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ISO 15189 Medical Laboratory Accreditation Comprehensive Checklist and Implementation Guide

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Includes a practical, ready-to-use toolkit with implementation templates, worksheets, checklists, and decision-support materials so you can apply what you learn immediately - no additional setup required.
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ISO 15189 Medical Laboratory Accreditation Comprehensive Checklist and Implementation Guide



Course Overview

This comprehensive course is designed to provide medical laboratory professionals with the knowledge and skills necessary to implement the ISO 15189 standard for medical laboratory accreditation. The course is interactive, engaging, and comprehensive, with a focus on practical, real-world applications.



Course Objectives

  • Understand the requirements of the ISO 15189 standard for medical laboratory accreditation
  • Develop a comprehensive checklist for ISO 15189 implementation
  • Implement the ISO 15189 standard in a medical laboratory setting
  • Prepare for ISO 15189 accreditation
  • Maintain ISO 15189 accreditation


Course Outline

Module 1: Introduction to ISO 15189

  • Overview of the ISO 15189 standard
  • History and evolution of the standard
  • Benefits of ISO 15189 accreditation
  • Key concepts and terminology

Module 2: Understanding the ISO 15189 Standard

  • Clause 4: General Requirements
  • Clause 5: Management Requirements
  • Clause 6: Technical Requirements
  • Annexes and appendices

Module 3: Developing a Comprehensive Checklist

  • Identifying key requirements
  • Creating a checklist template
  • Populating the checklist with requirements
  • Reviewing and revising the checklist

Module 4: Implementing ISO 15189

  • Gap analysis and risk assessment
  • Developing an implementation plan
  • Establishing a quality management system
  • Training and awareness

Module 5: Preparing for Accreditation

  • Understanding the accreditation process
  • Preparing for the accreditation audit
  • Addressing nonconformities
  • Maintaining accreditation

Module 6: Maintaining Accreditation

  • Continuing compliance with ISO 15189
  • Monitoring and measuring performance
  • Continual improvement
  • Surveillance and recertification

Module 7: Special Topics

  • ISO 15189 and laboratory information systems
  • ISO 15189 and point-of-care testing
  • ISO 15189 and molecular diagnostics
  • ISO 15189 and emerging technologies

Module 8: Case Studies and Group Work

  • Real-world examples of ISO 15189 implementation
  • Group discussions and problem-solving
  • Sharing experiences and best practices


Course Features

  • Interactive and engaging: The course includes a range of interactive elements, including quizzes, discussions, and group work.
  • Comprehensive and up-to-date: The course covers all aspects of ISO 15189 implementation and is updated regularly to reflect changes to the standard.
  • Practical and applicable: The course focuses on practical, real-world applications of the ISO 15189 standard.
  • Expert instructors: The course is taught by experienced professionals with expertise in ISO 15189 implementation.
  • Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
  • Flexible learning: The course is available online, allowing participants to learn at their own pace.
  • User-friendly: The course is designed to be easy to navigate and use.
  • Mobile-accessible: The course is accessible on a range of devices, including smartphones and tablets.
  • Community-driven: The course includes opportunities for participants to connect with each other and share experiences.
  • Actionable insights: The course provides participants with practical insights and tools to implement ISO 15189.
  • Hands-on projects: The course includes hands-on projects and activities to help participants apply their knowledge.
  • Bite-sized lessons: The course is broken down into manageable, bite-sized lessons.
  • Lifetime access: Participants have lifetime access to the course materials.
  • Gamification: The course includes gamification elements to make learning more engaging.
  • Progress tracking: Participants can track their progress throughout the course.


What to Expect

Upon completion of this course, participants will have a comprehensive understanding of the ISO 15189 standard and the skills necessary to implement it in a medical laboratory setting. Participants will receive a certificate upon completion, issued by The Art of Service.

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