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.

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.

Supplied as editable Microsoft Word documents with related forms as a digital download.