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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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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
Introduction 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. Figure 1 Schematic representation of the elements of a single process 0.3.2 Plan-Do-Check-Act cycle The PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle. Note: Numbers in brackets refer to the clauses in this standard. Figure 2 Representation of the structure of this standard in the PDCA cycle The PDCA cycle can be briefly described as follows: — Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities; — Do: implement what was planned; — Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results; — Act: take actions to improve performance, as necessary. 0.3.3 Risk-based thinking Risk-based thinking (see A.4) is essential for achieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of this standard including, for example, carrying out preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity. To conform to the requirements of this standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects. Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities. 0.4 Relationship with other management system standards This standard applies the framework developed by ISO to improve alignment among its standards for management systems (see A.1). This standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards. This standard relates to GB/T 19000 and GB/T 19004 as follows: — GB/T 19000 Quality Management Systems — Fundamentals and Vocabulary provides essential background for the proper understanding and implementation of this standard; — GB/T 19004 Managing for the Sustained Success of an Organization — A quality Management Approach provides guidance for organizations that choose to progress beyond the requirements of this standard. Annex B provides details of other standards on quality management and quality management systems that have been developed by SAC/TC 151 (identical with international standards developed by Technical Committee ISO/TC 176, Quality Management and Quality Assurance). This standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management. Sector-specific quality management system standards based on the requirements of this standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this standard within the particular sector. A matrix showing the correlation between the clauses of this standard and the previous edition (GB/T 19001-2008/ISO 9001:2008) can be found on the ISO/TC 176/SC 2 (Technical Committee ISO/TC 176, Quality Management and Quality Assurance, Subcommittee SC 2, Quality Systems) open access web site at: www.iso.org/tc176/sc02/public. Quality Management Systems — Requirements 1 Scope This standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. Note 1: In this standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer. Note 2: Statutory and regulatory requirements can be expressed as legal requirements. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 19000-2016 Quality Management Systems — Fundamentals and Vocabulary (ISO 9000:2015, IDT) 3 Terms and definitions For the purposes of this document, the terms and definitions given in GB/T 19000-2016 apply. 4 Context of the Organization 4.1 Understanding the organization and its context The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues. Note 1: Issues can include positive and negative factors or conditions for consideration. Note 2: Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Note 3: Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization. 4.2 Understanding the needs and expectations of interested parties Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and review information about these interested parties and their relevant requirements. 4.3 Determining the scope of the quality management system The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider: a) the external and internal issues referred to in 4.1; b) the requirements of relevant interested parties referred to in 4.2; c) the products and services of the organization. The organization shall apply all the requirements of this standard if they are applicable within the determined scope of its quality management system. The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. 4.4 Quality management system and its processes 4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this standard. The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: a) determine the inputs required and the outputs expected from these processes; b) determine the sequence and interaction of these processes; c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; d) determine the resources needed for these processes and ensure their availability; e) assign the responsibilities and authorities for these processes; f) address the risks and opportunities as determined in accordance with the requirements of 6.1; g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results; h) improve the processes and the quality management system. 4.4.2 To the extent necessary, the organization shall: a) maintain documented information to support the operation of its processes; b) retain documented information to have confidence that the processes are being carried out as planned.
