“Clinic laboratory accreditation with ISO 15189:2007 in the European Union”: report of the VI European symposium on clinical laboratory and in vitro diagnostic industry

Abstract

In May 2011, the Catalan Association of Clinical Laboratory Sciences (ACCLC) organized in Barcelona the VI edition of the biennial European symposium ‘‘The clinical laboratory and in vitro diagnostic industry’’ dedicated to the clinical laboratories accreditation according to ISO 15189:2007 standard [1]. It was chaired by Dr. Xavier Fuentes-Arderiu and technically prepared by Dr. Francesca Canalias. Welcoming the participants, X. Fuentes-Arderiu remarked on the importance of these symposia to promote the dialogue between professionals of the clinical laboratory and those of the diagnostic in vitro industry, in view of their inseparable activities and similar challenges. Later, Isabel de la Villa-Porras, from the Spanish Entidad Nacional de Acreditacion y Certificacion (ENAC) gave an opening speech on the current state of accreditation with the standard ISO 15189:2007 in the European Union. There was a starting situation of heterogeneity between countries because of differences in standards, evaluation bodies, international recognition of them, and a degree of implementation of ISO/IEC 17025:2005, ISO 9001:2008 [2] or other standards. The ISO 15189:2007 offered a common standard, including management system requirements and technical competence requirements [1, 3], with a language relevant to clinical laboratories and that can be evaluated by accreditation bodies that are recognition based on multilateral recognition arrangements (MLA) [4]. The publication of the Regulation (EC) No 765/2008 of the European Parliament and of the Council led to unifying the legislation of each state and to establishing requirements and authority of the national accreditation bodies. In Spain, the R.D. 1715/2010 designated ENAC as the accreditation body. ENAC performed a European survey that showed that most of the countries think that clinical laboratories would have to accredit all or part of their activity, in a voluntary manner or not, according to ISO 15189:2007 or ISO 17025:20005 standards. Although the number of clinical laboratories accredited according to the former standard has increased, this is difficult to quantify because of differences in the definitions of ‘‘clinical laboratory’’ (one or more centers and of very different sizes). The national accreditation bodies, assisted by national professional associations, should safeguard homogeneous interpretation of the standards, also in coordination with the international accreditation bodies. After this opening session, there were four round table discussions. The topics and results of which are reported in what follows. In each session, a moderator formulated a set of open questions; involving first the experts at the table and afterward addressing all participants present [5].