Qualitative Method Verification Plan template
A qc sheet in the Method Verification procedure (PR21), mapped to ISO 15189:2022 clause 7.3.2. Fill it in whenever the task occurs. Used by the laboratory team.
Qc sheetISO 15189 · 7.3.2As needed
Calculated automaticallyRed = outside limits
Your LaboratoryQualitative Method Verification Plan | YL-LAB-FRM-21-F01b v1.0
Record: Qualitative Method Verification Plan — October 2026
ExaminationGlucose
Method / kitGlucose reagent
Analyser / platformChemistry analyser
SectionHaematology
Reason (new / change / relocation)Main laboratory
Planned dates
Manufacturer Claims (Acceptance Criteria)
Diagnostic sensitivity claim (%)92.20
Diagnostic specificity claim (%)94.70
Other claims (limit of detection, cross-reactivity)Monthly QC review
Study Design
| No. | Element | Plan |
|---|---|---|
| 1 | Positive samples (minimum 10) | |
| 2 | Negative samples (minimum 10) | |
| 3 | Source of samples (PT, controls, previously tested) | |
| 4 | Comparator / reference method | |
| 5 | Operators (trained, authorized) | |
| 6 | Data analysis: 2×2 table, sensitivity, specificity, agreement | |
| 7 | Handling of discordant results |
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Prepared by | |||
| Approved by (Section Head) |
Shaded cells are calculated automatically. Values in red are outside their limits. † marks a corrected value (see Corrections).
Controlled document. Printed copies are uncontrolled unless stamped.Page 1
A4 portrait · first page · showing 7 of 7 rowsExactly as LabToolkit Pro prints it — with your logo and colours
What it records
- Element
- Plan
Sign-off
- Prepared by
- Approved by (Section Head)
Related templates
- Quantitative Method Verification Plan (PR21-F01a)
- Quantitative Method Verification Report (PR21-F02a)
- Qualitative Method Verification Report (PR21-F02b)
- Precision, Linearity & Accuracy Worksheet (PR21-F03)
- Guide: ISO 15189 documentation checklist
Clause references are to ISO 15189:2022; check them against your licensed copy of the standard.