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Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT19000-2016Quality management systems--Fundamentals and vocabulary ICS 03.120.10 A00 National Standards of People's Republic of China Replace GB/T 19000-2008 Quality Management System Foundation and Terminology (ISO 9000.2015, IDT) Released on December 18,.2016 2017-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Administration issued Content Foreword III Introduction IV 1 Scope 1 2 Basic concepts and quality management principles 1 2.1 General 1 2.2 Basic Concept 1 2.2.1 Quality 1 2.2.2 Quality Management System 1 2.2.3 Organizational Environment 1 2.2.4 Related parties 2 2.2.5 Support 2 2.3 Quality Management Principles 2 2.3.1 Focus on customers 2 2.3.2 Leadership 3 2.3.3 Full participation of all members 4 2.3.4 Process Method 4 2.3.5 Improvement 5 2.3.6 Evidence-based decision making 6 2.3.7 Relationship Management 6 2.4 Establishing a quality management system using basic concepts and principles 7 2.4.1 Quality Management System Model 7 2.4.2 Establishment of a quality management system 7 2.4.3 Quality Management System Standards, Other Management Systems and Excellence Models 8 3 Terms and Definitions 8 3.1 Terminology 8 of the person concerned 3.2 Terminology related to the organization 9 3.3 Terminology relating to activities 11 3.4 Terminology related to the process 12 3.5 Terminology relating to the system 13 3.6 Terms related to requirements 15 3.7 Terminology relating to results 17 3.8 Terms relating to data, information and documents 19 3.9 Terminology relating to customers 21 3.10 Terminology relating to characteristics 22 3.11 Terminology for determination 23 3.12 Terminology for measures 24 3.13 Terminology for review 25 Appendix A (informative) Conceptual relationship and its illustration 28 Reference 42 Index 44 ForewordThis 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 of standards. This standard replaces GB/T 19000-2008 "Quality Management System Foundation and Terminology". Compared with GB/T 19000-2008, the main technical changes in this standard are as follows. --- The basic knowledge part of the standard has been comprehensively adjusted; ---The quality management principle has been changed from eight to seven; --- As of the publication of this standard, all the terms in the GB/T 19000 family of standards are incorporated into this standard. This standard uses the translation method equivalent to ISO 9000.2015 "Quality Management System Foundation and Terminology". Because of the differences between the two different languages, the terms 3.6.112capability and 3.10.4competence are translated as "capabilities", but their definition It is different. In the GB/T 19000 family of standards, the term 3.6.112 capability refers specifically to the capabilities of an organization, system, or process. 3.10.4 competency refers to the ability of personnel. The “Notes” added to certain definitions are additional information provided to users of the English version of the International Standard (eg Note 3 of 3.2.2; Note 2 of 3.3.3; Note 2 of 3.4.8; Note 1 of 3.6.11; Note 2 of 3.8.5 and Note of 3.12.7), equivalent to the adoption of international standards, this standard is still Keep this content. This standard is proposed and managed by the National Quality Management and Quality Assurance Standardization Technical Committee (SAC/TC151). This standard was drafted. China National Institute of Standardization, National Certification and Accreditation Administration, China Certification and Accreditation Association, China qualified 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 Sign Certification Group Co., Ltd., Beijing New Century Inspection and Certification Co., Ltd., Guopei Certification Training (Beijing) Center, Huaxia Certification Center Co., Ltd., Shanghai Quality System Audit Center, China Quality Association Quality Assurance Center, SAIC GM Wuling Automobile Co., Ltd., Inner Mongolia North Heavy Vehicle Co., Ltd., Taixing Longyi Terminal Co., Ltd., Shanghai Jianke Engineering Consulting Consulting company, Inner Mongolia Yili Industrial Group Co., Ltd., Tianjin Tiandi Weiye Technology Co., Ltd., Chongqing Changan Automobile Co., Ltd. Inner Mongolia Hexinyuan Mengcao Drought Relief and Greening Co., Ltd., Nanjing Mint Co., Ltd., China Railway Construction Co., Ltd., China Building Materials Inspection Certification Group Co., Ltd., Beijing Oriental Yichu Standard Technology Co., Ltd. The main drafters of this standard. Li Jing, Gu Yanjun, Zhang Huicai, Li Qiang, Ren Qingyi, Li Ming, Zheng Yuanhui, Huang Xueliang, Qu Xintian, Zheng Yan, Liang Ping, Wang Mei, Li Ping, Xia Fang, Wang Jinde, Cao Hua, Deng Xiangning, Qi Jie, Lin Chuang, Zhou Hongbo, Li Qiqiu, Li Chenxi, Fan Yejuan, Xie Hui, Zhu Jiangtao, Wei Xiangyang, Liu Ye, Dong Xiaohong. The previous releases of the standards replaced by this standard are. ---GB 6583.1-1986; ---GB/T 6583-1992; GB/T 6583-1994; ---GB/T 19000-2000 (incorporating the contents of GB/T 19000.1. At the same time, the standard was cancelled); GB/T 19000-2008.introductionThis standard provides basic concepts, principles and terminology for the quality management system and lays the foundation for