SAE AS9100D-2016 中文版质量管理体系 —— 航空、航天和国防组织的要求

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本标准由 CAQG 需求工作组翻译，未经 CAQG 许可，不得复制或转发。

AEROSPACE

STANDARD

航空航天标准

9100

Issued 15 March 2016

发布时间：2016-3-15

Superseding January 2009

替代版本：2009-01

Technically equivalent writings published in

all IAQG sectors.

技术评价稿发布给 IAQG 的所有成员

(R) Quality Management Systems – Requirements for Aviation, Space,

and Defense Organizations

（R）质量管理体系——航空、航天和国防组织的要求

TABLE OF CONTENTS

RATIONALE 依据 ................................................................................................................ 1

FOREWORD 前言 ............................................................................................................... 1

INTENDED APPLICATION 预期应用 .................................................................................. 2

INTRODUCTION 引言 ......................................................................................................... 3

0.1 General 总则 .................................................................................................................. 3

0.2 Quality Management Principles 质量管理原则 ............................................................. 4

0.3 Process Approach 过程方法 .......................................................................................... 5

0.3.1 General 总则 ............................................................................................................. 5

0.3.2 Plan-Do-Check-Act Cycle 策划-实施-检查-处置循环 ............................................... 5

0.3.3 Risk-based Thinking 基于风险的思维 ....................................................................... 8

0.4 Relationship with Other Management System Standards 与其他管理体系标准的关系 8

9100

QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS

质量管理体系－要求

1 SCOPE 范围 ................................................................................................................. 9

2 NORMATIVE REFERENCES 规范性引用文件 .......................................................... 10

3 TERMS AND DEFINITIONS 术语与定义 ................................................................... 10

4 CONTEXT OF THE ORGANIZATION 组织环境 ........................................................ 12

4.1 Understanding the Organization and its Context 理解组织及其环境 ......................... 12

4.2 Understanding the Needs and Expectations of Interested Parties 理解相关方的需求和

期望 .................................................................................................................................... 12

4.3 Determining the Scope of the Quality Management System 确定质量管理体系的范围

........................................................................................................................................... 13

4.4 Quality Management System and its Processes 质量管理体系及其过程 .................. 13

5 LEADERSHIP 领导作用 ............................................................................................. 15

5.1 Leadership and Commitment 领导作用和承诺 ........................................................... 15

5.1.1Genera 总则 .............................................................................................................. 15

5.1.2 Customer Focus 以顾客为关注焦点 ........................................................................ 15

5.2 Policy 方针 .................................................................................................................. 16

5.2.1 Establishing the Quality Policy 制定质量方针 ......................................................... 16

5.2.2 Communicating the Quality Policy 沟通质量方针 .................................................... 16

5.3 Organizational Roles, Responsibilities, and Authorities 组织内的角色、职责和权限 16

6 PLANNING 策划 ......................................................................................................... 17

6.1 Actions to Address Risks and Opportunities 应对风险和机遇的措施......................... 17

6.2 Quality Objectives and Planning to Achieve Them 质量目标及其实现的策划 ........... 18

6.3 Planning of Changes 变更的策划 ............................................................................... 18

7 SUPPORT 支持 .......................................................................................................... 18

7.1 Resources 资源 .......................................................................................................... 18

7.1.1 General 总则 ............................................................................................................ 19

7.1.2 People 人员.............................................................................................................. 19

7.1.3 Infrastructure 基础设施 ............................................................................................ 19

7.1.4 Environment for the Operation of Processes 过程运行环境 ................................... 19

7.1.5 Monitoring and Measuring Resources 监测和测量资源 .......................................... 19

7.1.6 Organizational Knowledge 组织的知识 ................................................................... 21

7.2 Competence 能力 ....................................................................................................... 21

III

9100

7.3 Awareness 意识 .......................................................................................................... 22

7.4 Communication 沟通 .................................................................................................. 22

7.5 Documented Information 成文信息 ............................................................................ 23

7.5.1 General 总则 ........................................................................................................... 23

7.5.2 Creating and Updating 创建和更新 ......................................................................... 23

7.5.3 Control of Documented Information 成文信息的控制 ............................................. 23

8 OPERATION 运行 ....................................................................................................... 24

8.1 Operational Planning and Control 运行的策划和控制 ................................................ 24

8.1.1

Operational Risk Management

运行风险管理

..................................................... 27

8.1.2

Configuration Management

技术状态管理

.......................................................... 27

8.1.3

Product Safety

产品安全

....................................................................................... 27

8.1.4

Prevention of Counterfeit Parts

假冒件预防

....................................................... 28

8.2 Requirements for Products and Services 产品和服务的要求 .................................... 28

8.2.1 Customer Communication 顾客沟通 ....................................................................... 28

8.2.2 Determining the Requirements for Products and Services 产品和服务要求的确定

........................................................................................................................................... 29

8.2.3 Review of the Requirements for Products and Services 产品和服务要求的评审 ... 29

8.2.4 Changes to Requirements for Products and Services 产品和服务要求的更改 ...... 30

8.3 Design and Development of Products and Services 产品和服务的设计和开发 ........ 30

8.3.1 General 总则 ........................................................................................................... 30

8.3.2 Design and Development Planning 设计和开发策划 .............................................. 30

8.3.3 Design and Development Inputs 设计和开发输入 .................................................. 31

8.3.4 Design and Development Controls 设计和开发控制 .............................................. 32

8.3.5 Design and Development Outputs 设计和开发输出 ............................................... 33

8.3.6 Design and Development Changes 设计和开发更改 ............................................. 34

8.4 Control of Externally Provided Processes, Products, and Services 外部提供的过程、

产品和服务的控制 .............................................................................................................. 34

8.4.1 General 总则 ........................................................................................................... 34

8.4.2 Type and Extent of Control 控制类型和程度 ........................................................... 36

8.4.3 Information for External Providers 提供给外部供方的信息 .................................... 37

8.5 Production and Service Provision 生产和服务提供 .................................................... 39

8.5.1 Control of Production and Service Provision 生产和服务提供的控制 .................... 39

8.5.2 Identification and Traceability 标识和可追溯性........................................................ 42

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标签： #质量管理 #管 #管理体系

摘要：

本文档提供SAE AS9100D-2016标准的中文版完整内容，该标准是航空、航天和国防组织专用的质量管理体系要求，在ISO 9001基础上增加了对安全性、可追溯性、风险管理及关键特性控制的特殊要求。本版本覆盖了设计、开发、生产和交付全流程，适用于供应链中的各类组织，旨在帮助中国企业提升在航空航天与国防领域的合规性、客户信任度及国际竞争力。通过理解并实施AS9100D-2016，企业可有效减少质量事故、优化流程控制，并满足NADCAP、NATO及适航认证等监管要求。

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