Finding Analysis of Medical Device Manufacturer Audit in Suzhou Industrial Park for the Last Three Years / 中国医疗器械杂志

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.