Only create ~a form if it is going to capture a critical
activity or is going to help someone. A signature on, or
an extension to, an existing form may suffice.
l Remember, keep a record when:
l a problem arises;
l a good suggestion is raised, or
143
SP 65 : 1998
l a customer or employee expresses a need for action.
If the business is a partnership, this may be just a notepa.

which each partner looks at regularly. They can then
discuss and agree on appropriate action for the situations
which arise.
l To implement the quality system, everybody needs :I

be shown their relevant procedures and given som
insight into how the quality system works and why, for
example, document control ensures that they have the
latest copies of information relevant to theirjobs and can
rely on making decisions on up-to-date information.
. Everybody needs to be trained to understand how to
keep the quality system up-to-date themselves, if chan-
ges take place in areas they are responsible for.
Everybody needs to know how to make changes to the
quality system as well as noting problems and putting
forward ideas for improvement. Remember that you
need to approve any procedures or changes to proce-
dures before they are put in place.
Step 7 3 Keep the quality system simple, functional and relevant

to the business operations
The following points are worth noting:
l The purpose of implementing a quahty system is to
ensure that the business activities are operating in a
controlled manner and the people responsible for the
various activities know and understand their roles and
responsibilities.
l Quality system documentation should be a ready refer-

ence point to identify how, when, where and sometimes,
why a job should be done, or an activity managed. For
that reason, the wording should be simple and in the
language used in the workplace on a daily basis.
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SP 65 : 1998
l Documentation should be in a format that is easily used

in the organization. For example:
. if computers are available, itmay be easier to have a
computerized system, rather than a paper system;
. where there may be language or other differences in
the workforce, it may be necessary to use pictures or
several translations of the documents;
l Documentation should reflect what is currently happen-

ing in the business. During the audit process, questions
will be asked and objective evidence sought, to show
that personnel are using and understanding the quality
system. The objective evidence is provided by the
documentation.
Improving An effective quality system uses feedback loops to

the qua.ity improve how you go about doing things, which in turn
system should lead to an improvement in product quality.
Step 8 + Consider the feedback of information from the quality

system to lead to improvement in ideas and activities
Many small busisnesses do not consider that they are in a

position to take on major quality improvement
programmes. You are in fact able to commence these
activities in your own time and in your own way.
By noting areas of concern fromcotrective action activities
(step 6), you will gather data, or note trends which you can
look at and consider for improvement,
Improvements may be simple and easily achieved in the
initial stages but may become more challenging once the
obvious opportunitiesfor improvement have been~taken. It
is worthwhile persevering with a systematic approach to
145
SP 65 : 1998
quality improvement, since the benefits can be

considerable.
Normally, improvements are adopted over a period of time

as money and resources become available. A realistic
approach and steady progress will build confidence and
-maintain enthusiasm.
Step 9 4 Monitor-and measure the changes so you know whatyou

have gained
It is important to remember to measureyour progress. One

way of doing this is to monitor mistakes and their cost. This
gives you the opportunity to identify areas where cost
savings may be made.
Measurements may also be obtained by noting how long
or how many resources are spent on an activity or service
delivery. This should always be recorded on any activity
that has been chosen for improvement, prior to
commencement and compared again at the end - even
though the activity may be small and simple.
The various requirements of IS0 9001 should all combine
together to support the achievement of the business’s
quality goals. However, it may be useful to categorize these
according to their particular relevance to different aspects
of the business, since this may influence the order in which
you may wish to introduce these requirements. As might
be expected, many requirements are relevant to more than
one aspect of the business and appear in more than one
group below.
a) Those which relate to the overall management of the

business:
l management responsibilty (4.1)
146
SP 65 : 1998
l quality system (4.2)

l document and data control (4.5)
l control of nonconforming product (4.13)
l corrective and preventive action (4.14)
l control of quality records (4.16)
l internal quality audits (4.17)
b) Those which relate to the business’s activities:

l contract review (4.3)
l design control (4.4)
l purchasing (4.6)
l control of customer-suppliedproduct (4.7)
l process control (4.9)
l inspection and testing (4.10)
l handling, storage, packaging, preservation (4.15)
and delivery
l servicing (4.19)
c) Those which provide support to the business activities:

l product identification and traceability (4.8)
l control of customer-supplied product (4.7)
l control of inspection, measuring and (4.11)
testing equipment (calibration)
l inspection and test status (4.12)
l training (4.18)
l statistical techniques (4.20)
d) Those which may directly involve the,customer:

l contract review (4.3)
l design control (4.4)
l control of customer-supplied product (4.7)
l product identification and traceability (4.8)
147
SP 65 : 1998
l inspection and testing (4.10)

l control of nonconforming product (4.13)
l corrective and preventive action (4.14)
l handling, storage, packagiig, preservation (4.15)
and delivery
Conclusion Remember: small, steady changes, leading to improve-

ments, well-thought-out and effective, are going to have
long-term advantages.
These nine steps can help you take advantage of the quality
system approach and allow it to contribute to the growth
of your business.
148
SP 65 : 1998
Annex IV
Brief outline of certification/registration
Certification/registration of a quality system is not mandatory but the

following provides a brief outline for those wishing to follow this path.
Who does the There are two types of certification/registration: one is

