Quantitative 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 LaboratoryQuantitative Method Verification Plan | YL-LAB-FRM-21-F01a v1.0
Record: Quantitative Method Verification Plan — October 2026
Test / AnalyteGlucose
Instrument / EquipmentChemistry analyser
Manufacturer Claimed Precision (CV%)91.70
Manufacturer Claimed Accuracy (Bias%)91.50
Proposed Reference / Comparative MethodNC-26-001
Verification Planned Start Date2026-10-01
Planned Completion Date2026-10-01
Lead Analyst
Verification Parameters Planned
| Parameter | Plan (Y/N) | Samples Required | Acceptance Criteria | Days Required | Analyst Assigned | Notes |
|---|---|---|---|---|---|---|
| Within-Day Precision | Y | 20 replicates in 1 day | CV ≤ manufacturer claim | 1 | R. Naidoo | Within limits |
| Between-Day Precision | Y | Once/day × 20 days | CV ≤ manufacturer claim | 20 | S. Dlamini | |
| Accuracy – Comparability | Y | ≥20 patient samples × ≥3 days | r ≥ 0.95 | 3+ | A. Mensah | |
| Accuracy – Recovery | Y | Derived from precision data | Grand mean within verify interval | 20 | L. Banda | Within limits |
| Linearity | Y | 5 samples decreasing conc. | r ≥ 0.95 | 1-2 | K. Otieno | |
| Reference Ranges | Y | 20 healthy individuals per group | ≤2/20 outside proposed range | Per plan | T. Moyo | |
| Measurement Uncertainty | Y | IQC + EQA data (see PR22) | ≤ Maximum Allowable MU | Ongoing | R. Naidoo | Within limits |
| S. Dlamini |
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Completed by | |||
| Reviewed by |
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
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What it records
- Parameter
- Plan (Y/N)
- Samples Required
- Acceptance Criteria
- Days Required
- Analyst Assigned
- Notes
Sign-off
- Completed by
- Reviewed by
Related templates
- Qualitative Method Verification Plan (PR21-F01b)
- 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.