GB/T 19001-2016Quality management systems -- Requirements (English PDF)

Foreword

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

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

This Standard replaced GB/T 19001-2008 Quality Management Systems –

Requirements.

Compared with GB/T 19001-2008, this Standard has the major technical changes

besides the editorial modifications.

--- Adopt the high-level structure given in Annex SL of the ISO Supplementary

Provisions of Part 1 in the ISO/IEC Guidelines;

--- Adopt risk-based thinking;

--- Fewer prescriptive requirements;

--- More flexible requirements for documented information;

--- Improve the applicability of the service industry;

--- More emphasis on the organizational environment;

--- Strengthen the requirements for leadership;

--- Pay more attention to achieving expected process results to enhance customer

satisfaction.

Annex A gives a more detailed description of the changes relative to GB/T19001-2008.

This Standard uses translation method to equivalently adopt ISO 9001.2015 Quality

Management Systems – Requirements (English Version).

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;

Chinese Certification and Accreditation Association; China National Accreditation

Center for Conformity Assessment; China Quality Certification Center; Tianjin

Huacheng Certification Center; China Classification Society Certification Company;

Shenzhen Huantong Attestation Center Co., Ltd.; China Xinshidai Certification Center;

Fangyuan Sign Certification Group Co., Ltd.; Beijing New Century Inspection &

Certification Co., Ltd.; Guopei Renzheng Training (Beijing) Center; China Certification

Center Inc.; Shanghai Audit Center of Quality System; Quality Assurance Center of

China Association for Quality; SAIC-GM-Wuling Automotive Co., Ltd.; Inner Mongolia

North Hauler Joint Stock Co., Ltd.; Taixing Longyi Terminal Co., Ltd.; Shanghai Jianke

Engineering Consulting Co., Ltd.; Inner Mongolia Yili Industrial Group Co., Ltd.; Tianjin

Tiandy Technology Co., Ltd.; China Chang'an Automobile Group Co., Ltd.; Inner

Mongolia Hotision and Monsod Drought-Resistance Greening Co., Ltd.; Nanjing Mint

Co., Ltd.; China Railway Construction Corporation Limited; China Building Material

Test & Certification Group Co., Ltd.; and Beijing Dongfang Yichu Standard Technology

Co., Ltd.

Chief drafting staffs of this Standard. Tian Wu, Kang Jian, Zhang Huicai, Li Qiang, Ren

Qingyue, Li Ming, Zheng Yuanhui, Huang Xueliang, Qu Xintian, Zheng Yan, Liang Ping,

Wang Mei, Li Ping, Xia Fang, Wang Jinde, Cao Hua, Deng Xiangning, Pei Jie, Lin

Chuang, Zhou Hongbo, Li Huaqiu, Li Chenxuan, Fang Yejuan, Xie Hui, Zhu Jiangtao,

Wei Xiangyang, Liu Ye, Dong Xiaohong.

The historical editions replaced by this Standard are as follows.

--- GB/T 10300.2-1988;

--- GB/T 19001-1992.GB/T 19001-1994, GB/T 19001-2000, GB/T 19001-2008.

1 Scope

This Standard specifies requirements for a quality management system when an

organization.

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 purpose of this document, the terms and definitions given in GB/T 19000-2016

apply.

4 Context of the Organization

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.

5 Leadership

Top management shall demonstrate leadership and commitment with respect to

customer focus by ensuring that.

Top management shall ensure that the responsibilities and authorities for relevant roles

are assigned, communicated and understood within the organization.

Top management shall assign the responsibility and authority for.

6 Planning

When the organization determines the need for changes to the quality management

system, the changes shall be carried out in a planned manner (see 4.4).

The organization shall consider.

7 Support

The organization shall determine and provide the resources needed for the

establishment, implementation, maintenance and continual improvement of the quality

management system.

The organization shall determine, provide and maintain the infrastructure necessary

for the operation of its processes and to achieve conformity of products and services.

8 Operation

The organization shall establish, implement and maintain a design and development

process that is appropriate to ensure the subsequent provision of products and

services.

The organization shall determine the requirements essential for the specific types of

products and services to be designed and developed. The organization shall consider.

9 Performance Evaluation

The organization shall monitor customers' perceptions of the degree to which their

needs and expectations have been fulfilled. The organization shall determine the

methods for obtaining, monitoring and reviewing this information.

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