hb 18.53-2005 conformity assessment - guidance on the use of an organizations quality management...

7/31/2019 HB 18.53-2005 Conformity Assessment - Guidance on the Use of an Organizations Quality Management System in

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HB 18.532005ISO/IEC Guide 53:2004

Handbook

Conformity assessmentGuidance onthe use of an organizations qualitymanagement system in productcertification

HB18.5

32005


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This Australian Standard was prepared by Committee QR-010, ConformityAssessment. It was approved on behalf of the Council of Standards Australia on22 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 AustraliaInternational Accreditation Forum

Joint Accreditation System of Australia and New Zealand

National Association of Testing Authorit ies Australia

Keeping Standards up-to-date

Standards are living documents which reflect progress in science, technology andsystems. To maintain their currency, all Standards are periodically reviewed, andnew editions are published. Between editions, amendments may be issued.Standards may also be withdrawn. It is important that readers assure themselvesthey are using a current Standard, which should include any amendments whichmay have been published since the Standard was purchased.

Detailed information about Standards can be found by visiting the Standards WebShop at www.standards.com.au and looking up the relevant Standard in the on-linecatalogue.

Alternatively, the printed Catalogue provides information current at 1 January eachyear, and the monthly magazine, The Global Standard, has a full listing of revisionsand amendments published each month.

Australian StandardsTM and other products and services developed by StandardsAustralia are published and distributed under contract by SAI Global, whichoperates the Standards Web Shop.

We also welcome suggestions for improvement in our Standards, and especiallyencourage readers to notify us immediately of any apparent inaccuracies orambiguities. Contact us via email at [email protected], or write to the ChiefExecutive, Standards Australia, GPO Box 476, Sydney, NSW 2001.

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


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HB 18.532005

Handbook

Conformity assessmentGuidance onthe use of an organizations qualitymanagement system in productcertification

Originated as HB 18.531991.Second edition 2005.

COPYRIGHT

Standards Australia

All rights are reserved. No part o f this work may be reproduced or cop ied 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


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ii

PREFACE

This Handbook was prepared by the Australian members of the Joint Standards

Australia/Standards New Zealand Committee QR-010, Conformity Assessment. Afterconsultation 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.

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) Its number appears on the cover and title page while the international number appears

only on the cover.

(b) In the source text ISO/IEC Guide 53 should read HB 18.53.

(c) 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 orAustralian/New Zealand Standards as follows:

Reference to International Standard Australian/New Zealand Standard

ISO AS/NZS ISO

9000 Quality management systems

Fundamentals and vocabulary

9000 Quality management systems

Fundamentals and vocabulary

ISO/IEC AS ISO/IEC

17000 Conformity assessment

Vocabulary and general

principles

17000 Conformity assessment

Vocabulary and general

principles


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ii i

CONTENTS

Page

Introduction ........................................................................................................................................................iv

1 Scope...................................................................................................................................................... 12 Normative references ........................................................................................................................... 13 Terms and definitions........................................................................................................................... 14 Steps in the scheme ............................................................................................................................. 24.1 Deciding on the scheme....................................................................................................................... 24.2 Functions in the implementation of a product certification scheme............................................... 25 Selection ................................................................................................................................................ 26 Determination ........................................................................................................................................ 37 Review and attestation ......................................................................................................................... 48 Surveillance ...........................................................................................................................................59 Mark of conformity................................................................................................................................ 5Annex A (informative) Example of a data form for a product certification scheme that uses very

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

requirements of a quality management system............................................................................... 10Bibliography ..................................................................................................................................................... 21


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iv

INTRODUCTION

Product certification schemes incorporating an organizations quality management system can be beneficialfor 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 anorganization's quality management system to specified requirements, and the assessment of conformity of theproduct to specified product requirements. Certification bodies can conduct both types of assessment forproduct certification schemes that are covered by this Guide.

Product certification schemes can take many forms, including those that do not utilize an organizations qualitymanagement system. There is no inference in this Guide that one form of product certification scheme issuperior to another. Furthermore, when a certification body has several forms of product certification schemesavailable for a class of product, the organization has the right to choose the scheme under which it wishes toapply for certification.

NOTE In some countries, technical regulations predetermine the available type(s) of product certification scheme tobe used.

This Guide is based on the understanding that interested parties using it to develop product certificationschemes 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 inISO/IEC Guide 67, and

the specific product requirements.


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1

AUSTRALIAN HANDBOOK

Conformity assessment Guidance on the use of an

organization's quality management system in productcertification

1 Scope

1.1 This Guide outlines a general approach by which certification bodies can develop and apply productcertification schemes utilizing requirements of an organization's quality management system. The provisionsgiven in this Guide are not requirements for the accreditation of a product certification body and do notsubstitute 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 thefollowing principles:

a) assessment of an organizations quality management system and its capability to consistently supplyproducts conforming to specified requirements;

b) testing, inspection or comparable verification of the product's conformity to scheme criteria and specifiedrequirements;

c) application of a suitable surveillance scheme to ensure continual conformity to specified requirements ofproducts supplied by the organization;

d) 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 thespecified requirements through a variety of ways, including the assessment of an applicant's qualitymanagement system. Whatever the form of scheme that is developed, the certification body retains theauthority to certify or not. A certification body can at its discretion specify scheme criteria in addition to thosedescribed in this Guide.

2 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 referenceddocument (including any amendments) applies.

ISO 9000:2000, Quality management systems Fundamentals and vocabulary

ISO/IEC 17000:2004, Conformity assessment Vocabulary and general principles

3 Terms and definitions

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

www.standards.com.au Standards Australia


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