Implementation of ISO 15189 standard in a Quality Management System of Medical Laboratories

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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


16 Hours (2 Weekends, 4 Hours/Day)

Course Includes

  • Course Learning Material (theory and hands-on scenarios)
  • Sample forms and checklists
  • Certificate of professional development approved by CPD UK