Calibration System Procedure | ISO 13485 | FDA QMSR
Establish a traceable calibration system for medical device manufacturing and test equipment with this editable procedure and related forms. It covers entering equipment into the system, defining calibration requirements and frequency, recording status and results, and handling recalibration or out-of-calibration conditions.
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Supplied as two editable Microsoft Word documents (the procedure and one form) in a digital download.
Calibration frequency, status and equipment records
The Calibration System Procedure defines the process of entering equipment into the calibration system and establishing a calibration procedure for all calibrated equipment used in the manufacture or testing of medical devices. The Calibration System Procedure defines the process of establishing the calibration frequency and the requirements for re-calibration. The Calibration System Procedure includes detailed form used to log equipment into the calibration system and for documenting calibration information in files established for all calibrated equipment.
Calibration identification and frequency
Protection, recalibration and out-of-calibration handling
Equipment records and calibration status
The revised procedure includes ISO 10012:2026 measurement-management requirements and references ISO/IEC 17025:2017 where relevant to calibration services.
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 scheduled equipment servicing and maintenance records, see the separately sold Preventive Maintenance Procedure. Coordinate servicing with calibration where relevant.
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.
