ISO 15189 - MODULE 2. Method and Process Requirements for Competence in a Medical/Clinical Laboratory

Course Objectives

This module covers clauses 5.4, 5.5 and 5.7 of the standard and will take up to 3 hours to complete.

Once the resources and infrastructure are in place, medical/clinical laboratory staff are required to develop, validate and implement the processes to be used in the laboratory under controlled conditions so as to produce technically valid results that will affect patient outcomes.  

Both pre-analytical (pre-examination) and post-analytical (post examination) sets of processes are examined in this Module. Exercises are designed to help participants understand their roles and responsibilities in the lab. The focus is on assuring the quality of examination results and this is covered in significant depth in Module 3 which follows, on Clause 5.6-Ensuring the quality of examination results.

Module 2 also introduces the concepts and disciplines of evidence-based medicine.