1、Reference number ISO/TR 13881:2000(E) ISO 2000 TECHNICAL REPORT ISO/TR 13881 First edition 2000-04-15 Petroleum and natural gas industries Classification and conformity assessment of products, processes and services Industries du ptrole et du gaz naturel Classification et valuation de la conformit d
2、es produits, procds et servicesISO/TR 13881:2000(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the compute
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5、ntral Secretariat at the address given below. ISO 2000 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
6、 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 22 734 10 79 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2000 All rights reservedISO/TR 13881:2000(E) ISO 2000 All
7、 rights reserved iii Contents Page Foreword.iv Introduction.v 1 Scope 1 2 References1 3 Terms and definitions .1 4 Classification principles .2 5 Classification method based on calculation.3 6 Classification method based on judgement .4 7 Limitations6 8 Conformity assessment systems.6 9 System A.8 1
8、0 System B.10 11 System C.12 12 System D.13 13 System E.14 Annex A Classification method based on judgement.15 Annex B Frequently asked questions.18ISO/TR 13881:2000(E) iv ISO 2000 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of nati
9、onal 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 technical committee has been established has the right to be represented on that committee. Internat
10、ional 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 electrotechnical standardization. International Standards are drafted in accordance with the ru
11、les given in the ISO/IEC Directives, Part 3. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at
12、 least 75 % of the member bodies casting a vote. In exceptional circumstances, when a technical committee has collected data of a different kind from that which is normally published as an International Standard (“state of the art“, for example), it may decide by a simple majority vote of its partic
13、ipating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have to be reviewed until the data it provides are considered to be no longer valid or useful. Attention is drawn to the possibility that some of the elements of this Technical Report may
14、 be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TR 13881 was prepared by Technical Committee ISO/TC 67, Materials, equipment and offshore structures for petroleum and natural gas industries.ISO/TR 13881:2000(E) ISO 2000 All right
15、s reserved v Introduction When a user/purchaser wishes to procure a product, process or service, the user/purchaser may produce a functional specification (see ISO 13879). If so, the manufacturer/supplier provides a technical specification (see ISO 13880) as the basis for manufacturing or execution.
16、 The user/purchaser decides on the extent to which it is necessary to determine, directly or indirectly, that relevant requirements are fulfilled and states this in the contract with the manufacturer/supplier. This document describes: two methodologies which enable the required degree of assurance t
17、o be determined by classification, which in turn dictates the conformity assessment system; a set of five conformity assessment systems which when applied can give an increasing level of confidence that the product, process or service conforms to stated requirements.TECHNICAL REPORT ISO/TR 13881:200
18、0(E) ISO 2000 All rights reserved 1 Petroleum and natural gas industries Classification and conformity assessment of products, processes and services 1 Scope This Technical Report describes: two classification methods (one based on calculated risk, the other on judgement of risk) which may be used t
19、o determine the appropriate conformity assessment system for products, processes and services; a set of five conformity assessment systems from which the most suitable is chosen when conformity assessment of products, processes and services is required. NOTE Alternative classification models may be
20、used provided their results are consistent with the conformity assessment systems to be applied. 2 References ISO/IEC Guide 2:1996, Standardization and related activities General vocabulary. ISO/IEC Guide 22:1996, General criteria for suppliers declaration of conformity. ISO/IEC Guide 28:1982, Gener
21、al rules for a model third-party certification system for products. ISO 9001: 1) , Quality management systems Requirements. ISO 9002:1994, Quality systems Model for quality assurance in production, installation and servicing. ISO 9003:1994, Quality systems Model for quality assurance in final inspec
22、tion and test. ISO 13879:1999, Petroleum and natural gas industries Content and drafting of a functional specification. ISO 13880:1999, Petroleum and natural gas industries Content and drafting of a technical specification. 3 Terms and definitions For the purposes of this Technical Report, the terms
23、 and definitions of conformity-assessment-related terms given in ISO/IEC Guide 2 apply, with the exception of the terms defined below. 3.1 class number assigned to a product, process or service, associated with the risk of its failure during use due to design or manufacturing, process or service err
24、ors, that indicates the appropriate conformity assessment system to be adopted 1) To be published. (Revision of ISO 9001:1994)ISO/TR 13881:2000(E) 2 ISO 2000 All rights reserved NOTE The classification of a product, process or service does not take into consideration failure due to misuse or incorre
25、ct maintenance of the product, process or service. 3.2 probability of failure frequency of occurrence of a product, process or service failure happening within one year divided by the total number of the particular products, processes or services in operation during the same year 3.3 consequence of
26、failure results of the failure of the product, process or service NOTE In the petroleum and natural gas industries, the most commonly used measure of consequence is financial cost. This implies that the intangible aspects of the results following a failure, such as community acceptance, be translate
27、d to financial cost. The cost for failure can comprise cost for restoring the environment (i.e. damage to the environment), deferred or loss of production, reduction in efficiency, health and safety-related cost, etc. 3.4 risk of failure probability multiplied by consequence 3.5 design review formal
28、, documented, comprehensive and systematic examination of a design to evaluate the design requirements and the capabilities of the design to meet these requirements NOTE 1 In the context of the document, the acceptance criteria for the design review are defined in the functional and technical specif
