I N T E R N AT I O N AL I SO

S T AN D AR D 9000-2

S e co n d e d i ti o n

1 9 9 7- 0 6 - 1 5

Qu al i ty m an ag em en t an d q u al i ty assu ran ce
stan d ard s —

Part 2:
G e n e ri c g u i d el i n es fo r th e ap p l i cati o n of

I SO 9001 , I SO 9002 an d I SO 9003

N o rm e s po u r l e m an ag e m e n t de la q u al i té et l ' as s u ran ce de la q u al i té —

P arti e 2: Li g n e s d i re ctri ce s g é n é ri q u e s p o u r l ' ap p l i cati o n de l 'I SO 9001 ,

l 'I SO 9002 et l 'I SO 9003

A I SO
R e fe re n ce n u m be r

90 00 -2: 1 997(E )
ISO 9000-2: 1 997(E)

Contents Page

1 S cope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4 Quality s ys tem requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.1 Management res pons ibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.2 Quality s ys tem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.3 Contract review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.4 Des ign control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.5 Document and data control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.6 Purchas ing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.7 Control of cus tomer- s upplied product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.8 Product identification and traceability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.9 Proces s control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.1 0 Ins pection and tes ting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.1 1 Control of ins pection, meas uring and tes t equipment . . . . . . . . . . . . . . . . . . . . . . 21
4.1 2 Ins pection and tes t s tatus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.1 3 Control of nonconforming product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.1 4 Corrective and preventive action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.1 5 Handling, storage, packaging, pres ervation and delivery . . . . . . . . . . . . . . . . . 25
4.1 6 Control of quality records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.1 7 Internal quality audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.1 8 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.1 9 S ervicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.20 S tatis tical techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Annex A B ibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

© IS O 1 9 9 7

All rights res erved. Unles s otherwis e s p ecified, no part of this publication may be reproduced or utilized in any form or by any

means , electronic or mechanical, including photocopying and microfilm, without permis s ion in writing from the publis her.

International Organization for S tandardization

Cas e pos tale 5 6 • C H- 1 21 1 Genève 20 • S witzerland

Internet: central@ is o. ch

X. 400: c=ch; a=400net; p=is o; o=is ocs ; s =central

Printed in S witzerland

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© ISO ISO 9000-2: 1 997(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of

national standards bodies (ISO member bodies). The work of preparing International
Standards is normally carried out through ISO technical committees. Each member
body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates
closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
Draft International Standards adopted by the technical committees are circulated to the
member bodies for voting. Publication as an International Standard requires approval
by at least 75 % of the member bodies casting a vote.
International Standard ISO 9000-2 was prepared by Technical Committee ISO/TC 176,
Q u a lity Subcommittee SC 2,
m a n a g e m e n t a n d qu a lity a s s u ra n c e , . Q u a lity s ys te m s

This second edition cancels and replaces the first edition (ISO 9000-2:1993), which has
been technically revised.
ISO 9000 consists of the following parts, under the general title Q u a lity manage ment

a n d qu a lity a s s u ra n ce s ta n da rds

— Pa rt 1 : Gu ide lin e s fo r s e le ctio n and use

— Pa rt 2 : Ge n e ric g u ide lin e s fo r th e a p p lic a tio n o f ISO 9001 , ISO 9002 a n d ISO 9003

— Pa rt 3 : Gu ide lin e s for th e a p p lica tio n o f ISO 9001 to th e de v e lo p m e n t, s u p p ly and

m a in te n a n c e o f so ftw a re

— Pa rt 4 : Gu ide to de p e n da b ility manageme nt

Annex A of this part of ISO 9000 is for information only.

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Introduction

This part of IS O 9000 gives guidance for the application of IS O 9001 , IS O 9002 and
IS O 9003 . To facilitate cross-reference to those standards, this part of IS O 9000 has the
same clause structure as IS O 9001 , IS O 9002 and IS O 9003 .

In general, the number and scope of the quality system elements and procedures
required for quality assurance are greatest in IS O 9001 and least in IS O 9003 . For all
clauses, the guidelines of this part of IS O 9000 should be applied in a manner consistent
with the scope and requirements of the corresponding clause, if present, in the standard
involved (i. e. IS O 9001 , IS O 9002 or IS O 9003 ). Reference should be made to
subclause 8. 3 of IS O 9000-1 : 1 994 for guidance on the appropriate extent and degree of
demonstration.

IS O 9000-1 gives an overview of the IS O 9000 series of International S tandards, and

explains the use of the entire series. IS O 9004-1 gives guidance for designing and
installing a quality management system.

This part of IS O 9000 does not duplicate the guidance to users that is given in other IS O
guidance standards such as IS O 9000-1 , IS O 9000-3 , IS O 9004-1 and IS O 9004-2.

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INTERNATIONAL STANDARD © IS O ISO 9000-2: 1 997(E)

Quality management and quality assurance standards —

Part 2:
Generi c g ui deli nes fo r the ap p li c ati o n of IS O 9 0 01 , IS O 9 0 02 and

IS O 9 00 3

1 Scope

This p art of IS O 9 000 gi ves guidanc e on the ap p lic atio n of the 1 994 vers ions of IS O 9 001 ,

IS O 9 002 and IS O 9 003 .

It do es no t add to , o r o therw is e c hange, the requirements o f IS O 9 001 , IS O 9 002 o r IS O 9 003 .

In the c as e of c o nflic ting interpretatio ns of IS O 9 001 , IS O 9 002 or IS O 9 003 on the o ne

hand, and IS O 9 000- 2 on the other, the interp retatio n of the tex t in IS O 9 001 , IS O 9 002 or

IS O 9 003 takes prec edenc e. The us e of ' s ho uld' in this p art o f IS O 9 000 does no t w eaken the

requirements expres s ed as ' s hall' in IS O 9 001 , IS O 9 002 and IS O 9 003 .

This p art o f IS O 9 000 gives g uidanc e fo r the fo llo w ing us ers :

a) s up pliers invo lved in ap p lic ations o f IS O 9 001 , IS O 9 002 o r IS O 9 003 ;

b) c us to mers and third p arties .

2 Normative references

The fo llo w ing s tandards co ntain p ro vis io ns w hich, thro ugh reference in this tex t, c o ns titute

p ro vis io ns of this p art of IS O 9 000. At the time of p ub lic atio n, the editio ns indic ated w ere

valid. All s tandards are s ub j ec t to revis io n, and p arties to agreements b as ed on this p art of

IS O 9 000 are enc ouraged to inves tigate the po s s ib ility of app lyi ng the mo s t rec ent editio ns of

the s tandards indic ated b elo w . M emb ers o f IEC and IS O maintain regis ters o f currently valid

Internatio nal S tandards .

IS O 8 4 02: 1 9 9 4, Q u a lity m a n a g e m e n t a n d qu a lity a s s u ra n ce — Vo ca b u la ry .

IS O 9 001 : 1 9 9 4 , Q u a lity s ys te m s — Mo de l for qu a lity a s s u ra n c e in de s ig n , de ve lo p m e n t,

p ro du ctio n , in s ta lla tio n a n d s e rvic in g .

IS O 9 002: 1 9 9 4 , Q u a lity s y s te m s — Mo de l for qu a lity a s s u ra n ce in p ro du ctio n , in s ta lla tio n

a n d s e rvic in g .

IS O 9 003 : 1 9 9 4, Q u a lity s ys te m s — Mo de l fo r qu a lity a s s u ra n c e in fin a l in s p e ctio n a n d te s t.

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ISO 9000-2: 1 997(E) © IS O

3 Definitions

Fo r the purp os es o f this p art of IS O 9 000, the definitio ns gi ven in IS O 8 4 02 and the follo w ing

apply.

3.1 contract: Agreed requirements b etw een a s up p lier and c us to mer trans mitted by any

means .

[ IS O 9 001 ]

3.2 product: Res ult o f ac tivities o r p ro c es s es .

NO TE 1 A p ro duc t may i nc lude s ervi c e, hardware, p ro c es s ed materi als , s o ftware or a c o mb inatio n

thereo f.

NO TE 2 A p ro duc t c an be tangi b le ( e. g. as s emb lies or p ro c es s ed materials ) or i ntangib le ( e. g.

kno wledg e o r c o nc ep ts ) , o r a c o mb inatio n thereo f.

NO TE 3 Fo r the p urp o s es of this Internatio nal S tandard, the term ' p ro duc t' ap p lies to the i ntended

p ro duc t o ffering o nly and no t to uni ntended ` b y- p ro duc ts ' affec ti ng the envi ro nment. Thi s di ffers

fro m the definiti o n g iven in IS O 8 4 02.

[ IS O 9 001 ]

3.3 specified requirements

1) Produc t requirements pres c rib ed b y the c us tomer and ag reed b y the s upp lier.

2) Requi rements p res c ri b ed by the s upp lier that are p erc eived as s atis fying a market

need.

3.4 tender: O ffer made by a s up p lier in res po ns e to an invitatio n to s atis fy a c ontrac t

aw ard to p ro vide pro duc t.

[ IS O 9 001 ]

4 Quality system requirements

4.1 Management responsibility

4.1 .1 Quality policy

The s up plier’ s management w ith ex ec utive res po ns ib ility ( s ee 4 . 1 . 2. 1 ) is required to develo p

and define its quality p o licy, quality o b j ec tives and c o mmitment in ( a) rec o rded s tatement( s ) .

This is required to be relevant to its o rganiz atio nal go als , and the ex p ec tatio ns and needs of

its c us to mers . The s tatement( s ) s ho uld be p ub lis hed thro ugho ut the o rganiz atio n and be s een

to be fully s upp orted b y the manag ement.

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© IS O ISO 9000-2: 1 997(E)

All emp lo yees , inc luding new ly hired, p art- time and temp o rary emp lo yees , s ho uld be trained

so that they unders tand the o b j ec tives of the organizatio n and the c o mmitment required to

ac hieve thes e o b j ec tives . The p olic y s ho uld be ex pres s ed in language that is eas y to

unders tand and the o b j ec tives s ho uld b e ac hievab le, p lanned and perio dic ally review ed.

