GB/T 19002-2018 in English

《GB/T 19002-2018质量管理体系 GB/T 19001—2016应用指南》由TC151（全国质量管理和质量保证标准化技术委员会）归口，主管部门为国家标准化管理委员会。

Quality management system - Guidelines for the application of GB/T 19001-2016

1 Scope

This document provides guidance on the intent of the requirements in GB/T 19001-2016, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements.

This document does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.

2 Normative references

The following referenced documents are indispensable for the application of this standard. 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)
GB/T 19001-2016 Quality management systems - Requirements (ISO 9001:2015, IDT)

3 Terms and definitions

For the purposes of this document, the terms and definitions given in GB/T 19000-2016 apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at http://www.iso.org/obp;

— IEC Electropedia: available at http://www.electropedia.org/.

4 Context of the organization

4.1 Understanding the organization and its context

The intent of this subclause is to understand the external and internal issues that are relevant to the organization’s purpose and strategic direction and that can affect, either positively or negatively, the organization’s ability to achieve the intended results of its quality management system. The organization shall be aware that external and internal issues can change, and therefore, shall be monitored and reviewed. An organization many conduct reviews of its context at planned intervals and through activities such as management review.

Information about external and internal issues can be found from many sources, such as through internal documented information and meetings, in the national and international press, websites, publications from national statistics offices and other government departments, professional and technical publications, conferences and meetings with relevant agencies, meetings with customers and relevant interested parties, and professional associations.

Examples of external and internal issues relevant to the organization's context can include, but are not limited to:

a) external issues related to:

1) economic factors such as money exchange rates, economic situation, inflation forecast, credit availability;

2) social factors such as local unemployment rates, safety perception, education levels, public holidays and working days;

3) political factors such as political stability, public investments, local infrastructure, international trade agreements;

4) technological factors such as new sector technology, materials and equipment, patent expirations, professional code of ethics;

5) market factors such as competition, including the organization’s market share, similar products or services, market leader trends, customer growth trends, market stability, supply chain relationships;

6) statutory and regulatory factors which affect the work environment (see GB/T 19001-2016, 7.1.4) such as trade union regulations and regulations related to an industry;

b) internal issues related to:

1) overall performance of the organization;

2) resource factors, such as infrastructure (see GB/T 19001-2016, 7.1.3), environment for the operation of the processes (see GB/T 19001-2016, 7.1.4), organizational knowledge (see GB/T 19001-2016, 7.1.6);

3) human aspects such as competence of persons, organizational behaviour and culture, relationships with unions;

4) operational factors such as process or production and service provision capabilities, performance of the quality management system, monitoring customer satisfaction;

5) factors in the governance of the organization, such as rules and procedures for decision making or organizational structure.

At the strategic level, tools such as Strengths, Weaknesses, Opportunities and Threats analysis (SWOT) and Political, Economic, Social, Technological, Legal, Environmental analysis (PESTLE) can be used. A simple approach can be useful for organizations dependent on the size and complexity of their operations, such as brainstorming and asking "what if" questions.

4.2 Understanding the needs and expectations of interested parties

The intent of this subclause is to ensure that the organization considers the relevant requirements of relevant interested parties, beyond just those of its direct customers. The intention is to focus on only those relevant interested parties which can have an impact on the organization’s ability to provide products and services that meet requirements. While not directly stated in GB/T 19001, the organization could consider its external and internal issues (see GB/T 19001-2016, 4.1) before, and to assist in, determining its relevant interested parties.

The list of relevant interested parties can be unique to the organization. The organization can develop criteria for determining relevant interested parties by considering their:

a) possible influence or impact on the organization’s performance or decisions;

b) ability to create risks and opportunities;

c) possible influences or impact on the market;

d) ability to affect the organization through their decisions or activities.

EXAMPLE 1 Examples of relevant interested parties that can be considered relevant by an organization include, but are not limited to:

— customers;

— end users or beneficiaries;

— joint venture partners;

— franchisors;

— owners of intellectual property;

— parent and subsidiary organizations;

— owners, shareholders;

— bankers;

— unions;

— external providers;

— employees and others working on behalf of the organization;

— statutory and regulatory authorities (local, regional, national or international);

— trade and professional associations;

— local community groups;

— non-governmental organizations;

Foreword i
Introduction ii
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 Continuous improvement
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