The QMSR Training Compliance Checklist

Free compliance checklist covering every training documentation requirement FDA investigators audit under QMSR / ISO 13485

The QMSR Is Now in Effect — Here’s How to Prove Your Training Records Are Ready for FDA Inspection

The FDA investigator sits across from your Quality Manager and says: “I’d like to see training records for every employee who touched this CAPA.”

What happens next determines whether you walk away with observations — or a warning letter.

Training record deficiencies appear in the top five most-cited FDA 483 observations for medical device companies year after year. And with the February 2026 QMSR deadline forcing every regulated manufacturer to re-evaluate how their QMS documents human competency, the inspection stakes are higher than they’ve been in a decade.

The problem isn’t that quality teams don’t train their people. It’s that they can’t prove it in a way that satisfies FDA investigators — because their records are missing the specifics: which document version was trained on, whether the training was corrective or preventive in nature, whether effectiveness was verified before the CAPA was closed, whether the design reviewer was actually qualified to sign off on a DHF review.

This checklist maps every training documentation requirement your FDA investigator is authorized to ask about — so you know exactly what to build, what to fix, and what you can confidently produce on demand.

What’s Inside — The QMSR Training Compliance Checklist:

Section 1: Personnel Competency Documentation Requirements Role-to-training matrix requirements, individual training record (ITR) structure, 21 CFR Part 11 electronic record compliance, effectiveness verification evidence, and what “trained to a document version” actually means in an audit context.

Section 2: CAPA Training Records — Corrective vs. Preventive Separation The QMSR separates corrective action training (ISO 13485 §8.5.2) from preventive action training (§8.5.3) — and FDA investigators now verify that your records reflect this distinction. This section covers how to structure both, what cross-references must exist in your CAPA records, and how to prove training was completed before CAPA closure.

Section 3: Management Review and Supplier Audit Training Trails Executive QMSR transition training documentation, supplier auditor qualification records, audit independence requirements, and what qualifications your supplier auditors must have on file before they conduct a single audit.

Section 4: Design Control Traceability Documentation DHF-linked training records, design review attendee qualifications, ISO 14971 / IEC 62304 / IEC 62366 specialist training requirements, and the single most overlooked traceability gap FDA inspectors find in design controls: training records that can’t be linked to specific DHF approval decisions.

Section 5: Demonstrating Good-Faith Compliance Progress to FDA Investigators QMSR gap assessment documentation, LMS validation evidence, Training Program Master Plan requirements, mock inspection readiness, and how to prepare a QMSR Transition Status Summary that gives investigators documented evidence of systematic progress — not verbal assurances.

Priority Action Matrix Three-tier prioritization (P1 Immediate / P2 Short-Term / P3 Ongoing) with target timelines, owner assignments, and the 25+ items marked CRITICAL based on recurring FDA 483 citation patterns.

Who This Is For:

This checklist was built for regulated manufacturers who need to get training compliance documentation in order before the next inspection, as the QMSR transition is now in effect — specifically:

If you manufacture medical devices, pharmaceuticals, biologics, combination products, or other FDA-regulated goods — and you have employees whose work affects product quality — this checklist covers every category FDA investigators are authorized to review.