1、 ASD STANDARD NORME ASD ASD NORM ASD-STAN prEN 9110:2016 Edition 2016-10 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer, 10/5 - B-1000 Brussels, Belgium - Tel +32 2 775 81 26 - Fax +32 2 775 81 31 - www.asd-stan.org ICS: Descriptors: Note Techn
2、ically equivalent writings published in all IAQG sectors ENGLISH VERSION Quality Management Systems Requirements for Aviation Maintenance Organizations Qualittsmanagementsysteme Anforderungen fr Luftfahrt-Instandhaltungsbetriebe Systmes de management de la Qualit Exigences pour les Organismes dEntre
3、tien de lAronautique 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 ex
4、perts of 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
5、 by users and formal agreement of ASD-STAN, the ASD-STAN prEN 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 le
6、vel by giving the EN the status of a national standard and by withdrawing any national standards conflicting with the EN. ASD-STAN Technical Committee approves that: “This document is published by ASD-STAN for the needs of the European Aerospace Industry. The use of this standard is entirely volunta
7、ry and its applicability and suitability for any particular use, including any patent infringement arising therefrom, is the sole responsibility of the user.” ASD-STAN reviews each standard and technical report at least every five years at which time it may be revised, reaffirmed, stabilized or canc
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9、thout prior written permission of ASD-STAN. ISO 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
10、 can be obtained from any ISO member and from the web site of the ISO Central Secretariat at www.iso.org. Copyright remains with ISO. Order details: E-mail: salesasd-stan.org Web address: http:/www.asd-stan.org/ Edition approved for publication Comments should be sent within six months after the dat
11、e of publication to ASD-STAN Quality domain prEN 9110:2016 (E) 2 Contents Page 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 0.3.1 General 8 0.3.2 Plan-do-check-act cycle. 9 0.3.3 Risk-based thinking . 9
12、0.4 Relationship with other management system standards 10 1 Scope . 11 2 Normative references . 11 3 Terms and definitions 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 Determinin
13、g the scope of the quality management system 14 4.4 Quality management system and its processes. 14 5 Leadership 16 5.1 Leadership and commitment . 16 5.1.1 General . 16 5.1.2 Customer focus 16 5.2 Policy 17 5.2.1 Establishing the quality policy 17 5.2.2 Communicating the quality policy . 17 5.2.3 E
14、stablishing and communicating the safety policy 17 5.3 Organizational roles, responsibilities and authorities 17 5.3.1 Accountable manager 18 5.3.2 Quality manager . 18 5.3.3 Other appointed manager(s) 18 6 Planning . 19 6.1 Actions to address risks and opportunities 19 6.2 Quality objectives and pl
15、anning to achieve them . 19 6.3 Planning of changes . 20 7 Support 20 7.1 Resources 20 7.1.1 General . 20 7.1.2 People . 21 7.1.3 Infrastructure 21 7.1.4 Environment for the operation of processes . 21 prEN 9110:2016 (E) 3 7.1.5 Monitoring and measuring resources . 21 7.1.6 Organizational knowledge
16、22 7.2 Competence 23 7.3 Awareness . 23 7.4 Communication . 24 7.5 Documented information 24 7.5.1 General . 24 7.5.2 Creating and updating . 24 7.5.3 Control of documented information 25 8 Operation . 25 8.1 Operational planning and control 25 8.1.1 Operational risk management 27 8.1.2 Configuratio
17、n management . 27 8.1.3 Product safety . 27 8.1.4 Prevention of counterfeit parts . 28 8.1.5 Prevention of suspected unapproved parts 28 8.1.6 Installation of approved parts 28 8.2 Requirements for products and services . 29 8.2.1 Customer communication . 29 8.2.2 Determining the requirements for pr
18、oducts and services 29 8.2.3 Review of the requirements for products and services 29 8.2.4 Changes to requirements for products and services . 30 8.3 Design and development of products and services 30 8.3.1 General . 30 8.3.2 Design and development planning . 31 8.3.3 Design and development inputs 3
19、1 8.3.4 Design and development controls 32 8.3.5 Design and development outputs . 32 8.3.6 Design and development changes 33 8.4 Control of externally provided processes, products and services 33 8.4.1 General . 33 8.4.2 Type and extent of control 34 8.4.3 Information for external providers . 35 8.5
20、 Production and service provision 36 8.5.1 Control of production and service provision 36 8.5.2 Identification and traceability . 38 8.5.3 Property belonging to customers or external providers . 39 8.5.4 Preservation . 39 8.5.5 Post-delivery activities . 40 8.5.6 Control of changes 40 8.6 Release of
21、 products and services 40 8.7 Control of nonconforming outputs . 41 9 Performance evaluation . 42 9.1 Monitoring, measurement, analysis and evaluation . 42 9.1.1 General . 42 9.1.2 Customer satisfaction 42 9.1.3 Analysis and evaluation . 43 9.2 Internal audit . 43 9.3 Management review 44 9.3.1 Gene
22、ral . 44 9.3.2 Management review inputs . 44 9.3.3 Management review outputs 45 prEN 9110:2016 (E) 4 10 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 Annex A
23、A.1 Structure and terminology . 47 A.2 Products and services . 47 A.3 Understanding the needs and expectations of interested 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, prod
24、ucts and services . 50 (informative) Other international standards on quality management and quality Annex Bmanagement systems developed by ISO/TC 176 51 (informative) Other standards on quality management and quality management Annex Csystems developed by the international aerospace quality group 5
25、5 (informative) Bibliography 57 Annex D(informative) Aviation, space and defence bibliography 59 Annex EFigures Figure 1 Schematic representation of the elements of a single process 8 Figure 2 Representation of the structure of this international standard in the PDCA cycle 9 prEN 9110:2016 (E) 5 Rat
