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GB/T 42061-2022 English PDF (GBT42061-2022)

GB/T 42061-2022 English PDF (GBT42061-2022)

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GB/T 42061-2022: Medical devices - Quality management systems - Requirements for regulatory purposes
GB/T 42061-2022
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.
Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes
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. Such organizations can be involved in
one or more stages of the life-cycle, including design and development, production, storage and
distribution, installation, or servicing of a medical device and design and development or
provision of associated activities (e.g., technical support). This Standard can also be used by
suppliers or external parties that provide product, including quality management system-related
services to such organizations.
Requirements of this Standard are applicable to organizations regardless of their size and
regardless of their type except where explicitly stated. Wherever requirements are specified as
applying to medical devices, the requirements apply equally to associated services as supplied
by the organization.
The processes required by this Standard that are applicable to the organization, but are not
performed by the organization, are the responsibility of the organization and are accounted for
in the organization’s quality management system by monitoring, maintaining, and controlling
the processes.
If applicable regulatory require...
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