Establishing an Iranian medical laboratory standard based on ISO 15189

Abstract

To strengthen clinical laboratories’ capabilities, the Reference Health Laboratory (RHL) of the Ministry of Health decided to compile a national professional laboratory standard to be followed by all medical laboratories in the country. Providing a national laboratory standard, as approved criteria for competency assessment, is also essential for establishment of a national accreditation system for medical laboratories. ISO 15189 addresses different processes and activities in a medical laboratory, but considering the local situation and limitations in the country it was not feasible to implement all the requirements of ISO 15189 at once in laboratories in different sectors and in different provinces of the country. For this reason, the RHL decided to define and publish the national standard, as minimum quality requirements that could be mandatory for all clinical laboratories throughout the country. After conducting a countrywide situation analysis, a national standard was composed by RHL expert committees and officially announced in September 2007. The main reference of this standard was ISO 15189:2007, although some important technical details were added to it from other credible references, such as WHO documents and CLSI guidelines. In this study, the Iranian national standard is compared to ISO 15189:2007 in terms of format and content in order to show how an international standard was localized for compiling a national standard.