other standards of the quality management system. this The standards are designed to help users understand the basic concepts, principles and terminology of quality management so that quality management can be implemented effectively and efficiently. Department and realize the value of other standards of the quality management system. This standard is based on a collection of currently recognized frameworks for basic concepts, principles, processes and resources related to quality. Quality management systems to help organizations achieve their goals. This standard applies to all organizations regardless of their size, complexity or business model. Responsibility and commitment to enhance the organization's ability to meet the needs and expectations of its customers and stakeholders, as well as to achieve satisfaction with its products and services awareness. This standard contains seven quality management principles to support the basic concepts described in 2.2. In 2.3, for each quality management original Then, introduce each principle through “overview”; explain the reasons why the organization should pay attention to this principle through “baseline”; explain through “main benefits” Use the results of this principle; give measures that can be taken by the principle of organizational application through “activities that can be carried out”. At the time of publication, this standard includes all quality management and quality management system standards drafted by ISO /TC176 and based on these standards. Terms and definitions used in other specific areas of quality management system standards, these terms and definitions are arranged in order of concept. At the end of this standard, a Chinese and English index of the alphabetical terms is provided. Appendix A is a set of concepts in conceptual order System diagram. Note. In the common word guide of the quality management system standards drafted by ISO /TC176, some commonly used words have different meanings from the dictionary. Quality Management System Foundation and Terminology1 ScopeThe basic concepts and principles of quality management expressed in this standard generally apply to. --- Seeking an organization that continues to be successful through the implementation of a quality management system; --- Customers who seek to trust the organization's ability to provide products and services that meet its requirements; --- Organizations that seek to trust their products and services in the supply chain; --- Seeking organizations and stakeholders that promote mutual communication through a common understanding of the terminology used in quality management; --- Organizations that conduct conformity assessment in accordance with the requirements of GB/T 19001; --- The provider of training, evaluation and consultation for quality management; --- Drafters of relevant standards. The terms and definitions given in this standard apply to all quality management and quality management system standards drafted by SAC/TC151.2 Basic concepts and quality management principles2.1 General The concepts and principles of quality management expressed in this standard can help organizations to respond to the environment that has been very different from the last few decades. The ability to challenge. Currently, the environment facing the organization's work exhibits the following characteristics. accelerated change, market globalization, and knowledge as a function Major resources appear. The impact of quality has exceeded the scope of customer satisfaction, and it can directly affect the reputation of the organization. The improvement of the level of social education and the growth of demand have made the influence of relevant parties stronger. This standard proposes to establish a quality management body. The basic concepts and principles of the department provide a way for organizations to think more broadly. All concepts, principles, and their interrelationships should be considered as a whole, not isolated from each other. No concept or principle ratio The other is more important. When applying, it is crucial to make the appropriate trade-offs. 2.2 Basic concepts 2.2.1 Quality A quality-focused organization advocates a message that achieves its value by meeting the needs and expectations of customers and other interested parties. This culture will be reflected in its actions, attitudes, activities and processes. The quality of the products and services of the organization depends on the ability to satisfy the customer and the intentional and unintentional impact on the relevant parties. The quality of products and services includes not only their expected functions and performance, but also the perception of customers about their value and benefits. 2.2.2 Quality Management System A quality management system includes activities in which an organization determines its objectives and determines its processes and resources to achieve desired results. The quality management system manages the processes and resources required to provide value to relevant stakeholders and achieve results. A quality management system enables top management to optimize resource utilization by considering the long-term and short-term impact of its decisions. The quality management system provides a means of determining the actions taken to anticipate and anticipate results in providing products and services. 