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

$201.00
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Course access is prepared after purchase and delivered via email
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Self-paced • Lifetime updates
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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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What does the ISO 15189 course cover?

ISO 15189 is covered here in 8 modules: Introduction to ISO 15189: History and development of the standard, Laboratory Risk Management: Monitoring and reviewing risk management plans, Quality Management Systems: Introduction to in medical laboratories and 5 more. The outline lists 30 specific topics, opening with overview of ISO 15189 and its importance in medical laboratories and closing with maintaining certification and.

How do you approach ISO 15189 step by step?

The work is sequenced in 8 stages. It starts with Introduction to ISO 15189: History and development of the standard, moves through Laboratory Risk Management: Monitoring and reviewing risk management plans and Quality Management Systems: Introduction to in medical laboratories, and ends at ISO 15189 Implementation and Certification: Preparing for and undergoing certification audits.

What is in Module 1 of the ISO 15189 course?

Module 1 is Introduction to ISO 15189: History and development of the standard. It works through overview of ISO 15189 and its importance in medical laboratories, history and development of the standard and key principles and concepts of ISO 15189. It sets the vocabulary the remaining 7 modules build on.

How is the ISO 15189 course delivered?

The ISO 15189 course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.

How much does the ISO 15189 course cost?

The ISO 15189 course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.

Closely related courses: ISO 17025, ISO/IEC 17025.

More answers: what you get with every course, refund policy, all help answers.

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: History and development of the standard

  • 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: Monitoring and reviewing risk management plans

  • 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 in medical laboratories

  • 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: Understanding and complying with industry standards

  • 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 in medical laboratories

  • 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: Conducting and reporting audits

  • 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: Developing and implementing a plan

  • 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: Preparing for and undergoing certification audits

  • 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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