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1、J IS JAPANESE I NDUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS Q 9100 :20*1 Quality management systems- Aerospace-Requirements ICs 03.120.10; 49.020 Reference number : JIS Q 9100 : 2001 (E) PROTECTED BY COPYRIGHT 30 S Copyright Japanese Standards Association Provid
2、ed by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 09:56:10 MDTNo reproduction or networking permitted without license from IHS -,-,- Q 9100 : 2001 Foreword This translation has been made based on the original Japanese Industrial Standard
3、revised by the Minister of Economy, Trade and Industry through deliberations at the Japanese Industrial Standards Committee, as the result of proposal for revision of Japanese Industrial Standard submitted by the Society of Japanese Aerospace Companies (SJAC) with the draft being attached, based on
4、the provision of Article 12 Clause 1 of the In- dustrial Standardization Law. consequently JIS Q 9100 : 2000 is re- placed with this Standard. This Standard has been prepared based on IAQS (International Aerospace Quality Standard) 9100 : 2000 without modifying the technical contents. Date of Establ
5、ishment: 2000-08-20 Date of Revision: 2001-11-20 Date of Public Notice in Official Gazette: 2001-11-20 Investigated by: Japanese Industrial Standards Committee C onforrnity As se sment Board JIS Q 9100 : 2001, First English edition published in 2002-08 Translated and published by: Japanese Standards
6、 Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. O JSA 2002 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
7、 any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. Printed in Japan PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie No
8、t for Resale, 03/12/2007 09:56:10 MDTNo reproduction or networking permitted without license from IHS -,-,- Q 9100 : 2001 Contents Page Foreword . 1 Structure and application . 1 Quality management systems-Aerospace-Requirements based on JIS Q 9001 : 2000 2 Quality systems-Aerospace-Model for qualit
9、y assurance in design, development, production, installation and servicing based on JIS Z 9901 : 1998 30 (i) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 09:56:10
10、MDTNo reproduction or networking permitted without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS Q 9100: 2001 Quality management systems- Aerospace-Requirement s Foreword To assure customer satisfaction, aerospace industry organizations must produce, and continually improve, safe, reliable
11、 products that meet or exceed cus- tomer and regulatory authority requirements. The globalization of the aerospace industry, and the resulting diversity of regionalhational requirements and expecta- tions? has complicated this objective. End-product organizations face the challenge of assuring the q
12、uality of, and integrating, product purchased from suppliers throughout the world and at all levels within the supply chain. Aerospace suppliers and proces- sors face the challenge of delivering product to multiple customers having varying quality expectations and requirements. This document standar
13、dizes? to the greatest extent possible, quality management system requirements for the aerospace industry. The establishment of common re- quirements, 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
14、to the elimination or reduction of organization-unique requirements and the resultant variation inherent in these multiple expectations. Structure and application This Standard includes aerospace requirements ap- plied to, and integrated with, both the JIS Q 9001 : 2000 and the JIS Z 9901 : 1998 qua
15、lity management system models. Organization now having a QMS based on IS0 Standards shall, in consideration of intent for transition to the JIS Q 9001 : 2000 model, the requirements under con- tract and others, select and develop a QMS model, and document it on the manual of organizations QMS. JIS Z
16、 9901 : 1998 included in this Standard will be withdrawn on December 15, 2003 by the review of IAQG. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 09:56:10 MDTNo re
17、production or networking permitted without license from IHS -,-,- 2 Q 9100 : 2001 Quality management systems-Aerospace- Requirements based on JIS Q 9001 : 2000 Table of contents Page O Introduction . 1 Scope . 1.1 General 1.2 Application 2 Normative references . 3 Terms and definitions . 4 Quality m
18、anagement system 4.1 General requirements . 4.2 Documentation requirements 4.3 Configuration management . 5 Management responsibility 5.1 Management commitment 5.2 Customer focus . 5.3 Quality policy . 4 5 5 6 6 6 7 7 7 9 9 9 9 9 5.4 Planning 10 5.5 5.6 Management review 10 Responsibility, authority
19、 and communication 10 6 Resource management . 11 6.1 Provision of resources . 11 6.2 Human resources . 11 6.3 Infrastructure . 12 6.4 Work environment . 12 7 Product realization . 12 7.1 Planning of product realization 12 7.2 Customer-related processes . 13 7.3 Design and development 13 7.4 Purchasi
20、ng 17 7.5 7.6 Production and service provision 18 Control of monitoring and measuring devices . 22 PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 09:56:10 MDTNo repr
21、oduction or networking permitted without license from IHS -,-,- 3 Q 9100 : 2001 Page 8 Measurement. analysis and improvement . 23 8.1 General 23 8.2 Monitoring and measurement . 24 8.3 Control of nonconforming product 26 8.4 Analysis of data . 27 8.5 Improvement . 27 Annex Bibliography . 29 PROTECTE
22、D BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 09:56:10 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 Q 9100 : 2001 Quality management systems-
