EN ISO TS 29001-2011 en Petroleum petrochemical and natural gas industries - Sector-specific quality management systems - Requirements for product and service supply organizations《.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationDD CEN ISO/TS 29001:2011Incorporating corrigendum June 2011Petroleum, petrochemical and natural gas industries Sector-specific quality management systems Requirements for product

2、 and service supply organizationsDD CEN ISO/TS 29001:2011 DRAFT FOR DEVELOPMENTNational forewordThis Draft for Development is the UK implementation CEN ISO/TS29001:2011. It is identical to ISO/TS 29001:2010. It supersedes DD ISO/TS 29001:2010, which is withdrawn.This publication is not to be regarde

3、d as a British Standard.It is being issued in the Draft for Development series of publications and is of a provisional nature. It should be applied on this provisional basis, so that information and experience of its practical application can be obtained.Comments arising from the use of this Draft f

4、or Development are requested so that UK experience can be reported to the international organization responsible for its conversion to an international standard. A review of this publication will be initiated not later than 3 years after its publication by the international organization so that a de

5、cision can be taken on its status. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards.According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversio

6、n into an international Standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent to the Secretary of the responsible BSI Technical Committee at British Standards House, 389 Chiswick High Road, London W4 4AL.The UK participation in its preparation was ent

7、rusted to Technical Committee PSE/17, Materials and equipment for petroleum, petrochemical 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 contr

8、act. Users are responsible for its correct application.This corrigendum renumbers DD ISO/TS 29001:2010as DD CEN ISO/TS 29001:2011 BSI 2011ISBN 978 0 580 72222 6ICS 03.120.10; 75.020This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 30 Septe

9、mber 2010.Amendments/corrigenda issued since publicationDate Text affected30 June 2011TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 29001 February 2011 ICS 03.120.10; 75.020 English Version Petroleum, petrochemical and natural gas industries - Sector-specific qua

10、lity management systems - Requirements for product and service supply organizations (ISO/TS 29001:2010)Industries du ptrole, de la ptrochimie et du gaz naturel - Systmes de management de la qualit spcifiques au secteur - Exigences pour les organismes de fourniture de produits et de services (ISO/TS

11、29001:2010) Erdl-, petrochemische und Erdgasindustrie - Sektorspezifische Qualittsmanagementsysteme - Anforderungen an Hersteller- und Serviceorganisationen (ISO/TS 29001:2010) This Technical Specification (CEN/TS) was approved by CEN on 27 December 2010 for provisional application. The period of va

12、lidity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in th

13、e same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN me

14、mbers are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spai

15、n, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES 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 Me

16、mbers. Ref. No. CEN ISO/TS 29001:2011: Eii Foreword The text of ISO/TS 29001:2010 has been prepared by Technical Committee ISO/TC 67 “Materials, equipment and offshore structures for petroleum, petrochemical and natural gas industries” of the International Organization for Standardization (ISO) and

17、has been taken over as CEN ISO/TS 29001:2011 by Technical Committee CEN/TC 12 “Materials, equipment and offshore structures 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 docu

18、ment may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Specificat

19、ion: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United

20、Kingdom. Endorsement notice The text of ISO/TS 29001:2010 has been approved by CEN as a CEN ISO/TS 29001:2011 without any modification. DD CEN ISO/TS 29001:2011 CEN ISO/TS 29001:2011 (E) ISO 2011 iiiContents Page Foreword vi Introduction.vii 0.1 General .vii 0.2 Process approach viii 0.3 Relationshi

21、p with ISO 9004ix 0.4 Compatibility with other management systems.x 0.5 Goal of this Technical Specificationx 1 Scope1 1.1 General .1 1.1.1 Field of Application Supplemental1 1.2 Application .2 1.2.1 Application Supplemental2 2 Normative references2 3 Terms and definitions .2 3.1 Terms and definitio

22、ns for the petroleum, petrochemical and natural gas industries3 4 Quality management system4 4.1 General requirements .4 4.1.1 Outsourced processes and/or services Supplemental.4 4.2 Documentation requirements.5 4.2.1 General .5 4.2.2 Quality manual.5 4.2.2.1 Quality manual Supplemental5 4.2.3 Contr

23、ol of documents .6 4.2.3.1 Control of documents Supplemental 6 4.2.3.2 Control of document changes Supplemental 6 4.2.4 Control of records .6 4.2.4.1 Control of records Supplemental 7 5 Management responsibility 7 5.1 Management commitment 7 5.2 Customer focus .7 5.3 Quality policy .8 5.3.1 Quality

24、policy Supplemental8 5.4 Planning8 5.4.1 Quality objectives8 5.4.2 Quality management system planning8 5.5 Responsibility, authority and communication .9 5.5.1 Responsibility and authority 9 5.5.2 Management representative.9 5.5.3 Internal communication9 5.6 Management review 10 5.6.1 General .10 5.

