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Position: Chinese Standard in English/GB/T 19001-2016
GB/T 19001-2016   Quality management systems―Requirements (English Version)
Standard No.: GB/T 19001-2016 Status:valid remind me the status change

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Language:English File Format:PDF
Word Count: 16500 words Price(USD):420.0 remind me the price change

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Implemented on:2017-7-1 Delivery: via email in 1 business day
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Standard No.: GB/T 19001-2016
English Name: Quality management systems―Requirements
Chinese Name: 质量管理体系 要求
Chinese Classification: A00    Standardization and Quality Management
Professional Classification: GB    National Standard
ICS Classification: 03.120.10 03.120.10    Quality management and quality assurance 03.120.10
Issued by: AQSIQ,SAC
Issued on: 2016-12-30
Implemented on: 2017-7-1
Status: valid
Superseding:GB/T 19001-2008 Quality management systems - Requirements
Language: English
File Format: PDF
Word Count: 16500 words
Price(USD): 420.0
Delivery: via email in 1 business day
0.1 General The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements. This standard can be used by internal and external parties. It is not the intent of this standard to imply the need for: — uniformity in the structure of different quality management systems; — alignment of documentation to the clause structure of this standard; — the use of the specific terminology of this standard within the organization. The quality management system requirements specified in this standard are complementary to requirements for products and services. This standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. The process approach enables an organization to plan its processes and their interactions. The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on. Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see A.4). Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization. In this standard, the following verbal forms are used: — “shall” indicates a requirement; — “should” indicates a recommendation; — “may” indicates a permission; — “can” indicates a possibility or a capability. Information marked as “Note” is for guidance in understanding or clarifying the associated requirement. 0.2 Quality management principles This standard is based on the quality management principles described in GB/T 19000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization’s performance when applying the principle. The quality management principles are: — customer focus; — leadership; — engagement of people; — process approach; — improvement; — evidence-based decision making; — relationship management. 0.3 Process approach 0.3.1 General This standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4. Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced. The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results. The application of the process approach in a quality management system enables: a) understanding and consistency in meeting requirements; b) the consideration of processes in terms of added value; c) the achievement of effective process performance; d) improvement of processes based on evaluation of data and information. Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.
Foreword III Introduction V 1 Scope 2 Normative references 3 Terms and definitions 4 Context of the Organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes 5 Leadership 5.1 Leadership and commitment 5.1.1 General 5.1.2 Customer focus 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7 Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information 8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of the requirements for products and services 8.2.4 Changes to requirements for products and services 8.3 Design and development of products and services 8.3.1 General 8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls 8.3.5 Design and development outputs 8.3.6 Design and development changes 8.4 Control of externally provided processes, products and services 8.4.1 General 8.4.2 Type and extent of control 8.4.3 Information for external providers 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes 8.6 Release of products and services 8.7 Control of nonconforming outputs 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 9.2 Internal audit 9.3 Management review 9.3.1 General 9.3.2 Management review inputs 9.3.3 Management review outputs 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Annex A (Informative) Clarification of New Structure, Terminology and Concepts Annex B (informative) Other Standards on Quality Management and Quality Management Systems Developed by SAC/TC 151 Bibliography
GB/T 19001-2016 is referred in:
*GB/T 17505-2016 Steel and steel products General technical delivery requirements
*Q/SY GJX 106-2009 Technical Specification of Fittings with DN400 and Larger for Oil and Gas Pipeline Project
*Q/SY GJX 105-2009 Technical Specification of Fittings with DN350 and Smaller for Oil and Gas Pipeline Project
*GB 2585-2007 Hot-rolled steel rails for railway
*GB/T 35609-2017 Green product assessment—Waterproof matreials and sealants
*GB/T 35602-2017 Green product assessment—Coating material
*JB/T 11779-2014 Non-Destructive Testing Instrument - Specifications for Phased Array Ultrasonic Testing Instruments
*GB/T 23907-2009 Non-destructive testing—Shims for magnetic particle testing
*GB/T 17569-2013 Classification for the items of pressurized water reactor nuclear power pants
*GB 17691-2018 Limits and measurement methods for emissions from diesel fuelled heavy-duty vehicles (CHINA VI)