Management s ho uld c o ntinuo us ly demo ns trate vis ib le c o mmitment to the quality p o lic y by

ac tivities w hic h may inc lude, b ut no t b e limited to , the follo w ing :

- ens uring that the o rganiz atio n' s p ers o nnel unders tand and imp lement the quality

policy;

- ens uring that the o rganiz atio n' s p ers o nnel have quality o b j ec tives c o ns is tent w ith

the o rganization' s o verall ob j ec tives ;

- initiating, managing and fo llo w ing up on the imp lementatio n of the quality

po lic y, inc luding imp lementation and maintenanc e o f the quality s ys tem;

- not ac c epting deviations fro m the quality po lic y in any part or as p ec t of the

o rg anizatio n;

- p ro viding adequate res o urc es and training to s up p o rt quality s ys tem develo p ment

and imp lementatio n. ( S ee 4 . 1 . 2. 2. )

4.1 .2 Organization

4.1 .2.1 Responsibility and authority

Management w ith ex ec utive res p o ns ib ility is that p ers o n or gro up of pers ons w ithin an

o rganiz atio n w ith the neces s ary level of autho rity fo r making p o licy and s etting o b j ec tives ,

planning their implementatio n, review ing ac hievement and taking c o rrec tive ac tio n. The

s up p lier s hould c learly identify tho s e p ers ons having s uc h exec utive res p ons ib ility.

In partic ular the pers o nnel having the res p o ns ib ility and authority to make dec is io ns that

c o ntro l all the elements of the quality s ys tem and p ro c es s es s ho uld be identified and the j ob

requirements defined and doc umented ( s ee 4. 1 8 ) .

4.1 .2.2 Resources

C o ns ideratio n needs to be gi ven by the s up p lier' s management to the identific atio n and

p ro vis io n of adequate res o urc es needed to imp lement its quality p o lic y and ac hieve its

ob j ec tives as w ell as to s atis fy c us to mer needs and ex p ec tatio ns . The follo w ing s ho uld be

c o ns idered:

- p ers o nnel to p lan, manage, p erfo rm w ork, c o ntro l and c arry o ut verific atio n

ac tivities ;

- aw arenes s of s tandards , p ro c edures and o ther do c umented p rac tic es that are

needed;

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ISO 9000-2: 1 997(E) © IS O

- training and qualific ations ( s ee 4. 1 8 ) ;

- p lanning des ign, develo p ment and p ro duc tio n ac tivities to allo w s uffic ient time to

p erfo rm the w o rk;

- equip ment and p ro c es s es , inc luding ac quis itio n o f new equipment o r tec hno lo g y;

- means to ac c es s quality rec ords .

4.1 .2.3 Management representative

Within the s up p lier' s o rganiz atio n, a management rep res entative w ith delegated autho rity is

required to be ap po inted for arranging and o vers eeing the w o rking o f the quality s ys tem. This

management rep res entative is required to be ap po inted by management w ith ex ec utive

res po ns ib ility.

The functio ns of the management rep res entativ e may be to tally related to quality s ys tem

ac tivities or be in c o nj unc tio n w ith o ther func tio ns and res p o ns ib ilities w ithin the

o rganiz atio n. If the management repres entative has other func tio ns to p erfo rm, there s hould

be no c onflic t o f interes t b etw een the res p o ns ib ilities for the o ther func tio ns and tho s e fo r the

quality s ys tem. The management rep res entative s ho uld have the autho rity to ens ure that the

requirements of IS O 9 001 , IS O 9 002 or IS O 9 003 are s atis fied and that c o mp lianc e is

maintained, to gether w ith the res p o ns ib ility to ens ure that they are o p erated througho ut the

o rg aniz atio n.

The defined role s ho uld inc lude rep orting on the s uitab ility and effec tivenes s of the quality

s ys tem as a b as is fo r impro vement, management review , and liais on, as nec es s ary, w ith

c us to mers , s ub c o ntrac to rs and any o ther external p arties o n quality matters .

4.1 .3 Management review

The s upp lier’ s management w ith ex ec utive res p o ns ib ility, s ho uld review the quality s ys tem.

This may inc lude, b ut no t b e limited to , the fo llo w ing :

- the adequac y of the organiz atio nal s truc ture, inc luding its s taffing and o ther

res o urc es ;

- co nformity to IS O 9 001 , IS O 9 002 or IS O 9 003 , and effec tive imp lementatio n of

the quality s ys tem;

- co mplianc e w ith quality p olic y;

- informatio n b as ed on c us to mer feedb ac k, internal feedb ac k (s uc h as res ults of

internal audits ) , p ro c es s p erformanc e and pro duc t p erfo rmanc e, as w ell as

c o rrec tive and p reventive ac tio ns taken.

The intervals b etw een review s s ho uld be c arefully p lanned and p erio dic ally review ed to

ens ure the co ntinuing s uitab ility and effectivenes s of the quality s ys tem. The management

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© IS O ISO 9000-2: 1 997(E)

review p ro c es s , frequenc y of review s and levels of inputs w ill dep end on the individual

c irc ums tanc e. S ome organiz atio ns have fo und that annual management review s are

ac c eptab le.

Management s ho uld fo c us on trends that may indic ate pro b lems . C hro nic p ro b lem areas

s ho uld rec eive s p ec ial attentio n. Ac tio ns that are required fo llo w ing c hanges to the quality

s ys tem determined during management review s ho uld be implemented in a timely manner.

The effec tivenes s of any c hanges s ho uld be evaluated. Rec o rds of s uc h review s s ho uld be

maintained ( s ee 4. 1 6 ) .

4.2 Quality system

4.2.1 General

The implementatio n of a quality s ys tem by the s upp lier is mo s t effec tive w hen tho s e in the

o rganiz atio n unders tand its intentio n and ho w it func tio ns , in p artic ular, in the area of their

res po ns ib ility and its interfac e w ith o ther parts of the s ys tem. The quality manual has an

imp o rtant ro le in this regard, fo r b oth internal and ex ternal p arties . To give a c o herent view

of the quality s ys tem, the quality manual s ho uld inc lude the quality p o lic y, a des c rip tio n of

the o rganizatio n, and identify the quality s ys tem p roc edures w ith ap p ro p riate c ro s s - referenc es

to mo re detailed doc umentatio n. The quality manual c o uld, for ex amp le, be o ne do c ument

s up p o rted by s everal levels of o ther doc uments , eac h level b ec o ming p ro gres s ively mo re

detailed. There may als o be an o verall s ys tem manual, o ne or mo re s pec ific p ro c edural

manuals , w o rk ins truc tio ns and referenc e do c uments . Together, thes e do c uments define the

quality s ys tem. Further guidanc e on develop ment o f quality manuals is g iven in IS O 1 001 3 .

4.2.2. Quality system procedures

D o cumented quality s ys tem p ro cedures are required fo r ap p licab le requirements of IS O

9 001 , IS O 9 002 and IS O 9 003 and s ho uld be c o ns is tent w ith the s up p lier’ s quality p o lic y. It

is imp o rtant to rec o gnis e that the s truc ture and level of detail required in thes e p ro cedures

s ho uld be tailo red to the needs of the o rganizatio n' s p ers o nnel, w hic h w ill dep end up o n

methods us ed and the training requirements , s kills and qualific atio ns of s uc h pers onnel, as

indic ated in 4 . 1 8 .

A do c umented proc edure us ually s pec ifies the p urpo s e and s c op e o f an ac tivity:

- w hat s hall be do ne by w ho m;

- w hen, w here, and ho w it s hall be do ne;

- w hat materials , equip ment and do c uments s hall be us ed; and

- how an ac tivity s hall be c o ntrolled and rec o rded.

D oc umented p roc edures may make referenc e to w ork ins truc tio ns that define how an ac tivity

is p erfo rmed.

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4.2.3 Quality planning

The s up p lier needs to s ho w that p lanning ac tivities have b een p erfo rmed, and that they

es tab lis h the means by w hic h the requirements fo r quality w ill be met. Planning s ho uld

inc lude the ap p lic atio n of the quality s ys tem elements , and ho w the p ro duc t quality

requirements w ill be met.

This may require the follow ing.

a) Fo r managerial and o p eratio nal p lanning, p rep aring the ap p licatio n o f the quality

s ys tem.

b) Fo r p ro duc t p lanning, s etting o ut in a quality p lan or in any o ther do c umented

p ro cedures the s p ec ific quality p ractices , res o urc es and s equence of ac tivities

relevant to a p artic ular p ro duc t, p ro j ec t or c o ntrac t.

Mo re guidanc e o n quality p lans is given in IS O 1 0005 .

4.3 Contract review

4.3.1 General

In the s ituatio n w here a tender is offered or a c o ntrac t or o rder is to be es tab lis hed b etw een a

s upp lier and a c us tomer, the means of ac hievi ng s atis fac tion li es in the c ontrac t review

pro c es s .

C o ntrac t review is o ne of the s up pli er’ s p rimary interfac es w ith i ts c us to mers . The

do c umented p roc edures s hould inc lude a review of c us to mer requirements ( w hether

ex p res s ed in a tender, c o ntrac t or o rder, w hic h may be w ritten or verb al) and ho w cus to mer

requirements are review ed and c o mmunic ated w ithin the org aniz atio n.

The c o ntrac t review is p rio r to ac c ep ting a c o ntrac t or an o rder.

4.3.2 Review

The imp ortanc e of a tho ro ugh unders tanding of the c us to mer' s needs , fro m initial c o ntac t,

thro ugh tendering or rec eiving verb al orders , to the fo rmulatio n of the c ontrac t, or order and

in all s ub s equent s tages c anno t be overs tated. O ften, dialo gue w ill be nec es s ary to ac hieve

this unders tanding, that s ho uld c learly es tab lis h the c us to mer' s requirements as to the p ro duc t,

deli very and o ther c riti c al fac to rs . Where a verb al s tatement o f requirement is rec eived from

the c us to mer, the s upp lier s hould ens ure that an o rder (s tatement of requirements ) is

unders too d, adequately do c umented and ag reed to by the c us to mer.

