SAE AS 9110B-2012 Quality Management Systems - Requirements for Aviation Maintenance Organizations (ACTIVE UNTIL 9 15 2018)《质量保证系统 航空维修机构的要求》.pdf

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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 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 revised, reaffirmed, stabilized, or cancelled. SAE invites your written comments and suggestions. Copyright 2012 SAE International All rights reserved. No part of this p

3、ublication 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: Tel: 877-606-7323 (inside USA and Canada) Tel: +1 724-776-497

4、0 (outside USA) 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/AS9110B AEROSPACE STANDARD AS9110 REV. B Issued 2003-01 Revised 2012-04 Supersedi

5、ng AS9110A Quality Management Systems - Requirements for Aviation Maintenance Organizations RATIONALE This standard has been revised to address stakeholder needs through the addition of definitions and clarification of existing requirements to resolve interpretation issues, and incorporate editorial

6、 corrections. FOREWORD To assure customer satisfaction, aviation, and defense organizations must produce, maintain, repair, and continually improve safe, reliable products that meet or exceed customer and applicable statutory and regulatory requirements. The globalization of the industry and the res

7、ulting 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 chain. Suppliers have the challenge of delivering products to multiple

8、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 initiatives that make significant improvements in quality and reducti

9、ons 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 by organizations around the world. Its use should result in improv

10、ed 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 and defense industry organizations providing maintenance services, this standard can also be used in other

11、 industry sectors where a quality management system with additional requirements over an ISO 9001 system is needed. SAE AS9110B Page 2 of 35 TABLE OF CONTENTS RATIONALE . 1 FOREWORD . 1 INTRODUCTION . 5 0.1 General 5 0.2 Process Approach 5 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS . 7 1. SCOPE . 7 1.1

12、 General 7 1.2 Application 7 2. NORMATIVE REFERENCES 8 3. TERMS AND DEFINITIONS 8 3.1 Airworthy 8 3.2 Article . 8 3.3 Authority . 8 3.4 Certified Personnel 8 3.5 Certifying Staff 8 3.6 Counterfeit Part 8 3.7 Critical Items 8 3.8 Human Factors . 9 3.9 Key Characteristic 9 3.10 Maintenance . 9 3.11 Re

13、lease Certificate . 9 3.12 Risk 9 3.13 Safety Policy 9 3.14 Special Requirements 9 3.15 Suspected Unapproved Part 10 3.16 Technical Data . 10 4. QUALITY MANAGEMENT SYSTEM 10 4.1 General Requirements . 10 4.2 Documentation Requirements . 11 4.2.1 General 11 4.2.2 Quality Manual . 11 4.2.3 Control of

14、Documents 12 4.2.4 Control of Records . 12 5. MANAGEMENT RESPONSIBILITY 13 5.1 Management Commitment . 13 5.2 Customer Focus . 13 5.3 Quality Policy . 13 5.4 Planning . 13 5.4.1 Quality Objectives 13 5.4.2 Quality Management System Planning 14 5.4.3 Safety Objectives . 14 SAE AS9110B Page 3 of 35 5.

15、5 Responsibility, Authority, and Communication 14 5.5.1 Responsibility and Authority . 14 5.5.1.1 Accountable Manager . 14 5.5.1.2 Maintenance Manager(s) . . 14 5.5.2 Management Representative . 14 5.5.3 Internal Communication . 15 5.6 Management Review . 15 5.6.1 General 15 5.6.2 Review Input 15 5.

16、6.3 Review Output 15 5.7 Safety Policy 15 6. RESOURCE MANAGEMENT . 16 6.1 Provision of Resources 16 6.2 Human Resources . 16 6.2.1 General 16 6.2.2 Competence, Training, and Awareness . 16 6.3 Infrastructure 17 6.4 Work Environment 17 7. PRODUCT REALIZATION 17 7.1 Planning of Product Realization . 1

17、7 7.1.1 Project Management 18 7.1.2 Risk Management 18 7.1.3 Configuration Management 18 7.1.4 Control Of Work Transfers . 19 7.2 Customer-Related Processes 19 7.2.1 Determination of Requirements Related to the Product 19 7.2.2 Review of Requirements Related to the Product . 19 7.2.3 Customer Commun

18、ication . 20 7.3 Design and Development . 20 7.3.1 Design and Development Planning . 20 7.3.2 Design and Development Inputs 20 7.3.3 Design and Development Outputs . 21 7.3.4 Design and Development Review 21 7.3.5 Design and Development Verification 21 7.3.6 Design and Development Validation 22 7.3.

