This interactive course is designed for understanding how to implement the Quality Management System Model required for ISO 15189 standard at medical laboratories. It provides stepwise guidance towards ISO 15189 accreditation.
- Explain the principles of ISO 15189: 2012 “Medical laboratories – Requirements for quality and competence”
- Envisioning change to ISO15189 (2022)
- Step-Wise plan for the process of implementing the QMS model in the phases of the total laboratory testing cycle including:
- Safety requirements
- Employee competency, preparing lab staff for an audit
- Customer needs
- Preventive maintenance program, an inventory control program, sample management
- Quality control, accuracy, and precision, EQA program
- Occurrence Management
- Tools to monitor laboratory processes
- The quality manual, SOP, policy, and procedure
- Laboratory information management system
- Risk management process
- The sources of laboratory errors
- Use the tool Organizational Culture Assessment Instrument “OCAI”
- Discover other ISO standards available to help medical laboratories
- Quality management system introduction
- The need for laboratory norms and standards, principles of ISO 15189
- Quality assurance, quality control, accuracy, and precision
- Information Management System
- Continuous Process Improvement
- Laboratory document management system
- Quality assessment, accreditation, proficiency testing; and Audit Programs: Internal and External
- Occurrence, Nonconforming Event Management
- Risk management process. Apply FMEA, know Lean and Six Sigma, and root cause analysis
- Creating quality indicators
- Patient safety focus and lab diagnostic errors, building a “Just Culture”
Learning options range from completely classroom-based courses to interactive online live programs.
Courses could be tailored to fit the needs and schedules of group participants.
- Laboratory managers
- Quality managers
- Pathologists
- Technologists of medical laboratories, and public health laboratories
- Students of medical lab sciences