C o ntrac t review is a pro c es s that inc ludes the fo llo w ing :

a) review o f the requirement; this may be ap p ro p riate at the tendering or o rder entry

s tag e and at s ub s equent s tages prior to ac c ep tanc e of the c ontrac t o r the order;

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b) ag reement w ithin the s up plier' s o rg anization that

- the requirements have b een defined,

- the requirements are unders to o d,

- the s up p lier has the c ap ab ility to meet the requirements o f the co ntrac t, by go ing

thro ugh a defined p ro ces s to verify that the neces s ary res o urc es and facilities are

availab le to fulfil all the requirements of the c o ntrac t;

c) res olutio n o f any differenc es w ith the c us to mer;

d) c o ntrac t review of a s tandard pro duc t (e. g. “ off- the- s helf” items , a “ c o mmodity

item” , a c atalo gue item w ith p ub lis hed s p ec ific atio n, etc . ) c an be as s imp le as

verifying the ac c urac y of the information o n the o rder;

e) the requirements of the c o ntrac t, w here ap p ro p riate, may be trans lated into the

termino lo gy, to leranc es , and o ther nec es s ary info rmation fo r des igning,

p urc has ing and p ro c es s c o ntro l;

f) p reliminary quality p lan or do c umented p ro c edures , w here ap p ro p riate, may be

develop ed to give an unders tanding of ho w to imp lement the c o ntrac t

s uc c es s fully and s up p o rt the c o ntrac t review p roc es s .

It is b enefic ial fo r the s up p lier to ado p t a c o ntrac t or o rder review p ro c edure that has the

fo llo w ing features :

- affec ted parties have an o p p ortunity and adequate time to review the c o ntrac t;

- a c hec klis t or s ome o ther means (e. g. a s tandard form) is availab le for revi ew ers

to verify and rec o rd that they have review ed and unders to o d the requirements of

the c ontrac t o r o rder;

- a method is availab le for review ers to ques tio n the requirements o f the c o ntrac t o r

o rder, to have their ques tio ns c o ns idered and to have differenc es w ith other

affec ted parties res olved.

4.3.3 Amendment to contract

When cus to mer requirements c hange, c o ns ideratio n s ho uld be given to rep eating the c o ntrac t

review pro c edure ( s ee 4. 3 . 2) . It is b enefic ial for the s upp lier to have a proc edure for review s

by the s ame dep artmental func tions that review ed the origi nal c ontrac t or ac c ep ted o rder.

B efo re s uc h c hanges c o me into effec t, there s ho uld be metho ds availab le to ens ure that all

relevant c hanges are c o mmunic ated to tho s e affec ted.

4.3.4 Records

In all c as es , it s ho uld be s uffic ient to retain rec ords that the review has b een p erfo rmed ( s ee

4. 1 6 ) . Fo r internal p urp o s es , ho w ever, rec ords o f the evaluatio n as s o c iated w ith the c o ntrac t

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review may be retained in cas es s uch as complex or critical proj ects . Thes e records s hould

give obj ective evidence for audits , and facilitate the following:

- pos t- delivery proj ect review;

- proces s improvement; and

- the generation of propos als for future proj ects .

4.4 Design control

4.4.1 General

The es s ential quality as pects and the regulatory requirements s uch as s afety, performance, and

dependability of a product are es tablis hed during the des ign and development phas e.

Deficient des ign can be a maj or caus e of quality problems .

In cons idering des ign control, it is important to note that the des ign proces s may apply to

various activities in differing s tyles and times cales . S uch as pects are related to products , as

well as the proces s as s ociated with product des ign. The s upplier s hould cons ider all phas es of

the des ign as s ociated with product des ign and all phas es of the des ign proces s for which

controlled procedures are neces s ary.

4.4.2 Design and development planning

The s upplier s hould es tablis h procedures for des ign and development planning and, where

appropriate, include the following:

- identification, s cope and obj ectives ;

- s equential and parallel work s chedules ;

- timing, frequency, and nature of des ign verification and validation activities ;

- evaluation of the s afety, performance and dependability incorporated in the

product des ign;

- methods of product meas urement, tes t and acceptance criteria;

- as s ignment of res pons ibilities .

Des ign and development plans s hould be integrated with any other plans and verification

procedures related to the product and plans s hould be updated as neces s ary.

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The s upplier s hould clearly as s ign res pons ibilities for s pecific des ign leaders hip and other

des ign work functions to qualified pers onnel. The pers onnel in thes e functions s hould have

acces s to information and the res ources to complete the work.

Des ign activities s hould be defined to the level of detail neces s ary for carrying out the des ign

proces s .

4.4.3 Organizational and technical interfaces

When input to the des ign is from a variety of s ources , the inter- relations hips and interfaces , as

well as the pertinent res pons ibilities and authorities , s hould be defined, documented,

coordinated, and controlled.

Many organizational functions , both internal and external, may contribute to the des ign

proces s ; examples are as follows :

- res earch and development;

- marketing and s ales ;

- purchas ing;

- quality as s urance and quality management;

- engineering;

- materials technology;

- production/manufacturing;

- s ervice groups ;

- facilities management;

- warehous ing/trans portation/logis tics ;

- communications ;

- information s ys tems .

They s hould als o es tablis h, but not limit thems elves to, the following:

- what information s hould be received and trans mitted;

- identification of s ending and receiving groups ;

- the purpos e of the information trans mitted;

- identification of trans mittal methods ;

- document trans mittal and records maintenance.

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4.4.4 Design input

Us er needs ( thro ugh marketing) or c us to mer requirements ( thro ugh c o ntrac t) s ho uld be

es tab lis hed during c o ntrac t review ( s ee 4. 3 ) that, together w ith relevant s tatuto ry legis latio n,

w ill fo rm the des ig n inp ut requirements .

D es ign inp uts are typic ally in the fo rm of p roduc t requirement s p ec ific atio ns and/o r pro duc t

des c rip tio n w ith s p ec ific atio ns relating to c o nfiguratio n, c o mp o s itio n, inc o rp o rated elements ,

and o ther des ign features .

All p ertinent des ign inp uts ( s uc h as p erformanc e, func tional, des c rip tive, enviro nmental,

s afety and regulato ry requirements ) s hould be defined, review ed and rec o rded by the s up p lier.

The des ign inp uts s ho uld des c rib e all requirements to the greates t p o s s ib le ex tent; they lay

the fo undatio n and p ro vide a unified ap p ro ac h to the des ign. D etails agreed b etw een

cus to mer and s up p lier on ho w c us to mer, s tatuto ry and regulato ry requirements w ill be met

s ho uld b e inc luded. The rec o rd of the des ign inp uts s ho uld als o inc lude the res o lutio ns o f any

inc o mp lete, amb iguo us or c onflic ting requirements that have b een identified at the c o ntrac t

review and/o r des ig n verific atio n s tages or related des ign c o ntro l ac tivities .

The des ign inp uts s ho uld identify des ign c riteria, materials , and pro c es s es requiring

develo p ment and analys is , inc luding p roto typ e tes ting to verify their adequac y. D es ign inputs

s ho uld be p rep ared in a w ay that fac ilitates p erio dic up dates . They s ho uld indic ate ' w hen' or

' w hat c riteria' w ill c aus e the inp uts to be updated, w ho is res p o ns ib le fo r the up date, and under

w hat c irc ums tanc es the c us to mer w ill get a c op y. D es ign inp uts p rep ared in this w ay s erve as

the definitive up - to - date referenc e do c ument as the des ig n p ro g res s es to c o mp letio n.

4.4.5 Design output

Thro ugho ut the des ign pro c es s , the requirements c o ntained in the des ign des c rip tio n are

trans lated by the s up p lier into o utp uts . D es ign o utp uts s ho uld be do c umented in terms that

c an be verified and validated agains t des ign inp ut requirements and need to c o ntain or make

referenc e to ac c ep tanc e c riteria; examples o f thes e c an b e found in the fo llo w ing :

- draw ing s and p arts lis t;

- s p ec ific ations ( inc luding p roc es s and materials s p ec ific ations ) ;

- ins truc tio ns ;

- s o ftw are;

- s ervic ing proc edures .

D es ign o utp uts are the p roduc t requirements us ed fo r p urc has ing, pro duc tion, ins tallatio n,

ins p ec tio n and tes ting, and s ervic ing. B ec aus e of their imp ac t on fo llo w - o n ac tivities , it is

imp o rtant that the outputs are review ed and ap pro ved b efo re releas e.

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4.4.6 Design review

Design reviews should be planned. In order to achieve a degree of obj ectivity, they need to
involve all functions, both internal and external, concerned with the design stage being
reviewed. Design staff and other specialist personnel should also participate as required.
Design review may be a regulatory requirement for certain types of product. The timing and
frequency of these reviews will be influenced by the maturity, complexity and cost of the
product being designed. Records of such reviews should be maintained (see 4. 1 6).

The competence of the participants in the design reviews should be adequate to permit them
to examine designs and their implications. Design reviews may consider questions such as
the following.

a) Do designs satisfy all specified requirements for the product?

b) Are product design and processing capabilities compatible?

c) Are safety considerations considered?

d) Do designs meet functional and operational requirements, for example,

performance and dependability obj ectives?

e) Have appropriate materials and/or facilities been selected?

f) Is there adequate compatibility of materials, components and/or service elements?

g) Is the design satisfactory for all anticipated environmental and load conditions?

h) Are components or service elements standardized and do they provide for

reliability, availability and maintainability?

i) Is there a provision in tolerances, and/or configuration, for interchangeability and

replacement?

j) Are plans for implementing the design technically feasible (e. g. purchasing,
production, installation, inspection and testing)?

k) Where computer software has been used in design computations, modelling or

analyses, has the software been appropriately validated, authorized, verified and
placed under configuration control?

l) Have the inputs to such software, and the outputs, been appropriately verified and
documented?

m) Are the assumptions made during the design process valid?

n) Are the results of model or prototype testing considered?

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4.4.7 Design verification

IS O 9001 describes design control measures (e. g. design reviews, tests and demonstrations,
alternative calculations and comparison with a proven design) by which design verification
may be established by the supplier. Design verification is a necessary check to ensure that the
design outputs conform to specified requirements (design inputs). This is an ongoing activity
and in some instances a combination of these measures may be necessary. Design
verification measures should be recorded (see 4. 1 6).

The timing and personnel involved in these verifications should be considered in the design
and development planning phase.

When alternative calculations or comparison with a proven design are employed as forms of
design verification, the appropriateness of the alternative calculation method, and/or proven
design, should be reviewed in relation to this new application.

