1、 SAE Technical Standards Board Rules provide that: “This report is published by SAE to advance the state of technical and engineering sciences. The use of this report is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising there
2、from, is the sole responsibility of the user.” SAE reviews each technical report at least every five years at which time it may be reaffirmed, revised, or cancelled. SAE invites your written comments and suggestions. Copyright 2009 SAE International All rights reserved. No part of this publication m
3、ay be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of SAE. TO PLACE A DOCUMENT ORDER: Tel: 877-606-7323 (inside USA and Canada) Tel: 724-776-4970 (outside USA)
4、 Fax: 724-776-0790 Email: CustomerServicesae.org SAE WEB ADDRESS: http:/www.sae.org SAE values your input. To provide feedback on this Technical Report, please visit http:/www.sae.org/technical/standards/AS9100C AEROSPACE STANDARD AS9100C Issued 1999-11Revised 2009-01 Superseding AS9100B Quality Man
5、agement Systems - Requirements for Aviation, Space and Defense Organizations 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 respon
6、se to stakeholder needs. TABLE OF CONTENTS FOREWORD 4 REVISION SUMMARY/RATIONALE . 4 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 .
7、8 3.2 Special Requirements . 8 3.3 Critical Items . 8 3.4 Key Characteristic . 8 4. QUALITY MANAGEMENT SYSTEM . 9 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 . 10 4.2.4 Control of Records 11 SAE AS9100C Page 2 of
8、33 5. MANAGEMENT RESPONSIBILITY . 11 5.1 Management Commitment 11 5.2 Customer Focus 11 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 Man
9、agement Representative 12 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 Output . 13 6. RESOURCE MANAGEMENT 13 6.1 Provision of Resources . 13 6.2 Human Resources 14 6.2.1 General . 14 6.2.2 Competence, Training and Awareness . 14 6.3
10、 Infrastructure . 14 6.4 Work Environment. 14 7. PRODUCT REALIZATION . 15 7.1 Planning of Product Realization 15 7.1.1 Project Management . 15 7.1.2 Risk Management . 16 7.1.3 Configuration Management . 16 7.1.4 Control of Work Transfers . 16 7.2 Customer-Related Processes . 16 7.2.1 Determination o
11、f Requirements Related to the Product . 16 7.2.2 Review of Requirements Related to the Product 17 7.2.3 Customer Communication 17 7.3 Design and Development 18 7.3.1 Design and Development Planning 18 7.3.2 Design and Development Inputs . 18 7.3.3 Design and Development Outputs 19 7.3.4 Design and D
12、evelopment Review . 19 7.3.5 Design and Development Verification . 19 7.3.6 Design and Development Validation . 19 7.3.6.1 Design and Development Verification and Validation Testing 20 7.3.6.2 Design and Development Verification and Validation Documentation . 20 7.3.7 Control of Design and Developme
13、nt Changes . 20 7.4 Purchasing 20 7.4.1 Purchasing Process 20 7.4.2 Purchasing Information . 21 7.4.3 Verification of Purchased Product 22 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 Prod
14、uction Process Changes . 23 7.5.1.3 Control of Production Equipment, Tools and Software Programs 23 7.5.1.4 Post-Delivery Support . 24 7.5.2 Validation of Processes for Production and Service Provision . 24 7.5.3 Identification and Traceability . 24 SAE AS9100C Page 3 of 33 7.5.4 Customer Property 2
15、5 7.5.5 Preservation of Product 25 7.6 Control of Monitoring and Measuring Equipment . 26 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT . 27 8.1 General . 27 8.2 Monitoring and Measurement . 27 8.2.1 Customer Satisfaction . 27 8.2.2 Internal Audit . 28 8.2.3 Monitoring and Measurement of Processes . 28 8
16、2.4 Monitoring and Measurement of Product 29 8.3 Control of Nonconforming Product . 29 8.4 Analysis of Data 30 8.5 Improvement . 31 8.5.1 Continual Improvement . 31 8.5.2 Corrective Action . 31 8.5.3 Preventive Action 31 BIBLIOGRAPHY . 33 SAE AS9100C Page 4 of 33 FOREWORD To assure customer satisfa
17、ction, 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 e
18、xpectations 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 expectatio
19、ns. Industry 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 be
20、en 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, schedule and cost performance by the reduction or
21、 elimination 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 sy
22、stem 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. SAE AS9100C Page 5
23、of 33 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 organizations quality management system is influenced by a) its organizational environment, changes in that environment, and the risks ass
24、ociated 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 organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or u
25、niformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. This International Standard can be used
26、 by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regulatory requirements applicable to the product, and the organizations own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have bee
27、n taken into consideration during the development of this International Standard. 0.2 Process Approach 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 satisfactio
28、n by meeting customer requirements. For an organization to function effectively, it has to determine and manage numerous linked activities. 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. Ofte
29、n 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 identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”
30、 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, as well as over their combination and interaction. When used within a quality management system, such an approach emphasizes the importance
31、 of a) understanding and meeting requirements,b) the need to consider processes in terms of added value,c) obtaining results of process performance and effectiveness, andd) continual improvement of processes based on objective measurement.SAE AS9100C Page 6 of 33 The model of a process-based quality
32、 management system shown 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 percep
33、tion as to whether the 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
34、processes. PDCA can be 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, obje
35、ctives and requirements 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 SAE AS9100C Page 7 of 33 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS 1. SCOPE1.1 General This standard includes IS
36、O 9001:20081quality 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 specified in this standard are complementary (not alternative) to contractual and
37、 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 International Standard specifies requirements for a quality management system where an o
38、rganization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory andregulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system, including processes forcontinual improvement of the sy
39、stem and the assurance of conformity to customer and applicable statutory andregulatory requirements.NOTE 1 In this International Standard, the term “product” only applies to a) product intended for, or required by, a customer,b) any intended output resulting from the product realization processes.N
40、OTE 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, regardless of type, size and product provided. Where any requirement(s) of this Inte
41、rnational 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 acceptable unless these exclusions are limited to requirements within Clause 7, and
42、such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. This standard is intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by
43、 organizations providing post-delivery support, including 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 m
44、anufacturers with maintenance, repair and overhaul operations that operate autonomously, or that are substantially different from their manufacturing/production operations; should use the IAQG-developed 9110 standard (see Bibliography). 1With the permission of the International Organization for Stan
45、dardization (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. SAE AS9100C Page 8 of 33 Organizations that procure parts, ma
46、terials 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 smaller quantities for resale, should use the IAQG-developed 9120 standard (see Bibliography). 2. NORMATIVE REFERENCESThe fo
47、llowing referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005, Quality management systems Fundamentals
48、and vocabulary 3. TERMS AND DEFINITIONSFor 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
49、both a likelihood of occurring and a potentially negative consequence. 3.2 Special Requirements Those requirements identified by the customer, or determined by the organization, which have high risks to being achieved, thus requiring their inclusion in the risk management process. Factors used in the determination of special requirements include product or process complexity, past experience and product or process ma
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