Abstract

GARCIA TRETO, Diana Leydis et al. Integration of standards for the accreditation of biological tests at the Center for Bioactive Chemicals. Rev Salud Anim. [online]. 2021, vol.43, n.2  Epub Aug 15, 2021. ISSN 2224-4700.

The Center for Bioactive Chemicals (CBQ) requires biological testing to be sufficiently competitive and excellent, therefore it is working to continuously improve the effectiveness of its integrated management system and the accreditation of its laboratories. In order to make this work feasible, it is necessary to integrate the requirements of the current mandatory regulations for the accreditation of biological tests. The NC ISO/IEC 17025: 2017 standards were identified, with the criteria of the National Accreditation Body of the Republic of Cuba (ONARC) dated 2018, and the Regulation No. 39 of the Center for State Control of Medicines and Medical Devices (CECMED) dated 2004 (current edition).A high level of correspondence between both was evidenced by the integration of the highest percentage of the requirements, which allowed a better use of standard synergies, facilitated the diagnosis in the biological tests and saved efforts and expenditure of resources. In addition, the management system was improved by inserting the follow-up of nonconformities and the inclusion of the biological laboratory audits in the CBQ program.

Keywords : integration; regulations; accreditation; biological tests.

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