13485 P-852 Corrective Action

ISO 13485:2016 Procedure - Corrective Action - describe the process for eliminating the cause of nonconformance's through the use of a corrective action system. Include the process for initiating a corrective action request (CAR). (Any employee should be able to initiate a CAR.) Follow the process for tracking, investigating, implementing corrective action, following up and closing corrective actions. We also include a step of reporting to Management Review.