EN ISO IEC 17067-2013 en Conformity assessment - Fundamentals of product certification and guidelines for product certification schemes《合格评定 产品认证计划用产品认证和指南基础》.pdf

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1、BSI Standards PublicationBS EN ISO/IEC 17067:2013Conformity assessment Fundamentals of productcertification and guidelines for product certification schemes (ISO/IEC 17067:2013)BS EN ISO/IEC 17067:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO/IEC17067

2、:2013. It supersedes PD ISO/IEC Guide 67:2004 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CAS/1, Conformity assessment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport

3、to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 73380 2ICS 03.120.20Compliance with a British Standard cannot confer immunity fromlegal obligations.Thi

4、s British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO/IEC 17067 August 2013 ICS 03.120.20 English version Conformity assessment

5、 - Fundamentals of product certification and guidelines for product certification schemes (ISO/IEC 17067:2013) valuation de la conformit - lments fondamentaux de la certification de produits et lignes directrices pour les programmes de certification de produits (ISO/IEC 17067:2013) Konformittsbewert

6、ung - Grundlagen der Produktzertifizierung und Leitlinien fr Produktzertifizierungsprogramme (ISO/IEC 17067:2013) This European Standard was approved by CEN on 12 July 2013. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givin

7、g this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member. This European Standard exists in

8、 three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members a

9、re the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

10、 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Me

11、mbers and for CENELEC Members. Ref. No. EN ISO/IEC 17067:2013 EBS EN ISO/IEC 17067:2013EN ISO/IEC 17067:2013 (E) 3 Foreword This document (EN ISO/IEC 17067:2013) has been prepared by Technical Committee ISO/CASCO “Committee on conformity assessment“ in collaboration with Technical Committee CEN/CLC/

12、TC 1 “Criteria for conformity assessment bodies” the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2014, and conflicting national standards shall be

13、 withdrawn at the latest by February 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regul

14、ations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, It

15、aly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/IEC 17067:2013 has been approved by CEN as EN ISO/IEC 17067:2013 without any modification. BS E

16、N ISO/IEC 17067:2013ISO/IEC 17067:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Product certification 24.1 Concept of product certification 24.2 Objectives of product certification . 25 Product certificat

17、ion schemes 25.1 Basics . 25.2 Functions and activities in product certification schemes 35.3 Types of product certification schemes . 46 Development and operation of a product certification scheme 66.1 General . 66.2 Relationship between product certification scheme and product certification system

18、 66.3 Scheme owner . 76.4 Development of product certification schemes 86.5 Content of a scheme 96.6 Maintenance and improvement of a scheme .126.7 Scheme documentation 12Bibliography .13BS EN ISO/IEC 17067:2013ISO/IEC 17067:2013(E)ForewordISO (the International Organization for Standardization) and

19、 IEC (the International 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 wit

20、h particular fields 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 Committe

21、e on conformity assessment (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. Publicati

22、on as an International 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

23、.ISO/IEC 17067 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 17067 cancels and replaces ISO/IEC Guide 67:2004, which has been technically

24、 revised.The following major changes have been made compared with ISO/IEC Guide 67:2004: a new Clause 6 has been added, providing guidelines on setting up and operating a product certification scheme; some of the text originally in the main body of ISO/IEC Guide 67 has been moved to the Introduction

25、; the functional approach to conformity assessment has been emphasised; Table 1 has been extended to reflect the functional approach; explicit provision has been made for type and batch certification schemes; references to ISO/IEC 17065:2012 have replaced references to ISO/IEC Guide 65:1996; the tex

26、t has been made more concise in places.iv ISO 2013 All rights reservedBS EN ISO/IEC 17067:2013ISO/IEC 17067:2013(E)IntroductionThis International Standard describes the fundamentals of product certification and provides guidelines for product certification schemes. In this International Standard ref

27、erences to the term “product” can also be read to mean “services” or “processes”.As products are designed, produced, distributed, used and ultimately disposed of, they can give rise to concerns with purchasers, users and society in general. Such concerns could relate to safety, health or environment

28、al impacts, durability, compatibility, suitability for intended purposes or for stated conditions.Generally, these concerns are addressed by specifying the required product attributes in a normative document such as a standard.The supplier of the product then has the task of demonstrating that the p

29、roduct conforms to the requirements of the normative document.It might be sufficient for the supplier to assess and declare its products conformity, but in other cases the user or a regulatory authority might require that conformity be assessed by a competent and impartial third party.Assessment and

