EN 9110-2010 3125 Quality Management Systems - Requirements for Aviation Maintenance Organizations《质量管理体系 航空维修机构要求》.pdf

1、BS EN 9110:2010ICS 03.120.10; 49.020NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDQuality ManagementSystems Requirements forAviation MaintenanceOrganizationsCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo

2、 reproduction or networking permitted without license from IHS-,-,-This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010ISBN 978 0 580 70187 0Amendments/corrigenda issued since publicationDate CommentsBS EN 9110:2010National forewo

3、rdThis British Standard is the UK implementation of EN 9110:2010. Itsupersedes BS EN 9110:2005 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee ACE/1, International and European Aerospace Policy andProcesses.A list of organizations represented on this co

4、mmittee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.Copyright European Committee fo

5、r Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 9110:2010EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9110 June 2010 ICS 03.120.10; 49.020 Supersedes EN 9110:2005English Version Quality Managemen

6、t Systems - Requirements for Aviation Maintenance Organizations Systmes de management de la Qualit - Exigences pour les Organismes dEntretien de lAronautique Qualittsmanagementsysteme - Anforderungen fr Luftfahrt-Wartungsfirmen This European Standard was approved by CEN on 22 April 2010. CEN members

7、 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 obtained on application

8、to the CEN 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 CEN Management Centre has the

9、same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,

10、 Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any

11、means reserved worldwide for CEN national Members. Ref. No. EN 9110:2010: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 9110:2010EN 9110:2010 (E) 2 Contents Page Forewor

12、d 4FOREWORD .5REVISION SUMMARY/RATIONALE .50 Introduction 60.1 General .60.2 Process approach .6Quality management systems Requirements .81 Scope 81.1 General .81.2 Application .82 Normative references 93 Terms and definitions .94 Quality management system . 114.1 General requirements 114.2 Document

13、ation requirements . 124.2.1 General 124.2.2 Quality manual 124.2.3 Control of documents 134.2.4 Control of records 135 Management responsibility . 145.1 Management commitment . 145.2 Customer focus 145.3 Quality policy 145.4 Planning 145.4.1 Quality objectives . 145.4.2 Quality management system pl

14、anning 155.4.3 Safety objectives 155.5 Responsibility, authority and communication 155.5.1 Responsibility and authority . 155.5.2 Management representative 155.5.3 Internal communication . 165.6 Management review . 165.6.1 General 165.6.2 Review input . 165.6.3 Review output . 165.7 Safety policy .

15、176 Resource management 176.1 Provision of resources 176.2 Human resources . 176.2.1 General 176.2.2 Competence, training and awareness 176.3 Infrastructure 186.4 Work environment 187 Product realization . 187.1 Planning of product realization . 187.1.1 Project management 19Copyright European Commit

16、tee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 9110:2010EN 9110:2010 (E) 3 7.1.2 Risk management . 197.1.3 Configuration management . 197.1.4 Control of work transfers . 207.2 Customer-related pro

17、cesses 207.2.1 Determination of requirements related to the product . 207.2.2 Review of requirements related to the product . 207.2.3 Customer communication 217.3 Design and development 217.3.1 Design and development planning . 217.3.2 Design and development inputs 227.3.3 Design and development out

18、puts . 227.3.4 Design and development review . 227.3.5 Design and development verification . 237.3.6 Design and development validation 237.3.7 Control of design and development changes 237.4 Purchasing . 247.4.1 Purchasing process 247.4.2 Purchasing information 247.4.3 Verification of purchased prod

19、uct 257.5 Production and service provision . 267.5.1 Control of production and service provision . 267.5.2 Validation of processes for production and service provision 287.5.3 Identification and traceability 287.5.4 Customer property 287.5.5 Preservation of product 297.6 Control of monitoring and me

20、asuring equipment . 298 Measurement, analysis and improvement 308.1 General . 308.2 Monitoring and measurement 318.2.1 Customer satisfaction 318.2.2 Internal audit 318.2.3 Monitoring and measurement of processes 318.2.4 Monitoring and measurement of product . 328.3 Control of nonconforming product .

21、 338.4 Analysis of data . 348.5 Improvement 348.5.1 Continual improvement 348.5.2 Corrective action . 348.5.3 Preventive action 35Bibliography 36Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without licens

22、e from IHS-,-,-BS EN 9110:2010EN 9110:2010 (E) 4 Foreword This document (EN 9110:2010) 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 h

23、as 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 standard, either by publication of an identical text or by endorsement, at the latest by De

24、cember 2010, and conflicting national standards shall be withdrawn at the latest by December 2010. 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 pa

25、tent rights. This document supersedes EN 9110:2005. According 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

26、, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Copyright European Committee for Standardization Provided by IHS under license wit

27、h CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 9110:2010EN 9110:2010 (E) 5 FOREWORD To assure customer satisfaction, aviation and defense organizations must produce, maintain, repair and continually improve, safe, reliable products that meet or exceed c

28、ustomer 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 the wo

29、rld 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 Americas, A

30、sia/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 can be

31、 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 aviation a

32、nd defense industry, organizations providing maintenance, repair and overhaul 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. REVISION SUMMARY/RATIONALE This standard has been revised

33、 to incorporate the requirements of ISO 9001:2008 and IAQG developed 9100:2009. In addition, industry requirements, definitions and notes have been revised and additional requirements have been included in response to stakeholder needs. Copyright European Committee for Standardization Provided by IH

34、S under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 9110:2010EN 9110:2010 (E) 6 0 Introduction 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an o

35、rganizations 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 particular objectives; d) the products it provides; e) the processes it employs; f) its size and organ

36、izational structure. It is not the intent of this European Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this European Standard are complementary to requirements for products. Inform

37、ation marked “NOTE“ is for guidance in understanding or clarifying the associated requirement. This European Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regulatory requirements applicable t

38、o 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 this European Standard. 0.2 Process approach This European Standard promotes the adoption of a process approach when d

39、eveloping, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using re

40、sources, 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 input to the next. The application of a system of processes within an organization, together with the identification and interaction

41、s 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 ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over thei

42、r combination and interaction. When used within a quality management system, such an approach emphasizes the importance of: Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN

43、9110:2010EN 9110:2010 (E) 7 a) understanding and meeting requirements; b) the 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. The model of a process-based qual

44、ity management system shown in Figure 1 illustrates the process linkages presented in Clause 4 to Clause 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 custom

45、er perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this European 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

46、all processes. PDCA can be briefly described 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,

47、objectives and requirements for the product and report the results. Act: take actions to continually improve process performance. Figure 1 Model of a process-based quality management system Continual improvement of the quality management system Customers CustomersSatisfaction Resource management Man

48、agementresponsibility Measurement,analysis and improvementRequirements Input Product Output Product realization Key Value-adding activities Information flow Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without l