Method Validation & Measurement Uncertainty Record

ISO/IEC 17025:2017 (lab competence) – cl.7.2 method selection/ verification/validation + cl.7.6 measurement uncertainty (MU). Required before a lab reports results under accreditation.

Field	Value
Method	name/SOP ref
Validation ID	VAL-YYYY-NNN
Analyst	@name
Approved by	technical manager

1. Method identification

• Standard method (verified) or non-standard/lab-developed (validated)
• Scope: analytes, matrices, measurement range

2. Performance characteristics validated

Characteristic	Experiment	Acceptance criterion	Result	Pass?
Selectivity	interference check	no interference >N%
Linearity	N-point calibration	R2 ≥ 0.99N
LOD/LOQ	repeated blanks	LOD ≤ N
Precision (repeatability)	n≥N replicates	%RSD ≤ N
Reproducibility	analyst/day variation	%RSD ≤ N
Trueness/bias	CRM or spike recovery	N-N% recovery
Robustness	parameter variation	stable within N%

3. Measurement uncertainty budget (cl.7.6)

$U = k \cdot u_c, \quad u_c = \sqrt{\sum_i u_i^2}$

Component $u_i$	Type	Value	Distribution	Contribution
Calibration	B		normal
Repeatability	A		normal
Purity of standard	B		rectangular
Combined $u_c$
Expanded $U$ (k=2, 95%)

4. Quality control ongoing

• Control charts (Shewhart) per batch, acceptance rules
• PT/ILC participation – proficiency testing records

5. Reporting statement

Result reported as: value ± U (k=2) per scope of accreditation.