Status of Development and Implementation of Medical Laboratories Accreditation in Serbia

Abstract

Status of Development and Implementation of Medical Laboratories Accreditation in SerbiaThrough the release of the SRPS ISO 15189:2008 standard entitled >>Medicinske laboratorije: posebni zahtevi za kvalitet i kompetentnost<< conditions have been created for medical laboratory accreditation in Serbia. The application of the ISO 15189:2007 standard is an accepted mechanism for improvement of the quality of medical laboratory services throughout EU today. In that way, different approaches to the quality improvement of medical laboratories have been harmonized. Functional organisation of the accreditation process of medical laboratories in most European countries is mainly carried out in cooperation with national accreditation bodies, medical experts appointed by scientist associations and health departments. This type of collaboration has proven successful in the United Kingdom, Germany, Hungary, France, Finland, Croatia, etc. The experiences of the Accreditation Board of Serbia (ABS) in medical laboratory accreditation according to the SRPS ISO/IEC 17025:2006 standard (5 laboratories have been accredited) and the positive experiences of European countries in accreditation process constitute the basis for the development of the program for medical laboratory accreditation in Serbia. The first step in this direction is the set-up of the Committee consisting of experts from different medical fields, ABS experts and representatives of the competent Ministry, as well as the definition of their tasks, such as: preparation of the necessary documentation, set-up and preparation of qualification criteria and training programs for assessors, participation in the development of the external quality assessment scheme through interlaboratory testing, liaison with the European organisations for accreditation, organisation of mutual assessments with national and international assessors, participation in decision making on accreditation and accreditation maintenance.

Comparison of Laboratories Directors' and Assessors’ Opinions on Challenges and Solutions of Standardization in Iran: A Qualitative Study

“…Solutions proposed by both groups also mainly focused on the reasonable increase of laboratory tariff levels and the policy-level support of both standardization process and laboratories. The necessity of policy-level support for laboratory accreditation was also highlighted in studies conducted in Serbia and Thailand ( Gligic, 2008 ; Wattanasri et al, 2010 ). Also, in a study by Ravaghi et al the issue of lack of full support has been considered as a barrier affecting staff engagement with the quality improvement initiatives ( Ravaghi et al, 2014 ).…”