13485 P-826 Monitoring & Measurement of Product & Realization

ISO 13485:2016 Procedure - Monitoring & Measurement of Product & Realization - describe the monitoring and measuring of product and the monitoring and measuring of product realization processes. We refer to the Planning of Product Realization Procedure and Design and Development procedure, because that is where we have built in the determination of measuring and monitoring requirements. We then describe a process for collecting and recording the information and reporting it to management in a form that can be analyzed during Management Review.