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

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
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
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.
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 standard within the organization. The quality management system requirements specified in this standard are complementary to product and service requirements. This standard uses a process approach, which combines a "plan-implement-check-dispose" (PDCA) cycle and risk-based thinking. The process approach enables the organization to plan processes and their interactions. The PDCA cycle enables organizations to ensure that their processes are adequately resourced and managed, identify opportunities for improvement and take action. Risk-based thinking enables an organization to determine various factors that may cause its processes and quality management system to deviate from the planned results, and adopt Preventive control, minimize adverse effects, and maximize the use of opportunities (see A.4). Continuously meeting requirements in an increasingly complex and dynamic environment, and taking appropriate actions in response to future needs and expectations, is undoubtedly facing the organization A challenge. In order to achieve this goal, the organization may find that in addition to correction and continuous improvement, it is necessary to adopt various forms of reform. Progress, such as breakthrough change, innovation and reorganization.
The following auxiliary verbs are used in this standard.
---"Should" means request;
---"Suitable" means suggestion;
---"May" means allow;
---"Enable" means possible or capable.
The contents of "Notes" are guidelines for understanding and explaining the relevant requirements. 0.2 Quality management principles
This standard is formulated on the basis of the quality management principles set forth in GB/T 19000.The introduction of each principle includes an overview, the The basis for the importance of the principle to the organization, examples of the main benefits of applying the principle, and typical measures for applying the principle to improve organizational performance Example.
The principles of quality management are.
---focusing on customers;
---All staff actively participate;
---Process method;
---Evidence-based decision-making;
---Relationship management.
0.3 Process method
0.3.1 General
This standard advocates the use of process methods when establishing and implementing a quality management system and improving its effectiveness. Customer Satisfaction. See 4.4 for specific requirements to be considered when adopting process methods. Understanding and managing the interrelated processes as a system helps organizations achieve their expected results effectively and efficiently. This This method enables the organization to effectively control the inter-related and interdependent relationships between the processes of its system to improve the overall performance of the organization. The process method includes the systematic regulation and management of each process and its interaction in accordance with the organization's quality policy and strategic direction. And achieve the expected results. The PDCA cycle (see 0.3.2) and always risk-based thinking (see 0.3.3) can be used to The system is managed to effectively use opportunities and prevent undesirable results. The application of process methods in the quality management system can. a) Understand and continue to meet the requirements;
b) Consider the process from the perspective of value-added;
c) Obtain effective process performance;
d) Improve the process based on the evaluation data and information.
The elements of a single process and their interactions are shown in Figure 1.Each process has specific monitoring and measurement checkpoints for control These checkpoints vary according to the related risks.
Figure 1 Schematic diagram of a single process element
0.3.2 PDCA cycle
The PDCA cycle can be applied to all processes and the entire quality management system. Figure 2 shows that Chapters 4 to 10 of this standard are How to constitute the PDCA cycle.
Note. The numbers in parentheses indicate the corresponding chapters of this standard. Figure 2 The structure of this standard is shown in the PDCA cycle
The PDCA cycle can be briefly described as follows.
---Plan. According to customer requirements and organizational policy, establish system goals and processes, and determine what is needed to achieve results Resources, and identify and respond to risks and opportunities;
---Implementation (Do). execute the plan;
---Check. Monitor the process and the products and services formed according to the policies, goals, requirements and planned activities And measurements (when applicable), and report the results;
---Disposal (Act). When necessary, take measures to improve performance. 0.3.3 Risk-based thinking
Risk-based thinking (see A.4) is the basis for the effectiveness of the quality management system. Previous versions of this standard have implicitly based on wind The concept of risk thinking, such as. taking preventive measures to eliminate potential nonconformities, analyzing the occurrence of nonconformities, and adopting Measures to prevent its recurrence.
