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ISO 15189; A Step-by-Step Guide to Medical Laboratory Accreditation

ISO 15189; A Step-by-Step Guide to Medical Laboratory Accreditation

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ISO 15189: A Step-by-Step Guide to Medical Laboratory Accreditation



Course Overview

This comprehensive course provides a step-by-step guide to medical laboratory accreditation, based on the ISO 15189 standard. Participants will gain a thorough understanding of the requirements and processes involved in achieving accreditation, and will receive a certificate upon completion issued by The Art of Service.



Course Features

  • Interactive and engaging content
  • Comprehensive and personalized learning experience
  • Up-to-date and practical information
  • Real-world applications and case studies
  • High-quality content developed by expert instructors
  • Certification upon completion
  • Flexible learning options, including mobile accessibility
  • User-friendly interface and navigation
  • Community-driven discussion forums
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking features


Course Outline

Module 1: Introduction to ISO 15189 and Medical Laboratory Accreditation

  • Overview of the ISO 15189 standard
  • Importance of medical laboratory accreditation
  • Benefits of accreditation for laboratories and patients
  • Accreditation process and requirements

Module 2: Understanding the ISO 15189 Standard

  • Clause 1: Scope
  • Clause 2: Normative references
  • Clause 3: Terms and definitions
  • Clause 4: General requirements
  • Clause 5: Structural requirements
  • Clause 6: Resource requirements
  • Clause 7: Process requirements
  • Clause 8: Management requirements

Module 3: Implementing the ISO 15189 Standard

  • Establishing a quality management system
  • Defining policies and procedures
  • Identifying and addressing risks
  • Implementing corrective and preventive actions
  • Maintaining records and documentation

Module 4: Preparing for Accreditation

  • Conducting a gap analysis
  • Developing an action plan
  • Implementing changes and improvements
  • Training and awareness programs
  • Internal audits and management review

Module 5: The Accreditation Process

  • Application and initial assessment
  • On-site assessment and evaluation
  • Corrective actions and follow-up
  • Maintenance and surveillance
  • Re-accreditation and continuous improvement

Module 6: Maintaining Accreditation

  • Continual improvement and quality control
  • Internal audits and management review
  • Corrective and preventive actions
  • Changes and updates to the quality management system
  • Surveillance and re-accreditation

Module 7: Specialized Topics in Medical Laboratory Accreditation

  • Point-of-care testing and accreditation
  • Molecular diagnostics and accreditation
  • Quality control and quality assurance
  • Biosafety and biosecurity
  • Medical laboratory informatics and accreditation

Module 8: Case Studies and Group Discussions

  • Real-world examples of accreditation challenges and successes
  • Group discussions and problem-solving exercises
  • Sharing experiences and best practices


Certification

Upon completion of the course, participants will receive a certificate issued by The Art of Service, demonstrating their knowledge and understanding of the ISO 15189 standard and medical laboratory accreditation.



Conclusion

This comprehensive course provides a step-by-step guide to medical laboratory accreditation, based on the ISO 15189 standard. Participants will gain a thorough understanding of the requirements and processes involved in achieving accreditation, and will receive a certificate upon completion issued by The Art of Service.

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