In the "in vitro diagnostic testing medical laboratories" particular attention should be paid to the confidental and reliable operation as to 60-75% of the information for medical decisions are derived from laboratory tests. The high-quality laboratory work is based on the standards created by the national professional boards. Laboratories in Hungary (as any other country around the world) should comply with the various directives and/or standards set out requirements: MSZ EN ISO 15189:2013, MSZ EN ISO 22870:2006, MSZ EN ISO 15197:2013, Guide to the Expression of Uncertainty in Measurements (GUM), guidelines of the International Union of Pure and Applied Chemistry (IUPAC), etc. Special attention should be devoted to the quality of the work (internal and external quality assurance). Participation in proficiency testing (MSZ EN ISO 17043:2010) is a must, where the results are evaluated by statistical methods as defined by the ISO 13528:2005 standard. Some aspects are summarized how to select appropriate laboratory services.
|Translated title of the contribution||In vitro diagnostic medical testing laboratories and EU standards; Basic elements|
|Number of pages||12|
|Journal||Lege Artis Medicinae|
|Publication status||Published - 2014|
ASJC Scopus subject areas