BS EN ISO IEC 17020-2012 Conformity assessment Requirements for the operation of various types of bodies performing inspection《合格评定 实体机构执行检查的各种类型操作要求》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO/IEC 17020:2012Conformity assessment - Requirements for the operation of various types of bodies performing inspectionBS EN ISO/IEC 17020:2012 BRITISH STANDARDNational f

2、orewordThis British Standard is the UK implementation of EN ISO/IEC 17020:2012. It supersedes BS EN ISO/IEC 17020:2004 which is with-drawn.The UK participation in its preparation was entrusted to Technical Committee CAS/1, Conformity assessment.A list of organizations represented on this committee c

3、an be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012ISBN 978 0 580 78454 5 ICS 03.120.20 C

4、ompliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NO

5、RM EN ISO/IEC 17020 March 2012 ICS 03.120.20 Supersedes EN ISO/IEC 17020:2004 English version Conformity assessment - Requirements for the operation of various types of bodies performing inspection (ISO/IEC 17020:2012) valuation de la conformit - Exigences pour le fonctionnement de diffrents types d

6、organismes procdant linspection (ISO/IEC 17020:2012) Konformittsbewertung - Anforderungen an den Betrieb verschiedener Typen von Stellen, die Inspektionen durchfhren (ISO/IEC 17020:2012) This European Standard was approved by CEN on 18 February 2012. CEN and CENELEC members are bound to comply with

7、the CEN/CENELEC Internal Regulations which stipulate the conditions for giving 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 Managem

8、ent Centre or to any CEN and CENELEC member. This European Standard exists in 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 C

9、entre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

10、 Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre Avenue Marnix 17, B-1000 Brussels 2012 CEN/CENELEC All rights of exploitation in any form and by any means r

11、eserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17020:2012 EBS EN ISO/IEC 17020:2012EN ISO/IEC 17020:2012 (E) 3 Foreword This document (EN ISO/IEC 17020:2012) has been prepared by Technical Committee ISO/CASCO “Committee on conformity assessment” in collaborat

12、ion with Technical Committee CEN/CLC/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 September 2012, and c

13、onflicting national standards shall be withdrawn at the latest by September 2012. 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. This

14、 document supersedes EN ISO/IEC 17020:2004. According to the CEN/CENELEC Internal Regulations, 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, France

15、, Germany, Greece, Hungary, Iceland, Ireland, Italy, 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 17020:2012 has been approved by CEN as a EN

16、 ISO/IEC 17020:2012 without any modification. BS EN ISO/IEC 17020:2012ISO/IEC 17020:2012(E) ISO 2012 All rights reserved iiiContents Page Foreword ivg3Introduction . vg31g3 Scope 1g32g3 Normative references 1g33g3 Terms and definitions . 1g34g3 General requirements . 3g34.1g3 Impartiality and indepe

17、ndence . 3g34.2g3 Confidentiality 4g35g3 Structural requirements 4g35.1g3 Administrative requirements 4g35.2g3 Organization and management 4g36g3 Resource requirements 5g36.1g3 Personnel . 5g36.2g3 Facilities and equipment. 6g36.3g3 Subcontracting 8g37g3 Process requirements . 8g37.1g3 Inspection me

18、thods and procedures 8g37.2g3 Handling inspection items and samples . 9g37.3g3 Inspection records 9g37.4g3 Inspection reports and inspection certificates 9g37.5g3 Complaints and appeals . 10g37.6g3 Complaints and appeals process 10g38g3 Management system requirements . 11g38.1g3 Options . 11g38.2g3

19、Management system documentation (Option A) . 11g38.3g3 Control of documents (Option A) 12g38.4g3 Control of records (Option A) 12g38.5g3 Management review (Option A) 13g38.6g3 Internal audits (Option A) . 13g38.7g3 Corrective actions (Option A) 14g38.8g3 Preventive actions (Option A) 14g3Annex A (no

20、rmative) Independence requirements for inspection bodies 15g3Annex B (informative) Optional elements of inspection reports and certificates 17g3Bibliography 18g3BS EN ISO/IEC 17020:2012ISO/IEC 17020:2012(E) iv ISO 2012 All rights reservedForeword ISO (the International Organization for Standardizati

21、on) and 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 d

22、eal with 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 C

23、ommittee 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 national bodies for voting

24、. Publication as an International Standard requires approval by at least 75 % of the national 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

25、 patent rights. ISO/IEC 17020 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 second edition cancels and replaces the first edition (ISO/IEC 17020:1998), which ha

26、s been technically revised. BS EN ISO/IEC 17020:2012ISO/IEC 17020:2012(E) ISO 2012 All rights reserved vIntroduction This International Standard has been drawn up with the objective of promoting confidence in bodies performing inspection. Inspection bodies carry out assessments on behalf of private

27、clients, their parent organizations, or authorities, with the objective of providing information about the conformity of inspected items with regulations, standards, specifications, inspection schemes or contracts. Inspection parameters include matters of quantity, quality, safety, fitness for purpo

