ISO 13485 (Clause 7.5) - Servicing Report Form

Ensure proper documentation of all medical device servicing activities with our ISO 13485:2016 Clause 7.5 Medical Device Servicing Report Form Template. This essential template provides a clear and structured format for documenting all aspects of device servicing, including maintenance, repairs, calibration, and performance verification. By using this form, your organization can guarantee that servicing activities are properly tracked, ensuring ongoing compliance with ISO 13485:2016 and regulatory requirements for medical device safety and reliability.

✔ Pre-Formatted Servicing Report Form – Fully aligned with ISO 13485:2016 Clause 7.5 requirements for documenting servicing activities.
✔ Servicing Activity Details – Record specific tasks completed, service dates, and personnel involved in each servicing session.
✔ Device Performance & Condition – Capture device performance before and after servicing, including any issues identified and actions taken.
✔ Calibration & Maintenance Records – Document all calibration checks, maintenance tasks, and test results for compliance.
✔ Risk Assessment & Corrective Actions – Track any risks identified during servicing and corrective actions taken.
✔ Audit-Ready Documentation – Keep structured and traceable records for internal audits and regulatory reviews.
✔ Editable Digital Format – Fully customizable for various medical devices and servicing requirements.

This servicing report form template is ideal for service teams, quality managers, and compliance officers, ensuring a systematic, compliant approach to documenting servicing activities.

Download the ISO 13485:2016 Medical Device Servicing Report Form Template today and enhance your servicing documentation and regulatory compliance!