Introduction of Quality Management System Audit in Medical Device Single Audit Program.
10.3969/j.issn.1671-7104.2018.01.014
- VernacularTitle:医疗器械单一审核程序中质量管理体系检查工作的介绍
- Author:
Jing WEN
1
;
Jiangyi XIAO
1
;
Aijun WANG
1
Author Information
1. Center for Food and Drug Inspection of CFDA, Beijing, 100061.
- Publication Type:Journal Article
- Keywords:
audit;
medical device single audit program;
quality management system
- MeSH:
China;
Equipment and Supplies;
Medical Audit;
Quality Control
- From:
Chinese Journal of Medical Instrumentation
2018;42(1):53-55
- CountryChina
- Language:Chinese
-
Abstract:
The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.
