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GB/T 42061-2022 (GB/T42061-2022)

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GB/T 42061-2022: PDF in English (GBT 42061-2022)

GB/T 42061-2022
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 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
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 requirements permit exclusions of design and development controls,
this can be used as a justification for their exclusion from the quality management system.
These regulatory requirements can provide alternative approaches that are to be addressed in
the quality management system. It is the responsibility of the organization to ensure that claims
of conformity to this Standard reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of this Standard is not applicable due to the activities
undertaken by the organization or the nature of the medical device for which the quality
management system is applied, the organization does not need to include such a requirement in
its quality management system. For any clause that is determined to be not applicable, the
organization records the justification as described in 4.2.2.
a) review and approve documents for adequacy prior to issue;
b) review, update as necessary and re-approve documents;
c) ensure that the current revision status of and changes to documents are identified;
d) ensure that relevant versions of applicable documents are available at points of use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin, determined by the organization to be necessary
for the planning and operation of the quality management system, are identified and their
distribution controlled;
g) prevent deterioration or loss of documents;
h) prevent the unintended use of obsolete documents and apply suitable identification to
The organization shall ensure that changes to documents are reviewed and approved either by
the original approving function or another designated function that has access to pertinent
background information upon which to base its decisions.
The organization shall define the period for which at least one copy of obsolete documents shall
be retained. This period shall ensure that documents to which medical devices have been
manufactured and tested are available for at least the lifetime of the medical device as defined
by the organization, but not less than the retention period of any resulting record (see 4.2.5), or
as specified by applicable regulatory requirements.
4.2.5 Control of records
Records shall be maintained to provide evidence of conformity to requirements and of the
effective operation of the quality management system.
The organization shall document procedures to define the controls needed for the identification,
storage, security and integrity, retrieval, retention time and disposition of records.
The organization shall define and implement methods for protecting confidential health
information contained in records in accordance with the applicable regulatory requirements.
Records shall remain legible, readily identifiable and retrievable. Changes to a record shall
remain identifiable.
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.