1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM prEN 9110 Edition P 4 May 2012 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 3
2、 of June 2009 and will supersede EN 9110:2010 Descriptors: ENGLISH 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-W
3、artungsfirmen 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 o
4、f the concerned 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 use
5、rs and formal 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 t
6、he status of a national standard and by withdrawing any national standards conflicting with the EN. NOTE This standard is technically equivalent to AS9110 Edition approved for publication 01 May 2012 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain C
7、opyright 2012 by ASD-STAN prEN 9110:2012 (E) 2 Contents Page FOREWORD .4 REVISION SUMMARY/RATIONALE .4 0 Introduction 5 0.1 General .5 0.2 Process approach .5 Quality management systems Requirements .7 1 Scope 7 1.1 General .7 1.2 Application .7 2 Normative references 8 3 Terms and definitions .8 4
8、Quality management system 10 4.1 General requirements .10 4.2 Documentation requirements 11 4.2.1 General .11 4.2.2 Quality manual .12 4.2.3 Control of documents .12 4.2.4 Control of records .13 5 Management responsibility 13 5.1 Management commitment 13 5.2 Customer focus .13 5.3 Quality policy .13
9、 5.4 Planning .14 5.4.1 Quality objectives 14 5.4.2 Quality management system planning14 5.4.3 Safety objectives .14 5.5 Responsibility, authority and communication .14 5.5.1 Responsibility and authority 14 5.5.1.1 Accountable manager .14 5.5.1.2 Maintenance manager(s) 14 5.5.2 Management representa
10、tive .14 5.5.3 Internal communication 15 5.6 Management review 15 5.6.1 General .15 5.6.2 Review input 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 Inf
11、rastructure .17 6.4 Work environment .17 7 Product realization 17 7.1 Planning of product realization 17 7.1.1 Project management .18 prEN 9110:2012 (E) 3 7.1.2 Risk management . 18 7.1.3 Configuration management . 18 7.1.4 Control of work transfers . 19 7.2 Customer-related processes . 19 7.2.1 Det
12、ermination of requirements related to the product . 19 7.2.2 Review of requirements related to the product . 19 7.2.3 Customer communication 20 7.3 Design and development 20 7.3.1 Design and development planning . 20 7.3.2 Design and development inputs 21 7.3.3 Design and development outputs . 21 7.
13、3.4 Design and development review . 21 7.3.5 Design and development verification . 22 7.3.6 Design and development validation 22 7.3.6.1 Design and development verification and validation testing . 22 7.3.6.2 Design and development verification and validation documentation . 22 7.3.7 Control of desi
14、gn and development changes 22 7.4 Purchasing . 23 7.4.1 Purchasing process 23 7.4.2 Purchasing information 23 7.4.3 Verification of purchased product 24 7.5 Production and service provision . 25 7.5.1 Control of production and service provision . 25 7.5.1.1 Maintenance Process Verification . 26 7.5.
15、1.2 Control of Maintenance Process Changes . 26 7.5.1.3 Control of Maintenance Equipment, Tools, and Software Programs 26 7.5.1.4 Post-delivery support . 26 7.5.2 Validation of processes for production and service provision 26 7.5.3 Identification and traceability 27 7.5.4 Customer property 27 7.5.5
16、 Preservation of product 28 7.6 Control of monitoring and measuring equipment . 28 8 Measurement, analysis and improvement 29 8.1 General . 29 8.2 Monitoring and measurement 29 8.2.1 Customer satisfaction 29 8.2.2 Internal audit 30 8.2.3 Monitoring and measurement of processes 30 8.2.4 Monitoring an
17、d measurement of product . 31 8.3 Control of nonconforming product . 32 8.4 Analysis of data . 33 8.5 Improvement 33 8.5.1 Continual improvement 33 8.5.2 Corrective action . 33 8.5.3 Preventive action 34 9 Notes 34 Bibliography 35 Figure Page Figure 1 Model of a process-based quality management syst
18、em 6 prEN 9110:2012 (E) 4 FOREWORD To assure customer satisfaction, aviation and defence organizations must produce, maintain, repair and continually improve, safe, reliable products that meet or exceed customer and applicable statutory and regulatory requirements. The globalization of the industry
19、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 have the challenge of delivering products t
20、o 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 make significant improvements in quality a
21、nd 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 organizations around the world. Its use should result
22、 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 defence industry organizations providing maintenance services, this standard can also be use
23、d 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 address stakeholder needs through the addition of definitions and clarification of existing requirements to resol
24、ve interpretation issues, and incorporate editorial corrections. prEN 9110:2012 (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
25、: 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 organizational structure. It is not the intent of this Inter
26、national Standard to imply uniformity in 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 unders
27、tanding or clarifying the associated requirement. 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 ow
28、n requirements. The quality management principles stated in EN ISO 9000 and EN 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
29、, 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 resources, and managed i
30、n 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 interactions of these processes,
31、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-going control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and int
32、eraction. prEN 9110:2012 (E) 6 When used within a quality management system, such an approach emphasizes the importance of: 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) cont
33、inual 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. This illustration shows that customers play a significant role in defining requirements as input
34、s. 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 covers all the requirements of this International Standard, but does not show processes at a det
35、ailed 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 necessary to deliver results in accordance with customer requirements and the organizations polic
36、ies. 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 improve process performance. Figure 1 Model of a process-based quality management system Continual
37、 improvement of the quality management system Customers Customers Satisfaction Resource management Managementresponsibility Measurement,analysis and improvementRequirements Input Product OutputProduct realization Key Value-adding activities Information flow prEN 9110:2012 (E) 7 Quality management sy
38、stems Requirements 1 Scope 1.1 General This standard includes EN ISO 9001:2008 1)quality management system requirements and specifies additional aviation maintenance industry requirements, definitions and notes as shown in bold, italic text. NOTE 1 Baseline aviation maintenance requirements originat
39、e from IAQG developed 9100:2009 standard; modifications were made, as 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 requirem
40、ents. Should there be a conflict between the requirements of this standard 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 abil
41、ity to consistently provide product that meets customer and applicable 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 c
42、ustomer 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 requi
43、rements can be expressed as legal requirements. 1.2 Application All requirements 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
44、 due to the nature of an organization and its product, this can be considered 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 or
45、ganizations ability, or responsibility, to provide product that meets customer 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 S
46、ecretariat: 1, Ch. de la Voie-Creuse, Case postale 56, CH-1211 Geneva 20, SWITZERLAND, or visit www.iso.org. Copyright remains with ISO. prEN 9110:2012 (E) 8 This standard has been developed to benefit maintenance organizations that choose to adopt it, whether or not holders of a National Aviation A
47、uthority (NAA) repair station certificate. This standard is intended for use by maintenance organizations whose primary business is providing maintenance services for aviation commercial and military products; and for Original Equipment Manufacturer (OEM) organizations with maintenance operated auto
48、nomously or that are substantially different from their manufacturing/production operations. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edit
49、ion of the referenced document (including any amendments) applies. EN ISO 9000:2005, Quality management systems Fundamentals and vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 9000:2005 apply. Throughout the text of this International Standard, wherever the term “product“ occurs, it can also mean “service“. NOTE In the context of this standard, the term “product“ is synonymous with the term “maintenance service“. 3.1 Airworthy state of an article conforming to its type design and being in a condition for s
