EN 9110-2015 en Quality Management Systems - Requirements for Aviation Maintenance Organizations《质量管理体系 航空维修组织的要求》.pdf

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1、BSI Standards PublicationBS EN 9110:2015Quality Management Systems Requirements for AviationMaintenance OrganizationsBS EN 9110:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 9110:2015. It supersedes BS EN 9110:2010 which is withdrawn.The UK participation

2、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 purport to include all the necessary provisions of a co

3、ntract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 75995 6 ICS 03.120.10; 49.020 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published u

4、nder the authority of the Standards Policy and Strategy Committee on 28 February 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9110 February 2015 ICS 03.120.10; 49.020 Supersedes EN 9110:2010English Version Quality

5、 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 approved by CEN on 29 Nove

6、mber 2014. 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 standards may be ob

7、tained 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 and notified to the

8、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, Hungary, Iceland, Irela

9、nd, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Cent

10、re: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9110:2015 EBS EN 9110:2015EN 9110:2015 (E) 2 RATIONALE This standard has been revised to address stakeholder needs through the addition of d

11、efinitions and clarification of existing requirements to resolve interpretation issues, and incorporate editorial corrections. FOREWORD To assure customer satisfaction, aviation and defence organizations must produce, maintain, repair and continually improve, safe, reliable products that meet or exc

12、eed customer and applicable 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 from suppliers throughout t

13、he world and at all levels of the supply chain. Suppliers have the challenge of delivering products to multiple customers having varying quality requirements and expectations. Industry has established the International Aerospace Quality Group (IAQG), with representatives from companies in the Americ

14、as, Asia/Pacific and Europe, to implement initiatives that make significant improvements in quality and reductions in cost throughout the value stream. This standard has been prepared by the IAQG. This document standardizes quality management system requirements to the greatest extent possible and c

15、an be used at all levels of the supply chain by organizations around the world. Its use should result in improved quality, schedule, and cost performance by the reduction or elimination of organization-unique requirements and wider application of good practice. While primarily developed for the avia

16、tion and defence industry organizations providing maintenance services, this standard can also be used in other industry sectors where a quality management system with additional requirements over an ISO 9001 system is needed. BS EN 9110:2015EN 9110:2015 (E) 3 Contents Page RATIONALE . 2 FOREWORD 2

17、Foreword . 5 Introduction . 6 0.1 General . 6 0.2 Process approach . 6 Quality management systems Requirements . 8 1 Scope 8 1.1 General . 8 1.2 Application . 8 2 Normative references 9 3 Terms and definitions . 9 4 Quality management system 11 4.1 General requirements . 11 4.2 Documentation require

18、ments. 12 4.2.1 General . 12 4.2.2 Quality manual . 12 4.2.3 Control of documents . 13 4.2.4 Control of records . 13 5 Management responsibility 14 5.1 Management commitment 14 5.2 Customer focus . 14 5.3 Quality policy . 14 5.4 Planning 14 5.4.1 Quality objectives 14 5.4.2 Quality management system

19、 planning 15 5.4.3 Safety objectives . 15 5.5 Responsibility, authority and communication . 15 5.5.1 Responsibility and authority 15 5.5.1.1 Accountable manager . 15 5.5.1.2 Maintenance manager(s) 15 5.5.2 Management representative . 15 5.5.3 Internal communication 16 5.6 Management review 16 5.6.1

20、General . 16 5.6.2 Review input 16 5.6.3 Review output 16 5.7 Safety policy 16 6 Resource management . 17 6.1 Provision of resources 17 6.2 Human resources 17 6.2.1 General . 17 6.2.2 Competence, training and awareness . 17 BS EN 9110:2015EN 9110:2015 (E) 4 6.3 Infrastructure . 18 6.4 Work environme

21、nt 18 7 Product realization 18 7.1 Planning of product realization . 18 7.1.1 Project management 19 7.1.2 Risk management . 19 7.1.3 Configuration management . 19 7.1.4 Control of work transfers . 20 7.2 Customer-related processes . 20 7.2.1 Determination of requirements related to the product . 20

22、7.2.2 Review of requirements related to the product . 20 7.2.3 Customer communication . 21 7.3 Design and development . 21 7.3.1 Design and development planning . 21 7.3.2 Design and development inputs . 21 7.3.3 Design and development outputs . 22 7.3.4 Design and development review . 22 7.3.5 Desi

23、gn and development verification . 22 7.3.6 Design and development validation . 23 7.3.6.1 Design and development verification and validation testing . 23 7.3.6.2 Design and development verification and validation documentation . 23 7.3.7 Control of design and development changes 23 7.4 Purchasing 23

24、 7.4.1 Purchasing process . 23 7.4.2 Purchasing information . 24 7.4.3 Verification of purchased product 25 7.5 Production and service provision . 25 7.5.1 Control of production and service provision . 25 7.5.1.1 Maintenance process verification . 27 7.5.1.2 Control of maintenance process changes .

