Calibration System Procedure | ISO 13485 | FDA QMSR

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The ISO 13485:2016 Calibration System Procedure establishes the process and methodology used to ensure medical device manufacturing and test equipment is calibrated to defined specifications.
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Calibration System Procedure

The Calibration System Procedure establishes the process and methodology used to ensure medical device manufacturing and test equipment is calibrated to defined specifications.

Calibration System Procedure - Overview

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.

Standards addressed in the revised procedure

The revised procedure includes ISO 10012:2026 measurement-management requirements and references ISO/IEC 17025:2017 where relevant to calibration services.

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.