Quantitative Method Verification Report 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 Report | YL-LAB-FRM-21-F02a v1.0
Record: Quantitative Method Verification Report — October 2026
ExaminationGlucose
Method / analyserChemistry analyser
Plan ref. (PR21-F01a)REF-26-001
Study periodOctober 2026
Unitsmmol/L
Worksheets ref. (PR21-F03)REF-26-001
Enter the acceptance criterion (manufacturer claim or allowable limit) and the observed value. Choose ≤ when the observed value must not exceed the criterion (e.g. CV, bias) and ≥ when it must reach it (e.g. r, recovery).
| No. | Parameter | Criterion | Rule | Observed | Result | Comment |
|---|---|---|---|---|---|---|
| 1 | Repeatability (within-run CV %) | 8 | ≤ | 5.09 | Pass | Within limits |
| 2 | Intermediate precision (CV %) | 10 | ≤ | 4.96 | Pass | |
| 3 | Trueness / bias (%) | 4 | ≤ | 5.06 | Fail | |
| 4 | Linearity / reportable range | 5 | ≤ | 5.10 | Fail | Within limits |
| 5 | Method comparison (slope) | 6 | ≤ | 4.96 | Pass | |
| 6 | Method comparison (correlation r) | 4 | ≥ | 5.07 | Pass | |
| 7 | Carry-over (%) | 8 | ≤ | 5.05 | Pass | Within limits |
| 8 | Reference interval verification (% within) | 4 | ≥ | 4.92 | Pass | |
| 9 | Measurement uncertainty U (%) | 7 | ≤ | 5.04 | Pass |
Conclusion (method verified for use / not verified)T. Moyo
Limitations or conditions
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Performed by | |||
| Reviewed by (Section Head) | |||
| Approved for use by (Laboratory Director) |
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 9 of 9 rowsExactly as LabToolkit Pro prints it — with your logo and colours
What it records
- Parameter
- Criterion
- Rule
- Observed
- Result
- Comment
Instructions on the form
- Enter the acceptance criterion (manufacturer claim or allowable limit) and the observed value. Choose ≤ when the observed value must not exceed the criterion (e.g. CV, bias) and ≥ when it must reach it (e.g. r, recovery).
Sign-off
- Performed by
- Reviewed by (Section Head)
- Approved for use by (Laboratory Director)
Related templates
- Quantitative Method Verification Plan (PR21-F01a)
- Qualitative Method Verification Plan (PR21-F01b)
- 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.