Preventive Maintenance Procedure

The ISO 13485:2016 Preventive Maintenance Procedure governs all manufacturing, testing, and ancillary equipment requiring routine maintenance, repair, inspection, or adjustment.

• ISO 13485:2016 aligned

• FDA QMSR aligned

• Includes Related Forms

• MS Word Format

• Instant Download Digital Content

The Preventive Maintenance Procedure governs the process of conducting preventive maintenance for all manufacturing and test equipment.

Preventive Maintenance Procedure - Overview

The Preventive Maintenance Procedure governs all manufacturing, testing, and ancillary equipment requiring routine maintenance, repair, inspection, or adjustment. The Preventive Maintenance Procedure includes a system of entering, tracking and updating maintenance methods and requirements and includes a data form for capturing critical preventative maintenance information in the PM file.

Preventive Maintenance Procedure - Compliance

The Preventive Maintenance Procedure is FDA QMSR and ISO 13485:2016 aligned.

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Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.