ISO 15189:2022 · Section 7 · Process requirements
Clause 7.3.2: Verification of examination methods
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What this clause is about
Verification asks whether an established examination method performs adequately in the laboratory's own operating conditions for its stated intended use. It is not simply a check that the instrument starts or that a few controls fall within range. The study should address performance characteristics that matter for the examination and provide enough evidence for a defensible decision before patient reporting begins.
Begin with the intended use, manufacturer performance information, clinical requirements, and the laboratory's operating conditions. Choose characteristics to examine, such as precision, agreement or bias, measuring interval, or performance around clinically important thresholds. For qualitative methods, consider appropriate positive and negative materials and relevant challenging specimens. Set acceptance criteria before reviewing study results so that expectations are not adjusted to fit disappointing data.
Design practical experiments using suitable materials and enough observations to support the decision. Document material selection, concentrations or result categories, comparison arrangements, equipment, reagent lots, operators, and calculations. Investigate unexpected differences rather than removing inconvenient observations without explanation. Where reference materials or comparison methods have limitations, include those limitations in the interpretation.
An authorized reviewer should decide whether the evidence supports introduction, restricted use, additional work, or rejection. Carry important limitations into examination instructions, reporting arrangements, and staff preparation. Verification is distinct from validation: a modified or newly developed method may need a broader demonstration of fitness for purpose. LabToolkit Pro can help control verification plans, data forms, and approval records, but the laboratory must determine study adequacy and make the technical release decision.
What assessors typically ask to see
- What intended use and operating conditions define the scope of the proposed verification and its eventual approval?
- Which performance characteristics were selected, and why are they sufficient for the examination and associated clinical decisions?
- Were acceptance criteria documented before study results were reviewed, and what clinical or technical information supports them?
- Do study materials cover relevant concentrations, result categories, specimen characteristics, and important medical decision points?
- How were unexpected differences, exclusions, comparison limitations, and unsuccessful experiments investigated and reflected in the final conclusion?
- Who approved patient use, and how were any restrictions transferred into procedures, reporting rules, and staff authorization?
Documents and records that usually provide evidence
- Approved verification plan identifying intended use, selected characteristics, experimental design, materials, acceptance criteria, and responsible personnel.
- Manufacturer performance information and clinical requirement references used to justify the study scope and local performance expectations.
- Raw observation sheets linking measurements to dates, equipment, reagent lots, material identity, operators, and relevant operating conditions.
- Analysis worksheets showing calculations, comparisons, graphical review where useful, and transparent handling of exclusions or anomalous observations.
- Final technical report stating results against criteria, unresolved limitations, required additional work, and the authorized implementation decision.
- Implementation checklist linking approval to updated SOPs, quality control arrangements, reporting settings, and staff preparation before routine release.
Ready-made forms mapped to clause 7.3.2: Quantitative Method Verification Plan, Qualitative Method Verification Plan, Quantitative Method Verification Report, Qualitative Method Verification Report, Precision, Linearity & Accuracy Worksheet.
Common findings to avoid
- Verification is reduced to one successful control run without examining characteristics relevant to the intended clinical use.
- Acceptance limits are selected after the results are known, making the apparent success of the study misleading.
- Comparison specimens avoid important clinical thresholds, leaving agreement near treatment decisions unexplored despite acceptable overall correlation.
- The study report is approved but its restricted scope is not reflected in specimen acceptance or reporting settings.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 7.3.2 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 7.3.2 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Is correlation enough to verify a quantitative method?
No. Strong correlation can coexist with clinically important differences, especially when samples span a wide concentration range. Examine agreement, precision, and other relevant characteristics against predefined criteria. Consider differences at medical decision points and acknowledge limitations of the comparison method instead of treating a single summary statistic as proof of suitability.
Can manufacturer data replace local verification?
Manufacturer information helps define expectations and select an efficient study, but it does not show that local conditions reproduce suitable performance. Local evidence should address the intended use and relevant operating factors. The extent of work can be proportionate, but the rationale and authorized conclusion should be explicit and supported by records.
When is repeat verification needed?
Assess changes that could alter performance, such as moving an instrument, replacing a major component, or changing significant operating conditions. Not every change needs the entire original study. Decide which characteristics are affected, document the reasoning, and obtain sufficient evidence before relying on the changed arrangement for patient reporting.
Check the exact requirement in your licensed copy of the standard.
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