BS EN 9137-2012 Quality management systems Guidance for the Application of AQAP 2110 within an EN 9100 Quality Management System《质量管理体系 在EN 9100标准质量管理体系内AQAP 2110的应用指导》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 9137:2012Quality management systems Guidance for the Application of AQAP 2110 within an EN 9100 Quality Management SystemBS EN 9137:2012 BRITISH STANDARDNational forewordTh

2、is British Standard is the UK implementation of EN 9137:2012. The UK participation in its preparation was entrusted to T e c h n i c a l Committee ACE/1, International and European Aerospace Policy and Processes.A list of organizations represented on this committee can be obtained on request to its

3、secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012Published by BSI Standards Limited 2012ISBN 978 0 580 75041 0 ICS 03.120.10 Compliance with a British Standard c

4、annot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 February 2012.Amendments issued since publicationDate T e x t a f f e c t e dBS EN 9137:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9

5、137 February 2012 ICS 03.120.10 English Version Quality management systems - Guidance for the Application of AQAP 2110 within an EN 9100 Quality Management System Systmes de management de la qualit - Guide pour lapplication de lAQAP 2110 dans un Systme de Management de la Qualit EN 9100 Qualittsmana

6、gementsysteme - Anleitung fr die Anwendung von AQAP 2110 in einem EN 9100 Qualittsmanagementsystem This European Standard was approved by CEN on 26 June 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard th

7、e status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, Fren

8、ch, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria,

9、 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, Turkey and United Kingdom. EUROPEAN COMMITTEE

10、FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9137:2012: EBS EN 9137:2012EN 9137:2012 (E)

11、 2 Contents Page Foreword 31 Scope 42 Normative references 43 General guidance .44 Detailed guidance 5BS EN 9137:2012EN 9137:2012 (E) 3 Foreword This document (EN 9137:2012) has been prepared by the Aerospace and Defence Industries Association of Europe - Standardization (ASD-STAN). After enquiries

12、and votes carried out in accordance with the rules of this Association, this Standard has received the approval of the National Associations and the Official Services of the member countries of ASD, prior to its presentation to CEN. This European Standard shall be given the status of a national stan

13、dard, either by publication of an identical text or by endorsement, at the latest by August 2012, and conflicting national standards shall be withdrawn at the latest by August 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.

14、CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. Industry has established the International Aerospace Quality Group (IAQG), with representatives from companies in the Americas, Asia/Pacific, and Europe, to implement initiatives that make significant imp

15、rovements in quality and reductions in cost throughout the value stream. This standard has been developed under the auspices of the IAQG Defence Relationship Growth Strategy Stream and in collaboration with the North Atlantic Treaty Organization (NATO) AC/327, Working Group 2 (WG2) to provide guidan

16、ce on how the requirements of AQAP 2110 and EN 9100 can be fulfilled by one common Quality Management System. This guidance document has been prepared jointly by the IAQG and NATO, and the content of this standard is identical to AQAP 2009 Annex F from this point onwards. This is the initial release

17、 of this standard. This standard is intended to provide guidance and assist an organization in the use and understanding of the relationship between AQAP 2110 and EN 9100. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to

18、implement this European Standard: 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

19、, Switzerland, Turkey and the United Kingdom. BS EN 9137:2012EN 9137:2012 (E) 4 1 Scope 1.1 This European Standard has been prepared and issued to provide information and guidance on the application of AQAP 2110 when the Supplier adheres to the provisions of EN 9100. This document is published as AQ

20、AP 2009 Annex F and EN 9137. It was jointly developed by NATO and industry representatives for use by NATO and industry to facilitate the use and understanding of the relationship between the AQAP 2110 and EN 9100. 1.2 It aims to contribute to commonality of interpretation of the AQAP 2110 requireme

21、nts by the Acquirer and their EN 9100 Supplier. 1.3 Its content has no legal or contractual status nor does it supersede, add to, or cancel any of the AQAP 2110 or EN 9100 requirements. 1.4 Because of the multiplicity of conditions that can exist (dependent on such factors as the type of work or pro