2.2.3 Organizational environment Understanding the organizational environment is a process. This process identifies factors that influence the organization's goals, objectives, and sustainability. It both Internal factors need to be considered, such as organizational values, culture, knowledge and performance, as well as external factors such as. law, technology, competition Competition, market, cultural, social and economic environment. The organization's purpose can be expressed as including its vision, mission, direction and goals. 2.2.4 Related parties The concept of the relevant parties expands the focus on the customer only, and it is crucial to consider all relevant parties. Identifying stakeholders is part of the process of understanding the organizational environment. Relevant parties mean that if their needs and expectations are not met, they will Those parties involved in the continued development of the organization that pose significant risks. In order to reduce these risks, organizations need to determine what must be provided to relevant parties. The result. The success of an organization depends on attracting, winning and maintaining the support of relevant parties. 2.2.5 Support 2.2.5.1 General The top management's support for the quality management system and the active participation of all employees can. --- Provide sufficient human and other resources; --- Monitoring process and results; --- Identify and assess risks and opportunities; --- Take appropriate measures. Responsibly acquire, distribute, maintain, improve, and dispose of resources to support organizations in achieving their goals. 2.2.5.2 Personnel People are an indispensable resource in the organization. The performance of an organization depends on the performance of the people in the system. A common understanding of the quality policy and the desired outcomes of the organization allows for active participation and alignment within the organization. 2.2.5.3 Ability The quality management system is most effective when all personnel understand and apply the required skills, training, education and experience to perform their duties. of. Providing opportunities for people to develop the necessary capabilities is the responsibility of top management. 2.2.5.4 Consciousness Consciousness comes from people recognizing their responsibilities and how their actions contribute to the goals of the organization. 2.2.5.5 Communication Through planned and effective internal communication (such as the entire organization) and external (such as related parties), the participation of personnel can be improved. And understand more deeply. ---Organizational environment; ---The needs and expectations of customers and other relevant parties; ---Quality management system. 2.3 Quality Management Principles 2.3.1 Focus on customers 2.3.1.1 Overview The primary focus of quality management is to meet customer requirements and strive to exceed customer expectations. 2.3.1.2 Basis Organizations can only achieve sustained success by winning and maintaining the trust of customers and other interested parties. Each party interacting with the customer Faces provide opportunities to create more value for customers. Understanding the current and future needs of customers and other stakeholders helps the organization Continued success. 2.3.1.3 Main benefits The main benefits may be. --- Enhance customer value; --- Enhance customer satisfaction; --- Enhance customer loyalty; --- Increase repetitive business; --- Improve the reputation of the organization; --- Expand customer base; --- Increase revenue and market share. 2.3.1.4 Activities that can be carried out Activities that can be carried out include. --- Identify direct and indirect customers who derive value from the organization; --- Understand the current and future needs and expectations of customers; --- Linking the organization's goals to the needs and expectations of customers; --- Communicate customer needs and expectations throughout the organization; --- Plan, design, develop, produce, deliver and support products and services to meet customer needs and expectations; ---Measure and monitor customer satisfaction and take appropriate measures; --- Identify and take action on the needs and appropriate expectations of interested parties that may affect customer satisfaction; --- Actively manage relationships with customers to achieve continued success. 2.3.2 Leadership 2.3.2.1 Overview Leaders at all levels establish a unified purpose and direction, and create conditions for all members to actively participate in achieving the organization's quality objectives. 2.3.2.2 Basis The establishment of a unified purpose and direction, as well as the active participation of all members, enables organizations to align strategies, guidelines, processes and resources. To achieve its goals. 2.3.2.3 Main benefits The main benefits may be. --- Improve the effectiveness and efficiency of achieving organizational quality objectives; --- The process of organization is more coordinated; --- Improve communication between all levels of the organization and functions; --- Develop and enhance the capabilities of organizations and their people to achieve desired results. 