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Mastering ISO 15189; A Step-by-Step Guide to Implementing a Medical Laboratory Quality Management System

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Mastering ISO 15189: A Step-by-Step Guide to Implementing a Medical Laboratory Quality Management System

Mastering ISO 15189: A Step-by-Step Guide to Implementing a Medical Laboratory Quality Management System

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 15189 standard and the skills needed to implement a quality management system in a medical laboratory. Participants will receive a certificate upon completion issued by The Art of Service.



Course Curriculum

The course is divided into the following modules:

  • Module 1: Introduction to ISO 15189
    • Overview of the ISO 15189 standard
    • History and development of the standard
    • Key concepts and principles
    • Benefits of implementing a quality management system
  • Module 2: Understanding the Requirements of ISO 15189
    • Clause 1: Scope
    • Clause 2: Normative references
    • Clause 3: Terms and definitions
    • Clause 4: Quality management system
    • Clause 5: Management responsibility
    • Clause 6: Resource management
    • Clause 7: Product realization
    • Clause 8: Measurement, analysis and improvement
  • Module 3: Establishing a Quality Management System
    • Defining the scope of the quality management system
    • Establishing quality objectives
    • Defining roles and responsibilities
    • Developing a quality policy
    • Creating a quality manual
  • Module 4: Implementing a Quality Management System
    • Developing procedures and work instructions
    • Training personnel
    • Implementing quality control measures
    • Conducting internal audits
    • Management review and continuous improvement
  • Module 5: Maintaining and Improving a Quality Management System
    • Monitoring and measuring performance
    • Identifying and addressing nonconformities
    • Continuously improving the quality management system
    • Maintaining records and documentation
  • Module 6: Auditing and Certification
    • Understanding the audit process
    • Preparing for an audit
    • Conducting an audit
    • Addressing audit findings
    • Maintaining certification
  • Module 7: Risk Management and Quality Management
    • Understanding risk management principles
    • Identifying and assessing risks
    • Developing risk mitigation strategies
    • Implementing risk management measures
    • Monitoring and reviewing risk management effectiveness
  • Module 8: Quality Management in Medical Laboratories
    • Understanding the role of quality management in medical laboratories
    • Implementing quality management in medical laboratories
    • Addressing unique challenges in medical laboratories
    • Maintaining quality management in medical laboratories
  • Module 9: Case Studies and Best Practices
    • Reviewing case studies of successful quality management system implementation
    • Sharing best practices for quality management system implementation
    • Discussing common challenges and solutions
  • Module 10: Final Project and Certification
    • Completing a final project to demonstrate understanding of the course material
    • Receiving a certificate upon completion issued by The Art of Service


Course Features

  • Interactive and Engaging: The course is designed to be interactive and engaging, with a mix of lectures, discussions, and hands-on activities.
  • Comprehensive: The course covers all aspects of ISO 15189 and quality management system implementation.
  • Personalized: The course is designed to meet the needs of individual participants, with opportunities for Q&A and discussion.
  • Up-to-date: The course is regularly updated to reflect the latest developments in ISO 15189 and quality management system implementation.
  • Practical: The course focuses on practical applications and real-world examples.
  • Real-world applications: The course includes case studies and examples from real-world organizations.
  • High-quality content: The course content is developed by experts in the field and is of high quality.
  • Expert instructors: The course instructors are experienced professionals with expertise in ISO 15189 and quality management system implementation.
  • Certification: Participants receive a certificate upon completion issued by The Art of Service.
  • Flexible learning: The course is designed to be flexible, with options for online or in-person learning.
  • User-friendly: The course is designed to be user-friendly, with easy-to-use navigation and clear instructions.
  • Mobile-accessible: The course is accessible on mobile devices, allowing participants to learn on-the-go.
  • Community-driven: The course includes opportunities for discussion and networking with other participants.
  • Actionable insights: The course provides actionable insights and practical advice for implementing a quality management system.
  • Hands-on projects: The course includes hands-on projects and activities to help participants apply their knowledge.
  • Bite-sized lessons: The course is divided into bite-sized lessons, making it easy to fit learning into a busy schedule.
  • Lifetime access: Participants have lifetime access to the course materials and resources.
  • Gamification: The course includes gamification elements, such as quizzes and challenges, to make learning fun and engaging.
  • Progress tracking: The course includes progress tracking, allowing participants to track their progress and stay motivated.
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