What the checklist covers
Nineteen tasks across six phases: gap assessment (mapping legacy procedures to ISO 13485 clauses plus the FDA additions at 820.35 and 820.45), change-controlled document updates, management review as a producible record per ISO 13485 §5.6, the re-pointed internal audit program, training on every revised procedure, and readiness drills — including a timed retrieval exercise, because the new inspection program selects records by risk and waits while you produce them.
Each task row has owner, status (dropdown), evidence/record-reference, and notes columns, plus an Instructions tab and a worked example. Add site-specific rows as your gap assessment surfaces them.
- Gap assessment against ISO 13485 clauses plus 820.35 and 820.45
- Change-controlled document updates
- Management review as a producible record per §5.6
- Re-pointed internal audit program and training on every revised procedure
- Readiness drills including a timed retrieval exercise
Why run the transition as tracked, evidenced work
Most QSR-era systems need a structured gap assessment, not a rewrite — but the work that is needed leaves a trail an investigator can now follow: management review minutes, internal audit findings, and supplier audit records are all reviewable under compliance program CP 7382.850. A checklist with owners and evidence references means the transition itself becomes inspection evidence rather than an undocumented scramble.
Running the transition in a governed system
The checklist works on its own — and works better when the underlying activities run in governed workflows: the document wave under change control, the gap assessment in audit management, training evidence tied to revisions, and management review minutes as controlled, signed records.
