Maps to
FDA QMSR (Part 820): §820.72
ISO 13485: ISO 13485 §7.6
Requirement text
Monitoring and measuring equipment needed to demonstrate conformity must be determined. Equipment must be calibrated at specified intervals, identified with calibration status, protected from damage, and calibration records maintained. Software used for monitoring and measurement must be validated before use.
Atomic constraints
- •A calibration program must be documented identifying all monitoring and measuring equipment requiring calibration.
- •Calibration intervals and acceptance criteria must be defined for each instrument.
- •Equipment must be identified with calibration status (e.g., calibration due date label).
- •Calibration records must be maintained for each piece of calibrated equipment.
- •Out-of-tolerance findings must be evaluated for impact on previous measurements.
- •Measurement software must be validated before use and re-validated after changes.
Evidence signals
- •
FILE_EXISTS
(Calibration|Calibrated|Metrology|Instrument.*Register|Gauge.*Control|Measurement.*Equipment)
- •
CONTENT_MATCH
Does this document describe calibration procedures, calibration schedules, calibration records, or out-of-tolerance investigation requirements for measuring equipment?
Audit defense
Measurement and monitoring equipment for [your product] manufacturing and testing is controlled per [your document ID]. Our calibration program registers all instruments with defined intervals, maintains calibration records with NIST-traceable standards, labels equipment with calibration status, and includes out-of-tolerance impact assessment procedures per ISO 13485 7.6 and QMSR 820.72.