AECMA PREN 9110-2009 Quality Management Systems Requirements for Aviation Maintenance Organizations Edition P 3《飞机维修机构用质量管理系统的要求.版本P3》.pdf

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1、ASD STANDARD NORME ASD ASD NORM prEN 9110 Edition P 3 June 2009 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATIONAvenue de Tervuren, 270 - B-1150 Brussels - Tel. + 32 2 775 8126 - Fax. + 32 2 775 8131 - www.asd-stan.orgICS: Supersedes edition P 2 of February 2

2、003 and will supersede EN 9110:2005 Descriptors: ENGLISH VERSION Quality Management Systems Requirements for Aviation Maintenance Organizations Systmes de management de la Qualit Exigences pour les Organismes dEntretien de lAviation Qualittsmanagementsysteme Anforderungen fr Luftfahrt-Wartungsfirmen

3、 This “Aerospace Series“ Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). It is published for the needs of the European Aerospace Industry. It has been technically approved by the experts of the concern

4、ed Domain following member comments. Subsequent to the publication of this Prestandard, the technical content shall not be changed to an extent that interchangeability is affected, physically or functionally, without re-identification of the standard. After examination and review by users and formal

5、 agreement of ASD-STAN, it will be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full European Standard (EN). The CEN national members have then to implement the EN at national level by giving the EN the status of

6、a national standard and by withdrawing any national standards conflicting with the EN. NOTE This standard is technically equivalent to AS9110 Revision Marking Revisions to existing industry requirements, and new industry requirements, are indicated with a vertical line in the left margin. Areas wher

7、e previous requirements were deleted are indicated with a “D” and a vertical line. Requirements that were relocated in the standard are indicated with an “R” and a vertical line at the original location. Format or editorial changes to industry requirements are not marked. Edition approved for public

8、ation 30 June 2009 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2009 by ASD-STAN D R Copyright ASD-STAN Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 911

9、0:2009 (E) 2 Contents Page FOREWORD.4 REVISION SUMMARY/RATIONALE.4 0 Introduction5 0.1 General .5 0.2 Process approach .5 Quality management systems Requirements .7 1 Scope7 1.1 General .7 1.2 Application .7 2 Normative references8 3 Terms and definitions .8 4 Quality management system. 10 4.1 Gener

10、al requirements 10 4.2 Documentation requirements . 11 4.2.1 General 11 4.2.2 Quality manual 11 4.2.3 Control of documents 12 4.2.4 Control of records 12 5 Management responsibility. 13 5.1 Management commitment . 13 5.2 Customer focus 13 5.3 Quality policy 13 5.4 Planning 13 5.4.1 Quality objective

11、s. 13 5.4.2 Quality management system planning. 14 5.4.3 Safety objectives 14 5.5 Responsibility, authority and communication 14 5.5.1 Responsibility and authority. 14 5.5.2 Management representative 14 5.5.3 Internal communication. 15 5.6 Management review . 15 5.6.1 General 15 5.6.2 Review input .

12、 15 5.6.3 Review output. 15 5.7 Safety policy . 16 6 Resource management 16 6.1 Provision of resources 16 6.2 Human resources . 16 6.2.1 General 16 6.2.2 Competence, training and awareness 16 6.3 Infrastructure 17 6.4 Work environment 17 Copyright ASD-STAN Provided by IHS under license with AECMA No

13、t for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9110:2009 (E) 3 7 Product realization17 7.1 Planning of product realization .17 7.1.1 Project management.18 7.1.2 Risk management .18 7.1.3 Configuration management .19 7.1.4 Control of work transfers .19 7.2 Custo

14、mer-related processes .19 7.2.1 Determination of requirements related to the product .19 7.2.2 Review of requirements related to the product .19 7.2.3 Customer communication20 7.3 Design and development20 7.3.1 Design and development planning .20 7.3.2 Design and development inputs21 7.3.3 Design an

15、d development outputs .21 7.3.4 Design and development review .22 7.3.5 Design and development verification .22 7.3.6 Design and development validation22 7.3.6.1 Design and development verification and validation testing.22 7.3.6.2 Design and development verification and validation documentation.23

