Comparison of “if appropriate” in Quality System
LV Hong-guang;Shanghai NQA Certification Co., Ltd;
Currently, many medical device manufacturer simultaneously planing and establish Quality system according to ISO9001,ISO134845 and QSR part 820 regulation.However, the "if appropriate" often been misunderstand, term "if appropriate" has been compared and analyzed the in ISO9001, ISO134845 and QSR in this article. It is expected to help medical device manufacturer accurately understand and implementation of quality system requirement.
【CateGory Index】： F203