ASD-STAN PREN 9120-2016 Quality Management Systems - Requirements for Aviation Space and Defence Distributors.pdf

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1、 ASD STANDARD NORME ASD ASD NORM ASD-STAN prEN 9120:2016 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, Space and Defence Distributors Qualittsmanagementsysteme Anforderungen fr Hndler und Lagerhalter der Luftfahrt, Raumfahrt und Verteidigung Systmes de management de la Qualit

3、 Exigences pour les distributeurs en aronautique, spatial et dfense 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 Indus

4、try. It has been technically approved by the experts 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-identificatio

5、n of the standard. After examination and review 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 membe

6、rs have then to implement the EN at national level 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 Industr

7、y. The use of this standard is entirely voluntary 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

8、 may be revised, reaffirmed, stabilized or cancelled. ASD-STAN invites you to send your written comments or any suggestions that may arise. All rights reserved. No parts of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mecha

9、nical, photocopying, recording or otherwise, without 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 co

10、nsent 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. Order details: E-mail: salesasd-stan.org Web address: http:/www.asd-stan.org/ Edition approved for publication Comments

11、 should be sent within six months after the date of publication to ASD-STAN Quality domain prEN 9120:2016 (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-ch

12、eck-act cycle. 9 0.3.3 Risk-based thinking . 9 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 expecta

13、tions of interested parties . 13 4.3 Determining the scope of the quality management system 13 4.4 Quality management system and its processes. 14 5 Leadership 15 5.1 Leadership and commitment . 15 5.1.1 General . 15 5.1.2 Customer focus 16 5.2 Policy 16 5.2.1 Establishing the quality policy 16 5.2.

14、2 Communicating the quality policy . 16 5.3 Organizational roles, responsibilities and authorities 16 6 Planning . 17 6.1 Actions to address risks and opportunities 17 6.2 Quality objectives and planning to achieve them . 18 6.3 Planning of changes . 18 7 Support 19 7.1 Resources 19 7.1.1 General .

15、19 7.1.2 People . 19 7.1.3 Infrastructure 19 7.1.4 Environment for the operation of processes . 19 7.1.5 Monitoring and measuring resources 20 7.1.6 Organizational knowledge 20 7.2 Competence 21 7.3 Awareness . 21 prEN 9120:2016 (E) 3 7.4 Communication . 22 7.5 Documented information 22 7.5.1 Genera

16、l . 22 7.5.2 Creating and updating . 22 7.5.3 Control of documented information 22 8 Operation . 24 8.1 Operational planning and control 24 8.1.1 (Not used) . 25 8.1.2 Configuration management . 25 8.1.3 (Not used) . 26 8.1.4 Prevention of counterfeit parts . 26 8.1.5 Prevention of suspected unappro

17、ved parts 26 8.2 Requirements for products and services . 26 8.2.1 Customer communication . 26 8.2.2 Determining the requirements for products and services 27 8.2.3 Review of the requirements for products and services 27 8.2.4 Changes to requirements for products and services . 28 8.3 Design and dev

18、elopment of products and services 28 8.3.1 General . 28 8.3.2 Design and development planning . 28 8.3.3 Design and development inputs 28 8.3.4 Design and development controls 29 8.3.5 Design and development outputs . 29 8.3.6 Design and development changes 30 8.4 Control of externally provided proc

19、esses, products and services 30 8.4.1 General . 30 8.4.2 Type and extent of control 31 8.4.3 Information for external providers . 32 8.5 Production and service provision 33 8.5.1 Control of production and service provision 33 8.5.2 Identification and traceability . 35 8.5.3 Property belonging to cus

20、tomers or external providers . 36 8.5.4 Preservation . 36 8.5.5 Post-delivery activities . 36 8.5.6 Control of changes 37 8.6 Release of products and services 37 8.7 Control of nonconforming outputs . 38 9 Performance evaluation . 39 9.1 Monitoring, measurement, analysis and evaluation . 39 9.1.1 Ge

21、neral . 39 9.1.2 Customer satisfaction 39 9.1.3 Analysis and evaluation . 40 9.2 Internal audit . 40 9.3 Management review 41 9.3.1 General . 41 9.3.2 Management review inputs . 41 9.3.3 Management review outputs 41 10 Improvement 42 10.1 General . 42 10.2 Nonconformity and corrective action . 42 10