To meet the requirements of this standard, organizations need to plan and implement measures to deal with risks and opportunities. Responding to risks and opportunities, to improve quality management Lay the foundation for the effectiveness of the management system, obtain improved results, and prevent adverse effects. Certain situations that are conducive to achieving the expected results may lead to opportunities, such as. conducive to the organization to attract customers, develop new products, and A series of situations in which services, waste reduction, or productivity increases. Measures taken to take advantage of opportunities may also include consideration of related risks. risk It is the influence of uncertainty. Uncertainty may have a positive effect or a negative effect. The positive impact of risk may provide opportunities But not all positive impacts can provide opportunities.
0.4 Relationship with other management system standards
This standard adopts the management system standard framework developed by ISO to improve coordination and consistency with other management system standards (see A.1). This standard enables organizations to use process methods, combined with the PDCA cycle and risk-based thinking, and integrate their quality management system with Other management system standards require coordination or integration.
This standard has the following relationships with GB/T 19000 and GB/T 19004. ---GB/T 19000 "Quality Management System Basis and Terminology" provides the necessary foundation for the correct understanding and implementation of this standard; ---GB/T 19004 "Pursuing Organizational Quality Management Methods for Sustained Success" provides guidelines for selecting organizations that exceed the requirements of this standard. Appendix B gives other quality management and quality management system standards formulated by SAC/TC151 (equivalent to ISO /TC176 Detailed information about the international standards developed by the Technical Committee on Quantity Management and Quality Assurance. This standard does not include specific requirements for other management systems such as environmental management, occupational health and safety management, or financial management. On the basis of this standard, a number of industry-specific quality management system standards have been formulated. Some of these standards specify Additional requirements for the quality management system, while other standards are limited to providing guidelines for the application of this standard in specific industries. Quality management system requirements
1 Scope
This standard specifies the quality management system requirements for the following organizations. a) It is necessary to prove that it has the ability to stably provide products and services that meet customer requirements and applicable laws and regulations; b) Through the effective application of the system, including the process of system improvement, and ensuring compliance with customer requirements and applicable laws and regulations, Designed to enhance customer satisfaction.
All the requirements specified in this standard are universal and are intended to be applicable to organizations of various types, different sizes and offering different products and services. Note 1.The term "product" or "service" in this standard is only applicable to products and services that are expected to be provided to customers or required by customers. Note 2.Legal requirements can be referred to as legal requirements.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 19000-2016 Quality Management System Foundation and Terminology (ISO 9000.2015, IDT) 3 Terms and definitions
The terms and definitions defined in GB/T 19000-2016 apply to this document. 4 Organizational environment
4.1 Understanding the organization and its environment
The organization shall determine various external and internal factors related to its purpose and strategic direction and affecting its ability to achieve the expected results of the quality management system. The organization shall monitor and review the relevant information of these external and internal factors. Note 1.These factors may include positive and negative elements or conditions that need to be considered. Note 2.Considering factors from various international, domestic, regional or local laws and regulations, technology, competition, market, culture, social and economic environment will help Understand the external environment.
Note 3.Considering factors related to the organization's values, culture, knowledge, and performance will help understand the internal environment. 4.2 Understand the needs and expectations of related parties
As related parties have influence or potential on the organization’s ability to stably provide products and services that meet customer requirements and applicable laws and regulations In impact, therefore, the organization should determine.
a) Related parties related to the quality management system;
b) The requirements of related parties related to the quality management system. The organization shall monitor and review the information of these related parties and their related requirements. 4.3 Determine the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality management system to determine its scope. When determining the scope, the organization should consider.
a) Various external and internal factors mentioned in 4.1;
b) The requirements of related parties mentioned in 4.2;
c) The organization's products and services.
If all the requirements of this standard apply to the scope of the quality management system determined by the organization, the organization shall implement all the requirements of this standard. The scope of the organization's quality management system shall be available and maintained as documented information. The scope should describe the products and services covered If the organization determines that certain requirements of this standard do not apply to the scope of its quality management system, it should explain the reasons. Only when the determined non-applicable requirements do not affect the organization's ability or responsibility to ensure that its products and services are qualified, and to enhance customer satisfaction When there is no impact, it can claim to meet the requirements of this standard. 4.4 Quality management system and its process
4.4.1 The organization shall establish, implement, m...

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