ISO 13485 (Clause 7.6) - Master Calibration List Template

Maintain full control over your calibration records with our ISO 13485:2016 Clause 7.6 Master Calibration List Template. Proper calibration management is essential to ensuring that measuring and monitoring equipment remains accurate, reliable, and compliant with ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, and ISO 17025. This structured template helps organizations efficiently track, schedule, and document calibration activities, ensuring all equipment is audit-ready and meets regulatory requirements.

✔ Pre-Formatted Master Calibration List – Covers key ISO 13485:2016 Clause 7.6 requirements.

✔ Equipment Identification & Details – Track equipment ID, location, model, and serial number.

✔ Calibration Schedule & Due Dates – Log last calibration, next due date, and assigned personnel.

✔ Calibration Status & Results Tracking – Record pass/fail status and corrective actions for out-of-spec equipment.

✔ Traceability & Compliance Documentation – Maintain an audit-ready record for regulatory inspections.

✔ Approval & Sign-Off Section – Ensure proper review and accountability.

✔ Editable Digital Format – Fully customizable for different medical device classifications and equipment types.

This ready-to-use master list is ideal for quality managers, calibration teams, and regulatory professionals, ensuring a structured, organized, and compliant calibration management process.

Download the ISO 13485:2016 Master Calibration List Template today and ensure full control over your equipment accuracy and compliance!