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When an instrument is declared non-compliant (Cases 2, 3 or 4 ILAC-G8), ISO 17025 §7.10 requires an immediate and documented response.
Step 1 — Immediate Actions
- Withdrawal from service: Label the instrument in red and physically isolate it.
- Batch Blocking: Identify and isolate all batches controlled with this instrument.
- Notification: Inform the Quality Manager and the Metrology Manager.
Step 2 — Impact Analysis Sheet (Reverse-Tracking)
| Section | Data to fill in |
|---|---|
| Instrument identification | Serial number, brand, capacity |
| Anomaly description | Out-of-tolerance point, observed deviation, MPE exceeded |
| Risk period | Last compliant calibration → Date of observation |
| Part traceability | Work orders controlled during the risk period |
| Product risk assessment | Product tolerance / Error-tolerance ratio |
| Control actions | Recall/isolation of batches, substitution control |
| Material corrective action | Adjustment or scrapping |
| Approval & closing | Date, Metrology Manager, Quality Manager |
Step 3 — Product risk assessment
Ratio = |Instrument deviation| / Product tolerance × 100
- Ratio < 10% → Low risk, documented traceability is sufficient
- 10–33% → Moderate risk, substitution control of batches
- > 33% → High risk, mandatory recall and re-inspection
Step 4 — Corrective action on the instrument
- Electronic adjustment: If linear and recent drift → recalibration + re-calibration
- Scrapping: If mechanical drift or failed adjustment → definitive withdrawal
Step 5 — Closing and archiving
- Signed impact analysis sheet
- New calibration certificate after adjustment
- List of impacted work orders and decisions per batch
- Proof of customer notification if parts delivered (§7.10.3)
⚠️ Audit requirement: The auditor will verify that each non-conformity has generated a complete and closed impact sheet. An incomplete file is a major non-conformity.
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