GB/T 19001-2016 English PDF (GBT19001-2016)

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GB/T 19001-2016: Quality management systems -- Requirements
GB/T 19001-2016
Quality management systems - Requirements
ICS 03.120.10
A00
National Standards of People's Republic of China
Replace GB/T 19001-2008
Quality management system requirements
Released on.2016-12-30
2017-07-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Issued by China National Standardization Administration
Table of contents
Preface Ⅴ
Introduction Ⅵ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Organizational environment 1
4.1 Understanding the organization and its environment 1
4.2 Understanding the needs and expectations of related parties 1
4.3 Determine the scope of the quality management system 2
4.4 Quality management system and its process 2
5 Leadership 2
5.1 Leadership and commitment 2
5.1.1 General 2
5.1.2 Focus on customers 3
5.2 Policy 3
5.2.1 Formulate quality policy 3
5.2.2 Communication quality policy 3
5.3 Organizational posts, responsibilities and authorities 3
6 Planning 3
6.1 Measures to deal with risks and opportunities 3
6.2 Quality objectives and planning for their realization 4
6.3 Change planning 4
7 Support 4
7.1 Resources 4
7.1.1 General 4
7.1.2 People 5
7.1.3 Infrastructure 5
7.1.4 Process operating environment 5
7.1.5 Monitoring and measuring resources 5
7.1.6 Knowledge of the organization 5
7.2 Ability 6
7.3 Consciousness 6
7.4 Communication 6
7.5 Documented information 6
7.5.1 General 6
7.5.2 Create and update 7
7.5.3 Control of documented information 7
8 Run 7
8.1 Operational planning and control 7
8.2 Requirements for products and services 7
8.2.1 Customer communication 7
8.2.2 Determination of product and service requirements 8
8.2.3 Review of product and service requirements 8
8.2.4 Changes to product and service requirements 8
8.3 Design and development of products and services 8
8.3.1 General 8
8.3.2 Design and development planning 8
8.3.3 Design and development input 9
8.3.4 Design and development control 9
8.3.5 Design and development output 9
8.3.6 Design and development changes 9
8.4 Control of externally provided processes, products and services 10
8.4.1 General 10
8.4.2 Type and degree of control 10
8.4.3 Information provided to external providers 10
8.5 Production and service provision 10
8.5.1 Control of production and service provision 10
8.5.2 Identification and traceability 11
8.5.3 Property of customers or external providers 11
8.5.4 Protection 11
8.5.5 Post-delivery activities 11
8.5.6 Change control 11
8.6 Release of products and services 12
8.7 Control of unqualified output 12
9 Performance Evaluation 12
9.1 Monitoring, measurement, analysis and evaluation 12
9.1.1 General 12
9.1.2 Customer satisfaction 12
9.1.3 Analysis and Evaluation 12
9.2 Internal audit 13
9.3 Management review 13
9.3.1 General 13
9.3.2 Management review input 13
9.3.3 Management review output 14
10 Improvement 14
10.1 General 14
10.2 Nonconformities and corrective actions 14
10.3 Continuous improvement 14
Appendix A (informative appendix) New structure, terminology and concept description 15
Appendix B (informative appendix) Other quality management and quality management system standards formulated by SAC/TC151 18
Reference 21
Preface
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is one of the core standards of the GB/T 19000 family.
This standard replaces GB/T 19001-2008 "Quality Management System Requirements".
Compared with GB/T 19001-2008, the main technical changes of this standard are as follows except for editorial changes.
--- Use the high-level structure given in Annex SL of the ISO Supplementary Provisions of Part 1 of the ISO /IEC Guidelines;
---Adopt risk-based thinking;
--- Fewer prescriptive requirements;
---The requirements for documented information are more flexible;
---Improved the applicability of the service industry;
--- More emphasis on the organizational environment;
---Enhance the requirements for leadership;
--- Pay more attention to achieving the expected process results to enhance customer satisfaction.
Appendix A gives a more detailed description of the changes relative to GB/T 19001-2008.
The translation method used in this standard is equivalent to ISO 9001.2015 "Quality Management System Requirements" (English version).
This standard was proposed and managed by the National Standardization Technical Committee for Quality Management and Quality Assurance (SAC/TC151).
Drafting organizations of this standard. China National Institute of Standardization, National Certification and Accreditation Administration Committee, China Certification and Accreditation Association, China Qualified
Evaluation of National Accreditation Center, China Quality Certification Center, Tianjin Huacheng Certification Center, China Classification Society Quality Certification Company, Shenzhen Huantong Certification
Center Co., Ltd., China New Era Certification Center, Fangyuan Mark Certification Group Co., Ltd., Beijing New Century Inspection and Certification Co., Ltd., Guopei
Certification Training (Beijing) Center, China Certification Center Co., Ltd., Shanghai Quality System Audit Center, China Quality Assurance Center, SAIC GM
Wuling Automobile Co., Ltd., Inner Mongolia North Heavy Truck Co., Ltd., Taixing Longyi Terminal Co., Ltd., Shanghai Jianke Engineering Consulting Co., Ltd.
Consulting Company, Inner Mongolia Yili Industrial Group Co., Ltd., Tianjin Tiandi Weiye Technology Co., Ltd., Chongqing Changan Automobile Co., Ltd.,
Inner Mongolia Hexinyuan Mongolian Grass Drought Resistant Greening Co., Ltd., Nanjing Mint Co., Ltd., China Railway Construction Co., Ltd., China Building Materials Inspection
Certification Group Co., Ltd., Beijing Dongfang Yichu Standard Technology Co., Ltd.
The main drafters of this standard. Tian Wu, Kang Jian, Zhang Huicai, Li Qiang, Ren Qingyue, Li Ming, Zheng Yuanhui, Huang Xueliang, Qu Xintian, Zheng Yan, Liang Ping,
Wang Mei, Li Ping, Xia Fang, Wang Jinde, Cao Hua, Deng Xiangning, Pei Jie, Lin Chuang, Zhou Hongbo, Li Yeqiu, Li Chenxuan, Fan Yejuan, Xie Hui, Zhu Jiangtao,
Wei Xiangyang, Liu Ye, Dong Xiaohong.
The previous versions of the standard replaced by this standard are as follows.
---GB/T 10300.2-1988;
---GB/T 19001-1992, GB/T 19001-1994, GB/T 19001-2000, GB/T 19001-2008.
introduction
0.1 General
Adopting a quality management system is a strategic decision of an organization, which can help it improve its overall performance and lay a good foundation for promoting sustainable development.
basis.
The potential benefits of an organization implementing a quality management system based on this standard are.
a) The ability to stably provide products and services that meet customer requirements and applicable laws and regulations;
b) Facilitate opportunities to enhance customer satisfaction;
c) Respond to risks and opportunities related to the organization's environment and goals;
d) Demonstrate the ability to meet the requirements of the specified quality management system.
This standard can be used by internal and external parties.
The implementation of this standard does not require.
---Unify the structure of different quality management systems;
---Form a document consistent with the clause structure of this standard;
--- Use the specific terminology of this ...