29、ications (see ISO 13879 and ISO 13880). NOTE 2 A service is also designed and can be reviewed in the same manner. 3.6 witness point point in the chain of activities, defined in the quality or inspection plan agreed upon, to be witnessed by the conformity assessment body if deemed necessary 3.7 hold
30、point point, defined in an appropriate document, beyond which an activity should not proceed without the approval of a designated organization or authority NOTE The approval to proceed beyond a hold point is usually given in written form, but it may be given by any other agreed system of authorizati
31、on. 4 Classification principles For the purposes of this Technical Report, the following classification principles apply. CLASS should be determined taking full account of the total life of the product, process or service, starting with its functional specification and ending with its decommissionin
32、g/demobilization. CLASS should take full account of the health, safety and environmental requirements valid for the countries in which the product, process or service is created, used and/or decommissioned/demobilized. CLASS, when established according to clause 5 or clause 6, should be determined u
33、sing verifiable parameters. In this Technical Report, five classes are defined, from 1 to 5, of which CLASS 1 represents the highest risk of failure and CLASS 5 represents the lowest risk of failure. The relationship between the classes and the conformity assessment systems is defined in Table 1.ISO
34、/TR 13881:2000(E) ISO 2000 All rights reserved 3 CLASS only has a meaning and/or significance in combination with one of the conformity assessment systems defined. Table 1 Class and conformity assessment system relationship CLASS 1 System A CLASS 2 System B CLASS 3 System C CLASS 4 System D CLASS 5
35、System E Clause 5 and clause 6 provide two different methods of CLASS determination. 5 Classification method based on calculation 5.1 General This method can be used when specific data on costs and probabilities are available. Two sub-models are presented here. When combined, they provide a full mod
36、el for classification. The sub-models are based on the assumption that cost can be allocated to the level of certainty that the product, process or service will fulfil its intended purpose without failure. Other models may be used but are not described within this Technical Report. NOTE The classifi
37、cation models are used by the user/purchaser of a product, process or service to calculate and thereafter indicate which CLASS number is required to obtain the appropriate conformity assessment. The CLASS is related to the risk of failure during use of a product, process and/or service. 5.2 Explanat
38、ion of the factors used in the sub-models The sub-models are built on the following premises: every activity bears risks which can be translated into cost; the models are applicable to the design and manufacture as well as the operational life of the product, process or service. The risks are connec
39、ted with failures whereby the operational cost during the life is determined by in situ maintenance, periodic inspection, required level of spare parts, etc. NOTE The risk of failure can be reduced by, for example, more frequent inspections or supervisory actions, a thorough maintenance process, a b
40、etter controlled manufacturing/service process, etc. 5.3 Risk-related sub-model T r =( p 0 c 0 )+( p 1 c 1 )+( p 2 c 2 ) 1 where T r is the total risk, in monetary terms; p 0 is the probability of failure of the product, process or service during use, due to design; c 0 is the consequence of design-
41、related failure; p 1 is the probability of failure of the product, process or service during use, due to manufacturing of product or execution of services/processes;ISO/TR 13881:2000(E) 4 ISO 2000 All rights reserved c 1 is the consequence of manufacturing/execution-related failure; p 2 is the proba
42、bility of failure of the product, process or service during use, for other reasons such as absence of proper instructions, etc.; c 2 is the consequence of failure related to other reasons. The probability of failure can be obtained from historical data, preferably from a public database. In any case
43、, a record should be kept of where the probability data was obtained. Furthermore, for the purposes of this Technical Report, the probability factors have to be correlated to both the conformity assessment system which was adopted when producing the product or executing the service or process, and t
44、he verification of performance during the life cycle. 5.4 Integrity-related sub-model T v = C v + C c 2 where T v is the total cost for verification; C v is the planned cost for verifications during the life of the product, process or service per year; C c is the cost of obtaining a product, process
45、 or service using the conformity assessment system on the basis of which the probability factors have been derived. NOTE 1 Increasing the in situ verifications of products, processes or services will reduce the probability of failure because failures are generally not incidents which happen suddenly
46、 but are preceded by a deterioration of the products performance or service, process execution. NOTE 2 These increased verifications will have a risk-limiting effect and therefore act as a compensation for the risk-related costs. NOTE 3 The need for costs to be assessed on a yearly basis is related
47、to the fact that the probability of failure is also based upon annual figures. Furthermore, it should be noted that the cost spent on conformity assessment will also reduce the probability of failure. 5.5 CLASS calculation The CLASS calculation is based on the concept that the risk of failure of a p
48、roduct, process or service can be reduced by increasing the frequency or type of verifications during the various phases of its life cycle until the point where the risk, in monetary terms, T r , is about equal to the total cost for verification, T v . Therefore the CLASS calculation is iterated unt
49、il the following ratio is achieved: T r /T v u 1 3 When using this Technical Report in conjunction with conformity assessment, a record of the data used to calculate the class should be used. 6 Classification method based on judgement 6.1 General This method can be used when specific data on costs and probabilities of failure are not available.ISO/TR 13881:2000(E) ISO 2000 All rights reserved 5 6.2 Classification process Classification should be performed by a team of experts, from or under
