AS/NZS ISO 9000.

2:1998

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Australian/New Zealand Standard

Quality management and quality assurance Standards Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003

AS/NZS ISO 9000.2:1998 This Joint Australian/New Zealand Standard was prepared by Joint Technical Committee QR/8, Quality Systems. It was approved on behalf of the Council of Standards Australia on 17 March 1998 and on behalf of the Council of Standards New Zealand on 6 April 1998. It was published on 5 June 1998. The following interests are represented on Committee QR/8: Australian Association of Certication Bodies Australian Chamber of Commerce and Industry Australian Electrical and Electronic Manufacturers Association Australian Information Industry Association Federal Chamber of Automotive Industries, Australia Institute of Metals and Materials Australasia Institution of Engineers Australia Institution of Radio and Electronics Engineers Australia Main Roads Department, Queensland Master Builders Australia Plastics and Chemicals Industries Association Quality Society of Australasia Royal Australian Chemical Institute Sydney Water Corporation Telarc Telstra Corporation

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Australian Institute of Petroleum Australian Organization for Quality ARRB Transport Research Bureau of Steel Manufacturers of Australia Department of Defence, Australia Department of Industry, Science and Tourism (Australia) Department of Primary Industries and Energy (Australia) Department of Transport and Regional Development (Australia) Electricity Supply Association of Australia

Review of Standards. To keep abreast of progress in industry, Joint Australian/ New Zealand Standards are subject to periodic review and are kept up to date by the issue of amendments or new editions as necessary. It is important therefore that Standards users ensure that they are in possession of the latest edition, and any amendments thereto.

Full details of all Joint Standards and related publications will be found in the Standards Australia and Standards New Zealand Catalogue of Publications; this information is supplemented each month by the magazines The Australian Standard and Standards New Zealand, which subscribing members receive, and which give details of new publications, new editions and amendments, and of withdrawn Standards.

Suggestions for improvements to Joint Standards, addressed to the head office of either Standards Australia or Standards New Zealand, are welcomed. Notication of any inaccuracy or ambiguity found in a Joint Australian/New Zealand Standard should be made without delay in order that the matter may be investigated and appropriate action taken.

This Standard was issued in draft form for comment as DR 98005.

Acacias (Wattle) contain over 1,200 species of trees and shrubs from warm climates. Some are deciduous but most are evergreen. Over 700 are indigenous to Australia. They range from low-growing shrubs to tall trees and many have been introduced to other countries for economic and ornamental purposes. Acacias are also common in tropical and subtropical Africa; most African species are characterized by vicious spines and referred to as thorn trees. Acacias have either bipinnate leaves or their leaves are replaced by attened leaf stalks, known as phyllodes, which perform the function of photosynthesis. The tiny owers, ranging from deep golden yellow to cream or white, and crowded into globular heads or cylindrical spikes, are often fragrant and produce abundant, bee-attracting pollen.

AS/NZS ISO 9000.2:1998

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Australian/New Zealand Standard

Quality management and quality assurance Standards Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003

Originated in Australia as AS 3900.2(Int) 1992. Final Australian edition AS 3900.2 1994. Originated in New Zealand as NZS 9000.2(Int):1992. Final New Zealand edition NZS 9000.2:1994. Jointly revised and redesignated AS/NZS ISO 9000.2:1998.

Published jointly by: Standards Australia 1 The Crescent, Homebush NSW 2140 Australia Standards New Zealand Level 10, Radio New Zealand House, 155 The Terrace, Wellington 6001 New Zealand
ISBN 0 7337 1980 5

AS/NZS ISO 9000.2:1998

ii

PREFACE
This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee QR/8, Quality Systems. The Standard is technically equivalent to and has been reproduced from ISO 9000-2:1997, Quality management and quality assurance standards, Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003, published by the International Organization for Standardization (ISO). Committee QR/8 provided input to the International Committee ISO/TC 176 in the preparation of ISO 9000-2. Appendix AA, which contains supplementary guidance questions for Australia and New Zealand, has been prepared by Committee QR/8 and is included in this edition. Appendix AA is organized according to the clause structure of AS/NZS ISO 9001 for ease of cross-referencing. The term informative has been used in this Standard to define the application of Annex A and the Australian/New Zealand Appendix AA. An informative annex or appendix is for information and guidance only. For the purpose of this Joint Standard, the ISO text should be modified so that the words Joint Australian/New Zealand Standard replace the words International Standard wherever they appear.

