What?Genetic tests must be validated before diagnostic use to ensure that they perform according to the laboratory's requirements, and test validation is a formal requirement of many accreditation standards including ISO 15189. In this workshop, we will examine the validation requirements of ISO 15189 and address practical ways of meeting them in your laboratory. After the workshop, the participants will be able to...Explain the aims and the importance of validation.Describe the regulatory requirements and recommendations concerning validation and where to find themWrite a validation plan:Distinguish between validation and verificationDevelop a checklist of parameters to be addressedDefine key components of validation plan and apply these parameters to a simple exampleDetermine which type of validation is relevant for which testDesign experiments to validate a particular testExplain the content, the criteria and the required data for a comprehensive validation reportDesign and implement appropriate internal quality control to follow-up test performance