30、 impartial third party attestation that fulfilment of specified requirements has been demonstrated for the product is referred to as product certification.This International Standard outlines how schemes for product certification can be structured and managed. It identifies common assessment techniq

31、ues that are used as a basis for product certification, such as product testing, inspection and auditing.This International Standard is intended for use by those involved with product certification, particularly those who are, or who are considering becoming, product certification scheme owners. Pro

32、duct certification scheme owners can include:a) product certification bodies;b) government and regulators;c) purchasing agencies;d) non-government organizations;e) industry and retail associations; andf) consumer organizations.This International Standard provides only guidance and does not contain r

33、equirements. It is compatible with ISO/IEC 17065, which specifies requirements for product certification bodies.In this International Standard, the following verbal forms are used: “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability.The mo

34、dal verb “shall”, which indicates a requirement, is not used because this International Standard only provides guidelines.Further details can be found in the ISO/IEC Directives, Part 2. ISO 2013 All rights reserved vBS EN ISO/IEC 17067:2013BS EN ISO/IEC 17067:2013Conformity assessment Fundamentals o

35、f product certification and guidelines for product certification schemes1 ScopeThis International Standard describes the fundamentals of product certification and provides guidelines for understanding, developing, operating or maintaining certification schemes for products, processes and services.It

36、 is intended for use by all with an interest in product certification, and especially by certification scheme owners.NOTE 1 In this International Standard the term “product” can also be read as “process” or “service”, except in those instances where separate provisions are stated for “processes” or

37、“services”. Definitions of product, process and service are given in ISO/IEC 17065.NOTE 2 The certification of products, processes and services is a third-party conformity assessment activity (see ISO/IEC 17000) carried out by product certification bodies. The requirements for product certification

38、bodies are specified in ISO/IEC 17065.2 Normative referencesThe 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

39、) applies.ISO/IEC 17000:2004, Conformity assessment Vocabulary and general principlesISO/IEC 17065:2012, Conformity assessment Requirements for bodies certifying products, processes and services3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO/IEC 17000

40、, ISO/IEC 17065 and the following apply.3.1certification systemrules, procedures and management for carrying out certificationSOURCE: ISO/IEC 17000:2004, 2.7, modified3.2certification schemecertification system (3.1) related to specified products, to which the same specified requirements, specific r

41、ules and procedures applyNote 1 to entry: The rules, procedures and management for implementing product, process and service certification are stipulated by the certification scheme.SOURCE: ISO/IEC 17065:2012, 3.9, modifiedINTERNATIONAL STANDARD ISO/IEC 17067:2013(E) ISO 2013 All rights reserved 1BS

42、 EN ISO/IEC 17067:2013ISO/IEC 17067:2013(E)3.3scheme ownerperson or organization responsible for developing and maintaining a specific certification scheme (3.2)Note 1 to entry: The scheme owner can be the certification body itself, a governmental authority, a trade association, a group of certifica

43、tion bodies or others.SOURCE: ISO/IEC 17065:2012, 3.114 Product certification4.1 Concept of product certification4.1.1 Product certification is the provision of assessment and impartial third-party attestation that fulfilment of specified requirements has been demonstrated. Product certification is

44、carried out by product certification bodies which should conform to ISO/IEC 17065. Specified requirements for products are generally contained in standards or other normative documents.4.1.2 Product certification is an established conformity assessment activity that provides confidence to consumers,

45、 regulators, industry and other interested parties that products conform to specified requirements, including for example product performance, safety, interoperability and sustainability.4.1.3 Product certification can facilitate trade, market access, fair competition and consumer acceptance of prod

46、ucts on a national, regional and international level.4.2 Objectives of product certification4.2.1 The fundamental objectives of product certification are:a) to address the needs of consumers, users and, more generally, all interested parties by giving confidence regarding fulfilment of specified req

47、uirements;b) to allow suppliers to demonstrate to the market that their product has been attested to fulfil specified requirements by an impartial third party body.4.2.2 Product certification should provide the following: confidence for those with an interest in fulfilment of requirements, and suffi

48、cient value so that suppliers can effectively market products.5 Product certification schemes5.1 Basics5.1.1 Product certification schemes should implement the functional approach as described in ISO/IEC 17000:2004, Annex A. The functions are: selection, which includes planning and preparation activ

49、ities in order to collect or produce all the information and input needed for the subsequent determination function; determination, which may include conformity assessment activities such as testing, measuring, inspection, design appraisal, assessment of services and processes and auditing to provide information regarding the product requirements as input to the review and attestation functions; review, which means verification of the suitability, adequacy and effectiveness of selection and determination activities, and the results of thes