Quality System Requirements.
The QS regulation requires that planned and periodic audits of the quality system shall be performed to verify compliance with the quality system requirements. The audits are to be performed in accordance with written procedures by appropriately trained individuals who do not have direct responsibility for the matters being audited. Audit results shall be documented in written audit reports, which shall be reviewed by management personnel, who have responsibility for the matters audited, and by other involved parties. Follow-up corrective action, including documented re-audit of deficient matters, shall be taken when indicated. Upon request of a designated FDA employee, an employee in management with executive responsibility shall certify in writing that the audits have been performed and documented, the dates on which they were performed, all or any required corrective action has been completed satisfactorily and the company QS system is compliant with the regulatory requirements.
When an auditor discovers any none compliance concerns; they are duty bound to dig deeper and deeper to enable them to accurately define the extent of these none compliances.