1、PUBLISHED DOCUMENTPetroleum and natural gas industries Classification and conformity assessment of products, processes and servicesICS 75.020; 75.080PD CEN ISO/TR 13881:2011g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g5
2、1g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58National forewordThis Published Document is the UK implementation of CEN ISO/TR 13881:2011. It is identical to ISO/TR 13881:2000. It supersedes PD ISO/TR 13881:2001, which is withdrawn.The UK participation in its preparation wa
3、s entrusted to Technical Committee PSE/17, Petroleum and natural gas industries.A list of organizations represented on this committee can 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 cor
4、rect application.PD CEN ISO/TR 13881:2011This Published Document, having been prepared under the direction of the Engineering Sector Committee, was published under the authority of the Standards Committee and comes into effect on15 July 2001 BSI 2011Amendments/corrigenda issued since publicationDate
5、 Comments 30 June 2011 This corrigendum renumbers PD ISO/TR 13881:2001 as PD CEN ISO/TR 13881:2011.ISBN 978 0 580 72220 2TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN ISO/TR 13881 February 2011 ICS 75.080; 75.020 English Version Petroleum and natural gas industries - Classification and
6、conformity assessment of products, processes and services (ISO/TR 13881:2000) Industries du ptrole et du gaz naturel - Classification et valuation de la conformit des produits, procds et services (ISO/TR 13881:2000) Erdl- und Erdgasindustrie - Klassifizierung und Konformittsbewertung von Produkten,
7、Verfahren und Dienstleistungen (ISO/TR 13881:2000) This Technical Report was approved by CEN on 27 December 2010. It has been drawn up by the Technical Committee CEN/TC 12. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
8、 Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISC
9、HES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TR 13881:2011: EForeword The text of ISO/TR 13881:2000 has been prepared by Technical Committee I
10、SO/TC 67 “Materials, equipment and offshore structures for petroleum, petrochemical and natural gas industries” of the International Organization for Standardization (ISO) and has been taken over as CEN ISO/TR 13881:2011 by Technical Committee CEN/TC 12 “Materials, equipment and offshore structures
11、for petroleum, petrochemical and natural gas industries” the secretariat of which is held by AFNOR. 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 p
12、atent rights. Endorsement notice The text of ISO/TR 13881:2000 has been approved by CEN as a CEN ISO/TR 13881:2011 without any modification. iiPD CEN ISO/TR 13881:2011diiiContents PageForeword.ivIntroduction.v1 Scope 12 References13 Terms and definitions .14 Classification principles .25 Classificat
13、ion method based on calculation.36 Classification method based on judgement .47 Limitations68 Conformity assessment systems.69 System A.810 System B.1011 System C.1212 System D.1313 System E.14Annex A Classification method based on judgement.15Annex B Frequently asked questions.18PD CEN ISO/TR 13881
14、:2011ivForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which
15、 a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matter
16、s of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.The main task of technical committees is to prepare International Standards. Draft International Standards adoptedby the technical committees are circulated
17、to the member bodies for voting. Publication as an InternationalStandard requires approval by at 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 isnormally published as an International Sta
18、ndard (“state of the art“, for example), it may decide by a simple majorityvote of its participating members to publish a Technical Report. A Technical Report is entirely informative in natureand does not have to be reviewed until the data it provides are considered to be no longer valid or useful.A
19、ttention is drawn to the possibility that some of the elements of this Technical Report may be the subject of patentrights. 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 st
20、ructures forpetroleum and natural gas industries.PD CEN ISO/TR 13881:2011dvIntroductionWhen a user/purchaser wishes to procure a product, process or service, the user/purchaser may produce afunctional specification (see ISO 13879). If so, the manufacturer/supplier provides a technical specification
21、(seeISO 13880) as the basis for manufacturing or execution. The user/purchaser decides on the extent to which it isnecessary to determine, directly or indirectly, that relevant requirements are fulfilled and states this in the contractwith the manufacturer/supplier.This document describes:Gbe two me
22、thodologies which enable the required degree of assurance to be determined by classification, which inturn dictates the conformity assessment system;Gbe a set of five conformity assessment systems which when applied can give an increasing level of confidencethat the product, process or service confo
23、rms to stated requirements.PD CEN ISO/TR 13881:2011TECHNICAL REPORTd1Petroleum and natural gas industries Classification andconformity assessment of products, processes and services1 ScopeThis Technical Report describes:Gbe two classification methods (one based on calculated risk, the other on judge
24、ment of risk) which may be used todetermine the appropriate conformity assessment system for products, processes and services;Gbe a set of five conformity assessment systems from which the most suitable is chosen when conformityassessment of products, processes and services is required.NOTE Alternat
25、ive classification models may be used provided their results are consistent with the conformity assessmentsystems to be applied.2 ReferencesISO/IEC Guide 2:1996, Standardization and related activities General vocabulary.ISO/IEC Guide 22:1996, General criteria for suppliers declaration of conformity.