When tests and demonstrations are employed as a form of design verification, the safety and
performance of the product should be verified under conditions that are representative of the
full range of circumstances of actual use. The product units employed for tests and
demonstrations should be produced under the expected production conditions.

At any stage before release when the review of design outputs, is employed as a form of
design verification, this should be in accordance with relevant standards, practices and
predetermined acceptance criteria.

4.4.8 Design validation

Design validation is necessary to confirm that the end product fulfils the specified
requirements for its intended use. It may be necessary to involve the customer in design
validation.

After successful design verification, a design validation should be performed under defined
conditions for the use of the final product. However, it may need to be performed at earlier
stages during product development if there are features that it is not possible or practical to
validate at the final stage. Conversely, there will be other situations where validation can
only be performed by observation during initial use of the product.

The results of the examination, tests and demonstrations carried out under design validation
should be included in the design records.

4.4.9 Design changes

Design of a product may be changed or modified for a number of reasons, for example:

- omissions or errors (e. g. in calculation, material selection, etc. ) during the design
phase which have been identified afterwards;

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© IS O ISO 9000-2: 1 997(E)

- manufac turing, ins tallatio n and/o r s ervic ing diffic ulties fo und after the des ign

p has e;

- the c us to mer o r s ub c o ntrac to r reques ts c hanges ;

- the func tion o r p erformanc e o f a p ro duc t is to be imp ro ved;

- c hang es to s afety, reg ulatory, o r other requirements ;

- des ign review ( s ee 4. 4. 6) , des ign verific atio n ( s ee 4 . 4. 7 ) or des ign validatio n (s ee

4. 4. 8 ) requires c hang e;

- c o rrec tive o r p reventive ac tio n requires c hang e ( s ee 4 . 1 4) .

Any c hanges to des ign inp uts s ho uld be identified and review ed by the s up p lier to determine

w hether they influenc e the previous ly app roved des ign review , verific ation or validatio n

res ults . D es ign c hanges in one c o mpo nent of a pro duc t s ho uld be evaluated fo r their

influence on the w ho le. Imp roving o ne c harac teris tic may have unfo res een advers e influenc e

o n ano ther.

When s ignific ant des ign c hanges are made, the verific atio n p ro c edure s ho uld als o be

review ed and mo dified as app ro priate.

Pro c edures s hould be es tab lis hed to c ommunic ate the new des ign o utp ut to all c o nc erned, to

rec o rd any des ign c hanges and to ens ure, as w ell as doc ument, that all autho riz ed des ign

c hanges and o nly tho s e are imp lemented ( s ee 4. 5 . 3 ) .

4.5 Document and data control

4.5.1 General

D o c ument and data c o ntro l s ho uld inc lude tho s e do c uments and data p ertinent to des ign,

p urc has ing, p ro c es s ing, quality s tandards , ins p ec tio n of materials and the quality s ys tem

do c uments . Info rmatio n and/o r ins truc tions in do c uments and data c an be rec o rded,

trans mitted or rec eived us ing a variety of media ( e. g. hard c o py, magnetic dis ks or tap es ) .

D oc uments des c rib e or c ontro l how things are to be do ne and s ho uld be revis ed to reflec t

c hanging c irc ums tanc es . D ata c o mp ris e info rmatio n upo n w hic h a dec is ion may be made;

data may be c ontained in do c uments or o ther fo rms .

4.5.2 Document and data approval and issue

The s up p lier' s s ys tem s ho uld pro vide a c lear and p rec is e c ontro l of p roc edures and

res p o ns ib ilities fo r ap p ro val, is s ue, dis trib utio n, and adminis tratio n of internal and ex ternal

do c umentatio n and data, inc luding the remo val or identific atio n ( to p revent mis us e) of

o b s o lete doc uments . This c an be ac c omp lis hed, fo r ex amp le, by maintaining a mas ter li s t or

equivalent do c ument c ontro l p ro c edure of do c uments or data identifying the level of

ap p ro val, dis trib utio n ( lo catio n of co p ies ) and revis io n s tatus . A s up p lier' s internal w ritten

p ro c edures s hould des c rib e the follo w ing :

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ISO 9000-2: 1 997(E) © IS O

- how the documentation and data for these functions should be controlled;

- who is responsible for the control;

- what is to be controlled;

- where and when the control is to take place.

Applicable documents and data should be accessible in the relevant places of work.

4.5.3 Document and data changes

Recognizing that supplier documentation or data may be subj ect to revision and change,
controls should exist for the preparation, handling, issue and recording of changes. This
applies not only to internal documentation and data but also to externally updated
documentation (e. g. national standards) and data.

The supplier should establish a procedure for controlling changes in documentation and data,
which should

- provide for control of all types of documentation or data media;

- follow documented procedures;

- ensure accurate updating of documents and data;

- provide for using only authorized documents and data when implementing
changes;

- preclude confusion, especially where there is a multiplicity of sources authorizing

changes and releasing documents and data;

- record the reasons why a change was made.

Consideration should be given to the effect that the proposed changes may have on other parts
of the system or the product. Actions may be needed before a change is implemented to
assess the effect of the change on other parts of the organization and notify them as
appropriate.

Planned circulation of a change proposal to personnel in the affected functions can assist in
avoiding disruption. Timing of implementation of the change may be an important factor,
particularly when several changes of documentation or data are to be coordinated.

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4.6 Purchasing

4.6.1 General

To ens ure that purc has ed p ro duc ts that b ec ome p art o f, or affec t the quality of, the s up p lier' s

pro duc t c o nfo rm to s p ec ified requirements as w ell as s tatutory or regulato ry requirements ,

purc has ing s ho uld be p lanned and c arried o ut by the s up p lier under adequate c o ntro l. This

s ho uld inc lude, b ut no t b e limited to , the fo llo w ing :

- evaluatio n and s elec tio n of s ub c ontrac to rs (s ee 4 . 6 . 2) ;

- c lear and unamb ig uo us p urc has ing requirements ( s ee 4. 6. 3 ) ;

- the p erformanc e o f s uitab le verific atio n ( s ee 4. 6. 4) ;

- rec eiving ins p ec tio n pro c edures (s ee 4 . 1 0. 2) .

The s up plier s ho uld es tab lis h an effec tive w o rking relatio ns hip and feedb ac k s ys tem w ith its

s ub c o ntrac to rs .

4.6.2 Evaluation of subcontractors

In develop ing metho ds to ens ure the c onfo rmity o f p urc has ed p ro duc t, the s up p lier is required

to es tab lis h that all s ub c o ntrac to rs have the c ap ab ility of s up p lying p ro duc ts meeting the

s pec ified requirements .

The s up plier s ho uld o p erate a do c umented p roc edure to evaluate the c ap ab ilities of

s ub c ontrac tors . The ex tent of the evaluatio n vari es ac c ordi ng to the imp ortanc e of the

purc has ed p roduc t and its imp ac t o n the final p ro duc t.

An evaluatio n may vary fro m a c o mp rehens ive audit o f the s ub co ntrac to r' s quality s ys tem to

the ac c eptanc e of an evaluation and ap proval by referenc e to his to ric al data ( e. g. rec o rds of

pas t p erformanc e o r c ertified p roduc ts and quality s ys tem regis tratio n s c hemes ) . In any event,

the s up p lier is required to be ab le to demo ns trate that fo rmal c o ns ideratio n w as given to the

evaluatio n and that the s elec tion of a s ub c o ntrac to r w as b as ed on an ap prais al ap pro p riate to

the p ro duc t b eing p urc has ed.

The s up p lier s ho uld be ab le to demo ns trate that s ub c o ntrac tors are b eing evaluated on the

b as is o f p erformanc e. Rec o rds o f ac c eptab le s ub c ontrac to rs s ho uld b e maintained (s ee 4. 1 6) .

4.6.3 Purchasing data

The s up p lier' s purc has ing data s ho uld define the s pec ified requirements to the s ub c ontrac to r

to ens ure the quality of the p urc has ed p roduc t, inc luding tec hnic al p roduc t requirements ,

c alib ratio n s ervic es , s p ec ial p roc es s es and ins p ec tio n and tes t ac tivities . This may b e do ne, in

part, by referenc e to o ther ap p lic ab le tec hnic al info rmation s uc h as national or internatio nal

s tandards , tes t methods , etc . Ano ther app ro ac h is for info rmatio n to be c learly and p rec is ely

s tated to the s ub c o ntrac to r on the p urc has e o rder. Res p o ns ib ilities fo r review ing and

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IS O 9 000- 2: 1 997(E ) © IS O

ap pro ving the purc has ing data s ho uld be c learly as s igned to ap p rop riate p ers o nnel. The

revis io n s tatus of doc uments referenc ed in the purc has ing data s hould b e identified.

4. 6. 4 Verification of p urchased p roduct

4. 6. 4. 1 S up p lier verification at sub contractor' s p remises

When c o ntrac tually s p ec ified, the s up p lier may be invo lved w ith verific atio n ac tivities at the

s ub c o ntrac to r' s premis es .

The s up p lier s ho uld inc lude in p urc has ing do c uments s pec ial c laus es or s tatements regarding

verific atio n p ro c edures , and p roduc t releas e metho ds ( e. g. p ro duc t s hip ment s ho uld have prior

ap pro val o f the s upp lier) w hen verific atio n is to be c arried o ut at the s ub c o ntrac to r' s fac ilities .

4. 6. 4. 2 C ustomer verification of sub contracted p roduct

When s p ec ified by the c us to mer, the s up p lier s ho uld inc lude in s ub c o ntrac ts s pec ial c laus es

or s tatements w hen verific ation is c o ntrac tually required at s o urc e ( e. g. the s ub c ontrac to r' s

fac ilities ) .

When s p ecified in the c o ntrac t, the cus to mer may ex tend v erific atio n activities to the fac ilities

of the s ub c o ntrac to r to as s ure that the pro duc t fulfils the s p ec ified requirements . In s uc h

c as es , the s up p lier s ho uld arrange fo r the c us to mer to verify the quality of the s ub c o ntrac tor' s

pro duc t and, if nec es s ary, the effec tivenes s o f the p ro c es s .

Where the c o ntrac t p ro vides , the c us to mer may us e the s up p lier' s data to dec ide w hic h o f the

pro duc ts to be p urc has ed w ill require verific ation at s o urc e and to dec ide the nature and

extent o f s uc h verific atio n.

