Dirkjan: Created page with "There are several major differences: * FDA regulations are the federal law! * ISO 9000 consist of volontary quality standards, which manufacturers comply and docu..."

2020-08-25T07:19:28Z

Created page with "There are several major differences: * FDA regulations are the federal law! * ISO 9000 consist of volontary quality standards, which manufacturers comply and docu..."

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There are several major differences:
* FDA regulations are the federal law!
* [[ISO 9000|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]]
* [[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|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|ISO 9000]] expects finance to be fully controlled.
* FDA has little oversight over marketing & sales.
FDA compliance will always overshadow voluntary [[ISO 9001|ISO 9001]] certification expectations.
[[Category:fda]]

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Differences ISO 9000 and FDA quality system - Revision history

Dirkjan: Created page with "There are several major differences: * FDA regulations are the federal law! * ISO 9000 consist of volontary quality standards, which manufacturers comply and docu..."