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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 ther
2、efrom, 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
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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 AS9100C AEROSPACE STANDARD Issued 1999-11 Revised 2009-01 Superseding AS9100B Quality M
5、anagement 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 resp
6、onse 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 REQUIREMENTS7 1. SCOPE7 1.1 General .7 1.2 Application.7 2. NORMATIVE REFERENCES.8 3. TERMS AND DEFINITIONS.8 3.1 Risk .8 3.2 Special R
7、equirements.8 3.3 Critical Items .8 3.4 Key Characteristic.8 4. QUALITY MANAGEMENT SYSTEM.9 4.1 General Requirements9 4.2 Documentation Requirements 10 4.2.1 General .10 4.2.2 Quality Manual10 4.2.3 Control of Documents .10 4.2.4 Control of Records11 -,-,- SAE AS9100C Page 2 of 33 5.MANAGEMENT RESPO
8、NSIBILITY.11 5.1Management Commitment11 5.2Customer Focus11 5.3Quality Policy 12 5.4Planning 12 5.4.1Quality Objectives.12 5.4.2Quality Management System Planning.12 5.5Responsibility, Authority and Communication 12 5.5.1Responsibility and Authority12 5.5.2Management Representative12 5.5.3Internal C
9、ommunication13 5.6Management Review 13 5.6.1General .13 5.6.2Review Input .13 5.6.3Review Output.13 6.RESOURCE MANAGEMENT 13 6.1Provision of Resources.13 6.2Human Resources 14 6.2.1General .14 6.2.2Competence, Training and Awareness.14 6.3Infrastructure.14 6.4Work Environment.14 7.PRODUCT REALIZATIO
10、N.15 7.1Planning of Product Realization15 7.1.1Project Management.15 7.1.2Risk Management.16 7.1.3Configuration Management.16 7.1.4Control of Work Transfers.16 7.2Customer-Related Processes.16 7.2.1Determination of Requirements Related to the Product.16 7.2.2Review of Requirements Related to the Pro
11、duct17 7.2.3Customer Communication 17 7.3Design and Development18 7.3.1Design and Development Planning 18 7.3.2Design and Development Inputs.18 7.3.3Design and Development Outputs19 7.3.4Design and Development Review.19 7.3.5Design and Development Verification.19 7.3.6Design and Development Validati
12、on.19 7.3.6.1Design and Development Verification and Validation Testing20 7.3.6.2Design and Development Verification and Validation Documentation.20 7.3.7Control of Design and Development Changes .20 7.4Purchasing20 7.4.1Purchasing Process20 7.4.2Purchasing Information.21 7.4.3Verification of Purcha
13、sed Product 22 7.5Production and Service Provision.22 7.5.1Control of Production and Service Provision22 7.5.1.1Production Process Verification23 7.5.1.2Control of Production Process Changes.23 7.5.1.3Control of Production Equipment, Tools and Software Programs23 7.5.1.4Post-Delivery Support.24 7.5.
14、2Validation of Processes for Production and Service Provision.24 -,-,- SAE AS9100C Page 3 of 33 7.5.3Identification and Traceability .24 7.5.4Customer Property25 7.5.5Preservation of Product 25 7.6Control of Monitoring and Measuring Equipment .26 8.MEASUREMENT, ANALYSIS AND IMPROVEMENT.27 8.1General
15、 .27 8.2Monitoring and Measurement.27 8.2.1Customer Satisfaction.27 8.2.2Internal Audit.28 8.2.3Monitoring and Measurement of Processes.28 8.2.4Monitoring and Measurement of Product29 8.3Control of Nonconforming Product .29 8.4Analysis of Data30 8.5Improvement.31 8.5.1Continual Improvement.31 8.5.2C
16、orrective Action.31 8.5.3Preventive Action31 BIBLIOGRAPHY.33 -,-,- SAE AS9100C Page 4 of 33 FOREWORD To assure customer satisfaction, aviation, space and defense organizations must produce, and continually improve, safe, reliable products that meet or exceed customer and applicable statutory and reg
17、ulatory 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 world and at all levels of the supply chai
18、n. 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, Asia/Pacific and Europe, to implement ini
19、tiatives 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 used at all levels of the supply chain
20、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, space and defense industry, this standar
21、d 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 addition, industry requirements, definitions a
22、nd notes have been revised and additional requirements have been included in response to stakeholder needs. -,-,- SAE AS9100C Page 5 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 organ
23、ization s 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 organizat
24、ional 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.
25、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 regulatory requirements
26、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 promotes the adoption of a p
27、rocess 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
28、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, together with the identifi
29、cation 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 process
30、es, 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, c) obtaining results of process performance and eff
31、ectiveness, and d) continual improvement of processes based on objective measurement. -,-,- SAE AS9100C Page 6 of 33 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 play a si
32、gnificant 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 Internationa
33、l 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 accordance with
34、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 - MODEL OF
35、A PROCESS-BASED QUALITY MANAGEMENT SYSTEM -,-,- SAE AS9100C Page 7 of 33 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS 1. SCOPE 1.1 General This standard includes ISO 9001:20081 quality management system requirements and specifies additional aviation, space and defense industry requirements, definitions
36、 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 applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable sta
37、tutory or regulatory requirements, the latter 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 regulator
38、y requirements, and b) aims to enhance customer 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 Sta
39、ndard, 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. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. 1.2 Application All requirements of this Inter
40、national 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 International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. W
41、here exclusions are made, claims of conformity 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
42、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 organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own pro
43、ducts. 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
44、their manufacturing/production operations; should use the IAQG-developed 9110 standard (see Bibliography). 1 With 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 Vo
45、ie-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, materials and assemblies and resell these products to a customer in the aviation, space and defense industries, including org
46、anizations that procure products and split them into smaller 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 editio
47、n cited applies. For undated references, the latest edition 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 app
48、ly. 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 the organization, which have high risks to being achieved, thus requiring their inclusion