Implementation of ISO 15189:2022

This Course is design considering the needs for implementation of new medical laboratory standards in laboratories. The fourth edition of ISO 15189 is published in December 2022. The new standard ISO 15189:2022 is completely revised and appropriate knowledge of the standard is required for implementation of this standard in medical laboratory. One has to get trained into ISO 15189:2022 standard. Even after getting trained it is seen that many of the laboratory professional find it difficult and stuck with a question “From where to start?”, “How to start?”. Here with this course we have made an attempt to give a step by step approach for implementation of this new standard in medical laboratory. Although it is expected that those who are taking this course are already trained in the interpretation of all clauses of the ISO 15189:2022 standard, we have also given a brief overview of the ISO 15189:2022 standard in the beginning of the course. We have also explained about the need of quality manager, quality manual in medical laboratory. At the end of the course a brief overview of implementation of this standard in point of care testing facilities. We hope this course will be very useful for the medical laboratory professional for the implementation of ISO 15189:2022 in medical laboratory.

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