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6. Slovenski veterinarski kongres 2016 - Vabljeno predavanje
ZAGOTAVLJANJE KAKOVOSTI V VETERINARSKIH PRESKUŠEVALNIH LABORATORIJIH
Tina Pirš
Veterinarska fakulteta, Univerza v Ljubljani, Ljubljana, Slovenija tina.pirs@vf.uni-lj.si
Veterinarski preskuševalni laboratoriji s svojimi rezultati igrajo pomembno vlogo pri prostem prometu z živalmi in živalskimi produkti, varstvu zdravja živali in tudi pri pristopu »eno zdravje«. Pri tem sta ključni kakovost laboratorijskega preskušanja in standardizacija, s katero dosežemo mednarodno primerljivost in prepoznavnost rezultatov. Uradni laboratoriji morajo slediti zakonskim zahtevam in biti po direktivi (EC) 882/2004 akreditirani po standardu ISO/IEC 17025, hkrati pa je zagotavljanje zanesljivih rezultatov in pravilnega preskušanja pomembno za vse uporabnike laboratorijskih storitev. Z akreditacijo laboratorij dokaže, da v procesu laboratorijskega dela sledi načelom kakovosti v vseh korakih - pred analitiko, med analitiko in po analitiki ter da je zavezan k stalnemu izboljševanju in učinkovitosti. Sistem kakovosti po tem standardu predstavlja tudi osnovo za nadgradnjo z drugimi sistemi kakovosti kot sta dobra proizvodna praksa ali dobra laboratorijska praksa v skladu za načeli OECD. Priporočila kodeksa dobre veterinarske prakse natančno opisujejo zahteve sistema vodenja kakovosti za vse veterinarske organizacije in so dobra osnova za pridobitev certifikata ISO 9001. Pomembna razlika med izvajanjem dobrega strokovnega dela v katerikoli veterinarski organizaciji in pridobitvijo formalne akreditacije ali certifikacije je v količini potrebne dokumentacije sistema kakovosti. Namen prispevka je predstaviti različne možnosti sistemov vodenja kakovosti v veterinarski medicini, prednosti in bremena formalne akreditacije ali certifikacije ter njihovo uporabnost iz primerov v praksi.
Ključne besede: zagotavljanje kakovosti; preskuševalni laboratoriji; veterinarska medicina
Quality assurance in veterinary testing laboratories
Veterinary testing laboratories play an important role as providers of the test results that enable free trade of animals and animal products, animal health protection and also "one health" approach. The quality of testing and standardization are key factors for internationally comparable and recognized results. Official laboratories are required to be accredited to ISO/IEC 17025 by Regulation (EC) 882/2004. However, the guarantee of reliable results and soundness of testing are important for all users of laboratory services. Accreditation enables the laboratory to prove that the quality principles are followed in pre-analytical, analytical and post-analytical phases of the testing process. Laboratory is committed to continual improvements and effectiveness. The application of ISO/IEC 17025 standard can be a good basis for developing other quality systems such as good laboratory and manufacturing practice in accordance with OECD principles. The Code of Good Veterinary Practice describes the requirements relating to the quality management system within a veterinary organisation which are good basis to achieve ISO 9001
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certification. The important difference between good professional work and gaining a formal accreditation or certification is the amount of quality system documentation. The purpose of this presentation is to introduce different possibilities of quality management systems in veterinary medicine, benefits and also burden of formal accreditation or certification and their practical application.
Key words: quality assurance; testing laboratories; veterinary medicine