There are several major differences:
* FDA regulations are the federal law!
* [[ISO 9000]] consist of volontary quality standards, which manufacturers comply and document with periodic internal and external auditing
* FDA's management responsibility, management representative, management review, design controls and complaint regulations are more prescriptive and specific than [[ISO 9000]]
* [[ISO 9000]] has no failure-reporting requirement, recall requirement and in fact no effectiveness requirement
* On the other hand the FDA has limited control over personnel, largely personnel assesment, approval for their position, and training requirements. [[ISO 9000]] expects the personal department to be fully controlled.
* FDA has no control over a manufacturers financial department assuming its not the purchasing arm of the firm. [[ISO 9000]] expects finance to be fully controlled.
* FDA has little oversight over marketing & sales.
FDA compliance will always overshadow voluntary [[ISO 9001]] certification expectations.
bag
fda_public
created
Sat, 23 Jun 2012 19:09:40 GMT
creator
dirkjan
modified
Sat, 23 Jun 2012 19:09:40 GMT
modifier
dirkjan
tags
Model
creator
dirkjan