Preventive Maintenance Procedure

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

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Supplied as two editable Microsoft Word documents (the procedure and one form) in a digital download.

Equipment maintenance planning and service records

It covers routine maintenance, repair, inspection and adjustment of manufacturing, testing and ancillary equipment. The procedure includes a system for entering, tracking and updating maintenance methods and requirements, plus a form for recording work in the preventive maintenance file.

Equipment receives an identification number and a preventive-maintenance schedule. Work orders record the work performed, and a rationale is retained in the equipment file when a planned activity or interval changes. The procedure also covers equipment transfer, temporary storage, return to service and changes to the maintenance program. These records help the team see what equipment was available and in what maintenance state when a production or test activity occurred.

Standards and frameworks addressed: ISO 13485:2016; FDA QMSR.

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.

For control of equipment measurement accuracy, see the separately sold Calibration System Procedure. Maintenance and calibration address different equipment needs.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Equipment IQ, Calibration and Preventive Maintenance for workflow guidance, a checklist and common mistakes.