If the c us tomer, on verific atio n of the s ub c o ntrac to r’ s p ro duc t, ex p res s es s atis fac tio n, the

s up p lier s ho uld no t take this as an o p p o rtunity to relax c o ntro ls . The s up p lier retains full

res po ns ib ility fo r the quality of the p roduc t b eing s up p lied to the c us tomer.

4. 7 C ontrol of customer- sup p lied p roduct

The s up p lier, up o n rec eip t of c us tomer- s up p lied p roduc t that is furnis hed to the s upp lier fo r

us e in meeting the requirements of the c o ntrac t, ac c ep ts res p o ns ib ilities for p revention of

damage and for identific atio n, p res ervatio n, s torage, handling and us e w hile that p roduc t is in

the s up p lier' s p o s s es s io n.

The s upp lier s ho uld therefore es tab lis h arrang ements , as nec es s ary, fo r the fo llo w ing :

- ex amination of the p ro duc t up on rec eip t to c hec k the quantity rec eived and its

identity, and to detec t any damage in trans it;

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© IS O ISO 9000-2: 1 997(E)

- periodic inspection during storage to detect any signs of deterioration, to check

the limitations on time in storage, to assure maintenance of proper conditions and
to determine the current state of the product;

- compliance with any contractual requirements;

- identification and safeguarding of the supplied product to prevent any

unauthorized use or improper disposal.

The responsibility should be defined for reporting unsuitability to the customer, who is
responsible for providing acceptable product within the terms of the contract. Records of
products that are lost, damaged or otherwise unsuitable for use should be maintained (see
4. 1 6).

The supplier should consider the significance of customer-supplied product during contract
review, particularly when the customer-supplied product is a service (e. g. the use of a
customer’ s transport for delivery). The supplier should be able to show documentary
evidence that this is being done, where appropriate. The supplier should obtain from the
customer, as appropriate, information or requirements concerning handling, storage and
maintenance of customer-supplied product.

When necessary, the need for calibration of customer-supplied tools and equipment should be
specified by the customer.

4.8 Product identification and traceability

Where appropriate the supplier should define the means for product identification This may
be done by marking, tagging or the location of the product or its container. For example, on
visually identical parts where the functional characteristics are different, different colours
may be used. For bulk products or product from continuous processes, the identification may
be by marking of batches or well-defined lots and accompanying documents. S ervice
identification may be achieved by documentation that accompanies the service.

Product traceability involves the ability to trace the history, application or location of an item
or activity by means of recorded identification. Traceability is typically required when there
is a need to track a nonconformity back to its source and to determine the location of the
remainder of the affected batch. Traceability may entail additional cost and, when specified
in a contract, the extent of quality records should be stated.

The supplier can achieve traceability by each individual product having an identifier (e. g.
serial number, date code, batch code, lot number) unique to the source of operation. S eparate
identifiers could be required for changes in operative personnel, changes in raw materials,
changes in tooling, new or different machine set-ups, changes in process methods, etc.
Traceability identifiers should appear on applicable inspection and stock records (see 4. 1 6).
There may be situations where traceability requires identification of the specific personnel
involved in each phase of product processing or delivery. A sequence of individuals may
perform successive service functions, each of which is to be traceable. The recording of
identification evidence through signatures on serially numbered documents in invoicing and

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ISO 9000-2: 1 997(E) © IS O

b anking op eratio ns are ex amp les . Here there is no tangib le pro duc t as s uc h, b ut eac h

individual' s identific atio n evidenc e s ho uld b e trac eab le.

4.9 Process control

The s up p lier' s planning fo r the p ro duc tio n, ins tallatio n and s ervic ing p roc es s es s ho uld

c o ns ider eac h of the c o ntro lled c o nditio ns des c rib ed in s ub c laus e 4. 9 of IS O 9 001 : 1 9 9 4 and

IS O 9 002: 1 9 9 4 . C o ntro l w ithin the p ro c es s to p revent no nc o nfo rmities fro m o c c urring is

preferab le to ins p ec tion of finis hed p roduc t or s ervic ing alo ne. The c harac teris tic s that are

mo s t c ritic al to the p ro duc t and/o r s ervic ing quality s ho uld be identified and s ub j ec ted to

pro c es s c ontro l p ro c edures

Pro c es s c o ntrol ac tivities may inc lude p ro c edures fo r ac c ep ting materials or items into the

pro c es s and determining their c harac teris tic s w hile in- pro c es s . The amo unt of in- p ro c es s

tes ting and ins p ec tion perfo rmed w ill dep end partly on the effec t of no nc o nfo rmities on the

fo llo w ing p roc es s es . The adequac y of meas urement p ro c es s es s ho uld be c o ns idered w hen

review ing the effec tivenes s of p ro duc tio n p roc es s c o ntro l.

The s up p lier s hould inc lude w ithin the s cope o f the quality s ys tem the p rop er maintenanc e of

p ro c es s equip ment and es s ential materials . It is the s up p lier' s res p o ns ib ility to es tab lis h

p ro c es s cap ab ility and define the maintenanc e ac tivities that w ill ens ure c o ntinuing p ro ces s

capab ility.

S ome p ro c es s es are s uc h that the p ro duc t quality c harac teris tic s c anno t be fully verified after

the c o mp letio n of the p ro c es s es . Thes e are frequently referred to as ' s p ec ial p ro c es s es ' .

Altho ugh thes e pro c es s es are fo und in all generic p ro duc t c ategories ( hardw are, s o ftw are,

pro c es s ed materials and s ervic es ) , they are p artic ularly c o mmo n in the p ro duc tio n of

pro c es s ed materials . Examp les inc lude c irc ums tanc es w here:

- c ertain p ro duc t c harac teris tic s do no t exis t until later in the p ro c es s ;

- the metho d o f meas urement do es no t exis t o r is des truc tive to the p ro duc t;

- it is not p os s ib le or p rac ti c al to meas ure a c harac teris tic in later ins p ec tio ns or

tes ts .

S ome ex amp les w here c ritic al p roduc t quality c harac teris tic s fall w ithin o ne or mo re of the

three p ro c es s c irc ums tanc es ab o ve inc lude the fo llo w ing :

- s trength, ductility, fatigue life, co rro s io n res is tanc e of a metal p art, fo llo w ing

w elding , s o ldering , heat treatment o r plating ;

- dyeab ility, s hrinkag e, tens ile prop erties o f a p olymerized p las tic ;

- tas te, texture, app earanc e of a b akery p ro duc t;

- c o rrec tnes s of a s o ftw are p ro duc t o r a financ ial o r leg al do c ument.

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© IS O ISO 9000-2: 1 997(E)

S uc h p ro duc ts are typ ic ally the final res ult of a s eries of op eratio ns and require c lo s e

adherenc e to s p ec ified in- p ro c es s pro c edures and s equenc es s uc h as the fo llow ing.

a) Fo r a hardw are or p roc es s ed materials p ro duc t, thes e c an involve s tarting

materials , temp erature pro files , p hys ic al defo rmatio ns , mix ing and enviro nmental

c o nditio ns .

b) Fo r a s o ftw are or s ervic e pro duc t, thes e c an invo lve s o urc e data and doc uments

that are s ub j ec t to regulato ry and c op yrig ht requirements .

C o mprehens ive meas urement as s uranc e and c alib ratio n of equip ment us ed to p ro duc e or

meas ure the pro duc t s ho uld be required for s uc h pro c es s es . Where s uitab le, pro c es s c o ntro l

s ho uld inc lude s tatis tic al p ro c es s c o ntro l metho ds , s up p lemented by p ro c edures to maintain

the s uitab ility of s o ftw are, of in- p ro c es s materials and of ac tivities needed fo r ap p ro p riate

s torage, handling and s egregation.

S pec ial s kills , c apab ilities and training of p ers o nnel ( s ee 4. 1 8 ) may be needed. The

qualific atio n requirements ( e. g. s kills , kno w ledge, p hys ic al c ap ab ilities ) of p ers o nnel s ho uld

be s tated and c onformity to the requirements demo ns trated.

Pro c es s kno w ledge c an be c o ns idered as a b as is to differentiate finis hed p ro duc t

c harac teris tic s fro m meas urab le in- p ro c es s c harac teris tic s . S uc h pro c es s es s ho uld have s tated

qualific atio n requirements and s ho uld be qualified in advanc e, by ex amination, ins p ec tion,

meas urement or tes t to veri fy that the proc es s c an meet the s p ec ified requi rements . Rec ords

of thes e requirements s ho uld b e maintained (s ee 4. 1 6) .

4.1 0 Inspection and testing

4.1 0.1 General

This s ub c laus e c ons iders all of thos e ins pec tio n and tes t ac tivities c arried out fro m rec eiving

ins p ec tio n to p ro duc t delivery, ins tallatio n and s ervic ing as ap p ro p riate. It requires that the

s up p lier es tab lis h and maintain do cumented p ro c edures fo r thes e ac tivities , in o rder to verify

c o nfo rmity to s pec ified requirements and that the ap p rop riate rec o rds are kept.

4.1 0.2 Receiving inspection and testing

4.1 0.2.1 Rec eiving ins p ec tion is o ne metho d for the s up p lier to verify that p urc has ed items

delivered to the s up p lier' s fac ilities fulfil s p ec ified requirements for quality.

The s upp lier' s p ro c edures or quality plan s ho uld s p ec ify the metho d of verifying that

s hip ments rec eived are in ac c o rdanc e w ith s p ec ific ations , are c o mp lete, have p ro p er identity

and are undamaged. The p roc edures s ho uld als o inc lude p rovis io ns for verifying that

inc o ming items , materials or s ervic es are ac c o mp anied by the required s up p o rting

do c umentatio n ( e. g. c ertific ates o f c o nformity, mill tes t repo rts and ac c ep tanc e tes t rep o rts ) .

App ro priate ac tio n in the event of no nc o nfo rmities s hould be s p ec ified ( s ee 4. 1 3 ) . Analys is

of p revio us rec eiving ins p ec tio n data, i n- p lant rej ec ti on hi s to ry or c us to mer c o mp laints

s ho uld influenc e the s up plier' s dec is ions regarding the amount of ins pec tio n required, and the

need to reas s es s a s ub c o ntrac to r.

