ISO PAS 17001-2005 Conformity assessment - Impartiality - Principles and requirements《合格评定 公正性 原则和要求》.pdf

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1、 Reference numberISO/PAS 17001:2005(E)ISO 2005PUBLICLY AVAILABLE SPECIFICATION ISO/PAS17001First edition2005-10-01Conformity assessment Impartiality Principles and requirements valuation de la conformit Impartialit Principes et exigences Copyright International Organization for Standardization Repro

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5、odies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2005 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 mechan

6、ical, including photocopying and microfilm, without permission in writing 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.

7、org Published in Switzerland ii ISO 2005 All rights reservedCopyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO/PAS 17001:2005(E) ISO 2005 All rights reserved iiiForew

8、ord ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a techni

9、cal committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of e

10、lectrotechnical standardization. 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

11、2. Draft International Standards are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a tech

12、nical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent commit

13、tee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to dec

14、ide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn.

15、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/PAS 17001 was prepared by the ISO Committee on conformity assessment (CASCO). Copyright Internati

16、onal Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO/PAS 17001:2005(E) iv ISO 2005 All rights reservedIntroduction In 2001, the ISO Council asked its policy committee on conformity assess

17、ment (CASCO) to study and prepare a group of common elements for application in future ISO documents on conformity assessment. Subsequent to this request, ISO/CASCO approved the formation of Working Group 23, Common elements in ISO/IEC Standards for conformity assessment activities, to undertake thi

18、s task. The working group has identified several common elements, including among others impartiality (ISO/PAS 17001), confidentiality (ISO/PAS 17002), complaints and appeals (ISO/PAS 17003), disclosure of information (ISO/PAS 17004), management systems (ISO/PAS 17005). This Publicly Available Speci

19、fication (PAS) addresses the “impartiality” element that occurs in many of the ISO/IEC Guides and International Standards on conformity assessment. This Publicly Available Specification covers the agreed principles that give substance to the element of impartiality, and also provides requirements cl

20、auses intended to be included in future ISO/IEC International Standards on conformity assessment. This Publicly Available Specification is intended to apply to the drafting of documents on conformity assessment by ISO/CASCO. Clause 4 (Background) contains some comments on the importance of impartial

21、ity to conformity assessment. Clause 5 (Principles of impartiality) contains statements that are intended to orientate ISO/CASCO working groups in their task of creating requirements to address impartiality in their documents. The requirements to be inserted into future ISO/CASCO documents that cove

22、r the common element of “impartiality” are detailed in Clause 6. ISO/CASCO has adopted a common structure for presentation of requirements. Requirements are grouped under one or more of the following headings: a) General requirements; b) Structural requirements; c) Resource requirements; d) Process

23、requirements; e) Management system requirements. As such, each of the common elements will have requirements related to it grouped under one or more of the headings given in a) to e). This PAS is not intended to become a future International Standard. At the end of three years after the date of publ

24、ication, it is expected this PAS will be withdrawn and its contents incorporated as appropriate in relevant ISO/CASCO normative and guidance documents. Copyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permit

25、ted without license from IHS-,-,-PUBLICLY AVAILABLE SPECIFICATION ISO/PAS 17001:2005(E) ISO 2005 All rights reserved 1Conformity assessment Impartiality Principles and requirements 1 Scope This Publicly Available Specification (PAS) contains principles and requirements for the element of impartialit

26、y as it relates to standards for conformity assessment. It is an internal tool for use in the ISO/IEC standards development process by ISO/CASCO working groups when considering the element of impartiality in preparation of their documents. This Publicly Available Specification is not a stand alone n

27、ormative document to be used directly in conformity assessment activities. 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 referen

28、ced document (including any amendments) applies. ISO/IEC 17000:2004, 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 apply. NOTE The use of the term “body” in this Publicly Available S

29、pecification means either an accreditation body or a conformity assessment body as defined in ISO/IEC 17000. 4 Background 4.1 Impartiality is an element made up of several components. These components are attributes that are considered fundamental in a body or person that performs conformity assessm

30、ent activities. The components include: a) undertaking conformity assessment activities in an objective manner without bias; b) identification of existing and potential conflicts of interests and their active management so as to ensure objectivity; c) independence of the conformity assessment body,

