ISO 15189:2022 · Section 8 · Management system requirements
Clause 8.7: Nonconformities and corrective actions
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
A nonconformity occurs when an established requirement is not met. It may concern technical work, a reporting process, staff authorization or the management system itself. The first task is to control the situation and address consequences. Depending on the event, this can include stopping work, securing specimens, correcting information or contacting clinical teams. Immediate correction is important, but it does not necessarily remove the cause of the failure.
Evaluate the significance of the event and whether similar problems exist or could occur elsewhere. Examine the actual workflow, records, equipment conditions and decisions involved. Ask why existing safeguards failed rather than stopping at a label such as human error. A missed check may reflect an unclear interface, competing duties, poor task design or inadequate authorization. Select an investigation approach proportionate to the consequences and recurrence risk, and record the reasoning behind the conclusion.
Corrective actions should address supported causes. Assign responsibility, resources and completion dates, then consider whether changes require revised risk assessments, controlled instructions or competence checks. Training is appropriate when a genuine knowledge or skill gap exists, but it is weak treatment for a process that remains confusing or impractical. Consider effects on other examinations, locations and shifts before limiting the response to the area where the event was first detected.
Verify effectiveness after there has been a meaningful opportunity for recurrence. A completed action is not automatically an effective action. Review comparable work, targeted audits or relevant incident information, and reopen the investigation if the cause remains active. LabToolkit Pro can support incident forms, investigation records and action tracking, while the laboratory retains responsibility for clinical impact assessment, evidence-based causal reasoning and decisions about safe continuation of services.
What assessors typically ask to see
- How are immediate controls and patient-impact assessment distinguished from longer-term action intended to prevent recurrence?
- What evidence supports the identified causes, and how did the investigation look beyond an unsupported human-error explanation?
- How does the laboratory check whether similar failures exist in other examinations, sites, shifts or information pathways?
- Do selected actions address the identified causes, with clear ownership, resources and suitable changes to linked processes?
- What evidence was reviewed after implementation to decide whether the corrective action was effective and closure justified?
Documents and records that usually provide evidence
- Nonconformity and corrective-action procedure distinguishing containment, correction, causal investigation, action implementation and effectiveness review.
- Event records describing the unmet requirement, objective evidence, immediate controls and assessment of possible patient consequences.
- Investigation records connecting findings from records, interviews or workflow observation to supported causes and contributing conditions.
- Action plans assigning accountable owners, completion dates and specific changes that address the identified causes.
- Updated risk assessments, controlled procedures and competence records where corrective changes affect the management or examination process.
- Effectiveness reviews based on relevant follow-up evidence, with justified closure or additional action when recurrence risk persists.
Ready-made forms mapped to clause 8.7: Nonconformity & Corrective Action Form, Corrective & Preventive Action (capa) Form, Nonconformity Log, CAPA Register & Status Tracker, 5-why Root Cause Analysis Worksheet, Fishbone / Ishikawa Cause Analysis Worksheet, Failure Mode & Effect Analysis (fmea) Worksheet, CAPA Effectiveness Review Form, Nonconformity Trend Analysis Dashboard, Audit NC & Corrective Action Tracker.
Common findings to avoid
- Closing an incident after correcting a report without checking whether other patients or results could have been affected.
- Recording staff carelessness as the cause without examining the process conditions that made the mistake possible.
- Selecting retraining for every event regardless of whether knowledge, task design, equipment or communication actually caused the failure.
- Verifying effectiveness immediately after issuing a revised procedure, before there has been a meaningful opportunity to observe practice.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 8.7 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 8.7 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Does every minor failure need a lengthy investigation?
No. Match the response to significance, consequences and recurrence potential. Even a brief evaluation should explain the decision, document appropriate correction and consider whether the event suggests a wider or repeated problem.
What is the difference between correction and corrective action?
Correction addresses the detected problem, such as replacing an incorrect instruction. Corrective action addresses its cause, such as repairing the revision and distribution process that allowed the obsolete instruction to remain available.
How should effectiveness be checked?
Choose evidence that directly tests the original failure mechanism. This might include observing comparable tasks, reviewing subsequent reports or conducting a targeted audit. Define the check and its timing before treating implementation as final closure.
Check the exact requirement in your licensed copy of the standard.
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