A calibration record has to name its own standard

The same duty, moved the same way as the rest of Part 820

820.72, Inspection, measuring, and test equipment, is one of the Subpart G provisions QMSR removed and marked reserved, folding its substance into ISO 13485:2016 the same way Clause 7.3.4 absorbed 820.30(e) and the rest of the design-control paragraphs traced in the file that replaced the DMR. Clause 7.6, Control of monitoring and measuring equipment, now carries the job: equipment used to provide evidence of conformity has to be calibrated or verified, or both, at specified intervals or before use, adjusted as necessary, and its calibration status has to be identifiable. A calibration procedure still citing 820.72 by number is citing a provision that no longer has independent text to cite.

A hierarchy for when no standard reaches that far

Both the old rule and the clause that replaced it solve the same problem the same way. 820.72(b) required calibration standards traceable to national or international standards, and where no such standard was practical or available, an independent reproducible standard, with an in-house standard as the fallback of last resort when no applicable standard existed at all. Clause 7.6 keeps that same logic: calibration or verification has to run against measurement standards traceable to international or national standards, and where no such standard exists, the basis used for calibration or verification has to be recorded. Neither version treats the absence of a national standard as an excuse not to calibrate — it just changes what the record has to show. A calibration log that names only a due date and a pass-or-fail result, with no note of what the reading was actually checked against, hasn't answered the question either version of the rule is actually asking.

An out-of-tolerance finding looks backward, not just forward

820.72 didn't just require remedial action when a piece of equipment turned up outside its accuracy and precision limits — it required that remedial action to reestablish the limits and to evaluate whether the equipment's drift had any adverse effect on the device's quality while it was out of tolerance. That second half is easy to lose: recalibrating a scale that's drifted doesn't answer the question of what happened to every unit weighed on it since the last good reading. A calibration record that stops at “recalibrated, back in spec” without a documented look backward at what that equipment measured while it was out hasn't closed the finding — it's closed the easier half of it.

Status has to be visible on the equipment, not just in the log

Clause 7.6 requires equipment to be identified in a way that lets its calibration status be determined, safeguarded from adjustments that would invalidate a calibration result, and protected from damage during handling and storage. That's a requirement about the equipment itself, independent of whatever the calibration file says elsewhere — a technician picking up a gauge on the floor has to be able to tell its status without first tracking down the record. A calibration program that keeps immaculate records but leaves the equipment itself unlabeled has satisfied the paperwork half of the clause and left the floor half unaddressed.

The records still answer to 4.2.5, not a separate rule

Calibration and verification results still have to be maintained as records under Clause 4.2.5, the same general records requirement that governs every other document a quality system produces — the same clause a document-control SOP has to satisfy for the rest of the file. Calibration isn't a separate universe with its own retention and control rules; it's one more record that has to be legible, retrievable, and dated the way every other quality record does, which is exactly what lets an auditor trace a suspect measurement on a device back to the specific calibration event that produced it.

Where this meets the rest of the file

Calibrated equipment is the evidence underneath every other verification claim in the file — a validated process is only as trustworthy as the instruments that measured its own qualification runs. A calibration-log template built around the traceability hierarchy, the equipment-identification requirement, and the 4.2.5 records duty it still answers to is previewed in the launch catalog. If your program tracks calibration differently, the shelf takes that correction directly.