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ISO 9000-2: 1 997(E) © IS O

4.1 0.2.2 This s ub claus e do es no t imp ly that inc o ming items hav e to be ins p ected and tes ted

by the s up p lier, if the nec es s ary c o nfidenc e in the pro duc t c an be o b tained by other defined

pro c edures , p artic ularly in c as es w here the info rmatio n gi ven b y a s ub c ontrac to r is c o ns idered

s uffic ient ( s ee 4. 6 . 4) .

4.1 0.2.3 Releas e of inc o ming p roduc t s ub j ec t to rec all s ho uld be dis c ouraged as a matter of

go o d quality manag ement prac tic e. Pro duc t s ho uld only be releas ed s ub j ec t to rec all if

- an o b j ec tive evaluatio n o f quality s tatus and s o lutio n o f any no nc o nfo rmities c an

s till be imp lemented;

- c orrec tio n of nonc o nformities c anno t c omp ro mis e the quality of adj ac ent,

attac hed o r inc o rpo rated p ro duc t.

The s upp lier' s p ro c edures s ho uld define w ho is autho riz ed to allo w inc o ming p ro duc t( s ) to be

us ed w itho ut p rio r demo ns tratio n of c o nfo rmity to s p ec ified requirements fo r quality. The

s up p lier' s p ro c edures s ho uld als o define ho w s uc h p ro duc t w ill be p o s itively identified and

c o ntro lled in the event that s ub s equent ins p ec tio n finds no nc o nfo rmities .

4.1 0.3 In-process inspection and testing

In- p ro c es s ins p ec tio n and tes ting ap p lies to all fo rms of p ro duc t. It allo w s early rec o gnitio n

of no nc o nformities and their timely dis p o s itio n.

Where ap pro p riate, s tatis tic al c o ntro l tec hniques s ho uld be us ed to identify advers e trends for

b o th p ro duc t and p ro c es s b efore no nc onfo rmities ac tually o c c ur.

Early identific atio n o f no nc o nfo rmities , b efore arriving at the final ins p ec tion s tage, inc reas es

the effic ienc y o f the entire o peratio n b y avoiding further p ro c es s ing o f no nc o nforming items .

The s up p lier' s p ro c edures or quality p lan s ho uld ens ure the validity o f the ins pec tio n and tes t

res ults inc luding s ituatio ns w here in- p ro c es s ins p ec tio n is c arried o ut by p ro duc tio n

pers o nnel.

4.1 0.4 Final inspection and testing

Final ins p ec tio n invo lves ac tivities ( ex aminatio n, ins p ec tio n, meas urement or tes t) up o n

w hic h the final releas e of pro duc t is b as ed. Rec o rds of p revio us ly perfo rmed ins p ec tio n and

tes ting res ults may als o b e reviewed.

4.1 0.5 Inspection and test records

The s upp lier' s ins p ec tion and tes t rec o rds ( s ee 4. 1 6) s ho uld fac ilitate as s es s ment of pro duc ts

having fulfilled the requirements fo r quality. Rec o rds are us eful fo r s ho w ing c o mp liance w ith

s tatuto ry and regulatory requirements and may als o gi ve s up p orting evidenc e in pro duc t

liab ility c o ns ideratio ns . Rec o rds of p ro c es s failure are us eful in imp ro ving the p ro ces s ( s ee

4. 1 4. 3 ) .

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© ISO ISO 9000-2: 1 997(E)

4.1 1 Control of inspection, measuring and test equipment

4.1 1 .1 General

This subclause applies to inspection, measuring and test equipment used to demonstrate
conformity of the product to specified requirements. Some products in the service sector are
not subj ect to the use of equipment for inspection, measuring and test, as is typical for
suppliers of hardware and processed materials; in which case the requirements of this
subclause may not apply.

Although the requirements pertain explicitly to inspection, measuring and test equipment,
including test software, it is helpful to approach the subj ect from the perspective that
measuring is itself a process involving materials, equipment and procedures. The
requirements explicitly involve elements of the measurement process; elements whose
collective purpose is to choose suitable measurements, suitable inspection, measuring and test
equipment, and suitable measurement procedures. These elements are specified to give
confidence in the ability of the supplier's measuring systems to control adequately the
production and inspection of the product.

Statistical methods are valuable tools for achieving and demonstrating fulfilment of
requirements. In particular, statistical methods are the important tools in fulfilling the
requirement that " Inspection, measuring and test equipment shall be used in a manner which
ensures that measurement uncertainty is known and is consistent with the required
measurement capability" .

The requirements of this subclause also should be applied by the supplier when demonstrating
the conformity of the product to the specified requirements. This may contractually involve
measurements subsequent to production and inspection of a product, for example, during
handling, storage, packaging, preservation, delivery or servicing.

4.1 1 .2 Control procedure

This subclause defines the extent of control to be exercised with regard to inspection,
measuring and test equipment. Records of calibration should be maintained (see 4. 1 6). For
general background and guidance on the management of inspection, measuring and test
equipment, it is recommended that IS O 1 001 2-1 be consulted.

NOTE — It should be recognised that the requirements and guidance in ISO 1 001 2-1 are not
mandatory and do not add to, or otherwise change, the requirements of ISO 9001 , ISO 9002 or ISO
9003 .

4.1 2 Inspection and test status

The supplier's quality system and procedures should ensure that required inspections and tests
are performed. The system should provide a way of knowing the inspection and test status of
a product throughout production, installation and servicing. S tatus may be indicated by
marking, location, tagging or signing, either physically or by electronic means.

The status should indicate whether or not a product has been inspected and tested and either:

21
ISO 9000-2: 1 997(E) © IS O

- ac c epted as fully meeting requirements , or

- ac c ep ted w ith identified no nc onfo rmities under c o nc es s ion, or

- p ut on hold aw aiting further analys is /dec is io n, or

- rej ec ted as uns atis fac to ry.

S ep arate p hys ic al lo c ation of thes e c atego ries of a p ro duc t is o ften the mos t c ertain metho d of

as s uring b oth the s tatus and ac c urate dis p o s itio n. Ho w ever, in an auto mated p ro c es s ac c urate

dis p os ition may equally be ac hieved b y other means , s uc h as a c omp uter datab as e.

4.1 3 Control of nonconforming product

4.1 3.1 General

When any intermediate or final p ro duc t is fo und ( e. g. by tes t or ins p ec tio n) no t to c o nfo rm to

the s p ec ified requirements , inadvertent us e s ho uld be prevented. This is ap plic ab le to

no nc o nfo rming p ro duc t oc c urring in the s up p lier' s own fac ilities as w ell as to no nc o nfo rming

p ro duc t rec eived by the s up plier. Pro c edures s ho uld be es tab lis hed and maintained by the

s up p lier fo r the follo w ing p urp o s es :

- to determine w hic h p ro duc t is invo lved in the no nc onfo rmity, fo r ex ample, w hat

p ro duc tio n time interval, p ro duc tio n mac hines o r p ro duc ts are invo lved;

- to identify the no nc o nfo rming p ro duc t to make s ure that it c an be dis tinguis hed

fro m the c o nfo rming p ro duc t ( s ee 4 . 1 2) ;

- to doc ument the exis tenc e and s o urc e of the no nc onfo rmity;

- to evaluate the nature o f the no nc o nfo rmity;

- to c o ns ider the alternatives fo r dis po s ition of the no nc o nfo rming p ro duc t, to

dec ide and rec ord w hat dis p o s itio n s ho uld b e made;

- to c o ntrol (e. g. by p hys ic al s egregatio n) the s ub s equent p ro c es s ing of the

no nc o nfo rming p ro duc t c o ns is tent w ith the dis p o s itio n dec is io n;

- to no tify o thers that may be affec ted by the no nc o nfo rmity inc luding, w here

ap p ro p riate, the c us to mer.

4.1 3.2 Review and disposition of nonconforming product

The s upp lier s ho uld have a no nc o nfo rmity handling p ro c es s w ith des ignated dis p o s itio n

autho rity fo r tec hnic al s p ec ific atio ns , rew o rk p ro c es s es and c o ntrac tual requirements .

Repaired and rew o rked pro duc t s ho uld be re- ins p ec ted in ac c o rdanc e w ith the doc umented

pro c edures o r the quality plan.

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© IS O ISO 9000-2: 1 997(E)

Info rmatio n c o nc erning no nc o nfo rming items s ho uld b e p ro vided to all ap p ro p riate p ers o nnel,

so that ac tio n is taken if nec es s ary to identify and c orrec t the c aus e o f the no nc o nfo rmity and

prevent rec urrenc e (s ee 4 . 1 4) . Thes e rec o rds (s ee 4. 1 6) and their analys is fo rm a meas ure of

the effec tivenes s of the quality s ys tem.

Reques ts by the s up p lier fo r c o nc es s io ns or c hanges in s p ec ific atio n s ho uld be p ro c es s ed in

ac c o rdanc e w ith do c umented p ro c edures . The s upp lier s ho uld ens ure that s uc h reques ts are

c lear and ac c urate. Any additio nal info rmatio n, c o mment or rec o mmendation that might

as s is t the c us to mer to arrive at a dec is io n s ho uld be gi ven. C o nc es s ions reques ted by

s ub c ontrac tors may b e agreed b y the s upp lier. The c us to mer' s agreement to thes e c o nc es s io ns

may fo rm p art o f the c o ntrac t w ith the s up p lier.

The fo rego ing guidanc e is equally ap p lic ab le to p ro duc t p urc has ed fro m s ub c o ntrac to rs that is

fo und to dep art fro m the s p ec ified requirements .

While IS O 9 003 do es no t have a s ub c laus e dealing ex p lic itly w ith the review and dis p o s itio n

of no nc o nforming p roduc t, the guidanc e p res ented here may b e help ful in the imp lementatio n

of s ub laus e 4. 1 3 o f IS O 9 003 : 1 9 9 4.

4.1 4 Corrective and preventive action

4.1 4.1 General

The s up p lier s hould have doc umented p roc edures fo r identifying and eliminating the c aus es

of ac tual o r p o tential nonc onfo rmities in p ro duc ts , p ro c es s es o r the quality s ys tem.

