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Mastering ISO 15189; A Step-by-Step Guide to Laboratory Risk Management and Compliance

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Mastering ISO 15189: A Step-by-Step Guide to Laboratory Risk Management and Compliance



Course Overview

This comprehensive course is designed to provide laboratory professionals with a step-by-step guide to implementing ISO 15189, the international standard for medical laboratories. Participants will gain a deep understanding of laboratory risk management and compliance, and receive a certificate upon completion issued by The Art of Service.



Course Objectives

  • Understand the requirements of ISO 15189 and its application in medical laboratories
  • Develop a comprehensive risk management plan to ensure laboratory compliance
  • Implement effective quality management systems to improve laboratory operations
  • Ensure compliance with regulatory requirements and industry standards
  • Enhance patient safety and satisfaction through improved laboratory services


Course Outline

Module 1: Introduction to ISO 15189

  • Overview of ISO 15189 and its importance in medical laboratories
  • History and development of the standard
  • Key principles and concepts of ISO 15189

Module 2: Laboratory Risk Management

  • Introduction to risk management in medical laboratories
  • Identifying and assessing risks in the laboratory
  • Developing and implementing risk mitigation strategies
  • Monitoring and reviewing risk management plans

Module 3: Quality Management Systems

  • Introduction to quality management systems in medical laboratories
  • Developing and implementing a quality management system
  • Key components of a quality management system
  • Auditing and evaluating the quality management system

Module 4: Regulatory Compliance

  • Overview of regulatory requirements for medical laboratories
  • Understanding and complying with industry standards
  • Maintaining compliance with accreditation and certification requirements

Module 5: Patient Safety and Satisfaction

  • Introduction to patient safety and satisfaction in medical laboratories
  • Understanding patient needs and expectations
  • Developing and implementing patient-centered services
  • Measuring and evaluating patient satisfaction

Module 6: Auditing and Evaluating the Laboratory

  • Introduction to auditing and evaluating the laboratory
  • Developing and implementing an audit plan
  • Conducting and reporting audits
  • Evaluating and improving laboratory performance

Module 7: Continuous Improvement

  • Introduction to continuous improvement in medical laboratories
  • Developing and implementing a continuous improvement plan
  • Identifying and addressing areas for improvement
  • Evaluating and sustaining improvements

Module 8: ISO 15189 Implementation and Certification

  • Introduction to ISO 15189 implementation and certification
  • Developing and implementing an ISO 15189 implementation plan
  • Preparing for and undergoing certification audits
  • Maintaining certification and continuous improvement


Course Features

  • Interactive and engaging: The course includes interactive lessons, quizzes, and activities to keep participants engaged and motivated.
  • Comprehensive and personalized: The course covers all aspects of ISO 15189 and laboratory risk management, and provides personalized feedback and support.
  • Up-to-date and practical: The course includes the latest developments and best practices in laboratory risk management and compliance, and provides practical examples and case studies.
  • Real-world applications: The course includes real-world examples and case studies to illustrate key concepts and principles.
  • High-quality content: The course includes high-quality content, including video lessons, interactive activities, and downloadable resources.
  • Expert instructors: The course is taught by expert instructors with extensive experience in laboratory risk management and compliance.
  • Certification: Participants receive a certificate upon completion, issued by The Art of Service.
  • Flexible learning: The course is available online, and can be completed at any time and from any location.
  • User-friendly: The course is easy to navigate and use, and includes technical support and assistance.
  • Mobile-accessible: The course is accessible on mobile devices, allowing participants to learn on-the-go.
  • Community-driven: The course includes a community forum and discussion group, where participants can connect with each other and share experiences.
  • Actionable insights: The course provides actionable insights and practical advice, allowing participants to apply key concepts and principles in their own laboratories.
  • Hands-on projects: The course includes hands-on projects and activities, allowing participants to apply key concepts and principles in a practical way.
  • Bite-sized lessons: The course includes bite-sized lessons and activities, making it easy to fit learning into a busy schedule.
  • Lifetime access: Participants receive lifetime access to the course, allowing them to review and revisit key concepts and principles at any time.
  • Gamification: The course includes gamification elements, such as badges and points, to make learning fun and engaging.
  • Progress tracking: The course includes progress tracking and reporting, allowing participants to track their progress and stay motivated.
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