Exercises 2A– Risk Analysis – Significance of Non-conformities (NCs) in Medical Laboratories


The ISO 15189 Standard contains requirements for laboratory operations that promote the quality and competence of laboratory operations and the welfare and safety of patients and satisfaction of laboratory users. These requirements are also intended to address the risks that occur during a medical laboratory operation and the opportunities for improvement that may present. Failure to comply with these requirements are referred to as a lab being non-compliant. Non-compliances or non-conformities occur in many various aspects of lab operations.     

Identify potential non-conformities to the ISO 15189:2022 requirements that may occur in each of the Laboratory Discipline Areas listed below. List at least 3 different NCs for each Discipline. Address the areas 1-8 below (Sample Collection to Blood Bank).


In the microbiology area, a failure to monitor the incubator temperatures as required, is a non-conformity.

  1. Sample Collection & Handling
  2. Microbiology
  3. Haematology
  4. Chemistry
  5. Anatomic Pathology,
  6. Immunology & Serology
  7. Molecular Biology
  8. Blood Bank/Transfusion Services


Deadline: Friday April 12th, 2024