1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM prEN 9100 Edition P 3 January 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
2、 P 2 September 2001 and will supersede EN 9100:2003 Descriptors: ENGLISH VERSION Quality Management Systems Requirements for Aviation, Space and Defense Organizations Systmes de management de la Qualit Exigences des Organisations pour lAviation, lEspace et la Dfense Qualittsmanagementsysteme Anforde
3、rungen an Organisationen der Luftfahrt, Raumfahrt und Verteidigung This 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 and Defence Industry. It
4、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-identification of the
5、 standard. After examination and review by users 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 impleme
6、nt 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. Edition approved for publication 31 January 2009 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyri
7、ght 2009 by ASD-STAN Copyright ASD-STAN Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9100:2009 (E) 2 Contents Page FOREWORD.4 REVISION SUMMARY/RATIONALE.4 0 INTRODUCTION.5 0.1 General .5 0.2 Process approach .5 QUALI
8、TY MANAGEMENT SYSTEMS REQUIREMENTS .7 1 SCOPE 7 1.1 General .7 1.2 Application .7 2 NORMATIVE REFERENCES .8 3 TERMS AND DEFINITIONS .8 3.1 Risk .8 3.2 Special requirements 8 3.3 Critical items9 3.4 Key characteristic9 4 QUALITY MANAGEMENT SYSTEM9 4.1 General requirements .9 4.2 Documentation Require
9、ments 10 4.2.1 General 10 4.2.2 Quality Manual 10 4.2.3 Control of Documents 11 4.2.4 Control of Records. 11 5 MANAGEMENT RESPONSIBILITY 11 5.1 Management Commitment 11 5.2 Customer Focus . 12 5.3 Quality Policy 12 5.4 Planning 12 5.4.1 Quality Objectives 12 5.4.2 Quality Management System Planning
10、12 5.5 Responsibility, Authority and Communication . 12 5.5.1 Responsibility and Authority 12 5.5.2 Management Representative. 13 5.5.3 Internal Communication 13 5.6 Management Review 13 5.6.1 General 13 5.6.2 Review Input . 13 5.6.3 Review Ouput 14 6 RESOURCE MANAGEMENT 14 6.1 Provision of Resource
11、s . 14 6.2 Human Resources 14 6.2.1 General 14 6.2.2 Competence, Training and Awareness 14 6.3 Infrastructure 14 6.4 Work Environment 15 7 PRODUCT REALIZATION 15 7.1 Planning of Product Realization . 15 7.1.1 Project Management 16 Copyright ASD-STAN Provided by IHS under license with AECMA Not for R
12、esaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9100:2009 3 7.1.2 Risk Management16 7.1.3 Configuration Management16 7.1.4 Control of Work Transfers16 7.2 Customer-related processes .16 7.2.1 Determination of Requirements Related to the Product.16 7.2.2 Review of Requi
13、rements Related to the Product.17 7.2.3 Customer Communication .17 7.3 Design and Development .17 7.3.1 Design and Development Planning.17 7.3.2 Design and Development Inputs .18 7.3.3 Design and Development Outputs 18 7.3.4 Design and Development Review19 7.3.5 Design and Development Verification 1
14、9 7.3.6 Design and Development Validation.19 7.3.6.1 Design and Development Verification and Validation Testing.19 7.3.6.2 Design and Development Verification and Validation Documentation .20 7.3.7 Control of Design and Development Changes.20 7.4 Purchasing.20 7.4.1 Purchasing Process20 7.4.2 Purcha
15、sing Information21 7.4.3 Verification of Purchased Product 21 7.5 Production and Service Provision 22 7.5.1 Control of Production and Service Provision 22 7.5.1.1 Production Process Verification .23 7.5.1.2 Control of Production Process Changes23 7.5.1.3 Control of Production Equipment, Tools and So
16、ftware Programs23 7.5.1.4 Post-Delivery Support 23 7.5.2 Validation of Processes for Production and Service Provision.24 7.5.3 Identification and Traceability .24 7.5.4 Customer Property25 7.5.5 Preservation of Product .25 7.6 Control of Monitoring and Measuring Equipment .25 8 MEASUREMENT, ANALYSIS
17、 AND IMPROVEMENT.26 8.1 General.26 8.2 Monitoring and Measurement27 8.2.1 Customer Satisfaction27 8.2.2 Internal Audit .27 8.2.3 Monitoring and Measurement of Processes 28 8.2.4 Monitoring and Measurement of Product.28 8.3 Control of Nonconforming Product 29 8.4 Analysis of Data 30 8.5 Improvement30
18、 8.5.1 Continual Improvement30 8.5.2 Corrective Action 30 8.5.3 Preventive Action31 BIBLIOGRAPHY 32 Copyright ASD-STAN Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9100:2009 4 FOREWORD To assure customer satisfaction
19、 aviation, space and defense organizations must produce, and continually improve, safe, reliable products 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 expect
20、ations 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 to multiple customers having varying quality requirements and expectations. I
21、ndustry 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 and reductions in cost throughout the value stream. This standard has been pr
22、epared 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, schedule and cost performance by the reduction or elim
23、ination of organization-unique requirements and wider application of good practice. While primarily developed for the aviation, space and defense industry, this standard can also be used in other industry sectors where a quality management system with additional requirements over an ISO 9001 system
24、is needed. REVISION SUMMARY/RATIONALE This standard has been revised to incorporate the requirements of ISO 9001:2008. In addition, industry requirements, definitions and notes have been revised and additional requirements have been included in response to stakeholder needs. Copyright ASD-STAN Provi
25、ded by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9100:2009 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 organi
26、zations quality management system is influenced by 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 organizatio
27、nal structure. It is not the intent of this International 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. In
28、formation marked “NOTE” is for guidance in understanding 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 app
29、licable to the product, and the organizations own requirements. The quality management principles 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 proc
30、ess approach when developing, implementing 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
31、activities using resources, and managed in 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 identificat
32、ion and interactions of these processes, and their management to produce the desired outcome, 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, a
33、s well as over their combination and interaction. 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, Copyright ASD-STAN Provided by IHS under license with AE
34、CMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9100:2009 6 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 show
35、n in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This 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
36、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 detailed level. NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be
37、briefly described as follows. Plan: establish the objectives and processes necessary 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
38、 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 improvement of the quality management system Customers Customers Satisfaction Resource management Managementresponsibility Meas
39、urement,analysis and improvementRequirements Input Product OutputProduct realization 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 9100:2009 7 QUALITY MA
40、NAGEMENT SYSTEMS REQUIREMENTS 1 SCOPE 1.1 General This standard includes ISO 9001:2008 1)quality management system requirements and specifies additional aviation, space and defense industry requirements, definitions and notes as shown in bold, italic text. It is emphasized that the requirements spec
41、ified 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 standard and applicable statutory or regulatory requirements, the latter shall take precedence. This Internation
42、al 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 statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective ap
43、plication 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 In this International Standard, the term “product” only applies to a) product intended for, or required by, a
44、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 requirements of this International Standard are generic and are intended to be applicable to all organizations,
45、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 considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not
46、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 customer and applicable statutory and regulatory requirements. 1) With the permission of the International Org
47、anization 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 li
48、cense with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9100:20098 This standard is intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by organizations providing post-delivery support, inclu
49、ding the provision of maintenance, spare parts or materials for their own products. Organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and original equipment manufacturers with maintenance, repair and overhaul operations that operate autonomously, or that are substantially different from t
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