*GB/T 25119-2010 Railway applications—Electronic equipments used on rail vehicles
*JB/T 8428-2015 Non-destructive testing. General specification for ultrasonic blocks
*JB/T 6064-2006 Non-destructive testing-Blocks for penetrant testing
*JB/T 7902-2006 Non-destructive testing-Image quality indicators(wire type) for radiographic testing
*GB/T 35601-2017 Green product assessment—Wood-based panels and wooden flooring
*GB/T 1094.1-2013/XG1-2018 Power transformers―Part 1:General, inluding Amendment 1
*GB 1094.1-2013 Power transformers--Part 1: General
*GB/T 24626-2009 Explosion resistant equipment
*GB/T 25383-2010 Wind turbine generator system—Rotor blades
*GB/T 39781-2021 Technical specification for recycling of textile waste
*SH/T 3543-2017 Specification on technical documentation for construction process of petrochemical construction projects
*GB/T 35603-2017 Green product assessment—Sanitary wares
*GB/T 41748-2022 Quality evaluation scheme for welded fabric for the steel reinforcement
*JB/T 10815-2007 Non-destructive testing - Image resolution indicators for radioscopy testing
Code of China
Standard
GB/T 19001-2016  Quality management systems―Requirements (English Version)
Standard No.GB/T 19001-2016
Statusvalid
LanguageEnglish
File FormatPDF
Word Count16500 words
Price(USD)420.0
Implemented on2017-7-1
Deliveryvia email in 1 business day
Detail of GB/T 19001-2016
Standard No.
GB/T 19001-2016
English Name
Quality management systems―Requirements
Chinese Name
质量管理体系 要求
Chinese Classification
A00
Professional Classification
GB
ICS Classification
Issued by
AQSIQ,SAC
Issued on
2016-12-30
Implemented on
2017-7-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
GB/T 19001-2008 Quality management systems - Requirements
Language
English
File Format
PDF
Word Count
16500 words
Price(USD)
420.0
Keywords
GB/T 19001-2016, GB 19001-2016, GBT 19001-2016, GB/T19001-2016, GB/T 19001, GB/T19001, GB19001-2016, GB 19001, GB19001, GBT19001-2016, GBT 19001, GBT19001
Introduction of GB/T 19001-2016
0.1 General The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements. This standard can be used by internal and external parties. It is not the intent of this standard to imply the need for: — uniformity in the structure of different quality management systems; — alignment of documentation to the clause structure of this standard; — the use of the specific terminology of this standard within the organization. The quality management system requirements specified in this standard are complementary to requirements for products and services. This standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. The process approach enables an organization to plan its processes and their interactions. The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on. Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see A.4). Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization. In this standard, the following verbal forms are used: — “shall” indicates a requirement; — “should” indicates a recommendation; — “may” indicates a permission; — “can” indicates a possibility or a capability. Information marked as “Note” is for guidance in understanding or clarifying the associated requirement. 0.2 Quality management principles This standard is based on the quality management principles described in GB/T 19000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization’s performance when applying the principle. The quality management principles are: — customer focus; — leadership; — engagement of people; — process approach; — improvement; — evidence-based decision making; — relationship management. 0.3 Process approach 0.3.1 General This standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4. Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced. The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results. The application of the process approach in a quality management system enables: a) understanding and consistency in meeting requirements; b) the consideration of processes in terms of added value; c) the achievement of effective process performance; d) improvement of processes based on evaluation of data and information. Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.
Contents of GB/T 19001-2016
Foreword III Introduction V 1 Scope 2 Normative references 3 Terms and definitions 4 Context of the Organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes 5 Leadership 5.1 Leadership and commitment 5.1.1 General 5.1.2 Customer focus 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7 Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information 8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of the requirements for products and services 8.2.4 Changes to requirements for products and services 8.3 Design and development of products and services 8.3.1 General 8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls 8.3.5 Design and development outputs 8.3.6 Design and development changes 8.4 Control of externally provided processes, products and services 8.4.1 General 8.4.2 Type and extent of control 8.4.3 Information for external providers 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes 8.6 Release of products and services 8.7 Control of nonconforming outputs 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 9.2 Internal audit 9.3 Management review 9.3.1 General 9.3.2 Management review inputs 9.3.3 Management review outputs 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Annex A (Informative) Clarification of New Structure, Terminology and Concepts Annex B (informative) Other Standards on Quality Management and Quality Management Systems Developed by SAC/TC 151 Bibliography
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Keywords:
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