2.3.2.4 Activities that can be carried out Activities that can be carried out include. --- Communicate on mission, vision, strategy, direction and process throughout the organization; --- Create and maintain common values at all levels of the organization, as well as fair and ethical behavior patterns; ---Cultivate a culture of integrity and integrity; --- Encourage the implementation of quality commitments throughout the organization; --- Ensure that leaders at all levels become role models in the organization; --- Provide employees with the resources, training and authority required to perform their duties; --- Inspire, encourage and recognize the contributions of employees. 2.3.3 Active participation of all members 2.3.3.1 Overview Personnel who are competent, empowered, and actively involved throughout the organization are necessary to improve the organization's ability to create and deliver value. 2.3.3.2 Basis In order to manage the organization effectively and efficiently, it is extremely important that people at all levels are respected and involved. Through recognition, authorization and improvement Ability to promote the active participation of all members in achieving the organization's quality objectives. 2.3.3.3 Main benefits The main benefits may be. --- The organization has a deeper understanding of the quality objectives and a stronger motivation to achieve it; --- Increase the level of participation of personnel in improvement activities; --- Promote personal development, initiative and creativity; --- Improve the satisfaction of personnel; --- Enhance mutual trust and collaboration throughout the organization; --- Promote the organization's focus on shared values and culture. 2.3.3.4 Activities that can be carried out Activities that can be carried out include. --- Communicate with employees to enhance their awareness of the importance of personal contributions; --- Promote collaboration within the organization; --- Promote open discussion and share knowledge and experience; --- Let employees identify the constraints that affect execution, and actively participate without any concern; --- Appreciate and recognize the contributions, knowledge and progress of employees; --- Self-evaluation of performance against individual goals; --- Conduct a survey to assess the level of satisfaction of personnel, communicate results and take appropriate action. 2.3.4 Process method 2.3.4.1 Overview When the activities are understood and managed as a system of interrelated and functional processes, they can be more effectively and efficiently consistent. Predictable results. 2.3.4.2 Basis The quality management system consists of interrelated processes. Understand how the system produces results that enable the organization to be as complete as possible Be good at the system and optimize its performance. 2.3.4.3 Main benefits The main benefits may be. --- Improve the ability to focus on the outcomes of key processes and opportunities for improvement; --- Consistent, predictable results through a system of coordinated processes; --- Improve the performance of the project as much as possible through effective management of the process, efficient use of resources and reduction of cross-functional barriers; --- Enables organizations to provide stakeholders with confidence in their consistency, effectiveness, and efficiency. 2.3.4.4 Activities that can be carried out Activities that can be carried out include. --- Identify the goals of the system and the processes required to achieve them; --- Determine responsibilities, authorities and obligations for the management process; ---Understand the capabilities of the organization and predetermine resource constraints; --- Determine the interdependence of processes and analyze the impact of changes in individual processes on the overall system; --- Manage processes and their interrelationships as a system to effectively and efficiently achieve organizational quality objectives; --- Ensure that the necessary information is obtained to run and improve the process and to monitor, analyze and evaluate the performance of the entire system; ---Manage risks that may affect the overall outcome of the process output and quality management system. 2.3.5 Improvement 2.3.5.1 Overview Successful organizations continue to focus on improvement. 2.3.5.2 Basis Improvements are very important for organizations to maintain current levels of performance, respond to changes in their internal and external conditions, and create new opportunities. necessary. 2.3.5.3 Main benefits The main benefits may be. --- Improve process performance, organizational capabilities and customer satisfaction; --- Enhance attention to investigations and identify root causes and subsequent prevention and corrective actions; --- Improve the ability to predict and respond to internal and external risks and opportunities; --- Increase consideration of gradual and breakthrough improvements; --- Better use of learning to improve; --- Enhance the power of innovation. 