SAA HB18.561991 SANZ HB18.

56 1991 ISO/IEC GUIDE 56 1989

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Guidelines for third-party certification and accreditation

Guide 56 An approach to the review by a certification body of its own internal quality system

STANDARDS ASSOCIATION OF NEW ZEALAND The Standards Association of New Zealand (SANZ) is the national Standards authority in New Zealand. It is also an international product certification and quality system accreditation authority. Established in 1932, SANZ is an independent,non-profit organization governed by the Standards Council, under the Standards Act 1988. STANDARDS AUSTRALIA Standards Australia is an independent not-for-profit organization, established in 1922. It operates formally under a Royal Charter as the Standards Association of Australia and has recognition as the peak Standards body in Australia through a memorandum of Understanding with the Commonwealth Government. AUSTRALIAN AND NEW ZEALAND STANDARDS Australian and New Zealand Standards are prepared by committees made up of experts from industry, governments, user groups, and other sectors. The requirements or recommendations contained in published Standards are a consensus of the views of representative interests and also take account of comments received from other sources. They reflect the latest scientific and industry experience. Australian and New Zealand Standards are kept under continuous review after publication and are updated regularly to take account of changing technology. INTERNATIONAL INVOLVEMENT Standards Australia and the Standards Association of New Zealand have an important role internationally. They are responsible for ensuring that the Australian and New Zealand viewpoint is considered in the formulation of International Standards and that latest international experience is incorporated in national and trans-Tasman Standards. This role is vital in assisting local industry to compete in international markets. Both organizations are members of the International Organization for Standardization(ISO) and the International Electrotechnical Commission (IEC). Enquiries about subscribing membership, quality assurance services and the other services offered by Standards Australia and the Standards Association of New Zealand are welcomed.

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SAA HB18.561991 SANZ HB18.56 1991 ISO/IEC GUIDE 56 1989

This is a free 6 page sample. Access the full version at http://infostore.saiglobal.com.

Guidelines for third-party certification and accreditation

Guide 56 An approach to the review by a certification body of its own internal quality system
In Australia First published as SAA HB18.56 June 1991. In New Zealand First published as SANZ HB18.56 June 1991.

PUBLISHED JOINTLY BY: STANDARDS AUSTRALIA 1 The Crescent, Homebush NSW 2140 Australia STANDARDS NEW ZEALAND Level 10, Standards House, 155 The Terrace, Wellington 6001 New Zealand
ISBN 0 7262 6902 6

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PREFACE
This handbook is presented as a series of separate publications, each of which is identical with the corresponding guide published either jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) or solely by ISO. It has been issued as a joint publication under the terms of the Memorandum of Understanding between Standards Australia and the Standards Association of New Zealand. The information contained in the various guides making up this handbook is intended to assist organizations in understanding the basis of product certification and third-party certification systems and how the various bodies operating such schemes should function. Coverage is also given in some instances to guidance on the establishment and operation of laboratory accreditation bodies as well as the type of information that such bodies will require of testing laboratories, including those carrying out calibration, when making application for accreditation. It is anticipated that these guides will become of greater importance when the forthcoming Joint Accreditation Scheme Australia and New Zealand (JAS ANZ) becomes operational. Reference should also be made to the Standards for quality systems which are published jointly in Australia and New Zealand as the AS 3900/NZS 9000/ ISO 9000 series. The other guides covered in this handbook are as follows: Requirements for standards suitable for product certification Guide 7: Guide 16: Code of principles on third-party certification systems and related standards Guide 22: Information on manufacturers declaration of conformity with standards or other technical specifications Guide 23: Methods of indicating conformity with standards for third-party certification systems Guide 25: General requirements for the competence of calibration and testing laboratories Guide 27: Guidelines for corrective action to be taken by a certification body in the event of either misapplication of its mark of conformity to a product, or products which bear the mark of the certification body being found to subject persons or property to risk Guide 28: General rules for a model third-party certification system for products Guide 39: General requirements for the acceptance of inspection bodies Guide 40: General requirements for the acceptance of certification bodies Guide 42: Guidelines for a step-by-step approach to an international certification system Guide 43: Development and operation of laboratory proficiency testing Guide 44: General rules for ISO or IEC international third-party certification schemes for products Guide 48: Guidelines for third-party assessment and registration of a suppliers Quality System Guide 53: An approach to the utilization of a suppliers quality system in third-party product certification Guide 54: Testing laboratory accreditation systems General recommendations for the acceptance of accreditation bodies Guide 55: Testing laboratory accreditation systems General recommendationsfor operation
Copyri ght STANDARDS AUSTRALIA/STANDARDS NEW ZEALAND Users of Standards are reminded that copyri ght subsists in all Standards Austr alia and Standards New Zealand publications and soft ware. Except where the Copyri ght Act all ows and except where provided for below no publications or software produced by Standards Australi a or Standards New Zealand may be reproduced, stored in a retri eval system in any form or tr ansmit ted by any means without pri or permission in wri ti ng fr om Standards Australi a or Standards New Zealand. Permission may be conditi onal on an appropri ate royalty payment. Austr alian requests for permission and information on commercial software royalti es should be directed to the head offi ce of Standards Austr alia. 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 royalt y or advice to Standards Australi a or Standards New Zealand. Inclusion of copyri ght materi al in computer software programs is also permitt ed 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 edit ion 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 identif ied. The use of material in pri nt form or in computer soft ware 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 vari ed by Standards Austr alia or Standards New Zealand at any ti me.

