HB 18.

282005
ISO/IEC Guide 28:2004

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

HB 18.282005

Handbook
Conformity assessmentGuidance on a
third-party certification system for
products

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.

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

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

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Standards may also be withdrawn.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 05226.

HB 18.282005

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Handbook
Conformity assessmentGuidance on a
third-party certification system for
products

Originated as HB 18.281991.
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 6986 1

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 18.281991.
This Handbook is identical with, and has been reproduced from ISO/IEC Guide 28:2004,
Conformity assessmentGuidance on a third-party certification system for products.

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

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 guidelines for a third-party product certification
system for determining the conformity of a product with specified requirements through
(a)

initial testing of samples of the product;

(b)

assessment and surveillance of the involved quality system; and

(c)

surveillance by testing of product samples taken from the factory, open market or both.

This system corresponds to system 5 product certification as described in ISO/IEC Guide 67.
As this Handbook is reproduced from an international Guide, the following applies:
(i) Its number appears on the cover and title page while the international number appears only
on the cover.
(ii) In the source text ISO/IEC Guide 28 should read HB 18.28.
(iii) A full point substitutes for a comma when referring to a decimal marker.
The term informative has been used in this Handbook to define the application of the annex to
which it applies. 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

Australia/New Zealand Standard

ISO/IEC

AS ISO/IEC

17000

Conformity assessment
Vocabulary and general
principles

17000

Conformity assessment
Vocabulary and general
principles

iii

Contents

CONTENTS

Page

Page
Foreword ............................................................................................................................................................ iv

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Introduction .......................................................................................................................................................iv
1

Scope...................................................................................................................................................... 1

Normative references ........................................................................................................................... 1

Terms and definitions........................................................................................................................... 1

Application for certification ................................................................................................................. 1

5
5.1
5.2
5.3

Initial assessment ................................................................................................................................. 2

General ................................................................................................................................................... 2
Assessment of production process and quality system .................................................................. 2
Initial testing .......................................................................................................................................... 2

Evaluation (review) ............................................................................................................................... 3

Decision ................................................................................................................................................. 3

Licensing................................................................................................................................................ 3

Extension of the scope of certification............................................................................................... 3

10

Surveillance ........................................................................................................................................... 4

11
11.1
11.2

Use of a certificate or mark of conformity.......................................................................................... 4

Certificate or mark of conformity ........................................................................................................ 4
Marking................................................................................................................................................... 4

12

Publicity by licensees........................................................................................................................... 5

13

Confidentiality ....................................................................................................................................... 5

14

Misuse of a certificate or mark of conformity .................................................................................... 5

15

Suspension of a licence for a product ................................................................................................ 5

16

Withdrawal ............................................................................................................................................. 6

17

Implementation of modifications of a standard ................................................................................. 6

18

Liability................................................................................................................................................... 7

19

Appeals .................................................................................................................................................. 7

20

Fees ........................................................................................................................................................ 7

Annex A (informative) Model checklist of requirements ................................................................................ 8

Annex B (informative) Model form for application for product certification ................................................ 9
Annex C (informative) Model questionnaire for facility assessment .......................................................... 10
Annex D (informative) Model of a certificate of conformity ......................................................................... 14
Annex E (informative) Model of a licensing agreement for the use of a certification or mark of
conformity............................................................................................................................................ 15
Annex F (informative) Model of form for a licence for the use of the certificate or mark of
conformity............................................................................................................................................ 18
Bibliography ..................................................................................................................................................... 19

iv

INTRODUCTION

Introduction
This Guide serves to provide a model for a third-party certification system for products, but does not exclude
the existence of other useful models for third-party conformity assessment systems. There are many types of
possible systems depending on the type of product requiring certification.

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

The usefulness of ISO/IEC Guide 28:1982 as a model third-party certification system for products has been
well recognized. This revision confirms the status of this Guide as an authoritative and reliable, though not
exclusive, model of a product certification system.

1
AUSTRALIA HANDBOOK

Conformity assessment Guidance on a third-party

certification system for products

Scope

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

This Guide gives general guidelines for a specific product certification system.
It is applicable to a third-party product certification system for determining the conformity of a product with
specified requirements through initial testing of samples of the product, assessment and surveillance of the
involved quality system, and surveillance by testing of product samples taken from the factory or the open
market, or both. This Guide addresses conditions for use of a mark of conformity and conditions for granting a
certificate of conformity.
This system corresponds to system 5 product certification system as described in ISO/IEC Guide 67.
A model checklist of requirements for a third-party certification system is given in Annex A.

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
ISO/IEC Guide 65:1996, General requirements for bodies operating product certification systems

Terms and definitions

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

Application for certification

The application is made on a special form obtainable from the certification body. An example of such a form is
given in Annex B.
The application relates to the specific product or group of products for which certification is requested by the
applicant and as determined by the product certification scheme.
On acceptance of a completed application form and receipt of the deposit, if required, the certification body
provides the applicant with an estimate of the time required for conduct of the initial evaluation, and any
further information necessary for the processing of the application.

ISO 2004 All rights reserved

www.standards.com.au
www.standards.com.au

Standards Australia
Standards Australia

This is a free preview. Purchase the entire publication at the link below:

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

HB 18.28-2005, Conformity assessment - Guidance

on a third-party certification system for products

Looking for additional Standards? Visit SAI Global Infostore

Subscribe to our Free Newsletters about Australian Standards in Legislation; ISO, IEC, BSI and more
Do you need to Manage Standards Collections Online?
Learn about LexConnect, All Jurisdictions, Standards referenced in Australian legislation
Do you want to know when a Standard has changed?
Want to become an SAI Global Standards Sales Affiliate?
Learn about other SAI Global Services:
LOGICOM Military Parts and Supplier Database
Metals Infobase Database of Metal Grades, Standards and Manufacturers
Materials Infobase Database of Materials, Standards and Suppliers
Database of European Law, CELEX and Court Decisions

Need to speak with a Customer Service Representative - Contact Us