Control of Measuring and Monitoring Equipment Procedure - ISO 13485

Maintain precision, reliability, and regulatory compliance in your medical device manufacturing process with our ISO 13485:2016 Clause 7.6 Control of Measuring & Monitoring Equipment Procedure Template. Accurate measurement and monitoring equipment are essential for ensuring product quality, safety, and compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, and ISO 17025. This structured procedure template provides a systematic approach for managing calibration, verification, and maintenance of measuring and monitoring devices.

✔ Pre-Formatted Control of Measuring & Monitoring Equipment Procedure – Covers key ISO 13485:2016 Clause 7.6 requirements.

✔ Equipment Identification & Calibration Schedule – Track calibration dates, due dates, and equipment status.

✔ Verification & Validation Procedures – Define methods for ensuring equipment remains within tolerance levels.

✔ Non-Conformance & Out-of-Tolerance Handling – Establish corrective actions for failed calibration tests.

✔ Traceability & Record-Keeping Requirements – Maintain audit-ready calibration logs and verification reports.

✔ Regulatory Compliance with ISO 17025 & Risk-Based Approach – Ensure equipment meets industry standards.

✔ Approval & Sign-Off Workflow – Assign responsibilities for equipment calibration and monitoring.

✔ Editable Digital Format – Fully customizable for different business needs and device types.

This ready-to-use procedure template is ideal for quality managers, calibration teams, and regulatory professionals, ensuring a structured, compliant, and effective equipment control system.

Download the ISO 13485:2016 Control of Measuring & Monitoring Equipment Procedure Template today and improve your calibration compliance and product quality!