Introduction to the CQI Medical Laboratories Group . Also an overview of ISO 15189:2022 and the challenges for its implementation.
This presentation is divided into three parts and will present potential issues and shortfalls in current requirements management practices.
The first part provides a brief on the newly formed Medical Laboratories Special Interest Group that intends to provide practical guidance and solutions to medical laboratories around the world.
The second part addresses the changes that need to be considered during the ISO 15189:2022 implementation. Besides the continual release of highly relevant International Standards, additional change management considerations need to be applied during routine operations to maintain safe practices for both patients and personnel at all times.
The third part addresses the current challenges for internal auditing to fulfil Sub-clause 8.8.3 (Internal audits) of ISO 15189:2022 competently.
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