ISO FDIS 9001_2026质量管理体系要求中英文版

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Quality management systems—

Requirements

Systemes de management de la qualite—Exigenes

质量管理体系-要求

ISO/CEN PARALLEL PROCESSING

ISO/CEN并行处理

参考编号

Reference number

ISO/FDIS 9001:2026(en)

FINAL DRAFT

International

Standard

最终草案

国际

标准

ISO/FDIS 9001

ISO/TC 176/SC2

Secretaniat: BS1

Voting begins on:

2026-05- 14

Voting terminates on:

2026- 07-09

本草案的接收者被道请在提交意见的

同时，告知其所知的任何相关专利

权，并提供支持性文件。

除了对其在工业、技术、商业和甩户

用途方面的可接受性进行评估外，国

际标准草案有时还需根据其可能成为

国家法规中可引用的标准的潜力来加

以考虑，

eISO 2026

Foreword前言......................................................................................................... 5

Introduction 引言.................................................................................................... 9

0.1 General 总则............................................................................................ 9

0.2 Quality management principles质量管理原则....................................... 10

0.3 Process approach 过程方法....................................................................11

0.4 Relationship with other management system standards 与其他管理体系

标准的关系.................................................................................................... 16

1Scope范围......................................................................................................... 18

2Normative references规范性引用文件............................................................ 18

3Terms and definitions术语和定义.................................................................... 19

3.1 organization 组织.................................................................................... 19

3.2interested party 相关方............................................................................ 20

3.3 top management 最高管理者................................................................ 20

3.4 management system 管理体系............................................................... 21

3.4.1 quality management system质量管理体系........................................ 21

3.5 policy方针..............................................................................................22

3.6 objective目标...................................................................................... 22

3.7 risk3.7风险............................................................................................ 23

3.8 process 过程........................................................................................ 24

3.9 competence能力.....................................................................................25

3.10 documented information 成文信息....................................................... 25

3.11 performance绩效................................................................................ 25

3.12 continual improvement 持续改进........................................................ 26

3.13 effectiveness 有效性............................................................................ 26

3.14 requirement要求................................................................................... 26

3.15 conformity 符合.................................................................................... 27

3.16 nonconformity 不符合............................................................................ 27

3.17 corrective action纠正措施.................................................................... 27

3.18audit 审核............................................................................................... 27

3.19 measurement测量................................................................................ 29

3.20 monitoring监视...................................................................................29

4Context of the organization 组织所处的环境....................................................29

4.1 Understanding the organization and its context理解组织及其所处的环境

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

4.2 Understanding the needs and expectations of interested parties理解相

关方的需求和期望........................................................................................ 30

4.3 Determining the scope of the quality management system确定质量管理

体系的范围..................................................................................................... 31

4.4 Quality management system质量管理体系...........................................32

5Leadership领导作用........................................................................................ 33

5.1 Leadership and commitment领导作用和承诺........................................33

5.2 Quality policy质量方针............................................................................ 35

5.3 Roles, responsibilities and authorities角色、职责和权限...................... 36

6Planning 策划..................................................................................................... 37

6.1Actions to address risks and opportunities 应对风险和机遇的措施...... 37

6.2 Quality objectives and planning to achieve them质量目标及其实现的策

划.....................................................................................................................40

6.3 Planning of changes 变更的策划........................................................... 41

7Support 支持..................................................................................................... 42

7.1 Resources 资源........................................................................................42

7.2 Competence能力................................................................................... 46

7.3 Awareness意识 .......................................................................................46

7.4 Communication 信息交流........................................................................ 47

7.5 Documented information 成文信息........................................................47

8Operation 运行....................................................................................................50

8.1 Operational planning and control 运行策划和控制............................... 50

8.2 Requirements for products and services产品和服务的要求............... 51

8.3 Design and development of products and services 产品和服务的设计与

开发.................................................................................................................54

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....................................................................... 58

8.5 Production and service provision生产和服务提供................................ 61

8.6 Release of products and services产品和服务的放行........................... 65

8.7 Control of nonconforming outputs 不合格输出的控制........................... 65

9Performance evaluation绩效评价.................................................................... 67

9.1 Monitoring, measurement, analysis and evaluation监视、测量、分析和

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标签： #ISO #管理 #质量管理体系

摘要：

Qualitymanagementsystems—RequirementsSystemesdemanagementdelaqualite—Exigenes质量管理体系-要求ISO/CENPARALLELPROCESSINGISO/CEN并行处理参考编号ReferencenumberISO/FDIS9001:2026(en)FINALDRAFTInternationalStandard最终草案国际标准ISO/FDIS9001ISO/TC176/SC2Secretaniat:BS1Votingbeginson:2026-05-14Votingterminateson:2026-07-09本草案的接...

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