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1、 AEROSPACE STANDARD Quality Management Systems - Aerospace - Requirements 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
2、 for any particular use, including any patent infringement arising therefrom, 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 2
3、004 SAE International All rights reserved. No part of this publication may 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: T
4、el: 877-606-7323 (inside USA and Canada) Tel: 724-776-4970 (outside USA) Fax: 724-776-0790 Email: custsvcsae.org SAE WEB ADDRESS: http:/www.sae.org Issued 1999-11 Revised 2004-01 Superseding AS9100A AS9100 Technically equivalent to AECMA prEN 9100 REV. B TABLE OF CONTENTS FOREWORD.4 REVISION SUMMARY
5、4 INTRODUCTION 5 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS7 1. SCOPE 7 1.1 General 7 1.2 Application7 2. NORMATIVE REFERENCE.8 3. TERMS AND DEFINITIONS8 4. QUALITY MANAGEMENT SYSTEM .9 4.1 General Requirements.9 4.2 Documentation Requirements10 4.2.1 General 10 4.2.2 Quality Manual.11 4.2.3 Control
6、of Documents 11 4.2.4 Control of Records.12 4.3 Configuration Management12 SAE AS9100 Revision B - 2 - 5. MANAGEMENT RESPONSIBILITY.12 5.1 Management Commitment.12 5.2 Customer Focus.12 5.3 Quality Policy .13 5.4 Planning.13 5.4.1 Quality Objectives13 5.4.2 Quality Management System Planning13 5.5 R
7、esponsibility, Authority and Communication13 5.5.1 Responsibility and Authority.13 5.5.2 Management Representative.14 5.5.3 Internal Communication.14 5.6 Management Review .14 5.6.1 General 14 5.6.2 Review Input 15 5.6.3 Review Output15 6. RESOURCE MANAGEMENT15 6.1 Provision of Resources15 6.2 Human
8、 Resources .15 6.2.1 General 15 6.2.2 Competence, Awareness and Training16 6.3 Infrastructure16 6.4 Work Environment16 7. PRODUCT REALIZATION.17 7.1 Planning of Product Realization.17 7.2 Customer-Related Processes18 7.2.1 Determination of Requirements Related to the Product.18 7.2.2 Review of Requi
9、rements Related to the Product .18 7.2.3 Customer Communication19 7.3 Design and Development.19 7.3.1 Design and Development Planning19 7.3.2 Design and Development Inputs20 7.3.3 Design and Development Outputs.20 7.3.4 Design and Development Review21 7.3.5 Design and Development Verification21 7.3.
10、6 Design and Development Validation21 7.3.6.1 Documentation of Design and/or Development Verification and Validation.22 7.3.6.2 Design and/or Development Verification and Validation Testing.22 7.3.7 Control of Design and Development Changes.22 7.4 Purchasing.23 7.4.1 Purchasing Process.23 7.4.2 Purc
11、hasing Information24 7.4.3 Verification of Purchased Product25 SAE AS9100 Revision B - 3 - 7.5 Production and Service Provision26 7.5.1 Control of Production and Service Provision26 7.5.1.1 Production Documentation.27 7.5.1.2 Control of Production Process Changes27 7.5.1.3 Control of Production Equi
12、pment, Tools and Numerical Control (NC) Machine Programs27 7.5.1.4 Control of Work Transferred, on a Temporary Basis, Outside the Organizations Facilities.27 7.5.1.5 Control of Service Operations28 7.5.2 Validation of Processes for Production and Service Provision 28 7.5.3 Identification and Traceab
13、ility.29 7.5.4 Customer Property.29 7.5.5 Preservation of Product30 7.6 Control of Monitoring and Measuring Devices.30 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT .32 8.1 General 32 8.2 Monitoring and Measurement 32 8.2.1 Customer Satisfaction32 8.2.2 Internal Audit33 8.2.3 Monitoring and Measurement o
14、f Processes.34 8.2.4 Monitoring and Measurement of Product.34 8.2.4.1 Inspection Documentation35 8.2.4.2 First Article Inspection35 8.3 Control of Nonconforming Product.35 8.4 Analysis of Data.37 8.5 Improvement37 8.5.1 Continual Improvement37 8.5.2 Corrective Action37 8.5.3 Preventive Action.38 BIB
15、LIOGRAPHY .39 -,-,- SAE AS9100 Revision B - 4 - FOREWORD To assure customer satisfaction, aerospace industry organizations must produce, and continually improve, safe, reliable products that meet or exceed customer and regulatory authority requirements. The globalization of the aerospace industry, a
16、nd the resulting diversity of regional/national requirements and expectations, has complicated this objective. End-product organizations face the challenge of assuring the quality of, and integrating, product purchased from suppliers throughout the world and at all levels within the supply chain. Ae
17、rospace suppliers and processors face the challenge of delivering product to multiple customers having varying quality expectations and requirements. The aerospace industry established the International Aerospace Quality Group (IAQG) for the purpose of achieving significant improvements in quality a
18、nd safety, and reductions in cost, throughout the value stream. This organization includes representation from aerospace companies in the Americas, Asia/Pacific, and Europe. This international standard has been prepared by the IAQG. This document standardizes, to the greatest extent possible, qualit
19、y management system requirements for the aerospace industry. The establishment of common requirements, for use at all levels of the supply-chain, by organizations around the world, should result in improved quality and safety, and decreased costs, due to the elimination or reduction of organization-