16、7.3.7 Control of design and development changes23 7.4 Purchasing.23 7.4.1 Purchasing process23 7.4.2 Purchasing information24 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 Production process verificati

17、on 26 7.5.1.2 Control of production process changes.26 7.5.1.3 Control of production equipment, tools and software programs 27 7.5.1.4 Post-delivery support .27 7.5.2 Validation of processes for production and service provision27 7.5.3 Identification and traceability 27 7.5.4 Customer property28 7.5

18、.5 Preservation of product28 7.6 Control of monitoring and measuring equipment .29 8 Measurement, analysis and improvement30 8.1 General.30 8.2 Monitoring and measurement30 8.2.1 Customer satisfaction 30 8.2.2 Internal audit30 8.2.3 Monitoring and measurement of processes 31 8.2.4 Monitoring and mea

19、surement of product.31 8.3 Control of nonconforming product .32 8.4 Analysis of data.33 8.5 Improvement34 8.5.1 Continual improvement34 8.5.2 Corrective action.34 8.5.3 Preventive action 34 Bibliography36 Copyright ASD-STAN Provided by IHS under license with AECMA Not for ResaleNo reproduction or ne

20、tworking permitted without license from IHS-,-,-prEN 9110:2009 (E) 4 FOREWORD To assure customer satisfaction, aviation and defense organizations must produce, maintain, repair and continually improve, safe, reliable products that meet or exceed customer and applicable statutory and regulatory requi

21、rements. 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 world and at all levels of the supply chain. Suppliers

22、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, Asia/Pacific and Europe, to implement initiatives that

23、 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 used at all levels of the supply chain by organizati

24、ons 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 and defense industry, organizations providing maintena

25、nce, 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 to incorporate the requirements of ISO 9001:2008 and

26、 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 ASD-STAN Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted wi

27、thout license from IHS-,-,-prEN 9110:2009 (E) 5 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 organizations quality management system is influenced by a) its organizational environment, ch

28、anges 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 organizational structure. It is not the intent of this International Standard to imply uniformity i

29、n the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated re

30、quirement. This International 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 to the product, and the organizations own requirements. The quality management p

31、rinciples stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this 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

32、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 resources, and managed in order to enable the transformation of inputs

33、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 interactions of these processes, and their management to produce the desired out

34、come, 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 their combination and interaction. When used within a quality management

35、system, such an approach emphasizes the importance of Copyright ASD-STAN Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9110:2009 (E) 6 a) understanding and meeting requirements, b) the need to consider processes in te

36、rms 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 quality management system shown in Figure 1 illustrates the process linkages presented in Clause 4 to Clause 8. Th

37、is 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 has met the customer requirements. The model shown in Figure 1 co

38、vers 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 described as follows. Plan: establish the objectives and processes nec

39、essary 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 product and report the results. Act: take actions to continually impr

40、ove process performance. Figure 1 Model of a process-based quality management system Continual improvement of the quality management system Customers Customers Satisfaction Resource management Managementresponsibility Measurement,analysis and improvementRequirements Input Product OutputProduct reali

41、zation Key Value-adding activities Information flow Copyright ASD-STAN Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9110:2009 (E) 7 Quality management systems Requirements 1 Scope 1.1 General This standard includes I

42、SO 9001:20081)quality management system requirements and specifies additional aviation maintenance industry requirements, definitions and notes as shown in bold, italic text. NOTE Baseline aviation maintenance requirements originate from IAQG developed 9100:2008 standard; modifications were made, as

43、 required, to address maintenance 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 sta

44、ndard and applicable statutory 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

45、 statutory and regulatory requirements, 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 1 I

46、n 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 2 Statutory and regulatory requirements can be expressed as legal requirements. 1.2 Application All req

47、uirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be cons

48、idered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets c

49、ustomer and applicable statutory and regulatory requirements. 1) With the permission of the International Organization for Standardization (ISO). The complete standard can be obtained from any ISO member or from the ISO Central Secretariat: 1, ch. de la Voie-Creuse, Case postale 56, CH-1211 Geneva 20, SWITZERLAND, or visit www.iso.org. Copyright remains with ISO. Copyright ASD-STAN Provided by IHS under