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
组织应： a) 确定在其控制下工作的人员所需具备的能力，这些人员从来的工作影响质量管理体系绩效和有效性； b) 基于适当的教育、培训或经验，确保这些人员是胜任的； c) 适用时，采取措施以获得所需的能力，并评价措施的有效性； d) 保原适当的成文信息，作为人员能力的证据。 注：适用措施可包括对在职人员进行培训、辅导或重新分配工作，或者聘用、外包胜任的人员。
7.3 意识 组织应确积在其控制下上作的人员知晓； a) 质量方针； b) 相关的质量目标； c)他们对质量管理体系有放性的贡献，包括改进绩效的益处。
7.4 沟通 组织应确定与质量体系相关的内容和外部沟通，包括； a) 沟通什么 b) 何时沟通； c) 与谁沟通； d) 如何沟通； e) 谁来沟通。 7.5成文信息 7.5.1总则 组织的质量管理体系应包括： a） 本标准要求的成文信息； b） 组织所确定的、为确保质量管理体系有效性所需的成文信息。 注：对于不同组织，质量管理体系成文信息的多少与详略程度可以不同，取决于： ——组织的规模，以及活动、过程、产品和服务的类型； ——过程及其相互作用的复杂程度； ——人员的能力。
7.5 .2创建和更新 在创建和更新成文信息时，组织应确保适当的。 a)标识和说明(如标题、日期、作者、索引编号)； b 形式(如语言、软件版本、图表)和载体(如纸质的、电子的)； c)评审和批准，以保持适宜性和充分性。 7.5.3 成文俏息的控制 7.5.3.1 应控制质量管理体系和本标准所要求的成文信息，以确保； a) 在需要的场合和时机，均可获得开适用； b) 予以妥善保护(如防止泄密、不当使用或缺失)。 7.5.3.2 为控制成文信息，适用时，组织应进行下列活动： a) 分发、访问、检索和使用 b) 存储和防护，包括保持可读性； c )更改控制(如版本控制)； d) 保留和处置。 对于组织确定的策划利运行质量管理体系所必雳的来自外部分那的成文倍息，组织或进在适当识别，并予以控制。 对所保留的作为符合性证据的成文信息应予 以保护，防止非预期的更改。 注：对成文信息的“访问”可能意味着仅允许查阅，或者意味着允许查阅并授权修改。 8 运行 8.1 运行的策划和控制 为满足产品和服务提供的要求，并实施第6章所确定的措施组织应通过以下措施对所需的过程(见 4.4）进行策划、实龙和控制： a)确定产品和服务的要求； b) 建立下列内容的准则； 1) 过程； 2)产品和服务的接收。 c)确定所需的资源以使产品和服务符合要求， d) 按照准则实施过程控制； e)在必要的范围和程度上，确定并保持、保留成文信息，以： 1) 确信过程已经按策划进行； 2)证实产品和服务符合要求。 策划的输出应适合于组织的运行。 组织应控制策划的变更，评审非预期变更的后果，必要时，采取措慈减轻不利影响。 组织应确保外包过程受控(见8.4)。
