GB/T 19002-2018 English PDF (GB/T19002-2018)

GB/T 19002-2018: Quality management systems -- Guidelines for the application of GB/T 19001-2016
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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 and extent of its control, or corrective measures based on the potential impact of the identified non-conformity.
In addition, the version before GB/T 19001 also contains provisions on preventive measures. Adopting risk-based thinking can completely
Consider the risk. By identifying and taking measures in advance, the adverse effects of preventing or reducing risks can be changed from passive to active. The preventive measures are
An inherent part of a risk-based management system.
In terms of the organization's ability to achieve quality goals, not all processes of the quality management system present the same level of risk. Quality control
Some processes of the management system require more careful and formal planning and control than others.
GB/T 19001 does not require the use of formal risk management methods to identify and respond to risks and opportunities. The organization can choose
Method of demand. IEC 31010 provides a list of risk assessment tools and techniques, which organizations can consider according to their specific circumstances.
In some cases, the organization may already have a formal risk management process required by customers or laws and regulations. In this situation
Under the circumstances, the organization can adjust its formal risk management process to meet the requirements of GB/T 19001 regarding risks and opportunities.
Quality management system
GB/T 19001-2016 Application Guide
1 Scope
The purpose of this standard is to provide guidance on the requirements of GB/T 19001-2016, and give an indication of the steps that organizations may take to meet these requirements.
Example. This standard does not add, delete or modify these requirements in any way.
This standard does not prescribe mandatory implementation methods or provide any preferred interpretation methods.
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)
GB/T 19001-2016 Quality Management System Requirements (ISO 9001.2015, 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 purpose of this article is to ensure that the organization understands its ability to achieve the expected results of the quality management system related to its purpose and strategic direction.
External and internal factors that have a positive or negative impact. The organization should be aware that these external and internal factors may change.
Conduct monitoring and review. The organization can review its environment through activities such as management review at planned intervals.
There are multiple sources of information about external and internal factors, such as internal documented information and conferences, national or international media, websites, national statistics
Departments and other government department publications, professional and technical publications, meetings with related institutions, meetings with customers and related parties, and professional associations.
Examples of external and internal factors related to the organization's environment may include, but are not limited to.
a) External factors.
1) Economic factors, such as currency exchange rates, economic situation, inflation expectations, credit availability, etc.;
2) Social factors, such as local unemployment rate, safety perception, education level, public holidays and working days, etc.;
3) Political factors, such as political stability, public investment, local infrastructure, international trade agreements, etc.;
4) Technical factors, such as emerging industry technologies, materials and equipment, patent terms, professional ethics, etc.;
5) Market factors, such as competition, including the organization's market share, similar products or services, market leader trends, and customer growth trends
Trends, market stability, supply chain relationships, etc.;
6) Legal and regulatory factors that affect the working environment (see GB/T 19001-2016, 7.1.4), such as trade union regulations and industry regulations
Chapter etc.
b) Internal factors.
1) The overall performance of the organization;
2) Resource factors, such as infrastructure (see GB/T 19001-2016, 7.1.3), process operating environment (see GB/T 19001-
2016, 7.1.4), organizational knowledge (see GB/T 19001-2016, 7.1.6), etc.;
3) Personnel factors, such as personnel capabilities, organizational behavior and culture, relations with labor unions, etc.;
4) Operational factors, such as process or production and service provision capabilities, quality management system performance, customer satisfaction monitoring, etc.;
5) Organizational governance factors, such as rules and procedures in decision-making or organizational structure.
At the strategic level, analysis of strengths, weaknesses, opportunities and threats (SWOT) and political, economic, social, technological, legal, environmental
Environmental analysis (PESTLE) and other tools. Depending on the size of the organization and the complexity of the operation, such as brainstorming and "whatif", etc.
Simple methods may be beneficial to the organization.
4.2 Understand the needs and expectations of related parties
The purpose of this article is to ensure that the organization considers the relevant requirements of related parties, rather than just considering the requirements of direct customers. The purpose is to focus on that
These interested parties may have an impact on the organization’s ability to provide products and services that meet the requirements. Although GB/T 19001 does not directly
Make provisions, but consider external and internal factors in advance (see GB/T 19001-2016, 4.1), will help the organization to determine its related parties.
The list of related parties can be unique to the organization. By considering the following aspects of relevant parties, the organization can formulate
Criteria for determining relevant parties.
a) The possible impact or impact on organizational performance or decision-making;
b) the ability to bring risks and opportunities;
c) The possible impact or impact on the market;
d) The ability of its decisions or activities to influence the organization.
Example 1.Examples of related parties that the organization may consider include but are not limited to.
---customer;
---The end user or beneficiary; <...