21 CFR 820.72 - Inspection, Measuring and Test Equipment (QMSR)

What it says

Inspection, measuring and test equipment used to ensure device conformance to specified requirements must be suitable for its intended purpose, capable of producing valid results, and routinely calibrated, inspected, checked and maintained according to established procedures, with calibration traceable to national or international standards.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision closely parallels 21 CFR 211.68 for drug equipment calibration, establishing the same fundamental requirement, ongoing, documented, traceable calibration, adapted specifically for the device manufacturing and testing context.
• Traceability to national or international standards is explicit here, meaning calibration must connect back through a documented chain to recognised metrology standards, not simply be internally consistent within a facility's own reference equipment.
• Equipment found out of calibration during a routine check requires assessment of potential impact on any measurements or test results generated since the equipment's last known-good calibration, not just recalibration going forward.

What FDA inspectors look for

• Whether calibration records demonstrate genuine traceability to recognised national or international standards.
• Whether equipment found out of tolerance during a calibration check triggers a documented assessment of potential impact on prior test results generated using that equipment.
• Whether calibration intervals are followed as scheduled, with any lapses investigated rather than simply noted and corrected going forward.

Related regulations