Skip to content
HoldField

QMS demo · deterministic product illustration

See inspection evidence become controlled medical-device quality records.

A regulated-part defect prepares an NCR, links the risk file, and drafts a CAPA — QA signs before disposition.

Evidence sealedHuman approvalAudit packet prepared
Open present mode
Signal detected · 1 / 6A regulated part fails inspection and raises a blocking quality signal.
Use ← / → to step, 1–6 to jump, space to play or pause.

Evidence path

Inspection imagependingMeasurementpendingCalibration recordpendingTraining recordpendingQA e-signaturepending

QMS records prepared

Records are prepared once evidence is sealed.

QA signature requiredNot yet reached

The system prepared an NCR, a risk-file link, and a CAPA recommendation.

  • Approver: Quality engineer
  • Human approval required before any disposition.
  • No automatic disposition.

The record is prepared for a person. A controlled signature is required before disposition.

ISO 13485 / QMSR evidence view

Gaps remain
  • Nonconformance evidence — evidence completeImage, measurement, and calibration bound to the NCR.
  • Risk-file linkage — evidence completeNCR linked to the affected risk-management file.
  • Part 11 signature control view — evidence completeSignature is attributable, timestamped, and bound to the record.
  • CAPA effectiveness — gap remainsEffectiveness verification is planned, not yet evidenced.

An evidence view against ISO 13485 / QMSR — not a certification. Gaps remain visible.

Deterministic product illustration. Regulated decisions remain human-controlled. HoldField is compliance-aware, not a certification; QA owns every QMSR / ISO 13485 decision.

QMS story: Inspection evidence becomes controlled medical-device records

See inspection evidence become controlled medical-device quality records with human approval.

  1. Step 1 of 6 — Signal detected. A regulated part fails inspection and raises a blocking quality signal.
  2. Step 2 of 6 — Evidence sealed. The inspection image, measurement, and calibration record are bound and sealed.
  3. Step 3 of 6 — QMS record prepared. An NCR is prepared, the risk file is linked, and a CAPA recommendation forms.
  4. Step 4 of 6 — Human decision required. QA approval is required before disposition — no automatic disposition.
  5. Step 5 of 6 — Signature recorded. A controlled e-signature is recorded against the approved decision.
  6. 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.