26、ISO/IEC Guide 28:1982, General 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 as
27、surance in final inspection 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 definitionsFor the purposes of this Technica
28、l Report, the terms and definitions of conformity-assessment-related terms givenin ISO/IEC Guide 2 apply, with the exception of the terms defined below.3.1classnumber assigned to a product, process or service, associated with the risk of its failure during use due to design ormanufacturing, process
29、or service errors, that indicates the appropriate conformity assessment system to beadopted1) To be published. (Revision of ISO 9001:1994)PD CEN ISO/TR 13881:20112NOTE The classification of a product, process or service does not take into consideration failure due to misuse or incorrectmaintenance o
30、f the product, process or service.3.2probability of failurefrequency of occurrence of a product, process or service failure happening within one year divided by the totalnumber of the particular products, processes or services in operation during the same year3.3consequence of failureresults of the
31、failure of the product, process or serviceNOTE In the petroleum and natural gas industries, the most commonly used measure of consequence is financial cost. Thisimplies that the intangible aspects of the results following a failure, such as community acceptance, be translated to financialcost. The c
32、ost for failure can comprise cost for restoring the environment (i.e. damage to the environment), deferred or loss ofproduction, reduction in efficiency, health and safety-related cost, etc.3.4risk of failureprobability multiplied by consequence3.5design reviewformal, documented, comprehensive and s
33、ystematic examination of a design to evaluate the design requirementsand the capabilities of the design to meet these requirementsNOTE 1 In the context of the document, the acceptance criteria for the design review are defined in the functional andtechnical specifications (see ISO 13879 and ISO 1388
34、0).NOTE 2 A service is also designed and can be reviewed in the same manner.3.6witness pointpoint in the chain of activities, defined in the quality or inspection plan agreed upon, to be witnessed by theconformity assessment body if deemed necessary3.7hold pointpoint, defined in an appropriate docum
35、ent, beyond which an activity should not proceed without the approval of adesignated organization or authorityNOTE The approval to proceed beyond a hold point is usually given in written form, but it may be given by any other agreedsystem of authorization.4 Classification principlesFor the purposes
36、of this Technical Report, the following classification principles apply.Gbe CLASS should be determined taking full account of the total life of the product, process or service, starting withits functional specification and ending with its decommissioning/demobilization.Gbe CLASS should take full acc
37、ount of the health, safety and environmental requirements valid for the countries inwhich the product, process or service is created, used and/or decommissioned/demobilized.Gbe CLASS, when established according to clause 5 or clause 6, should be determined using verifiableparameters.In this Technica
38、l Report, five classes are defined, from 1 to 5, of which CLASS 1 represents the highest risk offailure and CLASS 5 represents the lowest risk of failure.The relationship between the classes and the conformity assessment systems is defined in Table 1.PD CEN ISO/TR 13881:2011d3CLASS only has a meanin
39、g and/or significance in combination with one of the conformity assessment systemsdefined.Table 1 Class and conformity assessment system relationshipCLASS 1 System ACLASS 2 System BCLASS 3 System CCLASS 4 System DCLASS 5 System EClause 5 and clause 6 provide two different methods of CLASS determinat
40、ion.5 Classification method based on calculation5.1 GeneralThis method can be used when specific data on costs and probabilities are available. Two sub-models arepresented here. When combined, they provide a full model for classification. The sub-models are based on theassumption that cost can be al
41、located to the level of certainty that the product, process or service will fulfil itsintended purpose without failure. Other models may be used but are not described within this Technical Report.NOTE The classification models are used by the user/purchaser of a product, process or service to calcul
42、ate and thereafterindicate which CLASS number is required to obtain the appropriate conformity assessment. The CLASS is related to the risk offailure during use of a product, process and/or service.5.2 Explanation of the factors used in the sub-modelsThe sub-models are built on the following premise
43、s:Gbe every activity bears risks which can be translated into cost;Gbe the models are applicable to the design and manufacture as well as the operational life of the product, processor service.The risks are connected with failures whereby the operational cost during the life is determined by in situ
44、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 thoroughmaintenance process, a better controlled manufacturing/service process, etc.5.3 Risk-related sub-modelTr=(p0Gd7 c0
45、)+(p1Gd7 c1)+(p2Gd7 c2) 1whereTris the total risk, in monetary terms;p0is the probability of failure of the product, process or service during use, due to design;c0is the consequence of design-related failure;p1is the probability of failure of the product, process or service during use, due to manuf
46、acturing of productor execution of services/processes;PD CEN ISO/TR 13881:20114c1is the consequence of manufacturing/execution-related failure;p2is the probability of failure of the product, process or service during use, for other reasons such asabsence of proper instructions, etc.;c2is the consequ
47、ence of failure related to other reasons.The probability of failure can be obtained from historical data, preferably from a public database. In any case, arecord should be kept of where the probability data was obtained.Furthermore, for the purposes of this Technical Report, the probability factors
48、have to be correlated to both theconformity assessment system which was adopted when producing the product or executing the service orprocess, and the verification of performance during the life cycle.5.4 Integrity-related sub-modelTv= Cv+ Cc2whereTvis the total cost for verification;Cvis the planne
49、d cost for verifications during the life of the product, process or service per year;Ccis the cost of obtaining a product, process or service using the conformity assessment system on the basisof 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 becausefailures are generally not incidents which happen suddenly but are preceded by a deterioration of the products performance orservice, process execution.NOTE 2 These increased verifications w
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