EN 9110-2018 en Quality Management Systems - Requirements for Aviation Maintenance 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 Maintenance OrganizationsBS EN 9110:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9110 May 2018 ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9110:2015E

2、nglish Version Quality Management Systems - Requirements for Aviation Maintenance Organizations Systmes de Management de la Qualit - Exigences pour les Organismes dEntretien de lAronautique Qualittsmanagementsysteme - Anforderungen fr Luftfahrt-Instandhaltungsbetriebe This European Standard was appr

3、oved by CEN on 10 March 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 bibliographical references concerning such national

4、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 responsibility of a CEN member into its own language a

5、nd 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 Republic of Macedonia, France, Germany, Greece, Hung

6、ary, 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 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG

7、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 9110:2018 ENational forewordThis British Standard is the UK implementation of EN 9110:2018. It supersedes BS

8、EN 9110:2015, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European Aerospace Policy and Processes.A list of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 request to its secretary.This publication does not p

9、urport 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 91465 2ICS 49.020; 03.100.70; 03.120.10Compliance with a British Standard cannot confer immuni

10、ty 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 9110:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9110 Ma

11、y 2018 ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9110:2015English Version Quality Management Systems - Requirements for Aviation Maintenance Organizations Systmes de Management de la Qualit - Exigences pour les Organismes dEntretien de lAronautique Qualittsmanagementsysteme - Anforderungen fr L

12、uftfahrt-Instandhaltungsbetriebe This European Standard was approved by CEN on 10 March 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-dat

13、e 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

14、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, Form

15、er 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 STANDARDIZATIO

16、N 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 9110:2018 EBS EN 9110:2018EN 9110:2018 (E) 2

17、Contents Page European foreword . 4 Rationale . 5 Foreword . 5 Intended application 6 0 Introduction 6 0.1 General 6 0.2 Quality management principles . 7 0.3 Process approach 8 0.4 Relationship with other management system standards 10 1 Scope . 11 2 Normative references . 11 3 Terms and definition

18、s 11 4 Context of the organization 13 4.1 Understanding the organization and its context 13 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. 14 5 Leadership 15 5.1 Le

19、adership and commitment . 15 5.2 Policy 16 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 . 20 7 Support 20 7.1 Resources 20 7.2 Competenc

20、e 22 7.3 Awareness . 23 7.4 Communication . 23 7.5 Documented information 24 8 Operation 25 8.1 Operational planning and control 25 8.2 Requirements for products and services 29 8.3 Design and development of products and services . 30 8.4 Control of externally provided processes, products and servic

21、es . 33 8.5 Production and service provision 36 8.6 Release of products and services . 40 8.7 Control of nonconforming outputs 40 9 Performance evaluation 42 9.1 Monitoring, measurement, analysis and evaluation . 42 9.2 Internal audit . 43 BS EN 9110:2018EN 9110:2018 (E) 3 9.3 Management review 44 1

22、0 Improvement 45 10.1 General . 45 10.2 Nonconformity and corrective action . 45 10.3 Continual improvement . 46 (informative) Clarification of new structure, terminology and concepts 47 A.1 Structure and terminology 47 A.2 Products and services . 47 A.3 Understanding the needs and expectations of i

23、nterested parties 48 A.4 Risk-based thinking . 48 A.5 Applicability . 49 A.6 Documented information 49 A.7 Organizational knowledge 50 A.8 Control of externally provided processes, products and services 50 (informative) Other international standards on quality management and quality management syste

24、ms developed by ISO/TC 176 51 (informative) Other standards on quality management and quality management systems developed by the international aerospace quality group . 55 (informative) Bibliography 57 (informative) Aviation, space and defence bibliography . 59 Figures Figure 1 Schematic representa

25、tion of the elements of a single process 8 Figure 2 Representation of the structure of this international standard in the PDCA cycle 9 BS EN 9110:2018EN 9110:2018 (E) 4 European foreword This document (EN 9110:2018) has been prepared by the Aerospace and Defence Industries Association of Europe - St

26、andardization (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 Standard sh

27、all 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 of this

28、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 9110:2015. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are

29、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, Poland, Port

30、ugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9110:2018EN 9110:2018 (E) 5 Rationale This document has been revised to incorporate the new clause structure and content of EN ISO 9001:2015. In addition, industry requirements, definitions an

31、d notes have been revised in response to both EN ISO 9001:2015 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 applicabl

32、e 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 the w

33、orld 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 aviat

34、ion, 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 requ

35、irements 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 of

36、 the quality management system and wider application of good practice. While primarily developed for civil and military aviation industry organizations providing maintenance services, this document can also be used in other industry sectors when a quality management system with additional requiremen

37、ts over an EN ISO 9001:2015 system is needed. This document includes EN ISO 9001:20151quality management system requirements and specifies additional civil and military aviation maintenance and continuing airworthiness industry requirements, definitions and notes as shown in bold, italic text. 1ISO

38、9001:2015 is reproduced in this document with the permission of the International Organization 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 th

39、e web site of the ISO Central Secretariat at www.iso.org. Copyright remains with ISO. BS EN 9110:2018EN 9110:2018 (E) 6 Intended application This document is intended for use by organizations whose primary business is providing maintenance or continuing airworthiness management services for civil or

40、 military aviation articles and products; and by original equipment manufacturers with maintenance, repair and overhaul operations that are operated autonomously or that are substantially different from their production operations. Organizations that design, develop or provide aviation, space and de

41、fence products and services; and organizations providing post-delivery activities, including the provision of maintenance, spare parts or materials for their own products and services should use the IAQG-developed EN 9100 standard (see Bibliography). Organizations that procure parts, materials and a

42、ssemblies and resell these products to a customer in the aviation, 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 re

43、gulatory controlled process on the product. 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

44、 an organization of implementing a quality management system based 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;

45、 c) addressing risks and opportunities associated with its context 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 Standa

46、rd to imply the need for: uniformity in the structure of different 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. The quality management system

47、requirements specified in this International 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. BS EN 9110:2018EN 9110:2018 (E) 7 The process ap

48、proach enables an organization to plan its processes and their interactions. 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 det

49、ermine the factors that could cause its processes and its quality 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 A.4). Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations 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