26、ionale This standard has been revised to incorporate the new clause structure and content of EN ISO 9001:2015. In addition, industry requirements, definitions and notes have been revised in response to both EN ISO 9001:2015 revisions and stakeholder needs. Foreword To assure customer satisfaction, a
27、viation, space and defence organizations must provide and continually improve, safe and reliable products and services that meet or exceed customer and applicable statutory and regulatory requirements. The globalization of the industry and the resulting diversity of regional and national requirement
28、s and expectations have complicated this objective. Organizations have the challenge of purchasing products and services from external providers throughout the world and at all levels of the supply chain. External providers have the challenge of delivering products and services to multiple customers
29、 having varying quality requirements and expectations. Industry has established the International Aerospace Quality Group (IAQG), with representatives from aviation, space and defence companies in the Americas, Asia/Pacific and Europe, to implement initiatives that make significant improvements in q
30、uality 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 organizations around the world. Its use shoul
31、d result in improved quality, cost and delivery performance through the reduction or elimination of organization-unique requirements, effective implementation of the quality management system and wider application of good practice. While primarily developed for civil and military aviation industry o
32、rganizations providing maintenance services, this standard can also be used in other industry sectors when a quality management system with additional requirements over an EN ISO 9001:2015 system is needed. This standard includes EN ISO 9001:20151)quality management system requirements and specifies
33、 additional civil and military aviation maintenance and continuing airworthiness industry requirements, definitions and notes as shown in bold, italic text. 1) ISO 9001:2015 is reproduced in this document with the permission of the International Organization for Standardization, ISO. No parts of thi
34、s 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 the web site of the ISO Central Secretariat at www.iso.org. Copyright remains with ISO. prEN 9110:2016 (E) 6 Intended application This sta
35、ndard is intended for use by organizations whose primary business is providing maintenance or continuing airworthiness management services for civil or military aviation articles and products; and by original equipment manufacturers with maintenance, repair and overhaul operations that are operated
36、autonomously or that are substantially different from their production operations. Organizations that design, develop or provide aviation, space and defence products and services; and by organizations providing post-delivery activities, including the provision of maintenance, spare parts or material
37、s for their own products and services should use the IAQG-developed EN 9100 standard (see Bibliography). Organizations that procure parts, materials and assemblies and resells these products to a customer in the aviation, space and defence industry should use the IAQG-developed EN 9120 standard (see
38、 Bibliography). This includes organizations that procure products and split them into smaller quantities, as well as those that coordinate a customer or regulatory controlled process on the product. 0 Introduction 0.1 General The adoption of a quality management system is a strategic decision for an
39、 organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) the ability to consistently provide pro
40、ducts and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality
41、management system requirements. This International Standard can be used by internal and external parties. It is not the intent of this International Standard to imply the need for: uniformity in the structure of different quality management systems; alignment of documentation to the clause structure
42、 of this International Standard; the use of the specific terminology of this International Standard within the organization. The quality management system requirements specified in this International Standard are complementary to requirements for products and services. This International Standard em
43、ploys the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. prEN 9110:2016 (E) 7 The process approach enables an organization to plan its processes and their interactions. The PDCA cycle enables an organization to ensure that its processes are adequatel
44、y resourced and managed and that opportunities for improvement are determined and acted on. Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls t
45、o 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 organiza
46、tion might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization. In this International Standard, the following verbal forms are used: “shall” indicates a requirement; “should” indicate
47、s a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability. Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement. 0.2 Quality management principles This International Standard is based on the quality management pr
48、inciples described in EN ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organizations performance when applyin
49、g the principle. The quality management principles are: customer focus; leadership; engagement of people; process approach; improvement; evidence-based decision making; relationship management. prEN 9110:2016 (E) 8 0.3 Process approach 0.3.1 General 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. Specific requirements considered essential to the adoption of a pro
