Method Validation & Measurement Uncertainty for Microbiology & Analytical Testing Laboratories

Overview

In today’s regulatory environment, results are only as strong as the evidence behind them. This practical, high‑impact course cuts through theory and ambiguity to show you exactly how to validate methods and quantify uncertainty in a way that stands up to ISO 17025 scrutiny – for both microbiological and analytical testing laboratories.

Using real laboratory data, worked examples, and auditor‑expectation insights, delegates will learn how to design defensible validations, distinguish true method performance from sample effects, and calculate uncertainty that actually supports decision‑making.

The focus is on clarity, confidence, and practical implementation, not abstract statistics. Delegates leave able to justify their approach, explain their calculations, and apply validation and uncertainty concepts immediately in routine laboratory work.

Progress Excellence Approach

• Dissecting the method validation requirements of ISO 17025.
• Explanation of the contents and lay-out of a validation report.
• Experimental design for validation criteria.
• Practical, worked examples of each of the validation criteria, such as calibration accuracy, working range, precision, limit of detection (LOD), limit of quantification (LOQ), sensitivity, specificity, accuracy, trueness and bias and recovery data, workability (repeatability & robustness), stability and total uncertainty of methods.

The course will equip delegates with the following:

• Understanding method validation requirements of ISO 17025.
• Practical performance and confirmation of each of the validation criteria.
• Ability to calculate uncertainty of measurement.
• Ability to develop an experimental design for validation criteria.
• Ability to interpret validation data and formalise a validation report.

The course is best suited to the following audiences:

• Laboratory Manager
• Technical Manager
• Quality Manager
• Laboratory staff tasked with method validation.

Delegate assessment will be in the form of:

• Full course attendance
• Successful completion of an assessment (pass mark 70%)
• Successful completion of validation of one analytical or microbiological method.