Journal of

Background and Aim: To improve the quality of laboratory services, World Health Organization (WHO) introduced ISO15189 standard. So, this study aimed to investigate implementation of the standard at Mycobacteriology Research Center (MRC) and determination of its adaptation.
Materials and Methods: At the first step, 12 organizational blocks of the laboratory was assessed by completion of the standard questionnaire. By implementation of the software and audit surveillance the second step was completed. Consequently, the given results were analyzed using SPSS Version 16. 
Results: By implementation of Quality Management System (QMS) at the three known focal points (pre analytical¸ analytical and post analytical), MRC was scored 80–100% points during 2013-2014; whereas previous QMS of the national reference TB laboratory (NRL) ranged from 48% to 79%
Conclusion: This study was the first of our knowledge in stepwise implementation of ISO15189 standard in Iran. Internal evaluation of the standard, our NRL ranked as a 5 star laboratory. We seeked international evaluation to accreditation of the national reference TB laboratory.