20、unique requirements and the resultant variation inherent in these multiple expectations. REVISION SUMMARY The portion of the standard that was based on ISO 9001:1994 has been deleted and the Bibliography has been updated. This revision has not changed the technical content of the standard and is con
21、sidered administrative in nature. -,-,- SAE AS9100 Revision B - 5 - INTRODUCTION 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 varying needs, particul
22、ar objectives, the products provided, the processes employed and the size and structure of the organization. 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 requiremen
23、ts 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 by internal and external parties, including certification bodies, t
24、o assess the organizations ability to meet customer, regulatory 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. Process Approach This International Stan
25、dard promotes 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 identify and manage numerous linked
26、 activities. An activity 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 t
27、he identification and interactions of these processes, and their management, 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, as well as over th
28、eir 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 effectiveness, and d) con
29、tinual improvement of processes based on objective measurement. SAE AS9100 Revision B - 6 - 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 significant role in definin
30、g 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 International Standard, but does not
31、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 customer requirements and
32、 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 a Process-Based Quality M
33、anagement System Customers Customers Continual improvement of the quality management system Satisfaction Resource management Management responsibility Measurement, analysis and improvement Requirements Input Product Output Product realization Key Value-adding activities Information flow -,-,- SAE AS
34、9100 Revision B - 7 - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS 1. SCOPE: 1.1 General: This standard includes ISO 9001:20001 quality management system requirements and specifies additional requirements for a quality management system for the aerospace industry. The additional aerospace requirements
35、are shown in bold, italic text. It is emphasized that the quality management system requirements specified in this standard are complementary (not alternative) to contractual and applicable law and regulatory requirements. This International Standard specifies requirements for a quality management s
36、ystem where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of t
37、he system and the assurance of conformity to customer and applicable regulatory requirements. NOTE: In this International Standard, the term “product” applies only to the product intended for, or required by, a customer. 1.2 Application: All requirements of this International Standard are generic an
38、d 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. Where exclusions are made, claims
39、 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 regulatory requirements. 1 With
40、the permission of the International Organization for Standardization (ISO). The complete standard may be obtained from any ISO member or from the ISO Central Secretariat, Case Postale 56, 1211 Geneva 20, Switzerland. Copyright remains with ISO. -,-,- SAE AS9100 Revision B - 8 - 2. NORMATIVE REFERENC
41、E: The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this I
42、nternational Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO (International Organization for Standardization)
43、 and IEC (International Electrotechnical Commission) maintain registers of currently valid International Standards. ISO 9000:2000, Quality management systems - Fundamentals and vocabulary. 3. TERMS AND DEFINITIONS: For the purposes of this International Standard, the terms and definitions given in I
44、SO 9000 apply. The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier organization customer The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which th
45、is International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. Key Characteristics: The features of a material, process, or part whose variation ha
46、s a significant influence on product fit, performance, service life, or manufacturability. -,-,- SAE AS9100 Revision B - 9 - 4. QUALITY MANAGEMENT SYSTEM: 4.1 General Requirements: The organization shall establish, document, implement and maintain a quality management system and continually improve
47、its effectiveness in accordance with the requirements of this International Standard. The organization shall a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these processes, c
48、) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f
49、) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard. Where an organization chooses to outsource any process that affects product conformity with requirements, the o