The  ISO 15189:2012 Lab Quality Management Foundation Training Course for medical laboratory management systems is a self-paced learning experience.  The over 3.5 hours of video content is delivered by one of the most reputable and experienced trainers in Africa. Students who invest time in this course will gain a foothold in understanding the ISO standard, gain the knowledge to begin to prepare their own facilities progress towards accreditation, and better appreciate the nuances required in establishing and maintaining quality management systems.

Learning Objectives

Upon completion of this course you will be able to: 

  • Understand in-depth the intent of the ISO 15189 standard and how clauses are implemented 
  • Be able to identify requirements for the ISO 15189 and actions needed to meet the intent 
  • Acquire skills needed for successful implementation and sustainment of quality management systems in the laboratory 
  • Understand the requirements of medical laboratory accreditation 
  • Understand the processes required to provide quality test results for patient care

Course Contributors

Risk Accredit Management Systems Global

RAMS Global is a team of experts in Quality Management Systems registered in Kenya.  Their experts have helped a number of institutions with certification and accreditation activities through training, mentorship, and assessments in Kenya, Uganda, Burundi, Tanzania, Botswana, Nigeria, Ethiopia, and Cameroon.
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Course Content

  • 1

    Welcome

    • How To Navigate This Course

    • ISO 15189 Foundation Course Pre-test

    • Introduction
  • 2

    Management Requirements

    • Quality Management Systems Establishment

    • Organization and Management Responsibility

    • Document Control and Control of Records

    • Service Agreements

    • Examination by Referral Facilities

    • External Services and Supplies

    • Advisory Services

    • Resolution of Complaints

    • Identification and Control of Non-Conformities

    • Corrective Action and Preventative Action

    • Continual Improvements

    • Evaluation and Audits

    • Management Reviews
  • 3

    Technical Requirements

    • Personnel

    • Accommodation and Environmental Condition

    • Laboratory Equipment

    • Pre-Examination Processes

    • Examination Processes

    • Ensuring Quality Examination Results

    • Post Examination Processes

    • Reporting of Results

    • Release of Results

    • Laboratory Information Management Systems
  • 4

    Conclusion

    • ISO 15189 Foundation Course Post-test

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