ASD-STAN PREN 9100-2016 Quality Management Systems Requirements for Aviation Space and Defence Organizations (Edition P 4).pdf

1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM ASD-STAN prEN 9100 Edition P 4 September 2016 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer 10 - 1000 Brussels - Tel. 32 2 775 8126 - Fax. 32 2 775 8131 - www.asd-stan.org ICS: Supersedes edition

2、P 3 of January 2009 and will supersede EN 9100:2009 Descriptors: Note: Technically equivalent writings published in all IAQG sectors ENGLISH VERSION Quality Management Systems Requirements for Aviation, Space and Defence Organizations Qualittsmanagementsysteme Anforderungen an Organisationen der Luf

3、tfahrt, Raumfahrt und Verteidigung Systmes de Management de la Qualit Exigences pour les Organismes de lAronautique, lEspace et la Dfense This “Aerospace Series“ Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardi

4、zation). It is published for the needs of the European Aerospace Industry. 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 interchangeabi

5、lity is affected, physically or functionally, without re-identification 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

6、 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 a national standard and by withdrawing any national standards conflicting with the EN. ASD-STAN Technical Committee approves that: “This document is

7、 published by ASD-STAN for the needs of the European Aerospace Industry. 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 s

8、tandard and technical report at least every five years at which time it 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 retrieva

9、l system or transmitted, in any form or by any means, electronic, mechanical, 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

10、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. Order details: E-mail: salesasd-stan.org Web ad

11、dress: http:/www.asd-stan.org/ Edition approved for publication 1st September 2016 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2016 ASD-STAN Licensed by ASD-STAN to Pari Aliyeva October 3, 2016 via asd-stan.org Single-user license only

12、, copying and networking prohibited.prEN 9100:2016 (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 0.4 Relati

13、onship with other management system standards 10 1 Scope . 11 2 Normative references . 11 3 Terms and definitions 11 3.1 Counterfeit part . 12 3.2 Critical items 12 3.3 Key characteristic . 12 3.4 Product safety 12 3.5 Special requirements . 12 4 Context of the organization 12 4.1 Understanding the

14、organization and its context 12 4.2 Understanding the needs and expectations of interested parties . 13 4.3 Determining the scope of the quality management system 13 4.4 Quality management system and its processes. 13 5 Leadership 15 5.1 Leadership and commitment . 15 5.1.1 General . 15 5.1.2 Custom

15、er focus 15 5.2 Policy 16 5.2.1 Establishing the quality policy 16 5.2.2 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 . 17 6

16、.3 Planning of changes . 18 7 Support 18 7.1 Resources 18 7.1.1 General . 18 7.1.2 People . 18 7.1.3 Infrastructure 18 Licensed by ASD-STAN to Pari Aliyeva October 3, 2016 via asd-stan.org Single-user license only, copying and networking prohibited.prEN 9100:2016 (E) 3 7.1.4 Environment for the oper

17、ation of processes 19 7.1.5 Monitoring and measuring resources . 19 7.1.6 Organizational knowledge 20 7.2 Competence 20 7.3 Awareness . 21 7.4 Communication . 21 7.5 Documented information 21 7.5.1 General . 21 7.5.2 Creating and updating . 22 7.5.3 Control of documented information 22 8 Operation .

18、 23 8.1 Operational planning and control 23 8.1.1 Operational risk management 25 8.1.2 Configuration management . 25 8.1.3 Product safety . 25 8.1.4 Prevention of counterfeit parts . 25 8.2 Requirements for products and services . 26 8.2.1 Customer communication . 26 8.2.2 Determining the requiremen

19、ts for products and services 26 8.2.3 Review of the requirements for products and services 26 8.2.4 Changes to requirements for products and services . 27 8.3 Design and development of products and services 27 8.3.1 General . 27 8.3.2 Design and development planning . 28 8.3.3 Design and development

20、 inputs 28 8.3.4 Design and development controls 29 8.3.5 Design and development outputs . 30 8.3.6 Design and development changes 30 8.4 Control of externally provided processes, products, and services . 31 8.4.1 General . 31 8.4.2 Type and extent of control 32 8.4.3 Information for external provid

21、ers . 33 8.5 Production and service provision 34 8.5.1 Control of production and service provision 34 8.5.2 Identification and traceability . 37 8.5.3 Property belonging to customers or external providers . 37 8.5.4 Preservation . 37 8.5.5 Post-delivery activities . 38 8.5.6 Control of changes 38 8.

