EN 9120-2018 en Quality Management Systems - Requirements for Aviation Space and Defence Distributors.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Quality Management Systems - Requirements for Aviation, Space and Defence DistributorsBS EN 9120:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9120 May 2018 ICS 03.100.70; 03.120.10; 49.020; 95.040 Supersedes

2、 EN 9120:2010English Version Quality Management Systems - Requirements for Aviation, Space and Defence Distributors Systmes de Management de la Qualit - Exigences pour les distributeurs de lAronautique, lEspace et la Dfense Qualittsmanagementsysteme - Anforderungen fr Hndler und Lagerhalter der Luft

3、fahrt, Raumfahrt und Verteidigung This European Standard was approved by CEN on 10 April 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-da

4、te 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, French, German). A version in any other language made by translation

5、 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, For

6、mer Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATI

7、ON COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9120:2018 ENational forewordThis British Sta

8、ndard is the UK implementation of EN 9120:2018. It supersedes BS EN 9120:2010, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European Aerospace Policy and Processes.A list of organizations represented on this committee can be

9、 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 correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 91466 9ICS 03.100.70; 95.040;

10、 49.020; 03.120.10Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS

11、 EN 9120:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9120 May 2018 ICS 03.100.70; 03.120.10; 49.020; 95.040 Supersedes EN 9120:2010English Version Quality Management Systems - Requirements for Aviation, Space and Defence Distributors Systmes de Management de la Qualit - Exigences pour l

12、es distributeurs de lAronautique, lEspace et la Dfense Qualittsmanagementsysteme - Anforderungen fr Hndler und Lagerhalter der Luftfahrt, Raumfahrt und Verteidigung This European Standard was approved by CEN on 10 April 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations

13、which stipulate the conditions for giving this European Standard the 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

14、 European Standard exists in three official versions (English, French, 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 membe

15、rs are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portuga

16、l, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation

17、 in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9120:2018 EBS EN 9120:2018EN 9120:2018 (E) 2 Contents Page European foreword . 5 Rationale . 6 Foreword . 6 Intended application 7 0 Introduction 7 0.1 General 7 0.2 Quality management principles . 8 0.3 Process a

18、pproach 9 0.3.1 General 9 0.3.2 Plan-do-check-act cycle 10 0.3.3 Risk-based thinking 10 0.4 Relationship with other management system standards 11 1 Scope . 12 2 Normative references . 12 3 Terms and definitions 12 4 Context of the organization 14 4.1 Understanding the organization and its context 1

19、4 4.2 Understanding the needs and expectations of interested parties . 14 4.3 Determining the scope of the quality management system 14 4.4 Quality management system and its processes. 15 5 Leadership 16 5.1 Leadership and commitment . 16 5.1.1 General . 16 5.1.2 Customer focus 17 5.2 Policy 17 5.2.

20、1 Establishing the quality policy 17 5.2.2 Communicating the quality policy . 17 5.3 Organizational roles, responsibilities and authorities 17 6 Planning . 18 6.1 Actions to address risks and opportunities 18 6.2 Quality objectives and planning to achieve them . 19 6.3 Planning of changes . 19 7 Sup

21、port 20 7.1 Resources 20 7.1.1 General . 20 7.1.2 People . 20 7.1.3 Infrastructure 20 7.1.4 Environment for the operation of processes . 20 7.1.5 Monitoring and measuring resources 21 7.1.6 Organizational knowledge 21 7.2 Competence 22 7.3 Awareness . 22 7.4 Communication . 23 BS EN 9120:2018EN 9120

22、:2018 (E) 3 7.5 Documented information 23 7.5.1 General . 23 7.5.2 Creating and updating . 23 7.5.3 Control of documented information 23 8 Operation . 25 8.1 Operational planning and control 25 8.1.1 (Not used) . 26 8.1.2 Configuration management . 26 8.1.3 (Not used) . 27 8.1.4 Prevention of counte

23、rfeit parts . 27 8.1.5 Prevention of suspected unapproved parts 27 8.2 Requirements for products and services . 27 8.2.1 Customer communication . 27 8.2.2 Determining the requirements for products and services 28 8.2.3 Review of the requirements for products and services 28 8.2.4 Changes to requirem

24、ents for products and services . 29 8.3 Design and development of products and services 29 8.3.1 General . 29 8.3.2 Design and development planning . 29 8.3.3 Design and development inputs 29 8.3.4 Design and development controls 30 8.3.5 Design and development outputs . 30 8.3.6 Design and developm

25、ent changes 31 8.4 Control of externally provided processes, products and services 31 8.4.1 General . 31 8.4.2 Type and extent of control 32 8.4.3 Information for external providers . 33 8.5 Production and service provision 34 8.5.1 Control of production and service provision 34 8.5.2 Identification