31、as well as the individuals performing the conformity assessment activities, from any other organization or person having an interest in the result of the conformity assessment activities; d) awareness of the responsibility and liability that come with undertaking conformity assessment activities and

32、 making conformity assessment decisions or/and attestations. Copyright International Organization for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO/PAS 17001:2005(E) 2 ISO 2005 All rights reserved4.2 Th

33、e lack of impartiality in conformity assessment activities could lead to incorrect or flawed conformity assessment practices and results. 4.3 While carrying out conformity assessment activities, it is important a) to be objective, b) to identify, avoid, mitigate and manage conflicts of interest, and

34、 c) to ensure independence, in order to increase the amount of trust, confidence and value that those activities have in the market place. 5 Principles of impartiality 5.1 The use of the term impartiality in this Publicly Available Specification is understood to be the actual and perceived presence

35、of objectivity. Objectivity is understood to mean that conflicts of interest do not exist or are resolved so as not to adversely influence the activities of the body. NOTE Impartially is characterized by one or more of the following: objectivity, independence, neutrality, fairness, open-mindedness,

36、even-handedness, detachment, balance, freedom from conflict of interests, freedom from bias, lack of prejudice. 5.2 It is necessary for bodies and their personnel to be, and be perceived as, impartial to give confidence in their activities and their outcomes. 5.3 Threats to impartiality include bias

37、 that may arise from: a) self-interest (e.g. overdependence on a contract for service or the fees, or fear of losing the customer or fear of becoming unemployed, to an extent that adversely affects objectivity in carrying out conformity assessment activities); b) self-review (e.g. performing conform

38、ity assessment activity in which the body evaluates the results of other services it has already provided, such as design or consultancy services); c) advocacy (e.g. a body or its personnel acting in support of, or in opposition to, a given company, which is at the same time its customer, in the res

39、olution of a dispute or litigation); d) over-familiarity, i.e. threats that arise from a body or its personnel being overly familiar or too trusting instead of seeking evidence of conformity (e.g. in a management systems conformity assessment context, the development of relationships over time betwe

40、en conformity assessment personnel and the customers personnel or organization that adversely affects the objectivity and rigour in the provision of conformity assessment activities for that customer; in the product certification and laboratory context, this risk is Copyright International Organizat

41、ion for Standardization Reproduced by IHS under license with ISO Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO/PAS 17001:2005(E) ISO 2005 All rights reserved 3more difficult to manage because the need for assessment personnel, with very specific expertise, of

42、ten limits the availability of qualified individuals); e) intimidation (e.g. the body or its personnel can be deterred from acting objectively by threats from or fear of, a client or other interested party); f) competition (e.g. between the assessed company and a contracted technical assessor). 6 Re

43、quirements for impartiality 6.1 General In developing this Publicly Available Specification, it was recognized that there are varying degrees of specificity that ISO/CASCO working groups should consider. Consequently, the requirements in this clause are categorized into three levels of specificity a

44、s follows. a) Obligatory: These are specific drafted requirements that shall be used by ISO/CASCO working groups where the element has to be addressed, without modification, except for substitution of more specific terms. For example, the phrase “Conformity assessment activities shall be undertaken

45、impartially”, may be substituted more specifically with “Management system certification activities shall be undertaken impartially”. Justification is required from ISO/CASCO working groups that do not use these requirements when dealing with the relevant common element. b) Recommended: These are dr

46、afted requirements that working groups should use if they wished to have a greater degree of specification. Modification is permissible. c) Suggested: These are considerations that could be taken into account in the drafting of requirements by the ISO/CASCO working group. By providing for these diff

47、erent levels of specificity, this Publicly Available Specification achieves the ISO/CASCO intent to have an agreed statement on elements that are common to all conformity assessment activities and, at the same time, maintains some flexibility for specific wording by individual ISO/CASCO working grou

48、ps. As an aid to future CASCO working groups, the following text that they shall either use (obligatory requirements) or otherwise incorporate (recommended requirements) in future International Standards is that which is contained in the boxes; the rest of the text is explanatory in nature. 6.2 Gene

49、ral requirements 6.2.1 Obligatory requirements 6.2.1.1 Conformity assessment activities shall be undertaken impartially. 6.2.1.2 The body shall be responsible for the impartiality of its conformity assessment activities and shall not allow commercial, financial or other pressures to compromise impartiality. Copyright International Organi