HB 18.

532005
ISO/IEC Guide 53:2004

HB 18.532005
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Handbook
Conformity assessmentGuidance on the use of an organizations quality management system in product certification

This Australian Standard was prepared by Committee QR-010, Conformity Assessment. It was approved on behalf of the Council of Standards Australia on 22 August 2005. This Standard was published on 21 November 2005.

The following are represented on Committee QR-010: Association of Accredited Certification Bodies Australian Information Industry Association Australian Quarantine and Inspection Service (Commonwealth) Certification Interests (Australia) Certification Interests (New Zealand) Consumer Electronics Suppliers Association Consumers Federation of Australia International Accreditation Forum Joint Accreditation System of Australia and New Zealand National Association of Testing Authorities Australia

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Keeping Standards up-to-date

Standards are living documents which reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments which may have been published since the Standard was purchased. Detailed information about Standards can be found by visiting the Standards Web Shop at www.standards.com.au and looking up the relevant Standard in the on-line catalogue. Alternatively, the printed Catalogue provides information current at 1 January each year, and the monthly magazine, The Global Standard, has a full listing of revisions and amendments published each month. Australian StandardsTM and other products and services developed by Standards Australia are published and distributed under contract by SAI Global, which operates the Standards Web Shop. We also welcome suggestions for improvement in our Standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Contact us via email at mail@standards.org.au, or write to the Chief Executive, Standards Australia, GPO Box 476, Sydney, NSW 2001.

This Standard was issued in draft form for comment as DR 05228.

HB 18.532005

Handbook
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Conformity assessmentGuidance on the use of an organizations quality management system in product certification

Originated as HB 18.531991. Second edition 2005.

COPYRIGHT Standards Australia All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher. Published by Standards Australia, GPO Box 476, Sydney, NSW 2001, Australia ISBN 0 7337 6987 X

ii

PREFACE
This Handbook was prepared by the Australian members of the Joint Standards Australia/Standards New Zealand Committee QR-010, Conformity Assessment. After consultation with stakeholders in both countries, Standards Australia and Standards New Zealand decided to develop this publication as an Australian Handbook rather than an Australian/New Zealand Handbook. It supersedes HB 18.531991. This Handbook is identical with, and has been reproduced from ISO/IEC Guide 53:2004, Conformity assessmentGuidance on the use of an organizations quality management system in product certification. This Handbook has undergone the transparency and consensus process of Combined Procedure public comment and postal ballot.
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The objective of this Handbook is to provide guidance on the development and application of product certification schemes. As this Handbook is reproduced from an international Guide, the following applies: (a) (b) (c) Its number appears on the cover and title page while the international number appears only on the cover. In the source text ISO/IEC Guide 53 should read HB 18.53. A full point substitutes for a comma when referring to a decimal marker.

The terms normative and informative have been used in this Handbook to define the application of the annex to which they apply. A normative annex is an integral part of a Handbook, whereas an informative annex is only for information and guidance. References to International Standards should be replaced by references to Australian or Australian/New Zealand Standards as follows: Reference to International Standard ISO 9000 ISO/IEC 17000 Conformity assessment Vocabulary and general principles Quality management systems Fundamentals and vocabulary Australian/New Zealand Standard AS/NZS ISO 9000 AS ISO/IEC 17000 Conformity assessment Vocabulary and general principles Quality management systems Fundamentals and vocabulary

iii

Contents

CONTENTS

Page

Page Foreword ............................................................................................................................................................ iv Introduction ........................................................................................................................................................iv 1 2 3 4 4.1 4.2 5

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Scope...................................................................................................................................................... 1 Normative references ........................................................................................................................... 1 Terms and definitions........................................................................................................................... 1 Steps in the scheme ............................................................................................................................. 2 Deciding on the scheme....................................................................................................................... 2 Functions in the implementation of a product certification scheme............................................... 2 Selection ................................................................................................................................................ 2 Determination ........................................................................................................................................ 3 Review and attestation ......................................................................................................................... 4 Surveillance ........................................................................................................................................... 5 Mark of conformity................................................................................................................................ 5

6 7 8 9

Annex A (informative) Example of a data form for a product certification scheme that uses very few requirements of a quality management system ......................................................................... 6 Annex B (informative) Example of a data form for a product certification scheme that uses many requirements of a quality management system............................................................................... 10 Bibliography ..................................................................................................................................................... 21

iv

Introduction

INTRODUCTION

Product certification schemes incorporating an organizations quality management system can be beneficial for both the organization and the certification body in determining the conformity of products to specified requirements and in assuring that products continue to conform to those requirements. In these types of schemes, product certification is based on both the assessment of conformity of an organization's quality management system to specified requirements, and the assessment of conformity of the product to specified product requirements. Certification bodies can conduct both types of assessment for product certification schemes that are covered by this Guide. Product certification schemes can take many forms, including those that do not utilize an organizations quality management system. There is no inference in this Guide that one form of product certification scheme is superior to another. Furthermore, when a certification body has several forms of product certification schemes available for a class of product, the organization has the right to choose the scheme under which it wishes to apply for certification.
NOTE be used. In some countries, technical regulations predetermine the available type(s) of product certification scheme to

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This Guide is based on the understanding that interested parties using it to develop product certification schemes are familiar with the principles and practices covered by the ISO 9000 family of International Standards, the more general certification and surveillance provisions established for product certification systems in ISO/IEC Guide 67, and the specific product requirements.

1 AUSTRALIAN HANDBOOK

Conformity assessment Guidance on the use of an organization's quality management system in product certification

Scope

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1.1 This Guide outlines a general approach by which certification bodies can develop and apply product certification schemes utilizing requirements of an organization's quality management system. The provisions given in this Guide are not requirements for the accreditation of a product certification body and do not substitute the requirements of ISO/IEC Guide 65. 1.2 The schemes contained in this Guide are for product certification only and in all cases involve the following principles: a) b) c) d) assessment of an organizations quality management system and its capability to consistently supply products conforming to specified requirements; testing, inspection or comparable verification of the product's conformity to scheme criteria and specified requirements; application of a suitable surveillance scheme to ensure continual conformity to specified requirements of products supplied by the organization; control of the mark of conformity and/or logo of the certification body.

1.3 Within product certification schemes, it is possible for certification bodies to verify conformity with the specified requirements through a variety of ways, including the assessment of an applicant's quality management system. Whatever the form of scheme that is developed, the certification body retains the authority to certify or not. A certification body can at its discretion specify scheme criteria in addition to those described in this Guide.

Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2000, Quality management systems Fundamentals and vocabulary ISO/IEC 17000:2004, Conformity assessment Vocabulary and general principles

Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000, ISO/IEC 17000 and the following apply.

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HB 18.53-2005, Conformity assessment - Guidance on the use of an organizations quality management system in product certification

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