Requirements for Servicing Activities Procedure - ISO 13485

Maintain high-quality servicing activities and ensure regulatory compliance with our ISO 13485:2016 Clause 7.5 Requirements for Servicing Activities Procedure Template. Servicing medical devices correctly is critical to ensuring safety, functionality, and ongoing compliance with regulatory requirements. This structured procedure template provides a clear and systematic approach for managing, documenting, and verifying servicing activities, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Servicing Activities Procedure – Covers key ISO 13485:2016 Clause 7.5 requirements.

✔ Service Request & Documentation Process – Define how servicing activities are logged and tracked.

✔ Inspection & Verification of Serviced Devices – Ensure repaired or maintained devices meet original specifications.

✔ Preventive & Corrective Maintenance Guidelines – Establish a structured process for routine and emergency servicing.

✔ Risk-Based Approach & Compliance with ISO 14971 – Identify and mitigate potential risks during servicing.

✔ Record-Keeping & Audit-Ready Documentation – Maintain service logs for regulatory inspections and traceability.

✔ Customer Communication & Reporting Requirements – Ensure effective follow-up and documentation of service activities.

✔ Editable Digital Format – Fully customizable for various medical device servicing requirements.

This ready-to-use servicing procedure template is ideal for quality managers, service technicians, and regulatory professionals, ensuring a structured, compliant, and effective servicing process.

Download the ISO 13485:2016 Requirements for Servicing Activities Procedure Template today and enhance your product reliability and compliance!