GB/T 19001-2016 PDF English
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GB/T 19001-2016: PDF in English (GBT 19001-2016) 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 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;
---Leadership;
---All staff actively participate;
---Process method;
---Improve;
---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, maintain and continuously improve the quality management system in accordance with the requirements of this standard, including the required processes and their interactions.
The organization shall determine the processes required for the quality management system and its application throughout the organization, and shall.
a) Determine the required inputs and expected outputs of these processes;
b) Determine the sequence and interaction of these processes;
c) Determine and apply the required criteria and methods (including monitoring, measurement and related performance indicators) to ensure the effective operation and control of these processes;
d) Determine the resources required for these processes and ensure their availability;
e) Assign responsibilities and authorities for these processes;
f) Respond to risks and opportunities in accordance with the requirements of 6.1;
g) Evaluate these processes and implement the required changes to ensure that the expected results of these processes are achieved;
h) Improve process and quality management system.
4.4.2 To the extent and extent necessary, the organization shall.
a) Maintain documented information to support the operation of the process;
b) Keep documented information to ensure that the process is proceeding as planned.
5 Leadership
5.1 Leadership and commitment
5.1.1 General
The top management shall verify its leadership and commitment to the quality management system through the following aspects.
a) Responsible for the effectiveness of the quality management system;
b) Ensure that the quality policy and quality objectives of the quality management system are formulated, adapted to the organizational environment, and consistent with the strategic direction;
c) Ensure that the quality management system requirements are integrated into the organization's business processes;
d) Promote the use of process methods and risk-based thinking;
e) Ensure that the resources required for the quality management system are available;
f) Communicate the importance of effective quality management and compliance with quality management system requirements;
g) Ensure that the quality management system achieves its expected results;
h) Promote the active participation of personnel, guide and support them to contribute to the effectiveness of the quality management system;
i) Promote improvement;
j) Support other relevant managers to play a leading role within their responsibilities.
Note. The term "business" used in this standard can be broadly understood as the core activities involving the purpose of the organization, whether it is a public, private, for-profit or non-profit organization.
5.1.2 Focus on customers
Top management should demonstrate its leadership and commitment to focus on customers by ensuring the following.
a) Determine, understand and continuously meet customer requirements and applicable laws and regulations;
b) Identify and respond to risks and opportunities that may affect the qualification of products and services and the ability to enhance customer satisfaction;
c) Always strive to enhance customer satisfaction.
5.2 Policy
5.2.1 Formulate quality policy
The top management shall formulate, implement and maintain a quality policy. The quality policy shall.
a) Adapt to the purpose and environment of the organization and support its strategic direction;
b) Provide a framework for establishing quality objectives;
c) includes a commitment to meet applicable requirements;
d) Including the commitment to continuously improve the quality management system.
5.2.2 Communication quality policy
The quality policy should.
a) Can obtain and maintain documented information;
b) Get communication, understanding and application within the organization;
c) When appropriate, it can be obtained by related parties.
5.3 Organizational positions, responsibilities and authorities
The top management shall ensure that the responsibilities and authorities of relevant positions in the organization are assigned, communicated and understood.
Top management should assign responsibilities and authorities to.
a) Ensure that the quality management system meets the requirements of this standard;
b) Ensure that each process obtains its expected output;
c) Report on the performance of the quality management system and opportunities for improvement (see 10.1), especially to top management;
d) Ensure that customer focus is promoted throughout the organization;
e) Ensure that the integrity of the quality management system is maintained when planning and implementing changes to the quality management system.
6 Planning
6.1 Measures to deal with risks and opportunities
6.1.1 When planning the quality management system, the organization shall consider the factors mentioned in 4.1 and the requirements mentioned in 4.2, and determine the risks and opportunities that need to be addressed to.
a) Ensure that the quality management system can achieve its expected results;
b) Enhance beneficial effects;
c) Prevent or reduce adverse effects;
d) Implement improvements.
6.1.2 The organization shall plan.
a) Measures to deal with these risks and opportunities;
b) How to.
1) Integrate and implement these measures in the quality management system process (see 4.4);
2) Evaluate the effectiveness of these measures.
Response measures should be commensurate with the potential impact of risks and opportunities on the conformity of products and services.
Note 1.In response to risks, you can choose to avoid risks, take risks in order to seek opportunities, eliminate risk sources, change the possibility or consequences of risks, and share risks.
Or retain risks through informed decisions.
Note 2.Opportunities may lead to adopting new practices, launching new products, opening new markets, winning new customers, establishing partnerships, using new technologies, and other feasible
Place to respond to the needs of the organization or its customers.
6.2 Quality objectives and planning for their realization
6.2.1 The organization shall establish quality objectives for related functions, levels and processes required by the quality management system.
Quality objectives should.
a) Consistent with the quality policy;
b) Measurable;
c) Consider the applicable requirements;
d) Related to product and service qualification and enhancement of customer satisfaction;
e) be monitored;
f) communicate;
g) Update in due course.
The organization shall maintain documented information on quality objectives.
6.2.2 When planning how to achieve the quality objectives, the organization shall determine.
a) what to do;
b) What resources are needed;
c) Who is responsible;
d) when it will be completed;
e) How to evaluate the results.
6.3 Planning of changes
When the organization determines the need to make changes to the quality management system, the changes should be implemented in the planned manner (see 4.4).
The organization should consider.
a) The purpose of the change and its potential consequences;
b) The integrity of the quality management system;
c) the availability of resources;
d) Assignment or reallocation of responsibilities and authorities.
7 support
7.1 Resources
7.1.1 General
The organization shall determine and provide the required resources to establish, implement, maintain and continuously improve the quality management system.
The organization should consider.
a) Ability and limitations of existing internal resources;
b) Reso......
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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