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GB/T 19002-2018Quality management systems -- Guidelines for the application of GB/T 19001-2016 (English PDF)

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

December 28, 2018

Implementation date

July 1, 2019

Scope

GB/T 19002-2018 (Quality management systems -- Guidelines for the application of GB/T 19001-2016) is available as an English-translated PDF.

GB/T 19002-2018 — 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.

Document preview — GB/T 19002-2018

National Standard of the People's Republic of China

Issued by: SAMR; SAC

Contents

  • Foreword...5
  • Introduction...6
  • 1 Scope...8
  • 2 Normative References...8
  • 3 Terms and Definitions...8
  • 4 Context of the Organization...9
  • 4.1 Understanding the organization and its context...9
  • 4.2 Understanding the needs and expectations of interested parties...10
  • 4.3 Determining the scope of the quality management system...13
  • 4.4 Quality management system and its processes...14
  • 5 Leadership...16
  • 5.1 Leadership and commitment...16
  • 5.1.1 General...16
  • 5.1.2 Customer focus...18
  • 5.2 Policy...19
  • 5.2.1 Establishing the quality policy...19
  • 5.2.2 Communicating the quality policy...20
  • 5.3 Organizational roles, responsibilities and authorities...20
  • 6 Planning...21
  • 6.1 Actions to address risks and opportunities...21
  • 6.2 Quality objectives and planning to achieve them...24
  • 6.3 Planning of changes...26
  • 7 Support...27
  • 7.1 Resources...27
  • 7.1.1 General...27
  • 7.1.2 People...27
  • 7.1.3 Infrastructure...28
  • 7.1.4 Environment for the operation of processes...29
  • 7.1.5 Monitoring and measuring resources...29
  • 7.1.6 Organizational knowledge...31
  • 7.2 Competence...32
  • 7.3 Awareness...33
  • 7.4 Communication...34
  • 7.5 Documented information...35
  • 7.5.1 General...35
  • 7.5.2 Creating and updating...36
  • 7.5.3 Control of documented information...36
  • 8 Operation...38
  • 8.1 Operational planning and control...38
  • 8.2 Requirements for products and services...39
  • 8.2.1 Customer communication...39
  • 8.2.2 Determining the requirements for products and services...40
  • 8.2.3 Review of the requirements for products and services...41
  • 8.2.4 Changes to requirements for products and services...42
  • 8.3 Design and development of products and services...42
  • 8.3.1 General...42
  • 8.3.2 Design and development planning...43
  • 8.3.3 Design and development inputs...44
  • 8.3.4 Design and development controls...45
  • 8.3.5 Design and development outputs...46
  • 8.3.6 Design and development changes...48
  • 8.4 Control of externally provided processes, products and services...48
  • 8.4.1 General...48
  • 8.4.2 Type and extent of control...49
  • 8.4.3 Information for external providers...51
  • 8.5 Production and service provision...52
  • 8.5.1 Control of production and service provision...52
  • 8.5.2 Identification and traceability...53
  • 8.5.3 Property belonging to customers or external providers...54
  • 8.5.4 Preservation...55
  • 8.5.5 Post-delivery activities...57
  • 8.5.6 Control of changes...57
  • 8.6 Release of products and services...58
  • 8.7 Control of nonconforming outputs...58
  • 9 Performance Evaluation...61
  • 9.1 Monitoring, measurement, analysis and evaluation...61
  • 9.1.1 General...61
  • 9.1.2 Customer satisfaction...61
  • 9.1.3 Analysis and evaluation...62
  • 9.2 Internal audit...63
  • 9.3 Management review...65
  • 9.3.1 General...65
  • 9.3.2 Management review inputs...66
  • 9.3.3 Management review outputs...67
  • 10 Improvement...68
  • 10.1 General...68
  • 10.2 Nonconformity and corrective action...68
  • 10.3 Continual improvement...70
  • Bibliography...71

Foreword

This Standard was one of the standards of GB/T 19000 family.

This Standard was drafted as per the rules specified in GB/T 1.1-2009.

