EN 9100-2018 en Quality Management Systems - Requirements for Aviation Space and Defence Organizations.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 OrganizationsBS EN 9100:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9100 May 2018 ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 910

2、0:2009English Version Quality Management Systems - Requirements for Aviation, Space and Defence Organizations Systmes de Management de la Qualit - Exigences pour les Organismes de lAronautique, lEspace et la Dfense Qualittsmanagementsysteme - Anforderungen an Organisationen der Luftfahrt, Raumfahrt

3、und Verteidigung This European Standard was approved by CEN on 27 February 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-date lists and b

4、ibliographical 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 under the res

5、ponsibility 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, Former Yugoslav R

6、epublic 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 STANDARDIZATION COMIT EUROP

7、EN 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 9100:2018 ENational forewordThis British Standard is the U

8、K implementation of EN 9100:2018. It supersedes BS EN 9100:2009, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European Aerospace Policy and Processes.A list of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 obtained on r

9、equest 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 91376 1ICS 49.020; 03.120.10Compliance with

10、 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 EN 9100:2018EUROPEAN STANDARD NO

11、RME EUROPENNE EUROPISCHE NORM EN 9100 May 2018 ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9100:2009English Version Quality Management Systems - Requirements for Aviation, Space and Defence Organizations Systmes de Management de la Qualit - Exigences pour les Organismes de lAronautique, lEspace e

12、t la Dfense Qualittsmanagementsysteme - Anforderungen an Organisationen der Luftfahrt, Raumfahrt und Verteidigung This European Standard was approved by CEN on 27 February 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this E

13、uropean 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 European Standard exists in three official vers

14、ions (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 members are the national standards bodies of Austria,

15、 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, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, S

16、weden, 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 in any form and by any means reserved worldwide

17、 for CEN national Members. Ref. No. EN 9100:2018 EBS EN 9100:2018EN 9100:2018 (E) 2 Contents Page European foreword . 3 Rationale . 4 Foreword 4 Intended application 5 0 Introduction 5 1 Scope . 10 2 Normative references . 10 3 Terms and definitions 10 4 Context of the organization 11 5 Leadership 1

18、4 6 Planning . 16 7 Support 17 8 Operation 22 9 Performance evaluation 39 10 Improvement . 42 (informative) Clarification of new structure, terminology and concepts . 44 (informative) Other international standards on quality management and quality management systems developed by ISO/TC 176 48 (infor

19、mative) Other standards on quality management and quality management systems developed by the international aerospace quality group 52 (informative) Bibliography 56 (informative) Aviation , space and defence bibliography 58 Figures Figure 1 Schematic representation of the elements of a single proces

20、s 7 Figure 2 Representation of the structure of this international standard in the PDCA cycle 8 BS EN 9100:2018EN 9100:2018 (E) 3 European foreword This document (EN 9100:2018) has been prepared by the Aerospace and Defence Industries Association of Europe - Standardization (ASD-STAN). After enquiri

21、es 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 s

22、tandard, 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 of this document may be the subject of patent r

23、ights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 9100:2009. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standa

24、rd: 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, Portugal, Romania, Serbia, Slovakia, Sloven

25、ia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9100:2018EN 9100:2018 (E) 4 Rationale This document has been revised to incorporate the new clause structure and content of EN ISO 9001:2015. In addition, industry requirements, definitions and notes have been revised in response t

26、o 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 applicable statutory and regulatory requirements. The

27、 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 the world and at all levels of the supply chain.

28、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 aviation, space and defence companies in the Amer

29、icas, 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 requirements to the greatest extent possible and

30、 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 of the quality management system and wider app

31、lication 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 needed. This document includes EN ISO 9001:20151qual

32、ity management system requirements and specifies additional aviation, space and defence industry requirements, definitions and notes as shown in bold, italic text. 1With the permission of the International Organization for Standardization (ISO). The complete EN ISO 9001 standard can be obtained from

33、 any ISO member or from the ISO Central Secretariat: BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, SWITZERLAND, or visit www.iso.org. Copyright remains with ISO. BS EN 9100:2018EN 9100:2018 (E) 5 Intended application This document is intended for use by organizations that design, de

34、velop, or provide aviation, space and defence products and services; and by organizations providing post-delivery activities, including the provision of maintenance, spare parts, or materials for their own products and services. NOTE Organizations whose products are deliverable software, or contain

35、deliverable software, should use the IAQG-developed EN 9115 standard (see Bibliography) when planning and evaluating the software design, development, or management activities of the organization. The EN 9115 standard provides guidance to the requirements of the EN 9100 standard when it is desired t

36、o add “software” to the EN 9100 quality management system scope. 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 overh

37、aul operations that are operated autonomously, or that are substantially different from their production operations; should use the IAQG-developed EN 9110 standard (see Bibliography). Organizations that procure parts, materials and assemblies and resells these products to a customer in the aviation,

38、 space and defence industry should use the IAQG-developed EN 9120 standard (see Bibliography). This includes organizations that procure products and split them into smaller quantities, as well as those that coordinate a customer or regulatory controlled process on the product. 0 Introduction 0.1 Gen

39、eral 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

40、 on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context

41、 and objectives; d) the ability to demonstrate conformity to specified quality management system requirements. This International Standard can be used by internal and external parties. It is not the intent of this International Standard to imply the need for: uniformity in the structure of different

42、 quality management systems; alignment of documentation to the clause structure of this International Standard; the use of the specific terminology of this International Standard within the organization. BS EN 9100:2018EN 9100:2018 (E) 6 The quality management system requirements specified in this I

43、nternational Standard are complementary to requirements for products and services. This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. The process approach enables an organization to plan its processes and their int

44、eractions. The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed and that opportunities for improvement are determined and acted on. Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality

45、management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see clause A.4). Consistently meeting requirements and addressing future needs and expectations poses a challenge for organi

46、zations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization. In this Internationa

47、l Standard, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability. Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.

48、0.2 Quality management principles This International Standard is based on the quality management principles described in EN ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with

49、the principle and examples of typical actions to improve the organizations performance when applying the principle. The quality management principles are: customer focus; leadership; engagement of people; process approach; improvement; evidence-based decision making; relationship management. BS EN 9100:2018EN 9100:2018 (E) 7 0.3 Process approach 0.3.1 General This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to e