Chapter 2 · Nonconformity management

A nonconformity is any failure to meet a requirement of ISO 15189, the laboratory’s own procedures, or a regulatory requirement. When a nonconformity is identified, the laboratory must: contain it immediately (stop using affected results if patient safety is at risk), investigate the root cause, implement corrective action, verify the corrective action was effective, and document the entire process. Nonconformity records must be retained.

Practical example

A QC failure is identified on the glucose analyser. Good practice: The analyst quarantines all results since the last successful QC, notifies the section head, investigates the cause (reagent lot change), replaces the reagent, re-runs QC, and documents the entire sequence. Affected clinicians are notified. Poor practice: The analyst re-runs QC until it passes and reports results without documenting the failure — results issued during a QC failure are potentially unreliable.

What this means for your practice: Patient results issued during a QC failure may need to be amended or recalled. Containment means protecting patients, not protecting the analyst.