QMSR on the Shop Floor: Turning 21 CFR 820 into Daily Records
Since 2 February 2026, 21 CFR 820 incorporates ISO 13485. On the floor that means current revisions, trained people and records made at the step.
In short
- QMSR in force since 2 February 2026.
- Record UDI where it applies.
- Handle nonconformances where found.
The Medical Device Production Guide
Built to revision. Inspected. On record.
32 pages · 4 worksheets · 15 primary sources
- What the QMSR changed in February 2026
- Supplier to finished build
- Inspect, review, correct
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We use your details to handle this request. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
Since 2 February 2026, 21 CFR 820 incorporates ISO 13485:2016 by reference and adds a few US requirements, including extra content for complaint, servicing and UDI records (820.35). On the floor, the change is mostly in vocabulary and records. Sources checked 3 Oct 2026.
What changed
Old term, QMSR term
| Old QSR | ISO 13485 / QMSR |
|---|---|
| Device master record | Medical device file |
| Device history record | Records of production and release |
| Quality system | Quality management system |
- Device master record
- ISO 13485 / QMSR
- Medical device file
- Device history record
- ISO 13485 / QMSR
- Records of production and release
- Quality system
- ISO 13485 / QMSR
- Quality management system
Controlled production
ISO 13485 clause 7.5 expects production under controlled conditions: documented procedures, qualified infrastructure, monitoring and measuring, and defined release. On the floor, that means the current revision at the step, trained operators and calibrated equipment.
Acceptance and records
Record inspection and test results with who did them and what equipment was used. The production record for each device or lot shows quantities made and released and links to its acceptance results.
Traceability and UDI
The extent of traceability is set by the manufacturer, with implantable devices held to more. 820.35 adds that records include the UDI where one applies.
More on traceability and UDI
Keep component lots and the device identifier linked so a field issue can be traced.
Nonconforming product
Identify, segregate and evaluate nonconforming product at the point it is found, and record the decision and who made it. Feed trends into corrective action rather than closing each one alone.
Check at one station
Questions
When did the QMSR take effect?
2 February 2026.
Does the QMSR replace ISO 13485?
No. It incorporates ISO 13485:2016 by reference and adds US requirements in 21 CFR 820.
What does 820.35 add?
Extra content for records of complaints, servicing and the UDI, among others, on top of ISO 13485 clause 4.2.5.
Does V5 decide device release?
No. V5 records production steps, inspections and nonconformances. Your quality personnel make release decisions.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
