SANS 17007-2009 Conformity assessment - Guidance for drafting normative documents suitable for use for conformity assessment《符合性评定 适于使用和符合性评定的标准化文件起草指南》.pdf

1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-23616-8 SANS 17007:2009Edition 1ISO/IEC 17007:2009Edition 1SOUTH AFRICAN NATIONAL STANDARD Conformity assessment Guidance for drafting nor

4、mative documents suitable for use for conformity assessment This national standard is the identical implementation of ISO/IEC 17007:2009 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private

5、 Bag X191 Pretoria 0001 Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 17007:2009 Edition 1 ISO/IEC 17007:2009 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 180, Conformity assessment (CAS

6、CO), in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in December 2009. Reference numberISO/IEC 17007:2009(E)ISO 2009INTERNATIONAL STANDARD ISO/IEC17007First edition2009-09-15Conformity assessment Guid

7、ance for drafting normative documents suitable for use for conformity assessment valuation de la conformit Directives pour la rdaction de documents normatifs appropris pour lvaluation de la conformit SANS 17007:2009This s tandard may only be used and printed by approved subscription and freemailing

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11、retariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in wri

12、ting from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2009 All rights reservedSANS 1700

13、7:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/IEC 17007:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Principles2 4.1 General .2 4.2

14、Principle 1: separation of specified requirements for the object of conformity assessment from specified requirements related to conformity assessment activities.2 4.3 Principle 2: neutrality towards parties performing conformity assessment activities 3 4.4 Principle 3: functional approach to confor

15、mity assessment3 4.5 Principle 4: comparability of conformity assessment results4 4.6 Principle 5: good practice in conformity assessment.4 5 Guidance for the preparation of normative documents that specify requirements for objects of conformity assessment 4 5.1 General .4 5.2 Drafting specified req

16、uirements 5 5.3 Sampling.6 5.4 Test methods .6 6 Guidance for the preparation of normative documents that specify requirements for conformity assessment systems.7 6.1 General .7 6.2 Identifying the need for conformity assessment systems8 6.3 Risk assessment .8 6.4 Designing conformity assessment sys

17、tems 8 6.5 Specifying requirements for conformity assessment systems9 6.6 Accreditation, peer assessment and other forms of recognition 9 6.7 Mutual recognition of conformity assessment results9 Annex A (informative) The conformity assessment toolbox10 Annex B (informative) Overview of conformity as

18、sessment activities .11 Bibliography12 SANS 17007:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/IEC 17007:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) and IEC (the Internat

19、ional Electrotechnical Commission) form the specialized system for worldwide standardization. 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 field

20、s of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the work. In the field of conformity assessment, the ISO Committee on conformity as

21、sessment (CASCO) is responsible for the development of International Standards and Guides. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Draft International Standards are circulated to the member bodies for voting. Publication as an Interna

22、tional Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/IEC 17007

23、 was prepared by the ISO Committee on conformity assessment (CASCO). It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. This first edition of ISO/IEC 17007 cancels and replaces ISO/IEC Guide 7:1994, of which it constitutes a technical rev

24、ision. SANS 17007:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/IEC 17007:2009(E) ISO 2009 All rights reserved vIntroduction This International Standard provides principles and guidance on how to write normative documents, such as s

25、tandards, technical specifications, codes of practice and regulations, such that they are concise and clear, especially in the context of any subsequent conformity assessment activity. Conformity assessment activities include testing, inspection and various forms of certification. These activities c

26、an result in attestations such as declarations, reports, certificates, marks of conformity or the granting of permissions and licences (see also ISO/IEC 17000:2004). This International Standard is intended for the following users: standards developers not applying the ISO/IEC Directives; industry as

27、sociations and consortia; purchasers; regulators; consumers and non-government groups; accreditation bodies; conformity assessment bodies; conformity assessment scheme owners; and other interested parties, e.g. insurance organizations. This International Standard is intended to assist the above user

28、s in developing specific normative documents at national, regional or international levels, both in regulated or non-regulated applications. Users of this International Standard may also find useful the good standardization practices defined in the ISO/IEC Directives (which specify the requirements

29、for ISO and IEC normative documents containing specified requirements) and the WTO Agreement on Technical Barriers to Trade, Annex 3, Code of Good Practice for the Preparation, Adoption and Application of Standards. The ISO/IEC Directives, Part 2, 2004, 6.7, also covers aspects for conformity assess