19、6.1 Design and Development Verification and Validation Testing . 22 7.3.6.2 Design and Development Verification and Validation Documentation 22 7.3.7 Control of Design and Development Changes 22 7.4 Purchasing . 22 7.4.1 Purchasing Process . 22 7.4.2 Purchasing Information 23 7.4.3 Verification of P

20、urchased Product . 24 7.5 Production and Service Provision 24 7.5.1 Control of Production and Service Provision . 24 7.5.1.1 Maintenance Process Verification . 26 7.5.1.2 Control of Maintenance Process Changes 26 7.5.1.3 Control of Maintenance Equipment, Tools, and Software Programs 26 7.5.1.4 Post-

21、Delivery Support 26 7.5.2 Validation of Processes for Production and Service Provision 26 7.5.3 Identification and Traceability 27 7.5.4 Customer Property . 27 7.5.5 Preservation of Product . 28 7.6 Control of Monitoring and Measuring Equipment 28 SAE AS9110B Page 4 of 35 8. MEASUREMENT, ANALYSIS, A

22、ND IMPROVEMENT . 29 8.1 General 29 8.2 Monitoring and Measurement 29 8.2.1 Customer Satisfaction 29 8.2.2 Internal Audit 30 8.2.3 Monitoring and Measurement of Processes 30 8.2.4 Monitoring and Measurement of Product . 30 8.3 Control of Nonconforming Product 31 8.4 Analysis of Data . 32 8.5 Improvem

23、ent 33 8.5.1 Continual Improvement 33 8.5.2 Corrective Action 33 8.5.3 Preventive Action . 33 9. NOTES . 34 FIGURE 1 MODEL OF A PROCESS-BASED QUALITY MANAGEMENT SYSTEM . 6 BIBLIOGRAPHY 35 SAE AS9110B Page 5 of 35 INTRODUCTION 0.1 General The adoption of a quality management system should be a strate

24、gic 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 associated with that environment,b. its varying needs,c. its particular objectives,d. the produ

25、cts 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 uniformity of documentation. The quality management system requirements specified in this Int

26、ernational 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, to assess the organizatio

27、ns 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 been taken into consideration during the development of this International Standard. 0.2 Proce

28、ss 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 satisfaction by meeting customer requirements. For an organization to function effectively, it has to

29、 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. Often the output from one process directly forms the input to the next. The application of a s

30、ystem 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”. An advantage of the process approach is the ongoing control that it provides over the li

31、nkage 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 of: a. understanding and meeting requirements,b. the need to consider processes in terms

32、of added value,c. obtaining results of process performance and effectiveness, andd. continual improvement of processes based on objective measurement.SAE AS9110B Page 6 of 35 The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in Clause

33、s 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 perception as to whether the organization has met the customer requirements. The model shown in

34、 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 processes. PDCA can be briefly described as follows. Plan: establish the objectives and

35、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, objectives, and requirements for the product and report the results. Act: take actions to co

36、ntinually improve process performance. FIGURE 1 MODEL OF A PROCESS-BASED QUALITY MANAGEMENT SYSTEM Customers Customers Continual improvement of the quality management system Satisfaction Resource management Management responsibility Measurement, analysis and improvementRequirements Input Product Out

37、putProduct realization Key Value-adding activities Information flow SAE AS9110B Page 7 of 35 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS 1. SCOPE1.1 General This standard includes ISO 9001:20081quality management system requirements and specifies additional aviation maintenance industry requirements, de

38、finitions, and notes as shown in bold, italic text. NOTE: Baseline aviation maintenance requirements originate from IAQG developed 9100:2009 standard; modifications were made, as required, to address maintenance industry specific requirements. It is emphasized that the requirements specified in this

39、 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 latter shall take precedence. This International Standard s

40、pecifies 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 andregulatory requirements, andb. aims to enhance customer satisfaction through the effective application of t

41、he system, including processes forcontinual improvement of the system 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

42、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 intended to be applicable to all organizations, regardless of typ

43、e, 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 conformity to this International Standard are not acceptable unles

44、s 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. This standard has been developed to benefit maintenance organiz

45、ations that choose to adopt it, whether or not holders of a National Aviation Authority (NAA) repair station certificate. This standard is intended for use by maintenance organizations whose primary business is providing maintenance services for aviation commercial and military products; and for Ori

46、ginal Equipment Manufacturer (OEM) organizations with maintenance operated autonomously or that are substantially different from their manufacturing/production operations. 1With the permission of the International Organization for Standardization (ISO). The complete standard can be obtained from any

47、 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 AS9110B Page 8 of 35 2. NORMATIVE REFERENCESThe following referenced documents are indispensable for the application of th

48、is 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 and vocabulary 3. TERMS AND DEFINITIONSFor the purposes of this document

49、, 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”. NOTE: In the context of this standard, the term “product“ is synonymous with the term “maintenance service“. 3.1 Airworthy State of an article conforming to its type design and being in a conditi