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 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 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 3.1 Risk
8、 .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 Requirements 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
9、 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 12 5.5 Responsibility, Authority and Communication . 12 5.5.1 Responsibility and Authority 12 5.5.2 Management Representative. 13 5.5.3 Interna
10、l 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 Resources . 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 PROD
11、UCT REALIZATION 15 7.1 Planning of Product Realization . 15 7.1.1 Project Management 16 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 R
12、eview of Requirements 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
13、Verification 19 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 Process2
14、0 7.4.2 Purchasing 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
15、, Tools and Software 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 MEASURE
16、MENT, ANALYSIS 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
17、 Improvement30 8.5.1 Continual Improvement30 8.5.2 Corrective Action 30 8.5.3 Preventive Action31 BIBLIOGRAPHY 32 prEN 9100:2009 4 FOREWORD To assure customer satisfaction, aviation, space and defense organizations must produce, and continually improve, safe, reliable products that meet or exceed cu
18、stomer 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 of purchasing products from suppliers throughout the wor
19、ld and at all levels of the supply chain. Suppliers have the challenge of delivering products to multiple customers having varying quality requirements and expectations. Industry has established the International Aerospace Quality Group (IAQG), with representatives from companies in the Americas, As
20、ia/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 to the greatest extent possible and can be
21、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 elimination of organization-unique requirements and wider application of good practice. While primarily developed for the aviation, s
22、pace 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 is needed. REVISION SUMMARY/RATIONALE This standard has been revised to incorporate the requirements of ISO 9001:2008. In additio
23、n, industry requirements, definitions and notes have been revised and additional requirements have been included in response to stakeholder needs. 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
24、 implementation of an organizations 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,
25、 f) its size and organizational 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 r
26、equirements for products. Information 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
27、 regulatory requirements applicable 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 pro
28、motes 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. For an organization to function effectively, it has to determine and manage numerous linked activi
29、ties. An activity or set of 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, t
30、ogether with the identification 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 withi
31、n the system of processes, as 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, prEN 9100:2009 6 c) obtainin
32、g 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 shown in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers
33、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 organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this Int
34、ernational 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 briefly described as follows. Plan: establish the objectives and processes necessary to deliver results in accordan
35、ce with customer requirements and the organizations policies. 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 Mod
36、el of a process-based quality management system Continual improvement of the quality management system Customers Customers Satisfaction Resource management Managementresponsibility Measurement,analysis and improvementRequirements Input Product OutputProduct realization Key Value-adding activities In
37、formation flow prEN 9100:2009 7 QUALITY MANAGEMENT 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. I
38、t is emphasized that the requirements specified 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 latt
39、er shall take precedence. This International 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 cust
40、omer satisfaction through the effective application 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
41、) product intended for, or required by, a 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 intend
42、ed to be applicable to all organizations, 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 conformi
43、ty to this International Standard are not 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) Wi
44、th the permission of the International Organization 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. p
45、rEN 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, including the provision of maintenance, spare parts or materials for their own products. Organizations who
46、se 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 their manufacturing/prod
47、uction operations; should use the IAQG-developed 9110 standard (see Bibliography). Organizations that procure parts, materials and assemblies and resell these products to a customer in the aviation, space and defense industries, including organizations that procure products and split them into small
48、er quantities for resale, should use the IAQG-developed 9120 standard (see Bibliography). 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 edition
49、 of the referenced document (including any amendments) applies. 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 ISO 9000 apply. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. 3.1 Risk An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence. 3.2 Special requirements Those requirements identified by the customer, or determined by
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