13485 P-760 Control of Monitoring and Measuring Equipment

ISO 13485:2016 Procedure - Control of Monitoring and Measuring Equipment - describe the requirements and process for control of measuring and monitoring equipment. Our procedure references a Calibration list that includes the required information. We detail the responsibilities and process for scheduling, conducting and recording calibration for the equipment. We also address action to be taken when equipment is found to be out of calibration.