GB/T 42061-2022 PDF English
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GB/T 42061-2022: Medical devices - Quality management systems - Requirements for regulatory purposes
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GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 03.100.70; 11.040.01
CCS C 30
GB/T 42061-2022 / ISO 13485.2016
Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes
(ISO 13458.2016, IDT)
Issued on. OCTOBER 12, 2022
Implemented on. NOVEMBER 01, 2023
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 5
Introduction... 6
1 Scope... 10
2 Normative References... 11
3 Terms and Definitions... 11
4 Quality Management System... 17
4.1 General requirements... 17
4.2 Documentation requirements... 18
4.2.1 General... 18
4.2.2 Quality manual... 19
4.2.3 Medical device file... 19
4.2.4 Control of documents... 19
4.2.5 Control of records... 20
5 Management Responsibility... 21
5.1 Management commitment... 21
5.2 Customer focus... 21
5.3 Quality policy... 21
5.4 Planning... 21
5.4.1 Quality objectives... 21
5.4.2 Quality management system planning... 22
5.5 Responsibility, authority and communication... 22
5.5.1 Responsibility and authority... 22
5.5.2 Management representative... 22
5.5.3 Internal communication... 22
5.6 Management review... 22
5.6.1 General... 22
5.6.2 Review input... 23
5.6.3 Review output... 23
6 Resource Management... 24
6.1 Provision of resources... 24
6.2 Human resources... 24
6.3 Infrastructure... 24
6.4 Work environment and contamination control... 25
6.4.1 Work environment... 25
6.4.2 Contamination control... 25
7 Product Realization... 25
7.1 Planning of product realization... 25
7.2 Customer-related processes... 26
7.2.1 Determination of requirements related to product... 26
7.2.2 Review of requirements related to product... 26
7.2.3 Communication... 27
7.3 Design and development... 27
7.3.1 General... 27
7.3.2 Design and development planning... 27
7.3.3 Design and development inputs... 28
7.3.4 Design and development outputs... 28
7.3.5 Design and development review... 29
7.3.6 Design and development verification... 29
7.3.7 Design and development validation... 29
7.3.8 Design and development transfer... 30
7.3.9 Control of design and development changes... 30
7.3.10 Design and development files... 31
7.4 Purchasing... 31
7.4.1 Purchasing process... 31
7.4.2 Purchasing information... 31
7.4.3 Verification of purchased product... 32
7.5 Production and service provision... 32
7.5.1 Control of production and service provision... 32
7.5.2 Cleanliness of product... 33
7.5.3 Installation activities... 33
7.5.4 Servicing activities... 33
7.5.5 Particular requirements for sterile medical devices... 34
7.5.6 Validation of processes for production and service provision... 34
7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier
systems... 35
7.5.8 Identification... 35
7.5.9 Traceability... 35
7.5.10 Customer property... 36
7.5.11 Preservation of product... 36
7.6 Control of monitoring and measuring equipment... 36
8 Measurement, Analysis and Improvement... 37
8.1 General... 37
8.2 Monitoring and measurement... 38
8.2.1 Feedback... 38
8.2.2 Complaint handling... 38
8.2.3 Reporting to regulatory authorities... 39
8.2.4 Internal audit... 39
8.2.5 Monitoring and measurement of processes... 39
8.2.6 Monitoring and measurement of product... 40
8.3 Control of nonconforming product... 40
8.3.1 General... 40
8.3.2 Actions in response to nonconforming product detected before delivery... 40
8.3.3 Actions in response to nonconforming product detected after delivery... 41
8.3.4 Rework... 41
8.4 Analysis of data... 41
8.5 Improvement... 42
8.5.1 General... 42
8.5.2 Corrective action... 42
8.5.3 Preventive action... 42
Annex A (Informative) Comparison of Content between this Document and YY/T
0287-2003... 44
Annex B (Informative) Correspondence between this Document and GB/T 19001-
2016... 47
Bibliography... 53
Foreword
This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for
Standardization – Part 1.Rules for the Structure and Drafting of Standardizing Documents.
This Document equivalently adopts ISO 13485.2016 Medical Devices – Quality Management
Systems – Requirements for Regulatory Purposes.
This Document made the minimum editorial modifications.
--- In order to coordinate with regulations, add NOTE 2 to “3.11 Medical Devices” in terms
and definitions.
--- Add a row after 8.3.3 with “8.3.4 Rework” in the first column, and “8.7 Control of
nonconforming outputs” in the second column correspondingly in the Table B.1; the
original text is omitted.
Please note some contents of this Document may involve patents. The issuing agency of this
Document shall not assume the responsibility to identify these patents.
This Document was proposed by National Medical Products Administration.
This Document shall be under the jurisdiction of National Technical Committee on Quality
Management and General Requirements for Medical Device of Standardization Administration
of China (SAC/TC 221).
Drafting organizations of this Document. Beijing Hua Guang Certification of Medical Devices
Co., Ltd.; National Institutes for Food and Drug Control; Shenzhen Mindray Bio-Medical
Electronics Co., Ltd.; Neusoft Medical Systems Co., Ltd.; Beijing Wandong Medical
Technology Co., Ltd.; Shanghai MicroPort Medical (Group) Co., Ltd.; Contec Medical Systems
Co., Ltd.; China National Institute of Standardization; Shandong Weigao Group Medical
Polymer Co., Ltd.; and China National Medical Device Co., Ltd.
Chief drafting staffs of this Document. Chang Jia, Li Xin, Zheng Jia, Wang Hongman, Wang
Zhiqiang, Xu Qiang, Li Yong, Li Xueyong, Zhang Jingshu, Liu Lina, Wang Fu, Li Chaohui, Xu
Huiwen, Wang Meiying, Zhang Jianfeng, Sun Ye, and Ai Yingying.
1 Scope
This Standard specifies requirements for a quality management system where an organization
needs to demonstrate its ability to provide medical devices and related services that consistently
meet customer and applicable regulatory requirements.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in 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 and
the following apply.
4 Quality Management System
For each medical device type or medical device family, the organization shall establish and
maintain one or more files either containing or referencing documents generated to demonstrate
conformity to the requirement of this Standard and compliance with applicable regulatory
requirements.
The organization shall retain the records for at least the lifetime of the medical device as defined
by the organization, or as specified by applicable regulatory requirements, but not less than two
years from the medical device release by the organization.
5 Management Responsibility
Top management shall ensure that quality objectives, including those needed to meet applicable
regulatory requirements and requirements for product, are established at relevant functions and
levels within the organization. The quality objectives shall be measurable and consistent with
the quality policy.
6 Resource Management
Personnel performing work affecting product quality shall be competent on the basis of
appropriate education, training, skills and experience.
For sterile medical devices, the organization shall document requirements for control of
contamination with microorganisms or particulate matter and maintain the required cleanliness
during assembly or packaging processes.
7 Product Realization
The organization shall document one or more processes for risk management in product
realization. Records of risk management activities shall be maintained (see 4.2.5).
The organization shall review the requirements related to product.
8 Measurement, Analysis and Improvement
As one of the measurements of the effectiveness of the quality management system, the
organization shall gather and monitor information relating to whether the organization has met
customer requirements.
The organization shall document procedures to determine, collect and analyze appropriate data
to demonstrate the suitability, adequacy and effectiveness of the quality management system.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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