This case review is a de-identified, representative scenario drawn from the pattern a laboratory usually meets the first time it runs an ISO 15189 internal audit; no named institution or individual is described, and the counts below are internal illustrative figures rather than published statistics. The laboratory had a working quality system, a shelf of procedures and a team that followed them, but it had never tested that system against itself. The audit found four clusters of gaps, all of them inexpensive to fix and all of them about records rather than science.
What triggered the internal audit?
The trigger was a planned audit cycle, not an incident. ISO 15189 asks for internal audits at planned intervals that cover the whole management system over a defined cycle; it does not fix a single frequency such as once a year. The laboratory had written the plan, named an auditor and blocked two days.
Because the auditor owned none of the sections being reviewed, independence was straightforward to document. A smaller laboratory usually has to spell that out, because one person may own most of the bench and the rule is that an auditor should not audit their own work.
Which areas produced the most findings?
Four areas produced findings: consumable acceptance, lot traceability, temperature records and document control. None of them involved a wrong result. Every finding was about the laboratory being unable to show, from its records alone, that the correct step had been taken at the correct time.
| Finding area | Evidence requested | What was missing | Corrective action and closure evidence |
|---|---|---|---|
| Consumable acceptance | Receipt records for collection devices | No documented acceptance step at receipt | Added a receiving checklist; closure = signed checklists for the audit period |
| Lot traceability | Lot numbers linked to reported results | Lot recorded on bench sheets only | Lot captured in the LIS field; closure = sample of 20 reports traced end to end |
| Temperature records | Fridge and freezer logs for reagents | Two gaps in the daily log | Log review moved into the daily opening routine; closure = 30 consecutive complete days |
| Document control | Current version of the sampling SOP | Superseded SOP still on the bench | Version-controlled binder plus stamp; closure = observation at next walkthrough |
The pattern is worth noting. The findings clustered around the handover points, where one person's action had to become another person's record, which is exactly where an internal audit earns its keep.
What did the consumable traceability gap look like?
The laboratory could say which collection devices it used, but not which lot had been used for a specific reported result. Lot numbers lived on bench sheets, and the sheets were filed by day rather than linked to reports.
Closing the gap did not require new equipment. The team added the lot field to the laboratory information system and then traced a sample of reports end to end to prove the field was actually being filled in.
How were corrective actions tracked and closed?
Each finding went into a corrective-action log with an owner, a due date and a written definition of what closure would look like. Closing a finding required evidence, not a signature: signed receiving checklists for the audit period, a traced sample of reports, a run of consecutive complete temperature days, and an observation at the next walkthrough for the document-control fix.
The management review then read the log as a whole and asked whether one root cause sat behind more than one finding. In this case it did, and the common cause was that handover steps had never been written down as anyone's task.
What would the lab do differently next cycle?
Three things. First, audit the handover points deliberately rather than section by section, because that is where the findings came from. Second, keep the receiving checklist inside the workflow instead of treating it as an audit task. Third, test traceability by sampling live reports during the cycle, so a gap surfaces as normal work rather than in the week before an assessor arrives.
Related Reading
- Compliance log centre
- Diagnostic laboratory supply checklist
- ISO 11737-1 and -2 bioburden and sterility testing
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Related Reading
- Diagnostic laboratory supply checklist
- ISO 11737-1 and -2 bioburden and sterility testing
- Compliance log centre
- Wholesale and multi-site ordering
Frequently Asked Questions
How often does ISO 15189 require an internal audit?
The standard requires audits at planned intervals that cover the whole management system over a defined cycle. It does not fix a single frequency such as once a year. What auditors look for is the plan, the competence of the auditor, the findings and the closure evidence.
What counts as a nonconformity in a lab audit?
A requirement that was not met. It can be a missing record, an uncontrolled document, a step performed differently from the written procedure, or a result that cannot be traced back to the consumable lot used. Severity changes how fast closure is required, not whether it must be closed.
Do internal audit findings have to be reported outside the laboratory?
Internal findings stay internal; they feed the management review and the corrective-action log. Separate rules apply to changes that affect accreditation scope or to notifiable incidents, which are handled through the accreditation body rather than the internal audit report.
Can a small laboratory run its own internal audit?
Yes, if the person is competent and independent of the activity being audited. In a two-person laboratory that often means documenting how independence was maintained, or arranging a peer laboratory review for the sections a person owns.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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