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Copyright

STANDARDS AUSTRALIA / STANDARDS NEW ZEALAND

Users of Standards are reminded that copyright subsists in all Standards Australia and Standards New Zealand publications and software. Except where the Copyright Act allows and except where provided for below no publications or software produced by Standards Australia or Standards New Zealand may be reproduced, stored in a retrieval system in any form or transmitted by any means without prior permission in writing from Standards Australia or Standards New Zealand. Permission may be conditional on an appropriate royalty payment. Australian requests for permission and information on commercial software royalties should be directed to the head office of Standards Australia. New Zealand requests should be directed to Standards New Zealand. Up to 10 percent of the technical content pages of a Standard may be copied for use exclusively in-house by purchasers of the Standard without payment of a royalty or advice to Standards Australia or Standards New Zealand. Inclusion of copyright material in computer software programs is also permitted without royalty payment provided such programs are used exclusively in-house by the creators of the programs. Care should be taken to ensure that material used is from the current edition of the Standard and that it is updated whenever the Standard is amended or revised. The number and date of the Standard should therefore be clearly identified. The use of material in print form or in computer software programs to be used commercially, with or without payment, or in commercial contracts is subject to the payment of a royalty. This policy may be varied by Standards Australia or Standards New Zealand at any time.

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AS/NZS ISO 9000.2:1998

CONTENTS
Page 1 2 3 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20 Annex A Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Normative references . . . . . . . . . . . . . . . . . . . . . . . . . Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality system requirements . . . . . . . . . . . . . . . . . . . Management responsibility . . . . . . . . . . . . . . . . . . . . . Quality system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contract review . . . . . . . . . . . . . . . . . . . . . . . . . . . . Design control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Document and data control . . . . . . . . . . . . . . . . . . . . Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Control of customer-supplied product . . . . . . . . . . . . . Product identification and traceability . . . . . . . . . . . . . Process control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Inspection and testing . . . . . . . . . . . . . . . . . . . . . . . . Control of inspection, measuring and test equipment . . Inspection and test status . . . . . . . . . . . . . . . . . . . . . . Control of nonconforming product . . . . . . . . . . . . . . . Corrective and preventive action . . . . . . . . . . . . . . . . . Handling, storage, packaging, preservation and delivery Control of quality records . . . . . . . . . . . . . . . . . . . . . Internal quality audits . . . . . . . . . . . . . . . . . . . . . . . . Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Statistical techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 2 2 5 6 8 13 15 16 17 18 19 21 21 22 23 25 26 27 29 29 30 32

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Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SUPPLEMENTARY GUIDANCE QUESTIONS FOR AUSTRALIA AND NEW ZEALAND . . . . . . . . . . . . . . . . . . .

APPENDIX AA

33

AS/NZS ISO 9000.2:1998

iv

INTRODUCTION
This part of ISO 9000 gives guidance for the application of ISO 9001, ISO 9002 and ISO 9003. To facilitate cross-reference to those standards, this part of ISO 9000 has the same clause structure as ISO 9001, ISO 9002 and ISO 9003. In general, the number and scope of the quality system elements and procedures required for quality assurance are greatest in ISO 9001 and least in ISO 9003. For all clauses, the guidelines of this part of ISO 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. ISO 9001, ISO 9002 or ISO 9003). Reference should be made to subclause 8.3 of ISO 9000-1:1994 for guidance on the appropriate extent and degree of demonstration. ISO 9000-1 gives an overview of the ISO 9000 series of International Standards, and explains the use of the entire series. ISO 9004-1 gives guidance for designing and installing a quality management system. This part of ISO 9000 does not duplicate the guidance to users that is given in other ISO guidance standards such as ISO 9000-1, ISO 9000-3, ISO 9004-1 and ISO 9004-2.

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AS/NZS ISO 9000.2:1998

AUSTRALIAN / NEW ZEALAND STANDARD

Quality management and quality assurance Standards Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003

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Scope

This part of ISO 9000 gives guidance on the application of the 1994 versions of ISO 9001, ISO 9002 and ISO 9003. It does not add to, or otherwise change, the requirements of ISO 9001, ISO 9002 or ISO 9003. In the case of conflicting interpretations of ISO 9001, ISO 9002 or ISO 9003 on the one hand, and ISO 9000-2 on the other, the interpretation of the text in ISO 9001, ISO 9002 or ISO 9003 takes precedence. The use of should in this part of ISO 9000 does not weaken the requirements expressed as shall in ISO 9001, ISO 9002 and ISO 9003. This part of ISO 9000 gives guidance for the following users: a) b) suppliers involved in applications of ISO 9001, ISO 9002 or ISO 9003; customers and third parties.

Normative references

The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 9000. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 9000 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 8402:1994, Quality management and quality assurance Vocabulary. ISO 9001:1994, Quality systems Model for quality assurance in design, development, production, installation and servicing. ISO 9002:1994, Quality systems Model for quality assurance in production, installation and servicing. ISO 9003:1994, Quality systems Model for quality assurance in final inspection and test.

COPYRIGHT

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AS/NZS ISO 9000.2:1998, Quality management and quality assurance Standards Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003

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