22、cess, the devices used, and the skill of personnel involved), this guidance should not be considered as all-encompassing nor should it be considered as imposing specific means or methods for meeting contract requirements. Stakeholders should be aware that other means or methods could be used to meet

23、 these requirements. 1.5 Users of this guidance should keep in mind that the requirements of AQAP 2110 are mandatory, as cited in the contract, on Suppliers and Sub-suppliers. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated

24、references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 9100, Quality Management Systems Requirements for Aviation, Space and Defence Organizations AQAP 2009 Edition 3, NATO Guidance on the Use of the AQ

25、AP 2000 Series AQAP 2070 Edition 2, NATO Mutual Government Quality Assurance (GQA) Process AQAP 2110 Edition 3, NATO Quality Assurance Requirements for Design, Development and Production AQAP 2120 Edition 3, NATO Quality Assurance Requirements for Production AQAP 2130 Edition 3, NATO Quality Assuran

26、ce Requirements for Inspection and Test ISO 9001:2008, Quality management systems Requirements ISO 10012:2003, Measurement management systems Requirements for measurement processes and measuring equipment 3 General guidance 3.1 In an EN 9100 certificated organization, the entire content of both stan

27、dards is within the purview of Government Quality Assurance (GQA). 3.2 When reviewing the two documents (i.e. AQAP 2110, EN 9100) it is helpful to note the differences in wording used to describe the stakeholders. The following equivalence (see Table 1) is offered as a workable translation. The cont

28、ract will normally define the points of contact, outlining their role and authority. BS EN 9137:2012EN 9137:2012 (E) 5 Table 1 AQAP 2110 and EN 9100 stakeholder terms AQAP 2110 EN 9100 Acquirer Customer, only if it is the Acquiring government. Government Quality Assurance Representative (GQAR) A Cus

29、tomers Quality Representative. Supplier Organization with a direct contract with the government. Sub-supplier Supplier or Organization without a direct contract with the government. 3.3 EN 9100 is complementary (not alternative) to contractual and applicable law and regulatory requirements. It inclu

30、des ISO 9001:2008 Quality Management System (QMS) requirements and specifies additional requirements for a quality management system for the aviation, space and defence industries. 3.4 The common ISO 9001:2008 baseline inherently makes EN 9100 and AQAP 2110 appear almost identical. However, four fea

31、tures differentiate the two documents: a) AQAP 2110 defines contractual requirements; while EN 9100 defines organizational provisions to be addressed within the scope of certification; b) AQAP 2110 reflects the agreement between NATO members to contract using the mandatory QMS clauses that enables r

32、eciprocal GQA; while industry conformance to EN 9100 is voluntary; c) The additions to ISO 9001:2008 of both documents add higher level quality management functions. AQAP 2110 also includes additional requirements related to communication and GQAR access to contract pertinent facilities, information

33、 and processes; d) EN 9100 can be tailored by exclusions, according to the scope of the QMS; whereas AQAP 2110 is pre-tailored into AQAP 2120 and AQAP 2130. 3.5 It is acceptable for a Supplier to offer a QMS that complies with the provisions of EN 9100 as a satisfactory response to the QMS requireme

34、nts of AQAP 2110, under two conditions: a) The Supplier formally states that, “All EN 9100 requirements applicable to the organization are applicable to this contract”; b) The Supplier formally states that, “No exclusions to EN 9100 taken by the organization shall in any way diminish, alter, or reli

35、eve the AQAP 2110 requirements of this contract”; These formal statements could be made in tender documentation, the contract, or the Quality Plan (QP) and should always be brought to the attention of the GQAR. 4 Detailed guidance Detailed guidance is provided only where there is either the need for

36、 clarification or the potential for conflict or misunderstanding exists. Each paragraph and sub-paragraph of the standards (i.e., EN 9100, AQAP 2110) are listed below in Table 2 EN 9100 and AQAP 2110 Detailed harmonization guidance. Where either standard contains additional requirements or notes to