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 Bibliography
Referred in GB/T 19001-2016:
*GB/T 18380.3-2001 Tests on electric cables under fire conditions-Part 3:Tests on bunched wires or cables
*GB/T 3326-2016 Furniture―Main sizes of tables,chairs and stools
*JB/ZQ 4265-2006 Yx-shaped Seal Ring for Axis
*GB/T 2423.3-2016 Environmental testing―Part 2:Testing method―Test Cab:Damp heat,steady state
*GB/T 2367-2016 Sodium nitrite for industrial use
*GB/T 1408.3-2016 Electric strength of insulating materials test methods - Part 3: Additional requirements for 1 2/50μs impulse tests
*GB/T 1408.2-2016 Electrical strength of insulating materials - Test methods - Part 2: Additional requirements for tests using direct voltage
*GB/T 1408.1-2016 Electrical strength of insulating materials - Test methods - Part 1: Tests at power frequencies
*GB/T 1222-2016 Spring steels
*GB/T 479-2016 Determination of plastometric indices of bituminous coal
*GB/T 3328-2016 Furniture―Main sizes of beds
*GB/T 3327-2016 Furniture―Main sizes of storage units
*GB/T 4236-2016 Steel examination by sulphur print (Baumann method)
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
*GB/T 32541-2016 Quality control system for heat treatment
*GB/T 12143-2008 General analytical methods for beverage
*QC/T 1159-2022 Guidelines on evaluation of automobile industry green supply chain management
*GB/T 34539-2017 Safety requirements on hydrogen-oxygen generator
*GJB 5309.32-2004 Test methods of initiating explosive devices 一Part 32: High frequency vibration test
*GB/T 22889-2021 Leather—Physical and mechanical tests—Determination of surface coating thickness
*GB/T 1551-2021 Test method for measuring resistivity of monocrystal silicon—In-line four-point probe and direct current two-point probe method
*GB/T 7735-2016/XG1-2021 Automated eddy current testing of seamless and welded (except submerged arc-welded) steel tubes for detection of imperfections, includes Amendment 1
*GB/T 39552.2-2020 Sunglasses and sunglare filters-Part 2:Test methods
*HJ 1014-2020 Emissions control technical requirements of non-road diesel mobile machinery
*GB/T 16895.21-2020 Low-voltage electrical installations—Part 4-41:Protection for safety—Protection against electric shock
*TSG 11-2020 Regulation on Safety Technology for Boiler
*GB 20075-2020 Passenger handholds and footrests on motorcycles
*GB 518-2020 Motorcycle tyres
*GJB 2919A-2015 Specification for germanium used in infrared optics
*GB/T 39514-2020 Terminology,defination,identification of biobased materials
*GB/T 39263-2020 Road vehicles—Advanced driver assistance systems—Terms and definitions
*GB/T 39172-2020 Non-steel wire rope suspension means for lifts
*GB/T 34370.11-2020 Nondestructive testing of amusement equipments—Part 11:Ultrasonic guided wave testing
*GB/T 4146.1-2020 Textiles—Man-made fibres—Part 1: Generic names
*GB/T 5620-2020 Road vehicles—Vocabulary and definition for braking of automotive vehicles and their trailers
*GB/T 29639-2020 Guidelines for enterprises to develop emergency response plan for work place accidents
*GB/T 39116-2020 Maturity model of intelligent manufacturing capability
*GB 16423-2020 Safety regulation for metal and nonmetal mines
*GB 146.1-2020 Gauge for standard gauge railways—Part 1: rolling stock gauge
*JT/T 475-2020 Trailer axle
*YD/T 3710-2020 Test methods of message layer of LTE-based vehicular communication
*YD/T 3709-2020 Technical requirements of message layer of LTE-based vehicular communication
*YD/T 3707-2020 Technical Requirements of Network Layer of LTE-based Vehicular Communication
*LY/T 1738-2020 Plywood for parquet
*GB 38850-2020 List for materials and restricted substances in disinfectant
*GB/T 38608-2020 Method for determination of the volatile organic compounds(VOCs)content in the ink
*GB/T 38574-2020 General technical requirement for two-dimensional code of food traceability
*GB/T 34015.2-2020 Recycling of traction battery used in electric vehicle—Echelon use—Part 2:Removing requirements
*GB/T 5137.2-2020 Test methods of safety glazing materials used on road vehicles—Part 2:Optical properties tests
*GB/T 5137.1-2020 Test methods of safety glazing materials used on road vehicles—Part 1: Mechanical properties tests
*GB 38448-2019 Minimum allowable values and grades of the energy efficiency and water efficiency for smart water closets
*GB 28378-2019 Minimum allowable values of water efficiency and water efficiency grades for showers
*GB 25501-2019 Minimum allowable values of water efficiency and water efficiency grades for faucets
*GB 21455-2019 Minimum allowable values of the energy efficiency and energy efficiency grades for room air conditioners
*GB 2811-2019 Head protection—Safety helmets
*GB 2626-2019 Respiratory protection—Non-powered air-purifying particle respirator
*YY/T 1630-2018 Fundamental requirements for unique device identifier
*YY/T 0681.1-2018 Test methods for sterile medical device package―Part 1:Test guide for accelerated aging
*GB/T 24610.3-2019 Rolling bearings—Measuring methods for vibration—Part 3:Radial spherical and tapered roller bearings with cylindrical bore and outside surface
*GB/T 24610.2-2019 Rolling bearings—Measuring methods for vibration—Part 2:Radial ball bearings with cylindrical bore and outside surface
*GB/T 38146.1-2019 China automotive test cycle—Part 1:Light-duty vehicles
*GB 16737-2019 Road vehicle—World manufacturer identifier (WMI) code
*GB/T 38009-2019 Spectacle frames—Requirement and method for the detection of nickel release
*GB 24154-2015 National food safety standard — General standard for sports nutrition food
*GB 24154-2015/XG1-2021 National food safety standard - General rule for sports nutrition food (including Amendment 1)
*GB/T 33761-2017 General principles for green product assessment
*GB/T 33460-2016 Specifications for compiling dismantling manual of end-of-life vehicles