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Foreword
ISO (the International Organization for Standardization) and IE C (the International Electrotechnical Commission) together form a system for worldwide standardization as a whole. National bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. O ther international organizations, governmental and non-governmental, in liaison with ISO and IEC , also take part in the work. This Guide was drawn up by the ISO Committee on conformity assessment, ISO/CA SC O. It was approved by the ISO Council in February 1989 and by the IEC Council in June 1989. The documents produced by CA SC O are issued as Guides and follow the general rules for development and promulgation of ISO and IEC standards except that they are the result of a consensus reached within a Council committee, endorsed by the ISO Council and the IEC Council. The work of ISO /CAS CO in preparing Guides relating to certification, assessment and testing, uses as a basis the principles established in ISO/IEC Guide 16, Code of principles on third-party certification systems and related standards. Guide 16 recognizes that third-party certification systems should, to the extent possible, be based on internationally agreed standards and procedures. While recognizing the major role of manufacturers declarations of conformity through normal manufacturer/customer relationship, Council resolutions have emphasized the preparation of guidance documents on third-party certification and assessment procedures in order that national systems may be compatible with one another so as to facilitate bilateral and multilateral agreements. Whilst these documents are intended to provide guidance, it is hoped that any changes from the documents made in introducing systems nationally would be minimal. In recognizing that some countries may choose to adopt the Guide directly, they are written to enable this to be done by including words such as shall to indicate those aspects which desirably would be mandatory. The overriding basis that the document is intended to provide guidance holds good. While this emphasis on creating the infrastructure for mutual recognition covers most of the work of ISO/CA SC O, notice has to be taken that a further objective is to create the basis for an international certification system in due course, if found to be required. Some ISO/CA SC O documents relate to the development of rules for such a system. It is recognized that there are already well established certification systems, e.g. in the electrotechnical field, which have been developed with the aim of facilitating trade and which are functioning satisfactorily in the spirit of relevant ISO/IEC Guides.

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STANDARDS AUSTRALIA/STANDARDS ASSOCIATION OF NEW ZEALAND

An approach to the review by a certification body of its own internal quality system

Introduction

mutual certification arrangements. 1) 2) use of equivalent standards; use of procedures which provide for appropriate organizational and administrative structure, comparable testing equipment and methods, comparable surveillance procedures, comparable legal protection and other features which assure that none of the participants is at undue risk in accepting other participants work.

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0.1 One of the most essential elements for the operation of an international certification system or for mutual recognition of national certification systems is confidence in the competence of the certification bodies participating in the system or engaged in mutual recognition. 0.2 Confidence can be built through a progressively expanding set of acceptance arrangements, bilateral or multilateral, in the process of a step-by-step approach to an international certification system, as described in ISO/IEC Guide 42. 0.3 The aim of the procedure recommended in this Guide is to facilitate and accelerate the initiation of such a process, by providing certification bodies with a means of maintaining and improving their competence. 1) 0.4 It is recognized that confidence in the conformity certification system operated by a certification body will be based both on the organizational structure and documented procedures of the certification body, and on the manner in which the procedures are applied and how the organizational structure serves to enhance the effectiveness of the certification bodys operation.

0.7 Agreements between parties operating certification systems in different countries will generally include provisions covering a number of items not dealt with in this Guide, including such items as exchanges of personnel, comparison of surveillance, testing and inspection techniques, the legal system to be utilized in case of dispute, etc. 1 Scope

This Guide provides a framework for use by a certification body in assessing itself, its procedures, and its operations. The framework incorporates requirements and recommendations to be found in all relevant ISO /IEC reference documents. Using this framework, a certification body should be able to compile a documentary record of its internal quality system review procedure. It will also be possible to use this documentary record for subsequent distribution to all parties concerned. Certification bodies may include other specific elements and criteria depending on specific needs. 2 References

0.5 Confidence should be based on identical fundamental elements and criteria to be met by certification bodies, which necessitates the appropriate organization and administrative structure, surveillance facilities and testing facilities (if included), and legal and fees structure the performance of all functions being specified by the certification system. 0.6 The following factors contribute to increased confidence among certification bodies participating in an international certification system, or involved in

ISO/ITC booklet, practice

Certification

Principles

and

ISO/IEC Guide 2, General terms and their definitions concerning standardization and related activities ISO/IEC Guide 7, Requirements for standards suitable for product certification

1)

Most of the points addressed in this Guide are covered in more detail in other ISO/IEC guides (see clause 2). The purpose of this Guide is only to facilitate the approach to the fir st steps recommended, for example, in ISO/IEC Guide 42. In no way is it implied, however, that a certi fi cati on body that has used this Guide to review it s internal qualit y procedures will automatically be recognized by other cert if ication bodies. Agreements between certi fying bodies (r eciprocity) requir e some form of assessment of each other s arr angements regarding procedures, experience, organizati onal structure, legal framework, rules, auditi ng, testing, etc. A system of assessment involving examinati on teams may be required for a valid implementation of mutual recognition, as is the case, for example, in the IEC Qualit y assessment system for electr onic components (IECQ). COPYRIGHT

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HB 18.56-1991, Guidelines for third-party certification and accreditation Guide 56 - An approach to the review by a certification body of its own internal quality system

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