Finding Analysis of Medical Device Manufacturer Audit in Suzhou Industrial Park for the Last Three Years.
10.3969/j.issn.1671-7104.2020.04.016
- Author:
Xiaoming QIAN
1
;
Meihua NI
2
;
Zeng LU
2
Author Information
1. Suzhou Industrial Park Food and Drug Safety Inspection Team, Suzhou, 215000.
2. Suzhou Industrial Park Administration for Market Regulation, Suzhou, 215000.
- Publication Type:Journal Article
- Keywords:
good manufacturing practice for medical devices;
medical device;
production management;
quality system
- MeSH:
Industry;
Quality Control;
Time Factors
- From:
Chinese Journal of Medical Instrumentation
2020;44(4):353-358
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:Common findings are to be found from 144 different type of medical device manufacturers' audit reports which are from Jan. 2017 to Jun. 2019. Advise is to be provided for medical device manufacturers on continual improvement.
METHODS:Classify and analyze the on-site audit findings from different type of medical device manufacturers.
RESULTS:The frequency of findings from chapter production management, buildings and facilities, quality control are comparatively high.
CONCLUSIONS:The key to improve the quality management system is to cultivate the staff sense of continual improvement of quality system, improve the staff ability of finding and solving problems, encourage staff participation in quality system, fit the quality system on product realization.
