FDA COMPLIANCE SOLUTIONS FROM QRS SINCE 1994
Assess the ability of the Quality System to comply with the requirements of the Center for Devices and Radiological Health/Food and Drug Administration (CDRH/FDA) Quality System Regulation and the requirements of the applicable ISO 13485 Quality System standard through:
- Internal Audits scheduled and performed by device manufacturer personnel who do not have direct responsibility for the matters being audited. QRS will also perform internal audits in compliance with the manufacture's procedure.
- Annual Audit performed by the Associates of Quality & Regulatory Services, Inc. (QRS) is conducted from the viewpoint of an FDA investigator or ISO auditor. The audit contributes to the improvement of the Quality System and has no negative impact on business, as might occur from an FDA inspection.
- Manufacturer Personnel accompanying QRS auditors are educated in auditing, findings and corrective actions.
Audit observations and recommendations are discussed with Management with Executive Responsibility.
Complete written report cites applicable QSR requirement and recommends corrective action for each observation.
- Supplier Audits performed by the Associates of Quality & Regulatory Services, Inc. (QRS) provide feedback on the supplier's ability to meet the manufacturer's specifications.
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