37、the base standard (i.e. ISO 9001:2008), the clause heading text is bolded. BS EN 9137:2012EN 9137:2012 (E) 6 Table 2 EN 9100 and AQAP 2110 detailed harmonization guidance EN 9100 CLAUSE AQAP 2110 CLAUSE DETAILED HARMONIZATION GUIDANCE 4.Quality management system 4.0 Quality management system 4.1 Gen

38、eral Requirements 4.1 General requirements The Acquirer has chosen the Supplier based in part, on their EN 9100 QMS. With respect to the NATO specific requirements: EN 9100 highlights the need to include customer and applicable statutory and regulatory requirements in the scope of the QMS in additio

39、n to the ISO 9001:2008 provisions relating to the product (see 7.2.1). The Acquirer and/or GQAR have the right to review and verify that the QMS meets the certification and contractual requirements. Where objective evidence of non-compliance is presented, the Supplier is obliged to take corrective a

40、ction. If corrective action is not taken or is shown to be persistently ineffective then ultimately the QMS might be rejected, but this is neither a desired or common outcome. Sharing details of EN 9100 certification results from the Online Aerospace Supplier Information System (OASIS) and audit rep

41、orts provides ongoing evidence of how the system is meeting the certification requirements and may reduce the need for the Acquirer/GQAR to conduct additional audits. 4.2 Documentation Requirements 4.2 Documentation requirements 4.2.1 General 4.2.1 General 4.2.2 Quality Manual 4.2.2 Quality manual I

42、n EN 9100 exclusions can be made based on the processes within the organization. Such exclusions are permissible as long as they match the tailoring criteria of the AQAP series as shown in AQAP 2009 Figure 2. With reference to AQAP 2110 subclause 5.4 it is permissible to detail any interpretational

43、clarifications or specific application of AQAP requirements in the QP. 4.2.3 Control of Documents 4.2.3 Control of documents 4.2.4 Control of Records 4.2.4 Control of records 5.Management responsibility 5.0 Management responsibility 5.1 Management Commitment 5.1 Management commitment 5.2 Customer Fo

44、cus 5.2 Customer focus 5.3 Quality Policy 5.3 Quality policy BS EN 9137:2012EN 9137:2012 (E) 7 EN 9100 CLAUSE AQAP 2110 CLAUSE DETAILED HARMONIZATION GUIDANCE 5.4 Planning 5.4 Planning Both EN 9100 and AQAP 2110 require planning for quality to be undertaken and recorded, describing how the product w

45、ill be realized (reference to 7.1). AQAP 2110 requires a contract specific QP be documented and provided to the Acquirer so that it may be reviewed against the contractual requirements. The QP describes the application of the QMS to fulfill the contract requirements; describing what the Supplier wil

46、l actually do (e.g. what requirements apply or how they are interpreted). To be compliant, QPs should address subclause 5.4 of AQAP 2110 and subclause 7.1 of both standards. QPs should be developed in conjunction with other project related planning (reference to EN 9100 subclause 7.1.1). 5.4.1 Quali

47、ty Objectives 5.4.1 Quality objectives 5.4.2 Quality Management System Planning 5.4.2 Quality Management system planning 5.5 Responsibility, Authority and Communication 5.5 Responsibility, authority and communication 5.5.1 Responsibility and Authority 5.5.1 Responsibility and authority 5.5.2 Managem

48、ent Representative 5.5.2 Management representative AQAP 2110 requires that the management representative reports directly to top management. EN 9100 requires that the management representative has unrestricted access to top management. The key aspect is that AQAP 2110 requires the management represe

49、ntative to have the necessary organizational authority and freedom to resolve matters pertaining to the QMS and product quality. In that respect, the standards are considered to be in harmony. 5.5.3 Internal Communication 5.5.3 Internal communication The NATO Specific requirement for communication with the GQAR should be considered as part of EN 9100 subclause 7.2.3 customer communication. 5.6 Management Review 5.6 Management review 5.6.1 General 5.6.1 General 5.6.2 Review Input 5.6.2 Review input 5.6.3 Review Output 5.6.3 Review output 6.