ISO 15189:2022 for Beginners

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About Course

This comprehensive introductory course demystifies the ISO 15189:2022 standard, the global benchmark for quality and competence in medical laboratories. Designed specifically for those new to accreditation, the course breaks down complex regulatory language into actionable laboratory practices. Through interactive simulations, “Grand Audit” quizzes, and clinical case studies, learners will transition from basic understanding to practical application, ensuring they can contribute meaningfully to a lab’s accreditation journey.

What Will You Learn?

  • Identify the core structure of the ISO 15189:2022 standard.
  • Distinguish between Management, Resource, and Process requirements.
  • Apply "Risk-Based Thinking" to everyday laboratory scenarios.
  • Execute basic Root Cause Analysis (RCA) for non-conformities.
  • Prepare documentation and evidence for internal and external audits.

Course Content

Topic 1: The Heart of Quality (Foundation & Ethics)
To understand that quality isn't just paperwork; it’s about patient safety and professional integrity.

Topic 2: Your Workspace & Tools (Resource Management)
Managing the daily tools of the trade—people, place, and equipment.

Topic 3: The Journey of a Sample (Process Requirements)
Following the workflow from the moment a test is requested to the moment the result is reported.

Topic 4: Fixing Mistakes and Getting Better (Management System)
Shifting the mindset from "hiding errors" to "learning from errors."

Final Course Exam & Assignment

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