Maps to
QMSR / ISO 13485: §820.72
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.
What changed
Part 820 section 820.72 was one of the more prescriptive sections of the old regulation, with detailed requirements for calibration procedures, calibration standards traceable to national standards, calibration intervals, and evaluation of impact when equipment is found out of tolerance. ISO 13485 section 7.6 covers substantially the same ground but adds two important requirements that many Part 820-era calibration programs miss.
First, ISO 13485 section 7.6 explicitly requires that 'where necessary to ensure valid results, measuring equipment shall be adjusted or re-adjusted as necessary' and that 'the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.' Part 820 also required out-of-tolerance evaluation, so this is not entirely new, but ISO 13485 makes the documentation of this assessment more explicit. Many Part 820 companies document the out-of-tolerance finding and the recalibration but do not document the impact assessment on products measured since the last valid calibration.
Second, and more significantly for modern devices, ISO 13485 section 7.6 requires that 'computer software to be used in monitoring and measurement applications shall be validated.' This means any software used in testing, inspection, or quality measurement — from automated test equipment software to Excel spreadsheets used for statistical analysis to database queries used for trending — must be validated before use and revalidated after significant changes. This extends calibration thinking beyond physical instruments to software tools, which is a gap for many companies.
The QMSR's incorporation of ISO 13485 7.6 replaces 820.72 directly, with the calibration fundamentals largely unchanged. Companies with mature calibration programs covering physical instruments will find minimal transition work. The main gap areas are software validation for measurement applications and documentation of out-of-tolerance impact assessments.
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.
Common gaps
Measurement Software Not Validated
moderateSoftware used for monitoring and measurement (automated test systems, data acquisition software, Excel calculation spreadsheets, statistical analysis tools, database queries for quality trending) has not been validated. The calibration program covers physical instruments but excludes software tools from its scope.
Out-of-Tolerance Impact Assessment Not Documented
moderateWhen instruments are found out of tolerance during calibration, they are recalibrated or replaced, but there is no documented assessment of the impact on measurements taken since the last valid calibration. Products released based on potentially invalid measurements are not evaluated for conformity.
Unvalidated calibration software
moderateSoftware used to record calibration data or control an automated test fixture was never validated. ISO 13485 §7.6 requires software validation.
Calibration Status Not Visible on Equipment
minorCalibrated equipment does not bear visible calibration status identification (calibration label with due date, color-coded status sticker, or equivalent). Users cannot readily determine whether an instrument is within its calibration period before use.
Calibration Intervals Not Justified
minorCalibration intervals are set at arbitrary periods (typically annual) without technical justification based on instrument stability, measurement criticality, usage frequency, or manufacturer recommendations. Intervals have never been reviewed or adjusted based on calibration history data.
Evidence signals
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FILE_EXISTS
(Calibration|Calibrated|Metrology|Instrument.*Register|Gauge.*Control|Measurement.*Equipment)
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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.