ISO 15189:2022 · Section 7 · Process requirements
Clause 7.3.3: Validation of examination methods
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What this clause is about
Validation establishes whether an examination method is fit for a defined intended purpose when established performance evidence does not adequately cover the proposed use. This commonly matters for laboratory-developed methods, modifications to established methods, or use beyond the scope already demonstrated. The question is broader than whether familiar equipment runs correctly: it is whether the complete examination supports the intended clinical decision.
Define the examination, specimen types, patient population where relevant, clinical application, and limitations before designing experiments. Identify performance characteristics that could affect that use. Depending on the method, these may include precision, trueness or agreement, analytical specificity, detection capability, measuring interval, interference, carryover, or qualitative classification performance. Not every characteristic applies to every examination, but omitted areas need a reasoned explanation.
Create a plan with acceptance criteria, materials, sample selection, calculations, responsibilities, and approval arrangements. Include challenging conditions that reflect the proposed service rather than only convenient specimens. Consider how specimen preparation, equipment, reagents, interpretation rules, and information processing interact. Preserve unsuccessful work and changes to the plan so the final report shows how conclusions were reached, not just the most favorable results.
Before introduction, review the complete evidence and decide whether to approve, restrict, revise, or abandon the proposed method. Transfer validated limits into controlled instructions and reporting rules. Later changes require an assessment of whether additional validation is needed. LabToolkit Pro can help manage plans, controlled drafts, and e-signature approvals; scientific design and the judgment of fitness for purpose remain laboratory responsibilities.
What assessors typically ask to see
- What intended purpose, specimen types, clinical application, and operating conditions define the boundaries of the validation claim?
- Why is validation necessary rather than verification, and which aspects lack adequate established performance evidence for the proposed use?
- How were clinically relevant acceptance criteria and performance characteristics selected before experimental work and data interpretation began?
- Do materials and sample selection challenge the method across relevant limits, interferences, classifications, and important decision points?
- How are changes to the study plan, unsuccessful experiments, exclusions, and residual limitations documented for an independent reviewer?
- How are the validated boundaries maintained when procedures, reagents, interpretation rules, or intended clinical applications subsequently change?
Documents and records that usually provide evidence
- Validation protocol defining the intended purpose, examination boundaries, performance claims to investigate, and justification for the study design.
- Risk assessment connecting possible examination errors to clinical consequences and the performance characteristics requiring particular attention.
- Experimental records identifying materials, specimens, equipment, reagents, operators, conditions, deviations, and complete original observations.
- Analysis files documenting calculation methods, acceptance comparisons, treatment of atypical data, and the limitations of available reference information.
- Validation report summarizing evidence, unmet criteria, restrictions, residual risks, and the authorized decision about clinical implementation.
- Change control and implementation records linking approved performance boundaries to SOPs, staff competence, report content, and ongoing quality monitoring.
Common findings to avoid
- A modified method is called verified even though the modification changes the specimen type or intended clinical application.
- The validation plan lists many experiments but does not connect them to predefined performance requirements or clinical risk.
- Only favorable observations appear in the final report, with no explanation for excluded runs or abandoned study conditions.
- Approval covers a narrow application, but routine users extend the examination to additional specimens without further assessment.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 7.3.3 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 7.3.3 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Does a minor modification always require full validation?
The extent of additional work should match the potential effect of the modification. Document what changed, which characteristics could be affected, and what existing evidence remains applicable. A limited change may justify targeted studies; a major change in specimen type or intended use may require a much broader assessment.
Can published studies support laboratory validation?
Yes. Relevant literature and established technical evidence can inform the design, expected performance, and interpretation. Check whether the published conditions match the local examination and intended use. External evidence should be critically assessed and combined with appropriate local work rather than copied into a report as an unsupported approval.
What happens when one acceptance criterion is not met?
Investigate the reason and its clinical significance. Additional experiments, method adjustment, a narrower intended use, or rejection may be appropriate. Do not simply relax the criterion after seeing the data. Any revised requirement needs a defensible justification, transparent documentation, and authorization before the method is used for patient care.
Check the exact requirement in your licensed copy of the standard.
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