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Module 14: Examination Process

Performance of laboratory examinations is second nature, but some elements of ISO 15189 can be challenging. This module will help you to decipher clauses on validation and verification, the documentation of technical procedures, traceability and uncertainty of measurement, the establishment of biological reference intervals and using external quality assessment.
  • Learn how to document procedures
  • Gain an understanding of method validation
  • Gain an understanding of uncertainty of measurement
  • Learn about requirements for quality control and quality assurance for both quantitative and qualitative examinations
  • Learn about proficiency testing or external quality assessment requirements
Bonus Material
  • Readiness Workbook
  • Coaching Tips
  • Downloadable PDF files
Key Content
  1. Selection of Procedures, Development of In-house Procedures
  2. Validation/Verification
  3. Documenting Procedures
  4. Traceability
  5. Performance Specifications
  6. Biological Reference Intervals
  7. Communication to Users
  8. Internal QC Systems
  9. Uncertainty of Measurement
  10. Calibration and Verification of Trueness
  11. EQA Schemes
  12. Quantitative QC and QA
  13. Qualitative QC and QA

Institute for Quality
Management in Healthcare

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