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.