ASTM ISO IEC17020-2012 Conformity assessment &x2014 Requirements for the operation of various types of bodies performing inspection《合格评定 各类检查执行机构的操作要求》.pdf

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2、NTERNATIONAL STANDARD ISO/IEC 17020 Second edition 2012-03-01 Conformity assessment Requirements for the operation of various types of bodies performing inspection valuation de la conformit Exigences pour le fonctionnement de diffrents types dorganismes procdant linspection ISO/IEC 17020:2012(E) COP

3、YRIGHT PROTECTED DOCUMENT ISO 2012 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 writing from either ISO at the address belo

4、w 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 2012 All rights reserved ISO/IEC 17020:2012(E) ISO 2012 All rights reserv

5、ed iii Contents 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 Confidentiality 4 5 Structural requirements 4 5.1 Administrative requirements 4 5.2 Organization and management 4 6 Re

6、source 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 items and samples . 9 7.3 Inspection records 9 7.4 Inspection reports and inspection certificates 9 7.5 Complaints a

7、nd 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 documents (Option A) 12 8.4 Control of records (Option A). 12 8.5 Management review (Option A) 13 8.6 Internal audits (Optio

8、n 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) Optional elements of inspection reports and certificates 17 Bibliography 18 ISO/IEC 17020:2012(E) iv ISO 2012 All rights re

9、served 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 the development of International Standards through

10、 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-governmental, in liaison with ISO and IEC, also ta

11、ke 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 given in the ISO/IEC Directives, Part 2. Draft Int

12、ernational 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. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent righ

13、ts. 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 (CASCO). It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. This second edition

14、cancels and replaces the first edition (ISO/IEC 17020:1998), which has been technically revised. ISO/IEC 17020:2012(E) ISO 2012 All rights reserved v Introduction This International Standard has been drawn up with the objective of promoting confidence in bodies performing inspection. Inspection bodi

15、es carry out assessments on behalf of private 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 o

16、f quantity, quality, safety, fitness for purpose, 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 th

17、is International Standard. This International 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 subseque

18、nt reporting of results of these activities to 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

19、 assessing conformity with general requirements. 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 testin

20、g and certification activities where these activities 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 compet

21、ence to perform the task. Inspection can be an 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

22、 no determination of conformity with requirements. 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 ins

23、pection bodys clients with respect to the bodys ability to carry out inspection work with impartiality. In this International Standard, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibili

24、ty or a capability. INTERNATIONAL STANDARD ISO/IEC 17020:2012(E) ISO 2012 All rights reserved 1 Conformity 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 insp

25、ection 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 examination, initial inspe

26、ction, 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 document (including any a

27、mendments) 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 (3.3), service (3.4),

28、 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 procedures or schemes ca

29、n 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 generic product categor

30、ies are noted in ISO 9000:2005: services (e.g. transport) (see definition in 3.4); software (e.g. computer program, dictionary); ISO/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 belongi

31、ng 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 plants and formation of other natural resources. NOTE 3 Adapted fr

32、om 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 necessarily performed at the interface between the supplier and the cus

33、tomer, which is generally intangible NOTE 1 Provision of a service 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 neede

34、d to prepare a tax return); the delivery of an intangible product (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

35、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 system can be operated at international, regional, national or sub-national level.

36、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 operated at international, regional, national or sub-national level. NOTE 2 Schemes are

37、 sometimes also referred to as “programmes”. NOTE 3 Adapted from ISO/IEC 17000:2004, definition 2.8. ISO/IEC 17020:2012(E) ISO 2012 All rights reserved 3 3.8 impartiality presence of objectivity NOTE 1 Objectivity means that conflicts of interest do not exist or are resolved so as not to adversely i

38、nfluence 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-mindedness, even-handedness, detachment, balance.

39、 3.9 appeal request by the provider of the item of inspection to the inspection body for reconsideration by that body of a decision it has made relating to that item NOTE Adapted from ISO/IEC 17000:2004, definition 6.4. 3.10 complaint expression of dissatisfaction, other than appeal, by any person o

40、r organization to an inspection body, relating to the activities of that body, where a response is expected NOTE Adapted from ISO/IEC 17000:2004, definition 6.5. 4 General requirements 4.1 Impartiality and independence 4.1.1 Inspection activities shall be undertaken impartially. 4.1.2 The inspection

41、 body shall be responsible for the impartiality of its inspection activities and shall not allow commercial, financial or other pressures to compromise impartiality. 4.1.3 The inspection body shall identify risks to its impartiality on an ongoing basis. This shall include those risks that arise from

42、 its activities, or from its relationships, or from the relationships of its personnel. However, such relationships do not necessarily present an inspection body with a risk to impartiality. NOTE A relationship that threatens the impartiality of the inspection body can be based on ownership, governa

43、nce, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new clients, etc. 4.1.4 If a risk to impartiality is identified, the inspection body shall be able to demonstrate how it elimin

44、ates or minimizes such risk. 4.1.5 The inspection body shall have top management commitment to impartiality. 4.1.6 The inspection body shall be independent to the extent that is required with regard to the conditions under which it performs its services. Depending on these conditions, it shall meet

45、the minimum requirements stipulated in Annex A, as outlined below. a) An inspection body providing third party inspections shall meet the type A requirements of Clause A.1 (third party inspection body). b) An inspection body providing first party inspections, second party inspections, or both, which

46、 forms a separate and identifiable part of an organization involved in the design, manufacture, supply, installation, use or maintenance of the items it inspects and which supplies inspection services only to its parent organization (in-house inspection body) shall meet the type B requirements of Cl

47、ause A.2. ISO/IEC 17020:2012(E) 4 ISO 2012 All rights reserved c) An inspection body providing first party inspections, second party inspections, or both, which forms an identifiable but not necessarily a separate part of an organization involved in the design, manufacture, supply, installation, use

48、 or maintenance of the items it inspects and which supplies inspection services to its parent organization or to other parties, or to both, shall meet the type C requirements of Clause A.3. 4.2 Confidentiality 4.2.1 The inspection body shall be responsible, through legally enforceable commitments, f

49、or the management of all information obtained or created during the performance of inspection activities. The inspection body shall inform the client, in advance, of the information it intends to place in the public domain. Except for information that the client makes publicly available, or when agreed between the inspection body and the client (e.g. for the purpose of responding to complaints), all other information is considered proprietary information and shall be regarded as confidential. NOTE Legally enfor