This course provides a comprehensive understanding of laboratory quality management systems based on ISO 15189 requirements. It is designed for laboratory professionals, quality managers, students, and anyone involved in medical laboratory operations who want to develop practical knowledge of accreditation and compliance. The course covers all key aspects of laboratory processes, including resource management, equipment calibration, metrological traceability, reagent and consumable control, and service agreements.
You will learn how to manage pre-examination, examination, and post-examination processes, including sample collection, handling, transportation, and reporting of results. The course also explains critical topics such as method verification and validation, measurement uncertainty, internal quality control (IQC), external quality assessment (EQA), and ensuring the validity of results.
In addition, it focuses on risk-based thinking, nonconformity management, corrective actions, audits, and continual improvement of the management system. Practical guidance is provided on documentation, record control, and effective implementation of laboratory information systems.