28、se, and continued safety compliance of installations or systems in operation. The general requirements with which these bodies are required to comply in order that their services are accepted by clients and by supervisory authorities are harmonized in this International Standard. This International

29、Standard covers the activities of inspection bodies whose work can include the examination of materials, products, installations, plants, processes, work procedures or services, and the determination of their conformity with requirements and the subsequent reporting of results of these activities to

30、 clients and, when required, to authorities. Inspection can concern all stages during the lifetime of these items, including the design stage. Such work normally requires the exercise of professional judgement in performing inspection, in particular when assessing conformity with general requirement

31、s. This International Standard can be used as a requirements document for accreditation or peer assessment or other assessments. This set of requirements can be interpreted when applied to particular sectors. Inspection activities can overlap with testing and certification activities where these act

32、ivities have common characteristics. However, an important difference is that many types of inspection involve professional judgement to determine acceptability against general requirements, for which reason the inspection body needs the necessary competence to perform the task. Inspection can be an

33、 activity embedded in a larger process. For example, inspection can be used as a surveillance activity in a product certification scheme. Inspection can be an activity that precedes maintenance or simply provides information about the inspected item with no determination of conformity with requireme

34、nts. In such cases, further interpretation might be needed. The categorization of inspection bodies as type A, B or C is essentially a measure of their independence. Demonstrable independence of an inspection body can strengthen the confidence of the inspection bodys clients with respect to the body

35、s ability to carry out inspection work with impartiality. In this International Standard, the following verbal forms are used: g127 “shall” indicates a requirement; g127 “should” indicates a recommendation; g127 “may” indicates a permission; g127 “can” indicates a possibility or a capability. BS EN

36、ISO/IEC 17020:2012BS EN ISO/IEC 17020:2012INTERNATIONAL STANDARD ISO/IEC 17020:2012(E) ISO 2012 All rights reserved 1Conformity assessment Requirements for the operation of various types of bodies performing inspection 1 Scope This International Standard contains requirements for the competence of b

37、odies performing inspection and for the impartiality and consistency of their inspection activities. It applies to inspection bodies of type A, B or C, as defined in this International Standard, and it applies to any stage of inspection. NOTE The stages of inspection include design stage, type exami

38、nation, initial inspection, in-service inspection or surveillance. 2 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 docu

39、ment (including any amendments) applies. ISO/IEC 17000, 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 and the following apply. 3.1 inspection examination of a product (3.2), process

40、(3.3), service (3.4), or installation or their design and determination of its conformity with specific requirements or, on the basis of professional judgment, with general requirements NOTE 1 Inspection of processes can include personnel, facilities, technology or methodology. NOTE 2 Inspection pro

41、cedures or schemes can restrict inspection to examination only. NOTE 3 Adapted from ISO/IEC 17000:2004, definition 4.3. NOTE 4 The term “item” is used in this International Standard to encompass product, process, service or installation, as appropriate. 3.2 product result of a process NOTE 1 Four ge

42、neric product categories are noted in ISO 9000:2005: g127 services (e.g. transport) (see definition in 3.4); g127 software (e.g. computer program, dictionary); BS EN ISO/IEC 17020:2012ISO/IEC 17020:2012(E) 2 ISO 2012 All rights reservedg127 hardware (e.g. engine, mechanical part); g127 processed mat

43、erials (e.g. lubricant). Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. NOTE 2 Products include results of natural processes, such as growth of pl

44、ants and formation of other natural resources. NOTE 3 Adapted from ISO/IEC 17000:2004, definition 3.3. 3.3 process set of interrelated or interacting activities which transforms inputs into outputs NOTE Adapted from ISO 9000:2005, definition 3.4.1. 3.4 service result of at least one activity necessa

45、rily performed at the interface between the supplier and the customer, which is generally intangible NOTE 1 Provision of a service can involve, for example, the following: g127 an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired); g127 an activity performed

46、on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); g127 the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); g127 the creation of ambience for the customer (e.g. in hotels and restaurants

47、). NOTE 2 Adapted from ISO 9000:2005, definition 3.4.2, Note 2. 3.5 inspection body body that performs inspection (3.1) NOTE An inspection body can be an organization, or part of an organization. 3.6 inspection system rules, procedures, and management for carrying out inspection NOTE 1 An inspection

48、 system can be operated at international, regional, national or sub-national level. NOTE 2 Adapted from ISO/IEC 17000:2004, definition 2.7. 3.7 inspection scheme inspection system (3.6) to which the same specified requirements, specific rules and procedures apply NOTE 1 Inspection schemes can be ope

49、rated at international, regional, national or sub-national level. NOTE 2 Schemes are sometimes also referred to as “programmes”. NOTE 3 Adapted from ISO/IEC 17000:2004, definition 2.8. BS EN ISO/IEC 17020:2012ISO/IEC 17020:2012(E) ISO 2012 All rights reserved 33.8 impartiality presence of objectivity NOTE 1 Objectivity means that conflicts of interest do not exist or are resolved so as not to adversely influence subsequent activitie