Illuminating the path to ISO 15189 accreditation: a view from the Republic of North Macedonia

Abstract

In the Republic of North Macedonia, the work of the diagnostic medical laboratories is regulated by the Law of Health Care. There is an urgent need for better development of an evidence-based, scientific, and sustainable national strategy for the improvement of health laboratory service. Clear indicators of improvement have to be established. A key indicator should be the number of laboratories that have achieved and can maintain accreditation. The Macedonian Society of Medical Biochemistry and Laboratory Medicine (MSMBLM) recommends that the quality system established meets the requirements of the International Standard for medical laboratories (‘Medical laboratories: Requirements for quality and competence [EN ISO 15189:2012]. The accreditation of Macedonian medical laboratories is not mandatory; the decision for accreditation is voluntary. So far, nine medical laboratories have been accredited according the MKS EN ISO 15189:2013. Four of them are public sector laboratories. The small number of accredited laboratories could be the result of the shortage of financial resources, poor government attention to laboratory service, the shortage of qualified personnel and/or the lack of a national laboratory policy. The experiences of laboratory professionals from accredited laboratories, who have a high level of knowledge, skills, and competence, are crucially important to the process of developing a competent laboratory service within the national health system.