HB 18.

672005
ISO/IEC Guide 67:2004

HB 18.672005
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Handbook
Conformity assessmentFundamentals of 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 26 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 Standards may also be withdrawn.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 05227.

HB 18.672005

Handbook
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Conformity assessmentFundamentals of product certification

First published as HB 18.672005.

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 6989 6

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. This Handbook is identical with, and has been reproduced from ISO/IEC Guide 67:2004, Conformity assessmentFundamentals of 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 product certification bodies and other interested parties with guidance on product certification systems by identifying their various elements based on current practices. This guide does not address first and second party product conformity assessment. 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 67 should read HB 18.67. A full point substitutes for a comma when referring to a decimal marker.

References to International Standards should be replaced by references to Australian or Australia/New Zealand Standards as follows:

Reference to International Standard ISO/IEC 17000 Conformity assessment Vocabulary and general principles

Australian/New Zealand Standard AS ISO/IEC 17000 Conformity assessment Vocabulary and general principles

iii

INTRODUCTION

Introduction
As products are designed, produced, distributed, used and ultimately disposed of, they may give rise to societal concerns. A very frequent concern is simply whether a product is what it appears to be. Concerns can involve such product attributes as safety, health or environmental impacts, durability, compatibility, suitability for intended purposes or for stated conditions, and similar considerations. Addressing these concerns through product certification serves a dual purpose: a) b) users and consumers are able to make better decisions about products in the marketplace; by demonstrating conformity, suppliers may more effectively achieve market acceptance.

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The type of activity undertaken to demonstrate conformity of product with requirements is often determined by the consequences of nonconformity. When consequences are insignificant or not severe, society may (require) expect little or no demonstration of conformity of product since the problems generated can be easily addressed and solved after they occur. In these cases the supplier's claims may be sufficient but they may be complemented by third-party product certification on a voluntary basis. However, where the consequences of nonconformity are significant, society may demand completion of activities that demonstrate conformity to requirements prior to allowing the product on the market, concurrent with the product appearing on the market, or both. One method of providing such assurance is through product certification. Product conformity assessment is carried out in many ways and by many different parties (first party, second party and third party). Product certification is a means by which a third party provides assurance that a product conforms to specified standards and other normative documents. This Guide was developed to respond to the need to provide better understanding of the diverse functions and types of product certification. This Guide describes some of the activities of product certification, identifies basic elements and types of product certification, and shows some of the ways of combining these elements to design a product certification system. Various parties who have involvement in product certification tend to view product certification only in terms of the manner in which it is carried out in their own particular circumstances. Therefore, this Guide emphasizes that there are many approaches to product certification, each having legitimacy for its own particular application. Furthermore, this Guide identifies the various activities that can be included within the general context of product certification. The consideration of each of these elements is not intended to imply that each of the elements should be present, but rather to address the way(s) in which each of the elements can be practised. This Guide shows various ways of combining these elements to design a product certification system. This Guide is intended to foster understanding of the wide range of possibilities that fall within the context of product certification, and thereby assist those wishing to develop product certification for a particular purpose, and those with responsibility for evaluating such systems.

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iv

NOTES

1 AUSTRALIAN HANDBOOK

Conformity assessment Fundamentals of product certification

Scope

This Guide gives guidance on product certification systems by identifying their various elements based on current practices.
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It is intended for use by product certification bodies and other interested parties wishing to understand, develop, establish or compare third-party product certification systems. This Guide is not intended to describe all existing forms of product certification. It does not address first- and second-party product conformity assessment.
NOTE 1 The term product is used in this Guide in its widest sense and includes processes and services; the term standard is used to include other normative documents such as specifications or technical regulations (see, for example, ISO/IEC Guide 65). NOTE 2 Product certification is a third-party conformity assessment activity (see ISO/IEC 17000).

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

Terms and definitions

For the purposes of this document, the terms and definitions in ISO/IEC 17000 and the following apply. 3.1 product certification system rules, procedures and management for carrying out third-party product conformity assessment
NOTE Adapted from ISO/IEC 17000:2004, definition 2.7.

3.2 product certification scheme product certification system related to specific products to which the same specified requirements, specific rules and procedures apply
NOTE 1 Adapted from ISO/IEC 17000:2004, definition 2.8.

NOTE 2 A distinction between product certification scheme and product certification system is not always made at the national level.

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HB 18.67-2005, Conformity assessment Fundamentals of product certification

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