23、Aerospace- Requirements based on JIS Q 9001 : 2000 O 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 varying needs, particular objectiv
24、es, the products provided? the processes employed and the size and structure of the or- ganization, It is not the intent of this Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this St
25、andard are comple- mentary to requirements for products. This Standard can be used by internal and external parties, including certifica- tion bodies, to assess the organizations ability to meet customer, regulatory and the organizations own requirements. The quality management principles stated in
26、JIS Q 9000 and JIS Q 9004 have been taken into consideration during the development of this Standard. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. The portions underlined with dots are the matters not including the original International Standa
27、rd. 0.2 Process approach This Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality man- agement system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to
28、 identify and manage numer- ous linked 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 w
29、ithin an organization, together with the 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 s
30、ystem 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) c) d) the need to consider processes in terms of added value, obtaining results of process
31、 performance and effectiveness, and continual improvement of processes based on objective measurement. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 09:56:10 MDTNo
32、reproduction or networking permitted without license from IHS -,-,- 5 Q 9100 : 2001 The model of a process-based quality management system shown in Fig. 1 illus- trates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requir
33、ements 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 Fig. 1 covers all the requirements of this Standard, but does not show processes at a deta
34、iled 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 the organizations poli
35、cies. 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. Continual improvement of the quality management system 1 Customers R
36、equire- ments Key d Value-adding activities - -3- Information flow Fig. 1 Model of a process-based quality management system 1 Scope 1.1 This Standard includes JIS Q 9001 : 2000 quality managernent system requirements and specifies additional requirements for a quality management system for the aero
37、space industry. The additional aerospace requirements are shown in bold, italic text. General PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 09:56:10 MDTNo reproduct
38、ion or networking permitted without license from IHS -,-,- 6 Q 9100 : 2001 It is emphasized that the quality management system requirements speci- fied in this Standard are complementary (not alternative) to contractual and applicable law and regulatory requirements. This Standard specifies requirem
39、ents for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets cus- tomer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including process
40、es for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. NOTE : In this Standard, the term ?product? applies only to the product in- tended for, or required by, a customer. 1.2 Application All requirements of this Standard are gen
41、eric and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s1 of this 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 con
42、formity to this Standard are not accept- able unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization?s ability, or responsibility, to provide prod- uct that meets customer and applicable regulatory requirements. 2 Normative references
43、The following normative document contains provisions which, through reference in this text, constitute provisions of this Standard. For dated references, subsequent amendments to, or revisions of, any of these publica- tions do not apply. JIS Q 9000 : 2000 Quality management systems-Fundamentals and
44、 vocabulary JIS Q 9001 : 2000 Quality management systems-Requirements 3 Terms and definitions For the purposes of this Standard, the terms and defi- nitions given in JIS Q 9000 apply. The following terms, used in this Standard to describe the supply chain, have been changed to reflect the vocabulary
45、 currently used: supplier - organization -t customer The term ?organization? replaces the term ?supplier? used in the former stan- dard corresponding to IS0 9000: 1994, and refers to the unit to which this Stan- dard applies. Also, the term ?supplier? now replaces the term ?subcontractor?. Throughou
46、t the text of this Standard, wherever the term ?product? occurs, it can also mean ?service?. Key characteristics: The features of a material, process, or part whose variation has a significant influence on product fit, performance, service life, or manufacturability. PROTECTED BY COPYRIGHT Copyright
47、 Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 09:56:10 MDTNo reproduction or networking permitted without license from IHS -,-,- 7 Q 9100 : 2001 4 Quality management system 4.1 General requirement
48、s The organization shall establish, document, imple- ment and maintain a quality management system and continually improve its effec- tiveness in accordance with the requirements of this Standard. The organization shall a) identify the processes needed for the quality management system and their ap- plication throughout the organization (see 1.21, determine the sequence and interaction of these processes, determine criteria and methods needed to ensure that both the operation and control of these processe