Medical Device Audit Checklist
An audit checklist allows quality managers to document evidence of compliance based on processes, standard requirements, and process characteristics.
Medical device manufacturers adhere to ISO 13485 and are mandated to perform internal audits to ensure the safety and effectiveness objectives are established and maintained. These audits focus on improving processes and ensuring that manufacturing, development, and other related control meet current good manufacturing processes (GMP), and the requirements of ISO 13485. These audits help determine the current status and health of the QMS and processes. The standard emphasizes that manufacturers must use a risk-based approach to all quality processes, which reiterates the value of an ISO 13485 checklist