GB/T 19002-2018 PDF English
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GB/T 19002-2018: Quality management systems -- Guidelines for the application of GB/T 19001-2016---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT19002-2018
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 03.120.10
A 00
GB/T 19002-2018 / ISO/TS 9002.2016
Quality Management Systems – Guidelines
for the Application of GB/T 19001-2016
(ISO/TS 9002.2016, Quality Management Systems
– Guidelines for the Application of ISO 9001.2015, IDT)
Issued on. DECEMBER 28, 2018
Implemented on. JULY 01, 2019
Issued by. State Administration for Market Regulation;
Standardization Administration of PRC.
Table of 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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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