This Standard uses translation method to equivalently adopt ISO/TS 9002.2016

Quality Management Systems - Guidelines for the Application of ISO 9001.2015.

This Standard made the following editorial modification.

--- Modify the standard name.

This Standard was proposed by and under the jurisdiction of National Technical

Committee for Standardization of Quality Management and Quality Assurance

(SAC/TC 151).

Drafting organizations of this Standard. China National Institute of Standardization;

Certification and Accreditation Administration of the People's Republic of China; China

Certification and Accreditation Association; China National Accreditation Center for

Conformity Assessment; China Quality Certification Center; China Certification Center

Inc.; Civil Aviation University of China; Chinese Classification Society Quality

Authentication Company; Guopei Renzhen Training Center (Beijing) Center; China

Association for Quality; Goodbaby Child Products Co., Ltd.; Beijing Junyou Chengxin

Quality Certification Co., Ltd.; Kocel Group Limited; Tianjin Huacheng Certification Co.,

Ltd.; Beijing New Century Inspection & Certification Co., Ltd.; Guangzhou Automobile

Group Co., Ltd.; China Building Material Test & Certification Group Co., Ltd.; Shanghai

Audit Center of Quality System; Naval Equipment Department Test Supervision

Bureau; Shanghai Jianke Engineering Consulting Co., Ltd.; Great Wall Center of

Quality Assurance of China; Shanghai Electric Group Company Limited; Yinchuan

Customs District; and Fenghua Entry-Exit Inspection and Quarantine Bureau.

Chief drafting staffs of this Standard. Gu Yanjun, Li Jing, Wang Yonggang, Duan

Yihong, Li Ming, Xia Fang, Li Ping, Zhu Yunlong, Wang Xinting, Wu Guiling, Yuan

Xiaolei, Zhang Huicai, Liang Xiaowen, Zhang Yanxia, Ruan Shelou, Zheng Yuanhui,

Tan Ping, Xia Ming, Zhou Hongbo, Li Chenxuan, Liu Xiaoling, Han Ronghui, Zhang

Xiaoqun, Wang Ping, and Liu Xiaojian.

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.

2 Normative References

The following documents are essential to the application of this document. For the

dated documents, only the versions with the dates indicated are applicable to this

document; for the undated documents, only the latest version (including all the

amendments) is applicable to this document.

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

A process is a set of interrelated or interacting activities that use inputs in order to

deliver intended results. For GB/T 19001-2016, 4.4.1, bullets a) to h).

Documented information is information required to be controlled and maintained by an

organization and the medium on which it is contained.

5 Leadership

For an organization, "top management" may include, for example, the chief executive

officer, managing director, general manager, chairman, board of directors, executive

directors, managing partner(s), single owner, partner(s) and senior

The intent of this subclause is to ensure that top management visibly demonstrates

leadership and commitment in maintaining the organization's focus on meeting

customer requirements and enhancing customer satisfaction.

6 Planning

There are various situations where risks and opportunities should be considered, for

example strategy meetings, management reviews, internal audits, different kinds of

meetings on quality, meetings to set quality objectives, the planning stages for the

design and development of new products and services, and the planning stages for

production processes.

7 Support

The intent of this subclause is to ensure that the organization has the right human

resources that are needed for the operation and control of its processes and the

effective implementation of the quality management system. Consideration should be

given to the current workload and competence of relevant persons to carry out

functions and roles in the quality management system (e.g. operational activities,

audits, inspection, testing, complaint investigations).

8 Operation

The intent of this subclause is to ensure there is clear communication between the

organization and its customer when determining requirements for the products and

services to be provided.

The intent of this subclause is to ensure that the organization determines the

requirements for its products and services. These requirements can be determined by

considering.

9 Performance Evaluation

The intent of this subclause is for the organization to analyze and evaluate data and

information from the results of monitoring and measurement in order to determine if

processes, products and services meet requirements and to determine any needed

actions and opportunities for improvement.

......

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — all pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 19000-2016 · ISO 9000.2015

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