External Quality Audit

DAMAS and FDA require periodic audits whether internally or externally conducted.

A quality system audit is an independant unbiased fact-finding exercise that evaluates an existing quality program to determine its conformance to company policies, contract commitments, and regulatory requirements. It is strongly recommended that two to four weeks prior to a third party audit that this external audit be performed. The external audit results and corrective actions would typically be taken into consideration by the third party auditor in their decision for certification.

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