22、.3 Continual improvement . 43 prEN 9120:2016 (E) 4 (informative) Clarification of new structure, terminology and concepts . 44 Annex AA.1 Structure and terminology . 44 A.2 Products and services . 44 A.3 Understanding the needs and expectations of interested parties . 45 A.4 Risk-based thinking 45 A

23、.5 Applicability . 46 A.6 Documented information 46 A.7 Organizational knowledge 47 A.8 Control of externally provided processes, products and services . 47 (informative) Other international standards on quality management and quality Annex Bmanagement systems developed by ISO/TC 176 48 (informative

24、) Other standards on quality management and quality management Annex Csystems developed by the international aerospace quality group 52 (informative) Bibliography 56 Annex D(informative) Aviation, space and defence bibliography 58 Annex EFigures Figure 1 Schematic representation of the elements of a

25、 single process 8 Figure 2 Representation of the structure of this international standard in the PDCA cycle 9 prEN 9120:2016 (E) 5 Rationale This standard has been revised to incorporate the new clause structure and content of EN ISO 9001:2015. In addition, industry requirements, definitions and not

26、es have been revised in response to both EN ISO 9001 revisions and stakeholder needs. Foreword To assure customer satisfaction, aviation, space and defence organizations must provide and continually improve, safe and reliable products and services that meet or exceed customer and applicable statutor

27、y 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 and services from external providers throughout the world and a

28、t all levels of the supply chain. External providers have the challenge of delivering products and services to multiple customers having varying quality requirements and expectations. Industry has established the International Aerospace Quality Group (IAQG), with representatives from aviation, space

29、 and defence companies in the Americas, 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 t

30、o the greatest extent possible and can be used at all levels of the supply chain by organizations around the world. Its use should result in improved quality, cost and delivery performance through the reduction or elimination of organization-unique requirements, effective implementation of the quali

31、ty management system and wider application of good practice. While primarily developed for the aviation, space and defence industry, this standard can also be used in other industry sectors when a quality management system with additional requirements over an EN ISO 9001 system is needed. This stand

32、ard includes EN ISO 9001:20151)quality management system requirements and specifies additional aviation, space and defence 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

33、 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 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 912

34、0:2016 (E) 6 Intended application This standard is intended for use by organizations that procure parts, materials and assemblies and resell these products to a customer in the aviation, space and defence industries. This includes organizations that procure products and split them into smaller quant

35、ities, including those that coordinate a customer or regulatory controlled process on the product. This standard is not intended for organizations that maintain or repair products or for organizations that perform work that affect or could affect product characteristics or conformity. Organizations

36、that design, develop or provide aviation, space and defence products and services should use the IAQG-developed EN 9100 standard (see bibliography). This includes organizations providing post-delivery activities, including the provision of maintenance, spare parts or materials for their own products

37、 and services. Organizations whose primary business is providing maintenance or continuing airworthiness management services for civil or military aviation articles and products and original equipment manufacturers with maintenance, repair and overhaul operations that are operated autonomously or th

38、at are substantially different from their production operations; should use the IAQG-developed EN 9110 standard (see bibliography). 0 Introduction 0.1 General The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and

39、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 products and services that meet customer and applicable statutory and

40、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 management system requirements. This International Standard can be

41、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 of this International Standard; the use of the specific terminolog

42、y 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 employs the process approach, which incorporates the Plan-Do-Check-Ac

43、t (PDCA) cycle and risk-based thinking. prEN 9120:2016 (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 adequately resourced and managed and that opportunities for improvement are

44、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 to minimize negative effects and to make maximum use of opportunitie

45、s 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 organization might find it necessary to adopt various forms of improvement

46、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” indicates a recommendation; “may” indicates a permission; “can” indicates a

47、 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 principles described in EN ISO 9000. The descriptions include a state

48、ment 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 applying the principle. The quality management principles are: customer fo

49、cus; leadership; engagement of people; process approach; improvement; evidence-based decision making; relationship management. prEN 9120:2016 (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 process approach are included in 4.4. Understanding and managing inter