certification/ carried out by your customer(s) and the other by an inde-
registration? pendent party. The outline below is based on that typically
adopted by independent, third-party certification/registra-
tion bodies.
Brief outline The process generally takes the form of the following
steps:
You make a formal application to the certification/registra-
tion body. The application normally includes a description
of your business activities, the product range, and any
other information requested. The certification/ registration
body may ask for a questionnaire to be filled out.
Next, the certification/registration body will review your
quality manual. What it will be looking for is how well the
quality manual describes what you say happens against
what the standard says should happen.
Where there are deficiencies, the certification/ registration
body will indicate where the problems are. Amendments
149
SP 65 : 1998
to the quality manual will usually overcome most

problems, but you may also have to develop additional
procedures. A further review of any changes is carried out
and is often combined with one of the subsequent stages.
The certification/registration body may then hold a

pre-assessment check or go straight to the certification/
registration audit.
In the certification/registration audit, the auditor (and there

may be more than one) will use the quality~manual and any
procedures as a guide to how your business operates. The
auditors operative words will be “Show me”. The auditor
will be looking for records, documents, or other objective
evidence to see that you are doing what your quality
manual/procedures say you do.
Where inconsistencies (nonconformities) are found, the
auditors actions depend on how serious these are. For major
nonconformities, the certification/registration could be
with-held pending rectification. For minor nonconformities,
a quality certification/registration might be issued,
pending rectification by the next compliance audit.
Once certification/registration is granted, the certification/
registration body will carry out surveillance audits of the
quality system over the period for which the certification/
registration is valid. These audits are not as comprehensive,
in that the full quality system is not necessarily assessed at
each surveillance audit.
If nonconformities are found during a surveillance audit
and not rectified within specified times, certification/
registration may be withdrawn, Minor nonconformities
will be required to be rectified by the next surveillance
audit, which under these circumstances may seem to come
round very quickly.
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SP65: 1998

December 1998 Price Rs 210.00

0 BUREAU OF INDIAN STANDARDS

ISBN 8 l-706 l-050-8

Published by Bureau of Indian Standards, New Delhi- 110002

Wherever the words ‘International Standard’ appear, they should be read

In the adopted Handbook, normative references appear to certain

IS0 8402 : 1994 IS/IS0 8402 : 1994 Quality Identical

In the adopted Handbook, informative references appear to certain

IS0 9000-I : 1994 IS/IS0 9000-l : 1994 Quality Identical

IS0 9000-3 : 1991 IS/IS0 9000-3 : 199 1 Quality do

IS0 9000 - 4 : 1993 IS/IS0 9000-4 : 1993 Quality do

IS0 9001 : 1994 IS/IS0 9001 : 1994 Quality systems Identical

IS0 9002 : 1994 IS/IS0 9002 : 1994 Quality systems do

IS0 9003 : 1994 IS/IS0 9003 : 1994 Quality systems - do

IS0 9004- 1 : 1994 ISO/ISO 9004-l : 1994 Quality do

IS0 9004 -2 : 1991 IS/IS0 9004-2 : 1991 Quality do

IS0 9004-3 : 1993 IS/IS0 9004-3 : 1993 Quality do

IS0 10005 : 1995 IS/IS0 10005 : 1995 Quality do

IS0 10007 : 1995 IS/IS0 10007 : 1995 Quality do

IS0 10011 - 1 : IS/IS0 1001 1- 1 : 1990 Guidelines for Identical

IS0 10011 - 2 : IS/IS0 1001 l-2 : 1991 Guidelines for do

IS0 10011 - 3 : IS/IS0 1001 l-3 : 1991 Guidelines for do

In Annex A of IS0 Handbook, under ~‘Guidance’, the designation of IS0

National Foreword ................................................................................... 3

About this Handbook ............................................................................... 9

Quality systems ....................................................................................... 11

How to start.. ........ . .................................................................................. 15

Annex A Bibliography.. ......................................................................... 1I 9

Annex III Steps towards a quality system ............................................ .135

Annex IV Brief outline of certification/registration .............................. 149

About this Handbook

within the~business. Decision making is confined to a few people (or even

l Greater focus on your business objectives and your

. Achievement and maintenance of the quality of your

Opening up new market opportunities or to maintain

NOTE - A customer’s order does not always provide

While the quality system can help in achieving these ex-

It won’t solve all your problems. It is a means for you to

Quality systems are not just for big companies. Since

Quality system standards should not be confused with

IS0 9001 sets out the requirements to be met where a

IS0 9002 gives the equivalent requirements where a busi-

IS0 9003 is the equivalent model where design control,

Two standards, which may be of particular use are:

First step This Handbook is written particularly for a small business

Having made this selection, you will need to see what

What’s Do you need more information? Some sources that you

If the decision is yes, the next question is “How much can

You will need to establish what personnel and time resour-

Because most small businesses will not always have suffi-

The key issue that you need to recognize in using external

Do it The section entitled “Guidance on IS0 9001, IS0 9002

to further develop your quality system. Probably many of

Sole traders or small partnerships may find that if !hey

For example, when placing job advertisements for

For a multi-cultural workforce, simple pictorial

An important requirement is that, whichever way the

The extent of documentation could be very simple for a

Use of-a If you decide to engage a consultant, it is essential that the

The following are some of the actions that should be

l Talk to several consultants.

l Choose your consultant carefully, check credentials,

l Ensure that the full scope of thebusiness’s activities and