EN ISO IEC 17020-2012 en Conformity assessment - Requirements for the operation of various types of bodies performing inspection《合格评定 各类检查机构运行要求》.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 iv Introduction . v 1 Scope 1 2 Normative references 1 3 Terms and definitions . 1 4 General requirements . 3 4.1 Impartiality and independence . 3 4.2 C

17、onfidentiality 4 5 Structural requirements 4 5.1 Administrative requirements 4 5.2 Organization and management 4 6 Resource requirements 5 6.1 Personnel . 5 6.2 Facilities and equipment. 6 6.3 Subcontracting 8 7 Process requirements . 8 7.1 Inspection methods and procedures 8 7.2 Handling inspection

18、 items and samples . 9 7.3 Inspection records 9 7.4 Inspection reports and inspection certificates 9 7.5 Complaints and appeals . 10 7.6 Complaints and appeals process 10 8 Management system requirements . 11 8.1 Options . 11 8.2 Management system documentation (Option A) . 11 8.3 Control of documen

19、ts (Option A) 12 8.4 Control of records (Option A) 12 8.5 Management review (Option A) 13 8.6 Internal audits (Option A) . 13 8.7 Corrective actions (Option A) 14 8.8 Preventive actions (Option A) 14 Annex A (normative) Independence requirements for inspection bodies 15 Annex B (informative) Optiona

20、l elements of inspection reports and certificates 17 Bibliography 18 BS EN ISO/IEC 17020:2012ISO/IEC 17020:2012(E) iv ISO 2012 All rights reservedForeword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for

21、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 fields of technical activity. ISO and IEC technical committees collabora

22、te 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 assessment (CASCO) is responsible for the development of Internationa

23、l 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. Publication as an International Standard requires approval by at least 75 % of the nationa

24、l 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 17020 was prepared by the ISO Committee on conformity assessment (CA

25、SCO). 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 has been technically revised. BS EN ISO/IEC 17020:2012ISO/IEC 17020:2012(E) ISO 2012 All right

26、s 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 clients, their parent organizations, or authorities, with the objective of providing informa

27、tion about the conformity of inspected items with regulations, standards, specifications, inspection schemes or contracts. Inspection parameters include matters of quantity, quality, safety, fitness for purpose, and continued safety compliance of installations or systems in operation. The general re

28、quirements 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 Standard covers the activities of inspection bodies whose work can include the examination o

29、f 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 clients and, when required, to authorities. Inspection can concern all stages during the li

30、fetime 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 requirements. This International Standard can be used as a requirements document for accreditation or p

31、eer 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 activities have common characteristics. However, an important difference is that many types of

32、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 activity embedded in a larger process. For example, inspection can be used as a surveillanc

33、e 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 requirements. In such cases, further interpretation might be needed. The categorization of inspection

34、 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 bodys ability to carry out inspection work with impartiality. In this International Standard, th

35、e following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability. BS EN ISO/IEC 17020:2012BS EN ISO/IEC 17020:2012INTERNATIONAL STANDARD ISO/IEC 17020:2012(E) ISO 2012 All rights reser

36、ved 1Conformity assessment Requirements for the operation of various types of bodies performing inspection 1 Scope This International Standard contains requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities. It applies

37、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 examination, initial inspection, in-service inspection or surveillance. 2 Normative references The following referenc

38、ed 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) applies. ISO/IEC 17000, Conformity assessment Vocabulary and general principles

39、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 (3.3), service (3.4), or installation or their design and determination of its conformity with specific requirem

40、ents 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 procedures or schemes can restrict inspection to examination only. NOTE 3 Adapted from ISO/IEC 17000:2004, definiti

41、on 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 generic product categories are noted in ISO 9000:2005: services (e.g. transport) (see definition in 3.4); software

42、 (e.g. computer program, dictionary); BS EN ISO/IEC 17020:2012ISO/IEC 17020:2012(E) 2 ISO 2012 All rights reserved hardware (e.g. engine, mechanical part); processed materials (e.g. lubricant). Many products comprise elements belonging to different generic product categories. Whether the product is

43、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 plants and formation of other natural resources. NOTE 3 Adapted from ISO/IEC 17000:2004, definition 3.3. 3.3 process set of interrela

44、ted 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 necessarily performed at the interface between the supplier and the customer, which is generally intangible NOTE 1 Provision of a service

45、can involve, for example, the following: an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired); an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); the delivery of an intangible product (

46、e.g. the delivery of information in the context of knowledge transmission); the creation of ambience for the customer (e.g. in hotels and restaurants). 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

47、an organization, or part of an organization. 3.6 inspection system rules, procedures, and management for carrying out inspection NOTE 1 An inspection 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 inspect

48、ion scheme inspection system (3.6) to which the same specified requirements, specific rules and procedures apply NOTE 1 Inspection schemes can be operated at international, regional, national or sub-national level. NOTE 2 Schemes are sometimes also referred to as “programmes”. NOTE 3 Adapted from IS

49、O/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 activities of the inspection body. NOTE 2 Other terms that are useful in conveying the element of impartiality are: independence, freedom from conflict of interests, freedom from bias, lack of prejudice, neutrality, fairness, open-mindednes