BS PD ISO IEC TR 17026-2015 Conformity assessment Example of a certification scheme for tangible products《合格评定 有形产品认证计划示例》.pdf

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1、BSI Standards Publication PD ISO/IEC TR 17026:2015 Conformity assessment Example of a certification scheme for tangible productsPD ISO/IEC TR 17026:2015 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of ISO/IEC TR 17026:2015. It supersedes PD ISO/IEC GUIDE 28:2

2、004 and PD ISO/IEC GUIDE 53:2005, which are withdrawn. The UK participation in its preparation was entrusted to Technical Committee CAS/1, Conformity assessment. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to in

3、clude all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 84054 8 ICS 03.120.20 Compliance with a British Standard cannot confer immunity from legal obligations.

4、This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 September 2015. Amendments issued since publication Date Text affectedPD ISO/IEC TR 17026:2015 ISO/IEC 2015 Conformity assessment Example of a certification scheme for tangible products val

5、uation de la conformit Exemple dun schma de certification pour des produits tangibles TECHNICAL REPORT ISO/IEC TR 17026 First edition 2015-02-01 Reference number ISO/IEC TR 17026:2015(E)PD ISO/IEC TR 17026:2015ISO/IEC TR 17026:2015(E)ii ISO/IEC 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT I

6、SO/IEC 2015 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can

7、be requested 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 SwitzerlandPD ISO/IEC TR 17026:2015ISO/IEC T

8、R 17026:2015(E) ISO/IEC 2015 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 Terms and definitions . 1 4 General description of the example scheme 1 4.1 Development and operation of a product certification scheme . 1 4.2 Outline of the example

9、product certification scheme . 2 4.3 Scope of the scheme . 3 4.4 Parties involved in the scheme 3 4.5 Selection elements in the scheme . 3 4.6 Sampling processes in the scheme 4 4.7 Determination procedures of the scheme . 4 5 Sequence of a certification cycle and involved activities 4 5.1 Applicati

10、on for certification and certification agreement . 4 5.2 Determination . 4 5.3 Assessment of the production process and audit of the management system 6 5.4 Nonconformities 8 5.5 Evaluation report 8 5.6 Review 8 5.7 Decision . 8 5.8 Attestation. 8 5.9 Licensing use of certificates and marks of confo

11、rmity . 9 5.10 Surveillance.11 6 Publicity by clients 12 7 Changes affecting certification .12 7.1 Changes to product requirements .12 7.2 Changes to other scheme requirements 13 7.3 Changes by client .13 8 Confidentiality .13 9 Product liability 14 10 Complaints and appeals .14 Annex A (informative

12、) Example of information provided with an application for product certification15 Annex B (informative) Example of information on production process and management system .17 Annex C (informative) Example of information to be included in a certificate of conformity 20 Annex D (informative) Example o

13、f contents of a licensing agreement for the use of a certificate and mark of conformity .21 Annex E (informative) Example of information to be included in a licence for the use of a certificate or mark of conformity.24 Annex F (informative) Example of contents of a certification agreement 25 Bibliog

14、raphy .27PD ISO/IEC TR 17026:2015ISO/IEC TR 17026:2015(E) Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in

15、 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. Other international organizations, governmental and non

16、-governmental, in liaison with ISO and IEC, also take part in the work. In the field of conformity assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of International Standards and Guides. International Standards are drafted in accordance with the rules

17、 given in the ISO/IEC Directives, Part 2. Draft International Standards are circulated to the national bodies for voting. Publication as an International Standard requires approval by at least 75 % of the national bodies casting a vote. In exceptional circumstances, when a technical committee has co

18、llected data of a different kind from that which is normally published as an International Standard (“state of the art”, for example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not

19、 have to be reviewed until the data it provides are considered to be no longer valid or useful. 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/I

20、EC TR 17026 was prepared by the ISO Committee on conformity assessment (CASCO).iv ISO/IEC 2015 All rights reservedPD ISO/IEC TR 17026:2015ISO/IEC TR 17026:2015(E) Introduction Product certification is used ever more widely to provide confidence that products, processes and services fulfil specified

21、requirements. This Technical Report is intended to provide useful information to those involved in product certification on the application of ISO/IEC 17067. It provides an example of a type 5 scheme, as outlined in ISO/IEC 17067, related to the certification of tangible products. There are many dif

22、ferent ways in which product certification is operated in practice. This Technical Report does not prevent scheme owners, in consultation with other stakeholders, from adopting other measures or using them in different combinations to achieve a fit-for-purpose scheme. In particular, the range of act

23、ivities used, and the intensity with which they are applied, need to be proportionate to the consequences and likelihood of a product in service failing to fulfil specified requirements. Factors such as the particular characteristics of the marketplace, the product technology and the production meth

24、ods related to the products also need to be taken into account. The principal stakeholders, who are most affected by the rules, procedures and management of the scheme, are the following: the scheme owner; the certification body/bodies; the manufacturers of certified products; users of the certified

25、 product and entities that rely on certification. NOTE Where a certification body runs its own scheme, the certification body is the scheme owner. Other stakeholders include, but are not limited to: regulatory authorities; specifiers, purchasers and users of certified products; conformity assessment

26、 bodies, such as testing laboratories and inspection bodies, involved in the product certification process; accreditation bodies and peer assessment groups; international certification schemes that facilitate the recognition of certification status from one scheme owner to another; consumers. This T

