Tuesday, July 7, 2009

Audit objectives - Medical device manufacturers

Audits are designed to:
a) determine conformance of a manufacturer's quality system with regulatory requirements;
b) determine the effectiveness of the implemented quality system for the purposes of meeting specified quality objectives which include all of the appropriate medical device regulatory requirements;
c) audit the quality system as the manufacturer has defined it (c.f.,note 12 below);
d) in the case of audits subsequent to the initial audit, ensure that corrective actions agreed as a result of the previous audit have been completed effectively.

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