This micro-module is designed to provide a basic awareness of two key requirements of ISO 15189:2022. Based on our gap analysis, these requirements are determined to represent a major change in the 2022 version of ISO 15189. The update of the module also includes a new notebook, which can be downloaded to support your learning.
(NOTE: This module is the re-launch of the previous version that was based on ISO 15189:2012)
This module has been devised so that it is accessible to all staff working in a medical laboratory or point of care (PoCT) service, whatever their job role, should they wish to refresh their awareness.
The aim of this module is to focus the learner on the difference between validation and verification and to support the implementation and demonstration of conformity within organisations that are accredited or seeking accreditation.
It includes “Top Tips for validation and verification” from one of UKAS’ Medical Laboratory Technical Focus Persons.