25、27 7.5.1.3 Control of maintenance equipment, tools, and software programs 27 7.5.1.4 Post-delivery support . 27 7.5.2 Validation of processes for production and service provision . 27 7.5.3 Identification and traceability 28 7.5.4 Customer property 28 7.5.5 Preservation of product . 29 7.6 Control o

26、f monitoring and measuring equipment . 29 8 Measurement, analysis and improvement . 30 8.1 General . 30 8.2 Monitoring and measurement . 30 8.2.1 Customer satisfaction 30 8.2.2 Internal audit . 31 8.2.3 Monitoring and measurement of processes 31 8.2.4 Monitoring and measurement of product 31 8.3 Con

27、trol of nonconforming product . 32 8.4 Analysis of data 33 8.5 Improvement . 34 8.5.1 Continual improvement 34 8.5.2 Corrective action. 34 8.5.3 Preventive action 34 9 Notes 35 Bibliography . 36 Figure Figure 1 Model of a process-based quality management system 7 BS EN 9110:2015EN 9110:2015 (E) 5 Fo

28、reword This document (EN 9110:2015) has been prepared by the Aerospace and Defence Industries Association of Europe - 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 Associatio

29、ns 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 standard, either by publication of an identical text or by endorsement, at the latest by August 2015, and conflicting national standards shall

30、 be withdrawn at the latest by August 2015. Attention is drawn to the possibility that some of the elements 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 9110:2010. Acc

31、ording to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, German

32、y, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9110:2015EN 9110:2015 (E) 6 Introduction 0.1 General The adoption of a quality manag

33、ement system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by: a. its organizational environment, changes in that environment, and the risks associated with that environment, b. its varying needs, c. its p

34、articular objectives, d. the products it provides, e. the processes it employs, f. its size and organizational structure. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management syst

35、em requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. This International Standard can be used by internal and external parties, including certificat

36、ion bodies, to assess the organizations ability to meet customer, statutory, and regulatory requirements applicable to the product, and the organizations own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of t

37、his International Standard. 0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing, and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an organizati

38、on to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the inpu

39、t to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“. An advantage of the process approach is the on-goin

40、g control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within a quality management system, such an approach emphasizes the importance of: a. understanding and meeting requirements, b. t

41、he need to consider processes in terms of added value, c. obtaining results of process performance and effectiveness, and d. continual improvement of processes based on objective measurement. BS EN 9110:2015EN 9110:2015 (E) 7 The model of a process-based quality management system shown in Figure 1 i

42、llustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization ha

43、s met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. NOTE In addition, the methodology known as “Plan-Do-Check-Act“ (PDCA) can be applied to all processes. PDCA can be briefly describ

44、ed as follows. Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies. Do: implement the processes. Check: monitor and measure processes and product against policies, objectives and requirements for the produc

45、t and report the results. Act: take actions to continually improve process performance. Figure 1 Model of a process-based quality management system BS EN 9110:2015EN 9110:2015 (E) 8 Quality management systems Requirements 1 Scope 1.1 General This standard includes ISO 9001:2008 1)quality management

46、system requirements and specifies additional aviation maintenance industry requirements, definitions and notes as shown in bold, italic text. NOTE 1 Baseline aviation maintenance requirements originate from IAQG developed 9100:2009 standard; modifications were made, as required, to address maintenan

47、ce industry specific requirements. It is emphasized that the requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory

48、or regulatory requirements, the latter shall take precedence. This International Standard specifies requirements for a quality management system where an organization: a. needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requ

49、irements, and b. aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE 2 In this International Standard, the term “product“ only applies to: a. product intended for, or required by, a customer, b. any intended output resulting from the product realization processes. NOTE 3 Statutory and regulatory requirements can be expressed as legal requirements. 1.2 Application All r