Audit Checklist for Medical Device Facility
Comprehensive Medical Device Facility Audit
Audited by: [Your Name]
Date of Audit: [Date]
Audit Objective: The objective of this audit is to systematically evaluate the regulatory compliance, product safety measures, quality management processes, and production controls within the medical device facility to ensure adherence to industry standards, mitigate risks, and enhance overall product quality and safety.
Regulatory Compliance
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Verify that all medical devices within the facility possess appropriate regulatory approvals or clearances, ensuring compliance with relevant national and international standards.
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Check for strict adherence to Quality System Regulation (QSR) requirements and compliance with ISO 13485 standards for medical device quality management systems.
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Confirm the proper implementation of risk management procedures in accordance with ISO 14971.
Product Safety
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Review adverse event and product problem reports to identify and address emerging trends promptly.
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Ensure the effective management of product recalls, including timely and accurate mandatory reports to regulatory agencies.
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Inspect packaging and labeling processes to identify and mitigate potential risks to product safety.
Quality Management
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Assess the effectiveness of the quality policy and the alignment of quality objectives with organizational goals.
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Review non-conformity and corrective action reports to identify areas for continuous improvement.
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Verify the integrity of device master records and design history files to ensure accurate documentation and traceability.
Production and Process Control
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Check the calibration and preventive maintenance of production equipment to maintain consistent manufacturing processes.
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Review the validation of manufacturing processes following any changes to ensure continued product quality and safety.
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Assess the control measures in place for nonconforming products, evaluating their impact on overall product quality.