25、6.1.1 General Supplemental 10 5.6.2 Review input 10 5.6.3 Review output11 6 Resource management.11 6.1 Provision of resources11 6.2 Human resources 11 6.2.1 General .11 6.2.2 Competence, training and awareness.12 DD CEN ISO/TS 29001:2011 CEN ISO/TS 29001:2011 (E) ISO 2011 iv 6.2.2.1 Training Supplem

26、ental12 6.3 Infrastructure12 6.4 Work environment .13 7 Product realization.13 7.1 Planning of product realization13 7.1.1 Planning of product realization Supplemental.13 7.2 Customer-related processes 14 7.2.1 Determination of requirements related to the product 14 7.2.2 Review of requirements rela

27、ted to the product 14 7.2.2.1 Review of requirements related to the product Supplemental .14 7.2.3 Customer communication 15 7.3 Design and development 15 7.3.1 Design and development planning 15 7.3.1.1 Design and development planning Supplemental .15 7.3.1.2 Design documentation Supplemental .15 7

28、.3.2 Design and development inputs 16 7.3.2.1 Design and development inputs Supplemental .16 7.3.3 Design and development outputs16 7.3.3.1 Design and development outputs Supplemental.16 7.3.4 Design and development review17 7.3.4.1 Design and development review Supplemental.17 7.3.5 Design and deve

29、lopment verification17 7.3.6 Design and development validation 18 7.3.7 Control of design and development changes.18 7.3.7.1 Control of design and development changes Supplemental18 7.4 Purchasing .18 7.4.1 Purchasing process 18 7.4.1.1 Purchasing process Supplemental .19 7.4.1.2 Criteria for suppli

30、er selection, evaluation, and re-evaluation Supplemental19 7.4.1.3 Supplier-provided processes that require validation Supplemental .19 7.4.2 Purchasing information 19 7.4.2.1 Purchasing information Supplemental .19 7.4.3 Verification of purchased product .20 7.4.3.1 Verification of purchased produc

31、t Supplemental 20 7.5 Production and service provision20 7.5.1 Control of production and service provision20 7.5.1.1 Control of production and service provision Supplemental.20 7.5.1.2 Process controls Supplemental.20 7.5.2 Validation of processes for production and service provision 21 7.5.2.1 Vali

32、dation of processes for production and service provision Supplemental .21 7.5.3 Identification and traceability.21 7.5.3.1 Identification and traceability Supplemental21 7.5.3.2 Identification and traceability maintenance and replacement Supplemental .22 7.5.3.3 Product status Supplemental.22 7.5.4

33、Customer property.22 7.5.4.1 Customer property Supplemental22 7.5.5 Preservation of product 22 7.5.5.1 Preservation of product Supplemental .22 7.5.5.2 Periodic assessment of stock Supplemental .22 7.6 Control of monitoring and measuring equipment23 7.6.1 Control of monitoring and measuring equipmen

34、t Supplemental 23 7.6.2 Environmental conditions Supplemental .24 8 Measurement, analysis and improvement 24 8.1 General24 8.2 Monitoring and measurement 25 8.2.1 Customer satisfaction .25 8.2.2 Internal audit 25 8.2.2.1 Internal audit Supplemental .25 8.2.2.2 Response times Supplemental 26 DD CEN I

35、SO/TS 29001:2011 CEN ISO/TS 29001:2011 (E) ISO 2011 v8.2.3 Monitoring and measurement of processes.26 8.2.4 Monitoring and measurement of product .26 8.2.4.1 Monitoring and measurement of product Supplemental 26 8.2.4.2 Acceptance inspection Supplemental 26 8.3 Control of nonconforming product .27 8

36、.3.1 Release or acceptance of nonconforming product Supplemental27 8.3.2 Field nonconformity analysis Supplemental .27 8.3.3 Customer notification Supplemental 28 8.4 Analysis of data .28 8.4.1 Analysis of data Supplemental28 8.5 Improvement 28 8.5.1 Continual improvement 28 8.5.2 Corrective action

37、.29 8.5.2.1 Corrective action Supplemental 29 8.5.2.2 Response times Supplemental 29 8.5.3 Preventive action.29 8.5.3.1 Preventive action Supplemental29 Bibliography30 DD CEN ISO/TS 29001:2011 CEN ISO/TS 29001:2011 (E) ISO 2011 vi Foreword ISO (the International Organization for Standardization) is

38、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 technical committee has been established has the right to be represent

39、ed 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 electrotechnical standardization. International Standards are dra

40、fted in accordance with the rules given in the ISO/IEC Directives, Part 2. 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 St

41、andard 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 technical committee may decide to publish other types of document: an ISO Publicly Available Specification (ISO/PAS) re

42、presents 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 committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical commit

43、tee 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 decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. Attent

44、ion 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/TS 29001 was prepared by Technical Committee ISO/TC 67, Materials, equipment and offshore structures fo

45、r petroleum, petrochemical and natural gas industries. This third edition cancels and replaces the second edition (ISO/TS 29001:2007), of which it constitutes a minor revision. In this third edition of ISO/TS 29001, the boxed text has been revised in order to ensure that it constitutes the text of I

46、SO 9001:2008 unaltered and in its entirety. No changes other than editorial have been made outside the boxed text. The fourth edition of ISO 9001 (ISO 9001:2008) cancelled and replaced the third edition (ISO 9001:2000), which was amended to clarify points in the text and to enhance compatibility wit

47、h ISO 14001:2004. Since the third edition, the title of ISO 9001 has been revised such that it no longer includes the term “Quality Assurance”. This reflects the fact that the quality management system requirements specified in ISO 9001 now also aim to enhance customer satisfaction, in addition to t

48、he quality assurance of a product. DD CEN ISO/TS 29001:2011 CEN ISO/TS 29001:2011 (E) ISO 2011 viiIntroduction 0.1 General ISO 9001:2008, Quality management systems Requirements Introduction 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influ