ISO 15189:2022 · Section 7 · Process requirements
Clause 7.5: Nonconforming work
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Nonconforming work occurs when a laboratory activity or its outcome does not meet an established requirement. It may involve specimen handling, examination performance, reporting, equipment, information transfer, or an external service. The immediate priority is to protect patients and prevent further unreliable work, not to decide who is at fault or wait for a complete root cause investigation before taking action.
Give staff a clear route to recognize, record, and escalate problems. Define who can stop work, withhold results, quarantine material, arrange an alternative service, or notify users. Actions should be proportionate to clinical risk and the extent of the problem. Some events affect one specimen; others require looking back across multiple runs, locations, or reporting periods. A documented assessment should explain how the affected scope was determined.
Evaluate the significance of the event, including work already released and possible consequences for patient care. Decide whether results need review, correction, withdrawal, or user notification. Record immediate corrections separately from actions intended to prevent recurrence. Before work resumes, an authorized person should confirm that the cause or immediate failure condition is sufficiently controlled and that required checks support safe operation.
Use the event record to decide whether formal corrective action is necessary, especially where recurrence is possible or confidence in the management system is affected. Review patterns across incidents and check whether actions remain effective. LabToolkit Pro can help connect incident forms, approval records, and corrective action follow-up, while laboratory leadership remains responsible for clinical risk decisions and authorization to resume work.
What assessors typically ask to see
- How can staff recognize and report nonconforming work without waiting for management permission or a completed technical investigation?
- Who has authority to stop activities, withhold results, control affected materials, and arrange a safe alternative service?
- How is the affected scope established, including previously released results, related equipment, other sites, and relevant time periods?
- How are clinical significance, user notification, report correction, and any need for additional patient follow-up assessed and documented?
- What evidence supports the decision to resume work, and who is authorized to accept any remaining restrictions?
- How are recurring events identified and connected to formal corrective action when immediate correction alone is insufficient?
Documents and records that usually provide evidence
- Nonconforming work procedure defining reporting routes, immediate containment options, responsibilities, risk assessment, communication, and authority for resumption.
- Event records describing what happened, how it was detected, affected processes or specimens, relevant dates, and initial protective actions.
- Scope and patient impact assessments explaining reviewed work, available evidence, uncertainty about the extent, and decisions about previously released results.
- Communication records identifying notified users, corrected reports, agreed clinical follow-up where relevant, and handling of unanswered contact attempts.
- Resumption authorization records documenting technical checks, remaining limitations, responsible approval, and arrangements for enhanced monitoring after restart.
- Corrective action links and trend reviews showing investigation decisions, preventive measures against recurrence, effectiveness assessment, and accountable closure.
Ready-made forms mapped to clause 7.5: Nonconformity & Corrective Action Form, Nonconformity Log, Nonconformity Trend Analysis Dashboard.
Common findings to avoid
- The record describes the equipment repair but does not assess patient results produced before the fault was discovered.
- Work resumes because a service engineer leaves the site, without laboratory acceptance checks or an authorized release decision.
- Every event is closed as staff reminded, even when repeated incidents indicate a process design or resource problem.
- An incident is considered complete when the form is signed, although required user communication or result corrections remain unfinished.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 7.5 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 7.5 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Is every incident a formal corrective action?
No. Every relevant event needs an appropriate response, assessment, and record, but the depth of investigation and follow-up should reflect risk and recurrence potential. A simple correction may resolve an isolated low risk problem. Repeated events, significant patient consequences, or broader system weaknesses usually justify more structured corrective action.
Who decides whether work can restart?
The laboratory should assign this authority in advance to people with suitable technical and operational competence. The decision should rely on evidence that the immediate failure is controlled and necessary checks are satisfactory. External service completion or a normal instrument display alone does not establish that patient testing can safely resume.
How far back should the investigation look?
Use available evidence to identify the earliest plausible affected point, such as a previous satisfactory control, calibration change, software update, or transport event. Consider whether that evidence truly excludes earlier problems. Document the reasoning, uncertainties, and any additional checks needed rather than applying an arbitrary time window to every incident.
Check the exact requirement in your licensed copy of the standard.
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