ISO 13485 (Clause 7.6) - Calibration Protocol Template

Maintain precise and reliable measurement equipment with our ISO 13485:2016 Clause 7.6 Calibration Protocol Template. Calibration is essential to ensuring that measuring and monitoring devices remain accurate, consistent, and compliant with regulatory requirements, directly impacting product safety and quality. This structured protocol provides a clear, standardized approach to equipment calibration, verification, and record-keeping, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, and ISO 17025.

✔ Pre-Formatted Calibration Protocol – Covers key ISO 13485:2016 Clause 7.6 requirements.
✔ Calibration Procedures & Test Methods – Define step-by-step calibration processes for each equipment type.
✔ Equipment Identification & Tracking – Log serial numbers, calibration intervals, and last service dates.
✔ Measurement Accuracy & Acceptance Criteria – Ensure compliance with defined tolerances and specifications.
✔ Pass/Fail Criteria & Non-Conformance Handling – Document deviations and corrective actions taken.
✔ Traceability & Compliance Records – Maintain audit-ready documentation for regulatory inspections.
✔ Approval & Sign-Off Section – Assign responsibilities for calibration verification.
✔ Editable Digital Format – Fully customizable for various medical device manufacturing environments.

This ready-to-use calibration protocol is ideal for quality managers, calibration technicians, and compliance officers, ensuring a structured, reliable, and fully compliant calibration process.

Download the ISO 13485:2016 Calibration Protocol Template today and ensure measurement accuracy and regulatory compliance!