Exercise 2B – Risk Analysis – Significance of Non-conformities (NCs) in Medical Laboratories

 

Identify potential non-conformities to the ISO 15189:2022 requirements that may occur in each of the following components of the Standard. List at least 3 different NCs for each component.

Example

In the Documentation & Records Component, a failure to give documents a unique ID is a non-conformity.

  1. Quality Management System
  2. Documentation & Records
  3. Personnel Competence & Training
  4. Equipment & Facilities
  5. Pre-analytic, Analytic, Post-analytic Phases
  6. Information Management
  7. Client Services
  8. Process Improvement
  9. Continual Improvement
  10. Corrective Actions
  11. Ethical Considerations
  12. Quality Control
  13. Test Validation & Verification
  14. Test Result Reporting
  15. EQA
  16. Safety & Environmental Practices
  17. Record Keeping & Data retention

 

Deadline: Friday April 12th, 2024