Validation and verification of examination methods in medical laboratories

About the course

Method validation is the process that provides evidence that a test method is capable of producing results that are suitable for a particular application. It is a requirement of the ISO 15189 laboratory accreditation standards and many other sectoral regulations and directives. Method verification or validation should always be a planned activity. This course introduces the statistics required for interpreting verification or validation data and provides the tools to plan and carry out adequate verification or validation studies. There is ample opportunity to practice the principles learned through laptop-based workshops using Analyse-it & Minitab Software.

What are the benefits?

This course is designed to provide you with the essential skills and knowledge required to:

• Understand the requirements for verification and validation examination methods based on ISO 15189:2022;
• Select and apply appropriate statistical techniques during the verification and validation of examination methods;
• Practice statistical principles through hands-on, laptop-based workshops.

You can use Analyse-it and XLSTAT software to perform statistical analysis.