Abstract

OBRET, Yalainne; VEGA, Armando; PERERA, Carmen Laura  and  BETANCOURT, Arsenio. Introduction of a quality management system into the Unit of Animal Virology Diagnosis (UDVA). Rev Salud Anim. [online]. 2016, vol.38, n.1, pp.67-69. ISSN 0253-570X.

The Animal Health Organization (OIE) recommends diagnosis laboratories to develop their assays in correspondence with a quality management system (QMS). The Animal Virology Laboratory at the National Center for Animal and Plant Health proposed the planning of a QMS under the requirements of the NC ISO/IEC 17025:2006, and the biosecurity requirements established in the 180/2007 Resolution on Biological Safety were included. The documentation system as support of a QMS was established, which as main document had the quality manual with 20 sections describing the execution of the requirements included in the standards of reference. The laboratory competence was demonstrated by its participation in 10 assays of international proficiency for testing Classical swine fever (CSFV) with satisfactory results. The introduction of a system of quality management propitiated the laboratory recognition as a candidate to the OIE Reference Laboratory for CSFV diagnosis in Latin America and the Caribbean and its designation to organize proficiency testing to detect this disease.

Keywords : Quality Management System; reference laboratory.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )