GB/T 42061-2022Medical devices - Quality management systems - Requirements for regulatory purposes (English PDF)

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.

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