22、6 Release of products and services 39 8.7 Control of nonconforming outputs . 39 9 Performance evaluation . 40 9.1 Monitoring, measurement, analysis, and evaluation. 40 9.1.1 General . 40 9.1.2 Customer satisfaction 41 9.1.3 Analysis and evaluation . 41 9.2 Internal audit . 41 9.3 Management review 4

23、2 9.3.1 General . 42 9.3.2 Management review inputs . 42 9.3.3 Management review outputs 43 10 Improvement 43 Licensed by ASD-STAN to Pari Aliyeva October 3, 2016 via asd-stan.org Single-user license only, copying and networking prohibited.prEN 9100:2016 (E) 4 10.1 General . 43 10.2 Nonconformity an

24、d corrective action . 43 10.3 Continual improvement . 44 (informative) Clarification of new structure, terminology and concepts . 45 (informative) Other international standards on quality management and quality management systems developed by ISO/TC 176 49 (informative) Other standards on quality ma

25、nagement and quality management systems developed by the international aerospace quality group 53 (informative) Bibliography 57 (informative) Aviation , space, and defence bibliography . 59 Figures Figure 1 Schematic representation of the elements of a single process 8 Figure 2 Representation of the

26、 structure of this international standard in the PDCA cycle . 9 Licensed by ASD-STAN to Pari Aliyeva October 3, 2016 via asd-stan.org Single-user license only, copying and networking prohibited.prEN 9100:2016 (E) 5 Rationale This standard has been revised to incorporate the new clause structure and

27、content of EN ISO 9001:2015. In addition, industry requirements, definitions, and notes 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

28、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 requirements and expectations have complicated this objective. Organizations have the challenge

29、 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 having varying quality requirements and expectations. Industry has established the

30、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 quality and reductions in cost throughout the value stream. This standard has been

31、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 in improved quality, cost, and delivery performance through the reduction

32、 or elimination of organization-unique requirements, effective implementation of the quality 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 man

33、agement system with additional requirements over an EN ISO 9001 system is needed. This standard 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

34、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 can be obtained from any ISO member and from th

35、e web site of the ISO Central Secretariat at www.iso.org. Copyright remains with ISO. Licensed by ASD-STAN to Pari Aliyeva October 3, 2016 via asd-stan.org Single-user license only, copying and networking prohibited.prEN 9100:2016 (E) 6 Intended application This standard is intended for use by organ

36、izations 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 materials for their own products and services. NOTE Organizations whose products are delivera

37、ble software, or contain deliverable software, should use the IAQG-developed EN 9115 standard (see Bibliography) when planning and evaluating the software design, development, or management activities of the organization. The EN 9115 standard provides guidance to the requirements of the EN 9100 stan

38、dard when it is desired to add “software” to the EN 9100 quality management system scope. 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 main

39、tenance, repair, and overhaul operations that are operated autonomously, or that are substantially different from their production operations; should use the IAQG-developed EN 9110 standard (see Bibliography). Organizations that procure parts, materials, and assemblies and resells these products to

40、a customer in the aviation, space, and defence industry should use the IAQG-developed EN 9120 standard (see 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 pro

41、duct. 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 provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a qua

42、lity management system based on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities

43、 associated with its context and objectives; d) the ability to demonstrate conformity to specified quality 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 i

44、n the structure of different quality management systems; alignment of documentation to the clause structure of this International Standard; the use of the specific terminology of this International Standard within the organization. Licensed by ASD-STAN to Pari Aliyeva October 3, 2016 via asd-stan.or

45、g Single-user license only, copying and networking prohibited.prEN 9100:2016 (E) 7 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 incorpor

46、ates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. 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

47、 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 to minimize negative effects and to make maximum use of opportu

48、nities as they arise (see clause 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

49、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” indicates 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 principles described