Signal detected · 1 / 6A regulated part fails inspection and raises a blocking quality signal.
QMS story: Inspection evidence becomes controlled medical-device records
See inspection evidence become controlled medical-device quality records with human approval.
Step 1 of 6 — Signal detected. A regulated part fails inspection and raises a blocking quality signal.
Step 2 of 6 — Evidence sealed. The inspection image, measurement, and calibration record are bound and sealed.
Step 3 of 6 — QMS record prepared. An NCR is prepared, the risk file is linked, and a CAPA recommendation forms.
Step 4 of 6 — Human decision required. QA approval is required before disposition — no automatic disposition.
Step 5 of 6 — Signature recorded. A controlled e-signature is recorded against the approved decision.
Step 6 of 6 — Audit packet prepared. An audit packet shows an ISO 13485 / QMSR evidence view with risk linkage visible.
Approval: The system prepared an NCR, a risk-file link, and a CAPA recommendation. Quality engineer must approve. Human approval required before any disposition. No automatic disposition.
Readiness — ISO 13485 / QMSR evidence view: Nonconformance evidence (evidence complete); Risk-file linkage (evidence complete); Part 11 signature control view (evidence complete); CAPA effectiveness (gap remains). An evidence view against ISO 13485 / QMSR — not a certification. Gaps remain visible.
HoldField is compliance-aware, not a certification; QA owns every QMSR / ISO 13485 decision.