The Quality Management System Regulation amends 21 CFR Part 820, replacing the former Quality System Regulation requirements by incorporating ISO 13485:2016 by reference — with FDA-specific additions. At the same time, FDA retired QSIT and began inspecting under a new risk-based compliance program. Records that were previously off-limits during inspection — internal audits, supplier audits, management review — are now reviewable. This page is the working summary for quality teams running the transition.
Three structural shifts took effect on the same day — February 2, 2026.
The QMSR incorporates ISO 13485:2016 by reference, replacing most of the former Part 820 requirements. FDA keeps additions ISO 13485 does not cover — control of records (820.35) and labeling and packaging controls (820.45).
FDA now inspects under compliance program CP 7382.850, Inspection of Medical Device Manufacturers — a risk-based approach organized around six QMS areas plus other applicable FDA requirements, with no fixed sampling tables.
FDA eliminated its longstanding policy of not requesting internal audit, supplier audit, and management review records. Under the new program, investigators can review them — they must be complete, current, and retrievable.
Scope the transition accurately before rewriting anything.
What CP 7382.850 changes about how an FDA investigator works through your quality system.
The fixed QSIT sampling tables are gone. Investigators select records based on identified product risks and professional judgment — so any record in scope needs to be defensible, not just the sampled ones.
The program organizes QMSR requirements into six quality management system areas plus other applicable FDA requirements, each broken into elements an investigator evaluates.
With internal audit and management review records now reviewable, the question is no longer whether those records exist — it is whether you can produce them, current and complete, while the investigator waits.
Where QMSR transition effort actually concentrates for teams that already ran a Part 820 QMS.
Map each legacy procedure to its ISO 13485:2016 clause and the FDA-specific additions (820.35, 820.45). Treat the gap list as your transition backlog.
Terminology, references, and procedure updates ripple across the document set. Run the wave as controlled changes so the transition itself leaves an inspectable trail.
Cadence, inputs, minutes, and resulting actions per ISO 13485 §5.6 — now producible on request, not just internally filed. See how Complere governs management review.
Audit against ISO 13485 clauses plus the FDA additions — and remember the findings, evidence, and follow-up are now within an investigator's reach.
Each updated SOP needs assigned training, completion evidence, and competency sign-off tied to the new revision before the old one retires.
Time how long it takes to produce a management review record, an internal audit file, and a CAPA chain end-to-end. That is the inspection experience now.
The QMSR transition is mostly document, change, audit, and training work — the workflows an eQMS exists to govern.
Run the transition as impact-assessed controlled changes — every terminology update, procedure revision, and process change carries its own approval chain and evidence.
Explore change controlAbsorb the document-update wave with one effective version per procedure, Part 11-aligned approvals, and automatic retirement of superseded revisions.
Explore document controlPlan the gap assessment and the re-pointed internal audit program in one flow — findings, evidence, and follow-up stay retrievable now that FDA can ask for them.
Explore audit managementTie training assignments to each revised procedure and hold completion evidence against the new revision — the loop inspectors trace first after a documentation change.
Explore training & competencyThe QMSR questions quality and regulatory teams ask most.
February 2, 2026. The final rule was published in the Federal Register on February 2, 2024, giving manufacturers a two-year transition. As of the effective date, FDA inspects against the QMSR — there is no grace period.
No. The QMSR incorporates ISO 13485:2016 by reference, but FDA does not require or recognize ISO 13485 certification as evidence of compliance. FDA continues to inspect manufacturers directly, and the QMSR adds FDA-specific requirements beyond ISO 13485 — including control of records under 21 CFR 820.35 and labeling and packaging controls under 820.45.
No. Part 11 requirements for electronic records and electronic signatures are unchanged. Records required under the QMSR that are kept electronically remain subject to Part 11 controls — audit trails, access controls, and signature manifestation. See Electronic Records & Signatures.
FDA retired the Quality System Inspection Technique on February 2, 2026 and replaced it with the inspection process in compliance program CP 7382.850, Inspection of Medical Device Manufacturers. The new approach is risk-based, organized around six quality management system areas plus other applicable FDA requirements, with no fixed sampling tables — investigators select records based on product risk and professional judgment.
Yes. Under QSIT, FDA's longstanding policy was not to request records of internal audits, supplier audits, or management reviews. The new compliance program eliminates that exemption — these records can now be reviewed during inspection, so they must be complete, current, and retrievable like any other quality record.
Most manufacturers with a mature Part 820 QMS need a structured gap assessment, not a rewrite. The work concentrates in terminology and document updates, management review cadence and records, risk-based thinking per ISO 13485, supplier controls, and the FDA-specific additions (820.35 records, 820.45 labeling and packaging). Run the transition itself under change control so the update trail is inspectable.
Going deeper? See the QMSR glossary definition, read QMSR vs ISO 13485 — what actually changes for the clause-level view, see the Best eQMS for FDA QMSR buyer guide if you are evaluating platforms, or start from the medical devices industry page.
Gap assessment, document updates, training rollout, and management review records — in one system, with the audit trail the new inspection program expects.
