Differences ISO 9000 and FDA quality system

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.