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ISO 13485 (Clause 6.3) - Maintenance Schedule and Log Template

ISO 13485 (Clause 6.3) - Maintenance Schedule and Log Template

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Template Overview

Maintain the reliability and performance of your critical infrastructure with our ISO 13485:2016 Clause 6.3 Maintenance Schedule & Log Template. Proper maintenance of equipment and facilities is essential for ensuring that your Quality Management System (QMS) operates effectively and in compliance with ISO 13485:2016. This ready-to-use template helps you manage and document the regular maintenance of key assets, ensuring that all necessary equipment is calibrated, inspected, and functioning properly to support product quality and safety.

Key Features

✔ Pre-Formatted Maintenance Schedule & Log Template – Covers all key ISO 13485:2016 Clause 6.3 requirements.
✔ Scheduled Maintenance Tracking – Plan and monitor maintenance activities, including frequency, tasks, and responsible personnel.
✔ Maintenance Task Documentation – Record details of maintenance activities, including inspections, repairs, and part replacements.
✔ Calibration & Validation – Ensure equipment calibration and validation are tracked to maintain compliance.
✔ Risk-Based Maintenance – Prioritize critical equipment and infrastructure based on operational risks.
✔ Audit-Ready Documentation – Maintain detailed logs for audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various business needs and equipment types.

Why choose a QMS Template?

This maintenance schedule and log template is ideal for quality managers, facilities teams, and compliance officers, ensuring efficient equipment management and regulatory compliance.

Download the ISO 13485:2016 Maintenance Schedule & Log Template today and streamline your maintenance management processes!

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  • About Patient Guard

    QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.

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