ISO 15189:2022 · Section 7 · Process requirements
Clause 7.3: Examination processes
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Examination processes turn a prepared specimen into information used in patient care. Reliability depends on choosing a suitable method, establishing its performance, providing clear operating instructions, and monitoring performance during routine use. The laboratory should connect these activities rather than keep separate folders that never inform daily decisions. A technically capable instrument cannot compensate for an unsuitable method or unclear interpretation rules.
Select methods that fit the intended clinical application, specimen types, available resources, and required performance. Establish whether local verification is sufficient or whether validation is needed because the method is developed, modified, or used outside its established scope. Define responsibilities for approving introduction, reviewing supporting data, and authorizing staff before patient reporting begins. Where uncertainty or interpretive limitations are relevant, address them as part of method implementation.
Controlled examination instructions should explain the operational steps and decision points staff actually need: preparation, calibration, quality control, examination sequence, calculations, interferences, reportable range, and action when performance is unacceptable. Include a reliable route to supporting technical information without relying on memory or uncontrolled notes beside the instrument. Staff should know what they may do independently and when they must stop and escalate.
After implementation, use internal control, external comparisons, incident investigation, and periodic performance review to detect deterioration or changed requirements. Evaluate changes to reagents, equipment, calculations, or software before assuming existing performance evidence still applies. LabToolkit Pro can support SOP drafting, document approvals, and QC chart records, while qualified personnel remain responsible for method suitability and clinical interpretation.
What assessors typically ask to see
- How does the selected examination method meet the intended clinical use, specimen requirements, and necessary performance characteristics?
- What evidence supports the decision to verify an established method or undertake a broader validation before introduction?
- Can an authorized staff member perform the examination using current instructions without depending on undocumented local knowledge?
- How are calibration, calculations, interferences, reportable limits, and quality control decisions addressed within the operating process?
- What changes trigger renewed performance assessment, revised instructions, or additional staff authorization before patient work continues?
- How are internal control findings, external comparisons, and incidents combined to evaluate whether the method remains fit for use?
Documents and records that usually provide evidence
- Method selection and implementation records describing intended use, required performance, resource needs, responsibilities, and authorization to proceed.
- Verification or validation reports linking predefined acceptance criteria to actual study data, interpretation, and approval for routine service.
- Controlled examination SOPs covering preparation, operation, calculations, limitations, quality checks, reporting rules, and escalation pathways.
- Staff competence and authorization records showing who may perform, review, troubleshoot, and release each examination activity.
- Routine performance records including calibration acceptance, internal control review, external comparison outcomes, and documented response to failures.
- Change assessments identifying affected performance characteristics, necessary studies, updated documents, staff communication, and implementation decisions.
Ready-made forms mapped to clause 7.3: Quantitative Method Verification Plan, Qualitative Method Verification Plan, Quantitative Method Verification Report, Qualitative Method Verification Report, Precision, Linearity & Accuracy Worksheet, Measurement Uncertainty Reporting Form, Measurement uncertainty calculator, IQC Frequency Determination Form, In-house IQC Preparation Log, IQC Statistical Tool — Levey-jennings Chart Setup, IQC Daily Log, CV Calculator — Alternative IQC Method and 6 more in the forms library.
Common findings to avoid
- The method has an extensive technical manual but no practical instructions for local decision points and escalation.
- Performance studies are completed after routine reporting begins, leaving no documented basis for the original release decision.
- Changes to calculations or operating conditions are treated as administrative updates despite their potential effect on results.
- Quality records are reviewed separately without examining whether repeated small problems indicate a wider method performance issue.
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 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 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Is the manufacturer manual enough as an examination procedure?
It may provide essential technical detail, but the laboratory must ensure staff also have the local instructions necessary for safe operation. These include responsibilities, local quality control arrangements, acceptance decisions, reporting practices, and escalation. Avoid unnecessary duplication, but ensure references are current, accessible, and consistent with actual practice.
When should an examination process be reviewed?
Review it at planned intervals and when evidence suggests a change is needed. Relevant triggers include revised clinical use, new reagent behavior, equipment changes, complaints, quality failures, and updated technical information. The depth of review should reflect the possible effect on patient results and may require new performance studies.
Can one procedure cover several related examinations?
Yes, when the shared instructions remain clear and examination-specific differences are easy to identify. Explicitly state different specimen requirements, quality limits, calculations, and reporting rules. Grouping should reduce confusion rather than conceal important distinctions, and staff should be able to locate the applicable instruction during routine work.
Check the exact requirement in your licensed copy of the standard.
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