Verification and Validation Flashcards
You introduce a new virology test
What is the broad definition of verification and validation, and when are they used
CE marked test from a manufacturer - needs verification. Confirms that the test achieves stated performance by manufacturer, and will continue to perform properly
Laboratory-developed assay - needs validation. According to ISO 15189:2012, validation is defined as “confirmation, through the
provision of objective evidence that the requirements for a specific intended use or application have been fulfilled”. It examines the whole process that is being used to check that results are correct and consistent. Simply - it checks your your developed test actually works as intended
Usually use old positive patient samples, or external samples for quality control
What is meant by laboratory accreditation?
UKAS provides indepdendent third party recognisation (accreditation) that the laboratory is competent to provide reliable test results, and their correct interpretation
UKAS sole accreditation body recognised by British Government. It does not have any power. But accreddits to provide trust to users of laboratories
What ISO number is UKAS accreditation?
ISO 15189 accreditation underpins confidence in the quality of medical laboratories through a process that verifies their integrity, impartiality and competence
