Thoughts on the Witnessed Audit in Medical Device Single Audit Program.
10.3969/j.issn.1671-7104.2018.02.012
- VernacularTitle:对医疗器械单一审核程序中见证检查工作的思考
- 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:
Medical Device Single Audit Program;
Quality Management System;
Witnessed Audit;
assessment
- MeSH:
Equipment and Supplies;
Medical Audit
- From:
Chinese Journal of Medical Instrumentation
2018;42(2):122-124
- CountryChina
- Language:Chinese
-
Abstract:
Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.