30、ment. This International Standard also includes guidance on specialized International Standards and Guides in the domain of conformity assessment, known as the conformity assessment toolbox. These are principally the work of CASCO in cooperation with IEC. Reference to these generic publications is i

31、ncluded to emphasise that they contain internationally agreed provisions covering conformity assessment activities. Reliance on such publications facilitates reproducibility and mutual acceptance of conformity assessment results around the world. To make this International Standard easy to follow, t

32、echnical terminology has been avoided as much as possible. However, in some cases, the use of some technical terminology has been unavoidable. For example, the requirements in normative documents can relate to many different areas, e.g. a particular material, product, service, installation, process,

33、 system, person or body. In a conformity assessment context, these are all examples of an “object of conformity assessment”. To avoid repeating a list of the examples throughout the text, the term “object of conformity assessment” is used, for which a definition is provided in Clause 3. SANS 17007:2

34、009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/IEC 17007:2009(E) vi ISO 2009 All rights reservedThe guidance in this International Standard is subdivided into three clauses, as follows: Clause 4 specifies five principles as the basis

35、for the subsequent guidance; Clause 5 provides guidance for the preparation of normative documents that specify requirements for characteristics of objects of conformity assessment; Clause 6 provides guidance for the preparation of normative documents specifying requirements for conformity assessmen

36、t systems. SANS 17007:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO/IEC 17007:2009(E) ISO 2009 All rights reserved 1Conformity assessment Guidance for drafting normative documents suitable for use for conformi

37、ty assessment 1 Scope This International Standard provides principles and guidance for developing normative documents that contain: specified requirements for objects of conformity assessment to fulfil; specified requirements for conformity assessment systems that can be employed when demonstrating

38、whether an object of conformity assessment fulfils specified requirements. This International Standard is intended for use by standards developers not applying the ISO/IEC Directives, industry associations and consortia, purchasers, regulators, consumers and non-government groups, accreditation bodi

39、es, conformity assessment bodies, conformity assessment scheme owners, and other interested parties, such as insurance organizations. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies

40、. For undated references, the latest edition of the referenced document (including any amendments) applies. 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/IEC 17000:2004 and

41、 the following apply. For convenience of use, the following definitions are repeated. 3.1 conformity assessment system rules, procedures and management for carrying out conformity assessment NOTE Conformity assessment systems may be operated at international, regional, national or sub-national level

42、. ISO/IEC 17000:2004, 2.7 3.2 conformity assessment scheme conformity assessment programme conformity assessment system related to specified objects of conformity assessment, to which the same specified requirements, specific rules and procedures apply NOTE Conformity assessment schemes may be opera

43、ted at international, regional, national or sub-national level. ISO/IEC 17000:2004, 2.8 SANS 17007:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO/IEC 17007:2009(E) 2 ISO 2009 All rights reserved3.3 object of conformity assessment par

44、ticular material, product (including services), installation, process, system, person or body to which conformity assessment is applied NOTE Adapted from ISO/IEC 17000:2004, 2.1, Note 2. 3.4 specified requirement need or expectation that is stated NOTE Specified requirements may be stated in normati

45、ve documents such as regulations, standards and technical specifications. ISO/IEC 17000:2004, 3.1 3.5 surveillance systematic iteration of conformity assessment activities as a basis for maintaining the validity of the statement of conformity ISO/IEC 17000:2004, 6.1 4 Principles 4.1 General The prin

46、ciples listed below are the basis for the subsequent guidance in this International Standard. This International Standard does not give specific guidance for all situations that can occur. Therefore, the following principles may provide guidance for such situations: principle 1: separation of specif

47、ied requirements for the object of conformity assessment from specified requirements related to conformity assessment activities (see 4.2); principle 2: neutrality towards parties performing conformity assessment activities (see 4.3); principle 3: functional approach to conformity assessment (see 4.

48、4); principle 4: comparability of conformity assessment results (see 4.5); principle 5: good practice in conformity assessment (see 4.6). Principles 1 and 2 are primarily directed towards the preparation of normative documents that contain specifications for objects of conformity assessment (Clause

49、5 provides further information). Principle 3 is directed towards the preparation of separate normative documents that contain specifications for how conformity assessment systems are structured and carried out. However, the functional approach can assist the developer of normative documents for characteristics of the object of conformity assessment to anticipate and formulate requirements that can be used in the subsequent conformity assessment activities. 4.2 Principle 1: separation of speci