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GB/T 19002-2018 English PDF (GBT19002-2018)

GB/T 19002-2018 English PDF (GBT19002-2018)

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GB/T 19002-2018: Quality management systems -- Guidelines for the application of GB/T 19001-2016
GB/T 19002-2018
Quality management systems - Guidelines for the application of GB/T 19001-2016
ICS 03.120.10
A00
National Standards of People's Republic of China
Quality management system
GB/T 19001-2016 Application Guide
2018-12-28 released
2019-07-01 implementation
State Administration for Market Regulation
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 2
4.3 Determine the scope of the quality management system 3
4.4 Quality management system and its process 4
5 Leadership 5
5.1 Leadership and commitment 5
5.1.1 General 5
5.1.2 Focus on customers 6
5.2 Policy 7
5.2.1 Formulate quality policy 7
5.2.2 Communication quality policy 7
5.3 Organizational posts, responsibilities and authorities 7
6 Planning 8
6.1 Measures to deal with risks and opportunities 8
6.2 Quality objectives and planning to achieve 9
6.3 Planning of changes 10
7 Support 11
7.1 Resources 11
7.1.1 General 11
7.1.2 People 11
7.1.3 Infrastructure 11
7.1.4 Process operating environment 12
7.1.5 Monitoring and measuring resources 12
7.1.6 Knowledge of the organization 13
7.2 Ability 14
7.3 Awareness 14
7.4 Communication 15
7.5 Documented information 15
7.5.1 General 15
7.5.2 Create and update 15
7.5.3 Control of documented information 16
8 Run 17
8.1 Operational planning and control 17
8.2 Requirements for products and services 17
8.2.1 Customer communication 17
8.2.2 Determination of product and service requirements 18
8.2.3 Review of product and service requirements 18
8.2.4 Changes to product and service requirements 19
8.3 Design and development of products and services 19
8.3.1 General 19
8.3.2 Design and development planning 19
8.3.3 Design and development input 20
8.3.4 Design and development control 20
8.3.5 Design and development output 21
8.3.6 Design and development changes 22
8.4 Control of externally provided processes, products and services 22
8.4.1 General 22
8.4.2 Type and degree of control 23
8.4.3 Information provided to external providers 23
8.5 Production and service provision 24
8.5.1 Control of production and service provision 24
8.5.2 Identification and traceability 25
8.5.3 Property of customers or external providers 25
8.5.4 Protection 26
8.5.5 Post-delivery activities 26
8.5.6 Change control 27
8.6 Release of products and services 27
8.7 Control of unqualified output 27
9 Performance Evaluation 28
9.1 Monitoring, measurement, analysis and evaluation 28
9.1.1 General 28
9.1.2 Customer satisfaction 29
9.1.3 Analysis and Evaluation 29
9.2 Internal audit 30
9.3 Management review 31
9.3.1 General 31
9.3.2 Management review input 31
9.3.3 Management review output 32
10 Improvement 32
10.1 General 32
10.2 Nonconformities and corrective actions 33
10.3 Continuous improvement 34
Reference 35
Preface
This standard is one of the GB/T 19000 family of standards.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
The translation method used in this standard is equivalent to ISO /T S9002.2016 "Guidelines for the Application of Quality Management System ISO 9001.2015".
This standard has made the following editorial changes.
---Modified the standard name.
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
Assessing National Accreditation Center, China Quality Certification Center, China Certification Center Co., Ltd., Civil Aviation University of China, China Classification Society Quality Certification Corporation
Company, National Training Certification Training (Beijing) Center, China Quality Association, Goodbaby Children's Products Co., Ltd., Beijing Junyou Integrity Quality Certification Co., Ltd.
Company, Ningxia Sharing Group Co., Ltd., Tianjin Huacheng Certification Co., Ltd., Beijing New Century Inspection and Certification Co., Ltd., GAC Group, China
China National Building Materials Inspection and Certification Group Co., Ltd., Shanghai Quality System Audit Center, Naval Equipment Department Test Supervision Bureau, Shanghai Jianke Engineering Consulting
Consult the company, Great Wall (Tianjin) Quality Assurance Center, Shanghai Electric Power Group, Yinchuan Customs, Fenghua Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this standard. Gu Yanjun, Li Jing, Wang Yonggang, Duan Yihong, Li Ming, Xia Fang, Li Ping, Zhu Yunlong, Wang Xinting, Wu Guiling,
Yuan Xiaolei, Zhang Huicai, Liang Xiaowen, Zhang Yanxia, Ruan Shelou, Zheng Yuanhui, Tan Ping, Xia Ming, Zhou Hongbo, Li Chenxuan, Liu Xiaoling, Han Ronghui, Zhang Xiaoqun,
Wang Ping and Liu Xiaojian.
introduction
This standard aims to help users of GB/T 19001-2016 "Quality Management System Requirements" apply their quality management system requirements.
This standard provides corresponding guidance for chapters 4 to 10 of GB/T 19001-2016, but does not provide for Appendix A and Appendix B
guide. If there is a direct correspondence between the items listed in certain clauses of GB/T 19001-2016 (such as a), b), c), etc. and the guidelines provided
Department, the instructions are given in the corresponding clauses of this standard.
For GB/T 19001, this standard gives examples of what organizations can do, but does not add new requirements. The indications given in this standard
The example is not prescriptive, it is only possible for the organization, not necessarily suitable for every organization.
GB/T 19001 contains requirements that can be audited or evaluated objectively. This standard provides information to help organizations implement quality management
Examples, descriptions and optional items for the management system and strengthen its connection with the entire management system of the organization. Although the guidelines provided by this standard are
The GB/T 19001 quality management system model is consistent, but this standard does not intend to provide an explanation of the requirements of GB/T 19001, nor is it intended to be used
For audit or evaluation purposes.
The requirements of GB/T 19001 are universal. Therefore, this standard is also applicable to organizations of all types, sizes, and maturity levels, and all
There are industry and geographic organizations. According to the size or complexity of the organization, the management model adopted, the scope of the organization’s activities and the wind
Factors such as the nature of risks and opportunities, the way organizations apply this standard can vary.
Risk refers to the degree of uncertainty inherent in the quality management system. All systems, processes and functions are at risk. Adopt based on
Risk thinking can ensure that these risks are identified, considered and controlled during the entire process of designing and applying the quality management system.
Risk-based thinking has been implicit in the version before GB/T 19001, such as determining the impact of products provided by external suppliers
The type a...
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