2.3.5.4 Activities that can be carried out Activities that can be carried out include. --- Promote the establishment of improvement goals at all levels of the organization; --- Educate and train all levels of personnel to understand how to apply basic tools and methods to achieve improvement goals; --- Ensure that employees have the ability to successfully promote and complete improvement projects; --- Development and deployment process to implement improvement projects throughout the organization; --- Track, review and review the planning, implementation, completion and results of the improvement project; --- Combine improvements with the development of new or changed products, services and processes; --- Appreciation and recognition for improvement. 2.3.6 Evidence-based decision making 2.3.6.1 Overview Decisions based on analysis and evaluation of data and information are more likely to produce desired results. 2.3.6.2 Basis Decision making is a complex process and always involves some uncertainty. It often involves input of multiple types and sources and its rationale Solution, and these understandings may be subjective. It is important to understand causality and potential unintended consequences. Division of facts, evidence and data Analysis can lead to more objective and credible decisions. 2.3.6.3 Main benefits The main benefits may be. --- Improve the decision process; --- Improve the assessment of process performance and the ability to achieve goals; --- Improve the effectiveness and efficiency of operations; --- Improve the ability to review, challenge and change perspectives and decisions; --- Improve the ability to confirm the effectiveness of past decisions. 2.3.6.4 Activities that can be carried out Activities that can be carried out include. -- Identify, measure and monitor key indicators to verify the performance of the organization; --- enable relevant personnel to obtain all the data required; ---Ensure that data and information are accurate, reliable and secure; --- Analyze and evaluate data and information using appropriate methods; --- Ensure that personnel have the ability to analyze and evaluate the required data; --- Weighing experience and intuition, making decisions based on evidence and taking action. 2.3.7 Relationship Management 2.3.7.1 Overview In order to continue to be successful, the organization needs to manage relationships with relevant parties (such as suppliers). 2.3.7.2 Basis Relevant parties affect the performance of the organization. When the organization manages the relationship with all relevant parties, to play its organizational performance as effectively as possible Sustained success is more likely to be achieved when it comes to effectiveness. Relationship management for suppliers and partner networks is especially important. 2.3.7.3 Main benefits The main benefits may be. --- Improve the performance of the organization and its related parties by responding to each opportunity and restriction associated with the relevant party; --- A common understanding of goals and values, and related parties; --- Enhance the ability to create value for stakeholders by sharing resources and people's capabilities, as well as managing quality-related risks; --- A supply chain with well-managed and stable supply of products and services. 2.3.7.4 Activities that can be carried out Activities that can be carried out include. --- Identify relevant parties (eg suppliers, partners, customers, investors, employees or society as a whole) and their relationship with the organization; --- Determine and sort the relationship of the parties that need to be managed; --- Establish a balance between short-term benefits and long-term considerations; --- Collect and share information, expertise and resources with relevant parties; --- Measure performance and report to relevant parties as appropriate to increase the initiative of improvement; --- Cooperate with suppliers, partners and other interested parties to develop and improve activities; --- Encourage and recognize the improvement and achievements of suppliers and partners. 2.4 Establishing a quality management system using basic concepts and principles 2.4.1 Quality Management System Model 2.4.1.1 General The organization has many of the same characteristics as human beings and is a social organism with survival and learning abilities. Both have adaptive energy Force, and consists of interacting systems, processes, and activities. In order to adapt to changing circumstances, it is necessary to have the ability to adapt. Organization often Breakthrough improvements through innovation. The organization's quality management system model can show that not all systems, processes and activities can be Predetermined. Therefore, in a complex organizational environment, its quality management system needs to be flexible and adaptable. 2.4.1.2 System The organization attempts to understand the internal and external environment to identify the needs and expectations of the relevant parties. This information was used to build a quality management system. To achieve sustainable development of the organization. The output of one process can be the input to other processes and connected in parallel to the entire network. 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