*WS 507-2016 Regulation for cleaning and disinfection technique of flexible endoscope
*GB/T 19000-2016 Quality management systems―Fundamentals and vocabulary
*GB 18352.6-2016 Limits and measurement methods for emissions from light-duty vehicles(CHINA 6)
*QC/T 1161-2022 Technical specifications for green-design product assessment- A utomobile
*GB/T 35607-2024 Green product assessment—Furniture
*GB/T 35603-2024 Green product assessment—Sanitary wares
*T/CEA 0054-2024 Evaluation requirements of green product —Traction lift
*GB/T 44907-2024 Technical criteria for quality evaluation of biomass fired boilers
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
Introduction 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. Figure 1 Schematic representation of the elements of a single process 0.3.2 Plan-Do-Check-Act cycle The PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle. Note: Numbers in brackets refer to the clauses in this standard. Figure 2 Representation of the structure of this standard in the PDCA cycle The PDCA cycle can be briefly described as follows: — Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities; — Do: implement what was planned; — Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results; — Act: take actions to improve performance, as necessary. 0.3.3 Risk-based thinking Risk-based thinking (see A.4) is essential for achieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of this standard including, for example, carrying out preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity. To conform to the requirements of this standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects. Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities. 0.4 Relationship with other management system standards This standard applies the framework developed by ISO to improve alignment among its standards for management systems (see A.1). This standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards. This standard relates to GB/T 19000 and GB/T 19004 as follows: — GB/T 19000 Quality Management Systems — Fundamentals and Vocabulary provides essential background for the proper understanding and implementation of this standard; — GB/T 19004 Managing for the Sustained Success of an Organization — A quality Management Approach provides guidance for organizations that choose to progress beyond the requirements of this standard. Annex B provides details of other standards on quality management and quality management systems that have been developed by SAC/TC 151 (identical with international standards developed by Technical Committee ISO/TC 176, Quality Management and Quality Assurance). This standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management. Sector-specific quality management system standards based on the requirements of this standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this standard within the particular sector. A matrix showing the correlation between the clauses of this standard and the previous edition (GB/T 19001-2008/ISO 9001:2008) can be found on the ISO/TC 176/SC 2 (Technical Committee ISO/TC 176, Quality Management and Quality Assurance, Subcommittee SC 2, Quality Systems) open access web site at: www.iso.org/tc176/sc02/public. Quality Management Systems — Requirements 1 Scope This standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. Note 1: In this standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer. Note 2: Statutory and regulatory requirements can be expressed as legal requirements. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 19000-2016 Quality Management Systems — Fundamentals and Vocabulary (ISO 9000:2015, IDT) 3 Terms and definitions For the purposes of this document, the terms and definitions given in GB/T 19000-2016 apply. 4 Context of the Organization 4.1 Understanding the organization and its context The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues. Note 1: Issues can include positive and negative factors or conditions for consideration. Note 2: Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Note 3: Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization. 4.2 Understanding the needs and expectations of interested parties Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and review information about these interested parties and their relevant requirements. 4.3 Determining the scope of the quality management system The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider: a) the external and internal issues referred to in 4.1; b) the requirements of relevant interested parties referred to in 4.2; c) the products and services of the organization. The organization shall apply all the requirements of this standard if they are applicable within the determined scope of its quality management system. The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. 4.4 Quality management system and its processes 4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this standard. The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: a) determine the inputs required and the outputs expected from these processes; b) determine the sequence and interaction of these processes; c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; d) determine the resources needed for these processes and ensure their availability; e) assign the responsibilities and authorities for these processes; f) address the risks and opportunities as determined in accordance with the requirements of 6.1; g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results; h) improve the processes and the quality management system. 4.4.2 To the extent necessary, the organization shall: a) maintain documented information to support the operation of its processes; b) retain documented information to have confidence that the processes are being carried out as planned.
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 Bibliography
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