For manufacturers of medical devices, the QSR demands that procedures are established (in writing) for audits. The audits must be conducted to assure that the quality system is effective in compliance with the QSR.
The QSR demands an unbiased auditor for internal audits, which is not involved in the audited matter. This allows to have external auditors used for internal audits.
Any conducted internal audit must be summarized in an audit report. In case of deviations, appropriate actions should be defined potentially in corrective and preventive (CAPA) measures. CAPA measures shoul dbe reaudited for implementation and effectiveness.
Management, as being resposible, must be informed on audits and potential actions derived thereof. It is recommended to implement an audit database to log each audit including derived tasks, task owner, due date, reaudit measures and effectiveness checks.