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GB/T 19001-2016 PDF English

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GB/T 19001-2016: Quality management systems -- Requirements
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GB/T 19001: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
GB/T 19001-2016English425 Add to Cart 0-9 seconds. Auto-delivery Quality management systems -- Requirements Valid
GB/T 19001-2008EnglishRFQ ASK 4 days [Replaced by GB/T 19001-2016] Quality management systems -- Requirements [including MODIFICATION 1] Obsolete
GB/T 19001-2000EnglishRFQ ASK 4 days Quality management system requirements Obsolete
GB/T 19001-1994EnglishRFQ ASK 3 days Quality systems--Model for quality assurance in design, development, production, installation and servicing Obsolete
GB/T 19001-1992EnglishRFQ ASK 3 days Quality systems--Model for quality assurance in design/development, production, installation and servicing Obsolete

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GB/T 19001-2016: Quality management systems -- Requirements

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GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 03.120.10 A 00 GB/T 19001-2016 / ISO 9001.2015 Replacing GB/T 19001-2008 Quality Management Systems – Requirements (ISO 9001.2015, IDT) Issued on. DECEMBER 30, 2016 Implemented on. JULY 01, 2017 Issued by. General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration of PRC.

Table of Contents

Foreword... 5 Introduction... 7 1 Scope... 13 2 Normative References... 13 3 Terms and Definitions... 13 4 Context of the Organization... 14 4.1 Understanding the organization and its context... 14 4.2 Understanding the needs and expectations of interested parties... 14 4.3 Determining the scope of the quality management system... 14 4.4 Quality management system and its processes... 15 5 Leadership... 16 5.1 Leadership and commitment... 16 5.1.1 General... 16 5.1.2 Customer focus... 16 5.2 Policy... 17 5.2.1 Establishing the quality policy... 17 5.2.2 Communicating the quality policy... 17 5.3 Organizational roles, responsibilities and authorities... 17 6 Planning... 18 6.1 Actions to address risks and opportunities... 18 6.2 Quality objectives and planning to achieve them... 19 6.3 Planning of changes... 19 7 Support... 20 7.1 Resources... 20 7.1.1 General... 20 7.1.2 People... 20 7.1.3 Infrastructure... 20 7.1.4 Environment for the operation of processes... 20 7.1.5 Monitoring and measuring resources... 21 7.1.6 Organizational knowledge... 21 7.2 Competence... 22 7.3 Awareness... 22 7.4 Communication... 23 7.5 Documented information... 23 7.5.1 General... 23 7.5.2 Creating and updating... 23 7.5.3 Control of documented information... 24 8 Operation... 24 8.1 Operational planning and control... 24 8.2 Requirements for products and services... 25 8.2.1 Customer communication... 25 8.2.2 Determining the requirements for products and services... 25 8.2.3 Review of the requirements for products and services... 26 8.2.4 Changes to requirements for products and services... 26 8.3 Design and development of products and services... 27 8.3.1 General... 27 8.3.2 Design and development planning... 27 8.3.3 Design and development inputs... 27 8.3.4 Design and development controls... 28 8.3.5 Design and development outputs... 28 8.3.6 Design and development changes... 29 8.4 Control of externally provided processes, products and services... 29 8.4.1 General... 29 8.4.2 Type and extent of control... 30 8.4.3 Information for external providers... 30 8.5 Production and service provision... 31 8.5.1 Control of production and service provision... 31 8.5.2 Identification and traceability... 31 8.5.3 Property belonging to customers or external providers... 32 8.5.4 Preservation... 32 8.5.5 Post-delivery activities... 32 8.5.6 Control of changes... 33 8.6 Release of products and services... 33 8.7 Control of nonconforming outputs... 33 9 Performance Evaluation... 34 9.1 Monitoring, measurement, analysis and evaluation... 34 9.1.1 General... 34 9.1.2 Customer satisfaction... 34 9.1.3 Analysis and evaluation... 35 9.2 Internal audit... 35 9.3 Management review... 36 9.3.1 General... 36 9.3.2 Management review inputs... 36 9.3.3 Management review outputs... 37 10 Improvement... 37 10.1 General... 37 10.2 Nonconformity and corrective action... 37 10.3 Continual improvement... 38 Annex A (Informative) Clarification of New Structure, Terminology and Concepts ... 39 Annex B (Informative) Other International Standards on Quality Management and Quality Management Systems Developed by SAC/TC 151... 44 Bibliography... 49

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. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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