26、 and traceability . 36 8.5.3 Property belonging to customers or external providers . 37 8.5.4 Preservation . 37 8.5.5 Post-delivery activities . 37 8.5.6 Control of changes 38 8.6 Release of products and services 38 8.7 Control of nonconforming outputs . 39 9 Performance evaluation . 40 9.1 Monitori

27、ng, measurement, analysis and evaluation . 40 9.1.1 General . 40 9.1.2 Customer satisfaction 40 9.1.3 Analysis and evaluation . 41 9.2 Internal audit . 41 9.3 Management review 42 9.3.1 General . 42 9.3.2 Management review inputs . 42 9.3.3 Management review outputs 42 10 Improvement 43 10.1 General

28、 . 43 10.2 Nonconformity and corrective action . 43 10.3 Continual improvement . 44 (informative) Clarification of new structure, terminology and concepts 45 BS EN 9120:2018EN 9120:2018 (E) 4 A.1 Structure and terminology . 45 A.2 Products and services . 45 A.3 Understanding the needs and expectatio

29、ns of interested parties . 46 A.4 Risk-based thinking 46 A.5 Applicability . 47 A.6 Documented information 47 A.7 Organizational knowledge 48 A.8 Control of externally provided processes, products and services . 48 (informative) Other international standards on quality management and quality managem

30、ent systems developed by ISO/TC 176 49 (informative) Other standards on quality management and quality management systems developed by the international aerospace quality group 53 (informative) Bibliography 57 (informative) Aviation, space and defence bibliography 59 Figures Figure 1 Schematic repre

31、sentation of the elements of a single process 9 Figure 2 Representation of the structure of this international standard in the PDCA cycle . 10 BS EN 9120:2018EN 9120:2018 (E) 5 European foreword This document (EN 9120:2018) has been prepared by the Aerospace and Defence Industries Association of Eur

32、ope - Standardization (ASD-STAN). After enquiries 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 Sta

33、ndard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018. Attention is drawn to the possibility that some of the elements

34、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 patent rights. This document supersedes EN 9120:2010. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countr

35、ies are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Pola

36、nd, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9120:2018EN 9120:2018 (E) 6 Rationale This document has been revised to incorporate the new clause structure and content of EN ISO 9001:2015. In addition, industry requirements, defini

37、tions and notes have been revised in response to both EN ISO 9001 revisions and stakeholder needs. Foreword To assure customer satisfaction, aviation, space and defence organizations must provide and continually improve, safe and reliable products and services that meet or exceed customer and applic

38、able statutory and regulatory requirements. The globalization of the industry and the resulting diversity of regional and national requirements and expectations have complicated this objective. Organizations have the challenge of purchasing products and services from external providers throughout th

39、e world and at all levels of the supply chain. External providers have the challenge of delivering products and services to multiple customers having varying quality requirements and expectations. Industry has established the International Aerospace Quality Group (IAQG), with representatives from av

40、iation, space and defence companies in the Americas, Asia/Pacific and Europe, to implement initiatives that make significant improvements in quality and reductions in cost throughout the value stream. This document has been prepared by the IAQG. This document standardizes quality management system r

41、equirements to the greatest extent possible and can be used at all levels of the supply chain by organizations around the world. Its use should result in improved quality, cost and delivery performance through the reduction or elimination of organization-unique requirements, effective implementation

42、 of the quality management system and wider application of good practice. While primarily developed for the aviation, space and defence industry, this document can also be used in other industry sectors when a quality management system with additional requirements over an EN ISO 9001 system is neede

43、d. This document includes EN ISO 9001:20151quality management system requirements and specifies additional aviation, space and defence industry requirements, definitions and notes as shown in bold, italic text. 1ISO 9001:2015 is reproduced in this document with the permission of the International Or

44、ganization for Standardization, ISO. No parts of this standard may be reproduced in any form without the prior written consent of ISO at copyrightiso.org. ISO Standards can be obtained from any ISO member and from the web site of the ISO Central Secretariat at www.iso.org. Copyright remains with ISO

45、. BS EN 9120:2018EN 9120:2018 (E) 7 Intended application This document is intended for use by organizations that procure parts, materials and assemblies and resell these products to a customer in the aviation, space and defence industries. This includes organizations that procure products and split

46、them into smaller quantities, including those that coordinate a customer or regulatory controlled process on the product. This document is not intended for organizations that maintain or repair products or for organizations that perform work that affect or could affect product characteristics or con

47、formity. Organizations that design, develop or provide aviation, space and defence products and services should use the IAQG-developed EN 9100 standard (see bibliography). This includes organizations providing post-delivery activities, including the provision of maintenance, spare parts or materials

48、 for their own products and services. Organizations whose primary business is providing maintenance or continuing airworthiness management services for civil or military aviation articles and products and original equipment manufacturers with maintenance, repair and overhaul operations that are oper

49、ated autonomously or that are substantially different from their production operations; should use the IAQG-developed EN 9110 standard (see bibliography). 0 Introduction 0.1 General The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) the ability to consistently provide pro