ISO 13485 Audit Checklist

An ISO 13485 audit checklist is an essential tool for organizations in the medical device industry to ensure compliance with regulatory standards and maintain the highest quality management system. This checklist typically includes a comprehensive review of documentation, such as quality manuals, procedures, and records; verification of personnel training and qualifications; assessment of risk management processes; and examination of production and process controls. Additionally, it covers supplier and subcontractor evaluations, internal audit results, corrective and preventive action records, and post-market surveillance activities. By meticulously following an ISO 13485 audit checklist, organizations can identify gaps, implement corrective actions, and achieve continuous improvement, ensuring that their products meet stringent regulatory requirements and maintain patient safety and satisfaction.