ORA Laboratory Policies
Food and Drug Administration
Internal audits are conducted according to a schedule included in the laboratory’s audit procedure. Internal audits are conducted of activities to verify that operations continue to conform to the requirements of the management system and ISO/IEC 17025. The internal audit program addresses all elements of the management system, including testing activities. The laboratory’s Quality Management System Manager is responsible for the coordination of internal audits as listed by the schedule and requested by management.
Trained and qualified personnel are responsible for conducting internal audits. Audits are performed by personnel other than those who performed the work being audited.
4.14.2 Corrective Action
When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory’s test results, corrective action is undertaken according to the laboratory’s corrective action procedure.
The customer is notified if investigations show that non-conformances related to audit results also have affected work performed for the customer. This notification is documented.
4.14.3 Audit Records
The area of activity audited, the audit findings, and corrective action that arise from them are recorded according the laboratory’s audit procedure
4.14.4 Follow-up Audit Activities
Follow-up audit activities are conducted to verify and record the implementation and effectiveness of the corrective action taken. This follow-up is included as part of the management review process.
- Each ORA laboratory has its own audit procedure. A template is provided. See Volume II, Section 1, ORA-LAB.4.14 Audits.
- Volume II, Section 1, ORA-LAB.4.11 Corrective Action.
- ORA-QMS.004, Audits.
- ORA-QMS.07, Corrective Action Procedure.