C aus es of detec ted nonc o nformities s ho uld p ro mp tly be identified so that c o rrec tive ac tio n

may be taken and rec urrenc e prevented. Thes e c aus es may inc lude the follow ing:

- failures , malfunc tio ns or no nc o nfo rmities in inc o ming materials , p ro c es s es , to o ls ,

equip ment or fac ilities in w hic h p roduc ts are p roc es s ed, s to red or handled,

inc luding the equip ment and s ys tems therein;

- inadequate o r no n- exis tent p ro c edures and do c umentatio n;

- non- c o mp lianc e w ith p roc edures ;

- inadequate p ro c es s c o ntro l;

- p oo r s c heduling ;

- lac k of training;

- inadequate w o rking c o nditio ns ;

- inadequate res o urc es (human o r material) ;

- inherent p ro c es s variab ility.

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ISO 9000-2: 1 997(E) © IS O

The conditions resulting from these causes may be revealed by analysis of the following:

- inspection and test records;

- nonconformity records;

- observations during process monitoring;

- audit observations;

- field, service or customer complaints;

- regulatory authority or customer observations;

- observations and reports by personnel;

- subcontract problems;

- management review results;

- inherent process variability.

The same causes and conditions may be involved in preventive action, where patterns or
trends that may indicate the potential for occurrence of nonconformities should be
investigated. The degree of corrective or preventive action taken should be dependent upon
and directly related to the risk, size and nature of the problems and their direct effects on
product quality.

It should be noted that the requirement for corrective action is less comprehensive in
IS O 9003 , and preventive action is not required in IS O 9003 .

4.1 4.2 Corrective action

Documented procedures should be established to determine corrective actions and how this
should be carried out and their effectiveness verified. It may be beneficial to take into
account information concerning corrective actions when carrying out management reviews
(see 4. 1 . 3 ).

It is useful to implement procedures to deal with nonconformities discovered in product that

has already been shipped as satisfactory. S uch procedures can include investigations to
establish whether the nonconformity is an isolated or a repetitive problem and any actions to
be taken, if necessary.

Corrective action to eliminate the cause of a nonconformity is not necessarily required for
every occurrence or for isolated incidents of a minor nature, but periodic analysis of patterns
of nonconformities should be considered to identify opportunities for process improvement.

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© IS O ISO 9000-2: 1 997(E)

4.1 4.3 Preventive action

It s ho uld be no ted that c o rrec tive ac tio n is taken after no nc o nfo rmities are identified.

Preventive ac tio n is taken w hen a p o tential no nc onfo rmity is identified as a res ult of the

analys is of rec o rds and o ther relevant s ourc es o f info rmation, s uc h as the follo w ing :

- s tatis tic al p ro c es s c o ntro l do c uments ;

- c us to mer c o mp laints ;

- internal and s ub c o ntrac tor- s o urc ed pro duc t, p roc es s and quality s ys tem

info rmatio n ( s ee 4. 1 4 . 1 ) .

Rec o rds relating to the p erfo rmanc e o f the pro duc t s hould be analys ed regularly, to detec t any

trends and to identify areas o f ris k that may lead to p otential no nc onfo rmities . The analys es

s ho uld als o determine the ac tions nec es s ary to prevent any identified p o tential p ro b lems .

Informatio n on p reventive ac tio ns taken is required to fo rm an integral p art of the

management review p ro c es s (s ee 4. 1 . 3 ) , to maintain and imp rove the effec tivenes s of the

quality s ys tem.

Preventive ac tio n to eliminate a p o tential nonc o nformity is not nec es s arily required fo r every

po tential no nc onfo rmity identified, b ut s ho uld b e c ons idered fo r s ys tem imp rovement.

4.1 5 Handling, storage, packaging, preservation and delivery

4.1 5.1 General

The s up p lier' s s ys tem s ho uld p ro vide adequate p lanning, c o ntro l and do c umentatio n fo r

handling, s to rage, p ac kaging, pres ervation and delivery of p ro duc t. This ap plies to materials

in- p ro c es s and finis hed p ro duc t.

4.1 5.2 Handling

The s up p lier' s metho d fo r handling p ro duc t s ho uld c o ns ider p ro viding equip ment s uc h as

anti- s tatic w ris t s trap s , glo ves and p ro tec tive c lo thing, als o trans p o rtatio n units s uc h as

p allets , c o ntainers , c o nveyo rs , ves s els , tanks , rigging, p ip elines and vehic les . This is

nec es s ary so that damage, deterioratio n or c o ntaminatio n (due to vib ratio n, s ho c k, ab ras io n,

c o rro s io n, temp erature variation, elec tro s tatic dis c harge, radiatio n or any o ther c o nditions

oc c urring during handling and s to rage) may be prevented. Maintenanc e of handling

equip ment is ano ther fac to r to be c o ns idered.

4.1 5.3 Storage

The s up plier s ho uld p ro vide s uitab le s to rage fac ilities , c o ns idering not o nly p hys ic al s ec urity

b ut als o enviro nmental c o nditio ns ( e. g. temperature and humidity) . It may be ap p rop riate to

c hec k p erio dic ally items in s to rage to detec t po s s ib le deterioratio n. The methods fo r

identific ation s ho uld give legib le, durab le informatio n in ac c o rdanc e w ith the s p ec ified

25
ISO 9000-2: 1 997(E) © IS O

requirements . C ons ideratio n may need to be given to adminis trative p ro c edures fo r p ro duc t

expiratio n dates , s to c k ro tatio n and lo t s eg regation.

4.1 5.4 Packaging

The s up p lier' s p ac kaging, materials , p ac king and lab elling s hould p rovide adequate p ro tec tion

agains t damage to the p roduc t. The vario us forms of s to rage and the typ es of trans po rtation

that c an b e enc ountered s ho uld b e c o ns idered.

The p ac kaging s hould p ro vide a c lear des c riptio n o f the c o ntents or ingredients o f the pro duc t

where reg ulatio ns or the c ontrac t s p ec ify.

Pro vis io ns s ho uld b e made fo r c hec king the effec tivenes s o f the pac kag ing .

4.1 5.5 Preservation

The s up p lier' s p res ervatio n metho ds s hould inc lude ap p ro p riate p ro tec tio n agains t

deterio ratio n and co ntaminatio n during s to rage, trans p o rtatio n or any later p erio d until the

s up p lier' s res p ons ib ility c eas es .

Examp les o f p res ervatio n meas ures are as fo llo w s :

- maintenanc e o f s terile c o nditio ns fo r medic al equip ment;

- maintenanc e o f dus t and s tatic free c onditio ns for s emic o nduc to rs ;

- p ro tec tio n fo r frag ile p ro duc ts ;

- c o ntro lled temp erature/humidity and hyg ienic c onditio ns fo r handling fo o ds tuffs .

4.1 5.6 Delivery

The s up p lier s hould pro vide fo r p ro tec tion o f the quality of p ro duc t after final ins pec tio n and

tes t. Where c o ntrac tually s p ec ified, the s up p lier s hould p rovide fo r the pro tec tio n of the

quality of the p roduc t during s hipp ing and o ther p has es of delivery. Fo r s o me p ro duc ts ,

delivery time is a c ritic al fac tor. C o ns ideration s ho uld be given to the vario us typ es of

delivery and variatio ns in enviro nmental c o nditions that may be enc o untered.

4.1 6 Control of quality records

Quality rec o rds s ho uld give evidenc e direc tly or indirec tly as to w hether or not the p ro duc t

meets s p ec ified requirements . Thes e rec o rds may be c onfidential and s hould be treated

ap prop riately.

The s up p lier' s quality rec o rds s ho uld give evidenc e that quality s ys tem elements falling

w ithin the requirements of IS O 9 001 , IS O 9 002 or IS O 9 003 have b een imp lemented. If the

res ults have not p ro ved s atis fac to ry, quality rec o rds s hould indic ate w hat has b een do ne to

c o rrec t the s ituatio n.

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© IS O ISO 9000-2: 1 997(E)

Quality rec ords s ho uld be p rep ared, s to red s afely, pro tec ted from unautho riz ed ac c es s ,

pro tec ted fro m alteratio n and maintained by the s up p lier. Quality rec o rds s ho uld be pro p erly

identified, c ollec ted, index ed and filed, and readily ac c es s ib le as and where needed. They may

be s to red or c o p ied in any s uitab le fo rm, for ex amp le hard copy or elec tro nic media. Where

rec o rds are held on elec tro nic media, c o ns ideratio n of the retentio n times and ac c es s ib ility of

the rec o rds s ho uld take into ac c o unt the rate of degradatio n of the elec tro nic images and the

availab ility of the devic es and s oftw are needed to ac c es s the rec o rds S uc h c o pies of quality

rec o rds s ho uld c ontain all the relevant info rmatio n in the o riginal quality rec o rds . The

s up p lier s hould c o ns ider ho w to trans late the requirements of the c o ntrac t into the needs for

s ub mis s io n and retentio n and dis p o s ition o f quality rec o rds .

There may be c i rc ums tanc es in w hi ch the c us tomer is required to s to re and maintain s elec ted

quality rec o rds attes ting to the quality of p ro duc ts for a s pec ified part of the o perating

lifetime. The s upp lier s ho uld make due allo w anc e fo r the p ro vis io n of s uc h do c uments to the

c us to mer.

IS O 9 001 , IS O 9 002 and IS O 9 003 do no t s p ec ify a minimum time perio d fo r the retentio n of

quality rec ords . There may be c irc ums tanc es w here it is the s up plier' s res po ns ib ility to verify

w ith regulato ry autho rities w hat their requirements are. The as p ec ts of p ro duc t liab ility and

legality of vario us fo rms of rec ord- keep ing s ho uld be taken into c ons ideration. If a s p ec ific

period of time is required, it s ho uld be s p ec ified in the c o ntrac t. If time p erio ds are not

pres c rib ed by legis latio n or in the c o ntrac t, the s up p lier s ho uld c o ns ider the ex pec ted lifetime

of the p ro duc t and s ho uld do c ument the ap pro p riate retention times . Rec o rds may b e dis po s ed

of after the s p ec ified retentio n p eriod. The s up p lier may als o take into ac c o unt the nature of

the p ro duc t and determine an ap p ro p riate retention time.

