
Learn how to implement ISO 15189:2022 in medical laboratories, from understanding the fourth edition to conducting a gap analysis and applying an effective transfer within three years.
Understand ISO 15189:2022's eight-section framework, focusing on patient welfare, risk management, opportunities for improvement, and quality management, with implications for medical laboratories, imaging, and point-of-care testing.
This video explains the ISO 15189:2022 standard's emphasis on technical requirements and risk-based thinking, prioritizing patient safety, staff, environment, and facility risks, with a three-year transition until December 2025.
Identify training needs for ISO 15189 2022 implementation by training the trainers, raising awareness, and outlining a step-by-step plan across related standards, risk management, auditing, and disaster preparedness.
Explain how to implement ISO 15189:2022 through comprehensive gap analysis, training, and documentation updates, aligning current practices with the new standard to ensure risk management, patient care, and continual improvement.
Explain dilemmas in implementing ISO 15189:2022, noting a person with authority must manage the quality system, while quality manager and quality manual are not mandatory, with emphasis on emergency preparedness.
Learn how to implement ISO 15189:2022 in point-of-care testing facilities, covering readiness, infrastructure, operator training, service agreements, multidisciplinary committees, and quality assurance within a central laboratory management system.
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.