Principles of Pathology Test Validation: What is "Extensive as Necessary"?
Description
Implementation of a new medical diagnostic test is a complex process, with test validation an integral component. Performing a test validation can be daunting, but it doesn’t have to be if you follow a structured best practise approach.
When trying to conform with standards such as ISO 15189, the wording can cause some consternation when it describes the requirement for test validation to be “extensive as necessary”.
Following a structured best-practise approach to test validation in medical laboratories will aid in compliance with standards such as ISO 15189. Clear processes will provide laboratory staff with confidence to perform test validations and present their data in concise reports that are audit ready.
What You’ll Achieve
- Understand what “extensive as necessary” means in the context of ISO 15189 and how to determine an appropriate scope for pathology test validation.
- Apply a structured, best-practice approach to planning, performing and documenting test validations, producing concise, defensible and audit-ready reports.
- Identify common pitfalls in test validation and use practical strategies to ensure validation evidence is scientifically sound, fit for purpose and compliant with laboratory requirements.
About this Webinar
Implementation of a new medical diagnostic test is a complex process, with test validation an integral component. Performing a test validation can be daunting, but it doesn’t have to be if you follow a structured best practise approach.
When trying to conform with standards such as ISO 15189, the wording can cause some consternation when it describes the requirement for test validation to be “extensive as necessary”.
Following a structured best-practise approach to test validation in medical laboratories will aid in compliance with standards such as ISO 15189. Clear processes will provide laboratory staff with confidence to perform test validations and present their data in concise reports that are audit ready.
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