A numb er of c laus es throughout IS O 9 001 make referenc e to rec ords and to this s ub c laus e

(4 . 1 6 ) . S ome examp les o f quality rec ords are

- management review rec o rds ,

- c o ntrac t review ,

- ins p ec tion and tes t rec o rds ,

- internal quality audit rec ords .

4.1 7 Internal quality audits

Internal quality audits s ho uld be c arried o ut by the s up p lier in order to determine w hether the

vario us quality s ys tem elements are effectiv e and s uitab le to ac hiev e the s tated quality

ob j ec tives . The frequenc y o f p erio dic audits s ho uld b e defined in an internal audit s c hedule.

The s up plier s ho uld s elec t and as s ign qualified audito rs for the ac tivity b eing audited. The

requirement fo r the audit ac tivity to be c arried out by p ers o nnel independent o f tho s e having

direc t res p o ns ib ility fo r the ac tivity b eing audited does no t p rec lude pers o ns w ho have

s p ec ific func tio ns and res p o ns ib ilities w ithin the o rganizatio n fro m b eing internal audito rs of

other func tio ns and areas w ithin the o rg anization.

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ISO 9000-2: 1 997(E) © IS O

Perio dic internal audits may be p erfo rmed on p arts o f the quality s ys tem or the w ho le quality

s ys tem

- to determine the adequacy and co nfo rmity o f the quality s ys tem elements w ith the

requirements fo r their do c umentatio n and imp lementatio n requirements ;

- to determine the effec tivenes s o f the implemented quality s ys tem;

- to g ive an o pp ortunity to imp ro ve the s upp lier' s quality s ys tem;

- to fac ilitate external quality audits .

In additio n to the p erio dic internal audits , an internal audit may be initiated fo r the fo llo w ing

reas o ns :

- initially to evaluate the quality s ys tem w here there is a des ire to es tab lis h a

c o ntrac tual relatio ns hip ;

- w ithin the framew o rk of a co ntrac tual relatio ns hip , to verify that the quality

s ys tem c o ntinues to meet s p ec ified requirements and is b eing imp lemented;

- w hen s ignific ant c hanges have b een made in func tio nal areas , fo r ex ample,

reo rg anizatio ns and p roc edures revis io ns ;

- w hen s afety, p erfo rmanc e o r dependab ility o f the p ro duc ts are in, o r are s us pec ted

to be in, j eo p ardy due to no nc o nformities ;

- w hen it is nec es s ary to verify that required c o rrec tive ac tio ns have b een taken and

have b een effec tive.

The res ults of audits s ho uld be s tated in a w ritten rep o rt (s ee 4. 1 6) and the rec o rds s ho uld

indic ate the defic ienc ies fo und and c o rrec tive ac tio n(s ) required.

Target dates fo r res p o nding to audit findings s ho uld als o be inc luded. The audit res ult s ho uld

be c o mmunic ated as fo llo w s :

- given to the management p ers o nnel res p o ns ib le for the department or func tio n

b eing audited; and

- an inp ut to management review s ( s ee 4. 1 . 3 ) .

It is imp o rtant that fo llo w - up audit activities demo ns trate and c o nfirm that co rrec tive actio n

has b een taken and is effec tive ( s ee 4. 1 6) .

Fo r general guidelines fo r auditing quality s ys tems , it is rec o mmended that IS O 1 001 1 - 1 , IS O

1 001 1 - 2 and IS O 1 001 1 - 3 be c o ns ulted.

NO TE — The gui danc e in the IS O 1 001 1 s eries do es no t add to , or o therw is e c hange, the

requirements o f IS O 9 001 , IS O 9 002 and IS O 9 003 .

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4.1 8 Training

The training of p ers o nnel, inc luding new ly hired, part- time and temp o rary pers onnel, is

es s ential fo r the ac hievement of quality o b j ec tives . This s ub claus e p ertains to all lev els of

p ers o nnel w ithin the o rganizatio n that are p erfo rming ac tivities affec ting quality. This

inc ludes s p ec ific training nec es s ary fo r p erfo rming as s igned tas ks , and general training to

b uild inc entives and to heighten quality aw arenes s . Pers o nnel s ho uld be trained in the us age

of, and the underlying reas ons fo r, the pro c edures and do c uments in the quality management

ap pro ac h o f the s up p lier.

To ac hieve and maintain pro fic ienc y, a numb er of s tep s c an p erio dic ally be taken by the

s up p lier, as fo llo w s :

- evaluating the general educ atio n, ex p erienc e, qualific atio ns and c o mp etenc e of

the p ers o nnel for the ac tivities to be p erfo rmed;

- identific ation of the individual training needs agains t tho s e required fo r

s atis fac to ry p erformanc e;

- p lanning, o rganiz ing and c arrying o ut ap p ro p riate training or retraining either

in- hous e or by an external org aniz atio n;

- rec o rding training and ac hievement so that rec o rds c an be up dated and gap s in

training c an readily be identified and filled (s ee 4. 1 6) ;

- evaluating all c hang es in eac h p ro c es s fo r any additio nal training requirements .

4.1 9 Servicing

When the func tionality o f p ro duc ts may dep end on s ervic ing fo r maintenanc e o r p ro p er us e of

the pro duc ts and w hen the s up plier p ro vides fo r s o me of or all p roduc t s ervic ing by w arranty

or by c o ntrac t, the s up p lier' s quality s ys tem s ho uld inc lude p ro vis io ns fo r the typ e and ex tent

of s ervic ing p rovided. The follo w ing ac tivities s ho uld b e c o ns idered as app ro priate:

- c larific atio n o f s ervic ing res p o ns ib ilities amo ng s up plier, dis trib uto rs and us ers ;

- p lanning o f s ervic e ac tivities , w hether c arried out by the s up p lier or by a s ep arate

ag ent;

- validatio n of des ign and func tion of s p ec ial- p urpo s e to o ls or equipment fo r

handling and s ervic ing p ro duc ts after ins tallatio n;

- c o ntro l o f meas uring and tes t equipment us ed in field s ervic ing and tes ts ;

- p ro vis io n and s uitab ility of do c umentatio n, inc luding ins truc tio ns fo r us e in

dealing w ith the s pares o r parts lis ts , and in s ervic ing o f the pro duc t;

- p rovis io n fo r adequate b ac k- up , to inc lude tec hnic al advic e and s up p ort, c us to mer

p ers o nnel training and s p ares o r p arts s up ply;

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ISO 9000-2: 1 997(E) © IS O

- training of servicing personnel;

- provision of competent servicing personnel;

- feedback of information that would be useful for improving product or servicing

design;

- other customer support activities.

Even when not specified in the contract, the guidance given here may be helpful to the
supplier.

4.20 Statistical techniques

4.20.1 Identification of need

The use of statistical methods can be beneficial to the supplier in a wide range of
circumstances, including data collection, analysis and application. These techniques are
useful for demonstrating process capability, as well as product conformity to specified
requirements. They assist in deciding what data to obtain, and making the best use of the
data, to gain a better understanding of customer requirements and expectations. S tatistical
methods are useful in product and process design, in process control, nonconformity
avoidance, problem analysis, risk determination, finding root causes, establishing product and
process limits, forecasting, verification and measurement or assessment of quality
characteristics.

Among the statistical methods that can be beneficial for these purposes are the following:

- graphical methods (histograms, sequence charts, scatter plots, Pareto diagrams,

cause and effect diagrams, etc. ) that help to diagnose problems and suggest
appropriate computational approaches to further statistical diagnosis;

- statistical control charts for monitoring and controlling production and

measurement processes for all types of product (hardware, software, processed
materials and services);

- design of experiments for determining which candidate variables have significant

influence on process and product performance, and for quantifying the effects;

- regression analysis which provides a quantitative model for the behaviour of a

process or a product when the conditions of process operation or product design
are changed;

- analysis of variance (separating the total observed variability), leading to variance

component estimates useful for designing sample structures for control charts and
for product characterization and release; the magnitudes for the variance
components are also a basis for prioritizing quality improvement efforts;

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© IS O ISO 9000-2: 1 997(E)

- methods of s ampling and acceptance;

- s ampling at all s tages of production;

- s tatis tical methods for ins pections and tes ting.

The s upplier s hould s elect the s tatis tical techniques required to s atis fy the identified need.

Thes e should be chos en from available s tandards or es tablis hed by the s upplier.

4.20.2 Procedure

Once the appropriate s tatis tical techniques are chos en, it is important to document and

implement thos e techniques in s uch a manner that appropriate data are collected and

evaluated, and the res ult are reported to the relevant departmental functions , s o that neces s ary

actions may be taken. The data res ulting from the application of s tatis tical techniques can be

an effective means of demons trating conformity to requirements for quality and can be us ed

as quality records .

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ISO 9000-2: 1 997(E) © IS O

Annex A
(informative)

B ibliography

[1 ] IS O 9004-1 : 1 994, Quality management and quality system elements - Part 1 : Guidelines

[2] IS O 9004-2: 1 991 , Quality management and quality system elements - Part 2 : Guidelines
for services

[3 ] IS O 9004-3 : 1 993 , Quality management and quality system elements - Part 3: Guidelines
for processed materials

[4] IS O 1 0005 : 1 995, Quality management - Guidelines for quality plans

[5 ] IS O 1 001 1 -1 : 1 990, Guidelines for auditing quality systems - Part 1 : A uditing

[6] IS O 1 001 1 -2: 1 991 , Guidelines for auditing quality systems - Part 2 : Qualification

criteria for quality systems auditors

[7] IS O 1 001 1 -3 : 1 991 , Guidelines for auditing quality systems - Part 3: Management of
audit programmes

[8] IS O 1 001 2-1 : 1 993 , Quality assurance requirements for measuring equipment - Part 1 :
Metrological confirmation system for measuring equipment

[9] IS O 1 001 3 : 1 995, Guidelines for developing quality manuals

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I SO 9000-2: 1 997(E) © I SO

I CS 03. 1 20. 1 0

Descri ptors: qu al i ty m an ag em en t, qu al i ty assu ran ce, q u al i ty assu ran ce prog ram m e, q u al i ty assu ran ce system s, stan dards, i n tern ati on al
stan d ard s, i m pl em en tati on , ru l es (i n stru cti on s) .

Pri ce based on 26 pag es