27、echnical Report contains neither normative requirements (expressed by “shall”) nor recommendations (expressed by “should”). It is intended solely as an example of a type 5 product certification scheme. ISO/IEC 2015 All rights reserved vPD ISO/IEC TR 17026:2015PD ISO/IEC TR 17026:2015Conformity asses

28、sment Example of a certification scheme for tangible products 1 Scope This Technical Report provides an example of a type 5 product certification scheme for tangible products as described in ISO/IEC 17067. NOTE 1 The example provided in this Technical Report relates to a certification scheme for pro

29、ducts. However, if applicable, it can also be used as a basis for developing certification schemes for services and processes (see type 6 as described in ISO/IEC 17067). NOTE 2 In the context of this Technical Report, the assessment of a management system as part of product certification does not co

30、nstitute the certification of the management system. NOTE 3 This Technical Report is intended to provide useful information to those involved in product certification on the application of ISO/IEC 17067. 2 Normative references The following documents, in whole or in part, are normatively referenced

31、in this document and are indispensable for its application. 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/

32、IEC 17065:2012, Conformity assessment Requirements for bodies certifying products, processes and services ISO/IEC 17067:2013, Conformity assessment Fundamentals of product certification and guidelines for product certification schemes 3 Terms and definitions For the purposes of this document, the te

33、rms and definitions given in ISO/IEC 17000, ISO/IEC 17067 and ISO/IEC 17065 apply. 4 General description of the example scheme 4.1 Development and operation of a product certification scheme General provisions for the development and operation of a product certification scheme are stipulated in ISO/

34、IEC 17067:2013, Clause 6. This Technical Report provides an example of how those general provisions are implemented in a particular type 5 product certification scheme. The example is not intended to limit in any way the decisions of scheme owners when developing and operating their own schemes. The

35、y may develop alternative product certification schemes including those described in ISO/IEC 17067. TECHNICAL REPORT ISO/IEC TR 17026:2015(E) ISO/IEC 2015 All rights reserved 1PD ISO/IEC TR 17026:2015ISO/IEC TR 17026:2015(E) 4.2 Outline of the example product certification scheme This example of a p

36、roduct certification scheme reflects a type 5 product certification scheme as explained in ISO/IEC 17067. It includes the following functions, activities and elements, which are further described in this Technical Report: a) selection (see 4.5), including: 1) specified requirements for the products

37、covered by the scope of the scheme (e.g. those in a standard or other normative document); 2) elements of the production process to be assessed and of the management system to be audited; 3) determination activities, and the basis on which those activities be undertaken (e.g. reference ISO/IEC 17065

38、 for product certification bodies, and to the applicable requirements of ISO/IEC 17025 for testing, ISO/IEC 17020 for inspection and ISO/IEC 17021 for management system auditing); 4) sampling methods and frequency; 5) requirements which the client has to fulfil in order to gain and maintain certific

39、ation of the product (e.g. signing a certification agreement, the ongoing operation of a management system, maintaining control over the use of the mark of conformity, advising the certification body of changes affecting product conformity); 6) any other certification requirements; b) determination

40、(see 5.2), including: 1) evaluation of the product; 2) assessment of the production process and audit of other elements of the clients management system critical to managing product conformity through document review and onsite assessment; c) review of the evaluation results; d) decision on certific

41、ation and attestation of conformity (see 5.7 and 5.8); e) licensing and control of the mark (see 5.9), including: 1) mark of conformity; 2) publicity to clients; 3) misuse of certificate and marks of conformity; f) surveillance (see 5.10), including: 1) testing and inspection of product samples; 2)

42、assessment of the production process and audit of the management system; g) suspending or withdrawing a certification and license (see 5.9.5); h) managing changes affecting certification (see Clause 7). NOTE These functions are consistent with the requirements specified in ISO/IEC 17065, in which th

43、e functions selection and determination are together referred to as “evaluation”. A description of the functions listed above appears in ISO/IEC 17000:2004, Annex A.2 ISO/IEC 2015 All rights reservedPD ISO/IEC TR 17026:2015ISO/IEC TR 17026:2015(E) 4.3 Scope of the scheme The scope of the scheme is d

44、efined in terms of the types of product, the product requirements and other requirements specified by the certification scheme and the geographical areas within which it operates. 4.4 Parties involved in the scheme The main parties involved in the operation of the scheme are: a) the scheme owner; b)

45、 the certification body; c) the organization that has a certification agreement with the certification body, or that has applied for (this organization is referred to as “the client”). NOTE 1 For further information on the certification agreement, see ISO/IEC 17065:2012, 4.1.2. All product certifica

46、tion schemes have a scheme owner. The scheme owner can be a certification body, a regulatory authority, an industry group, a group of certification bodies or others. The scheme owner is responsible for the rules, procedures, management and integrity of the scheme. NOTE 2 Further information on schem

47、e owner can be found in ISO/IEC 17067. The certification body may outsource some activities to other organizations but always retains responsibility for the outcome. The review, decision and attestation cannot be outsourced. The client is often the manufacturer, who may use sub-contractors for some

48、of the production operations, but sometimes the manufacturers agent or another organization in the supply chain (e.g. a distributor) can act as the client and seek certification. In such cases, the client may not have control of the manufacturing processes nor access to the production facilities. Be

49、fore signing a certification agreement, the client needs to be able to ensure that the certification body can perform all necessary assessment activities of the production processes and the manufacturers quality management system. 4.5 Selection elements in the scheme Within the declared scope (see 4.3), the scheme specifies the requirements that the products, production process and management system are intended to fulfil. These requirements are specified by reference to standards, technical specifications or other normat