Application of ISO-IEC 17025 Technical Requirements in Industrial Laboratories Method Validation

Table of contents

INTRODUCTION 1

Method validation - what is it? 1

Method validation - why is it necessary? 1

Method validation- when should it be done? 2

Relation of method validation to method verification 2

USING AN APPROPRIATE METHOD 3

What is method development? 3

Measurand 4

What is method selection? 5

Fitness for purpose 5

Data concepts that impact fitness for purpose 6

Accuracy and Uncertainty Conundrum (AKA Accuracy and Precision Trade-off) 6

Reportable Value 7

Sampling ц

Decision rule approach and target uncertainty 11

Measurement uncertainty 11

Decision rules 12

Determining the target uncertainty 13

How to determine a target measurement uncertainty 13

Impact of Bias and Uncertainty Conundrum on Target Uncertainty

15

Decision rules approach: 16

Using the N:1 decision rule 16

Simple decision rule for an upper specification limit that includes the uncertainty 17