PREPARATION FOR IMPLEMENTATION OF ISO 9001 ON DEPARTMENT OF NEUROLOGY, UNIVERSITY MEDICAL CENTRE, LJUBLJANA

POVZETEK V letu 2011 se je vodstvo Univerzitetnega kliničnega centra Ljubljana (UKCL) odločilo za vpeljavo sistema managementa kakovosti po standardu ISO 9001:2008. Tako mora klinični oddelek za bolezni živčevja (KOBŽ), ki je del UKCL-ja, tudi izpolniti zahteve standarda ISO 9001:2008. V diplomskem delu je podrobneje predstavljen standard managementa kakovosti ISO 9001:2008, njegove zahteve in dokumentacija. Identificirani so procesi, ki se odvijajo na KOBŽ, katere je potrebno popisati pred uvedbo omenjenega sistema managementa kakovosti. Opisane so smernice za implementacijo standarda ISO 9001:2008, ki so razdeljene na šest korakov: identifikacija procesov, popis procesov, pregled popisov ter vpeljava morebitnih izboljšav trenutnih procesov, določitev protokolov za posamezne aktivnosti, izdelava »priročnika kakovosti«, vpeljava notranjih presoj. Ključnega pomena so se izkazale klinične poti in klinične smernice, ki bi lahko nudile podlago za popis in lastništvo procesov ter hkrati način izvajanja procesov. Predstavljena je analiza trenutnega stanja in primerjava z zahtevami standarda ISO 9001:2008. Kjer so ugotovljena neskladja z zahtevami so pripravljeni ukrepi za odpravo neskladij s pomočjo smernic za uvajanje standarda ISO 9001 v zdravstvo, IWA1.ABSTRACT In the Diploma Thesis a comprehensive overview of the requirements and documentation of the ISO 9001:2008 criteria for a quality management system which should be introduced at the Department of Neurology, University medical centre Ljubljana was elaborated. The ongoing processes of implementation of the ISO 9001:2008 standard are identified and guidelines for the implementation of the ISO 9001:2008 are described. These are divided in six steps: identification of the processesprocesses listing and overview (in addition, an advice for improvement of some of the processes is given)protocol identification for the activities needed to implement the standardsintroduction of a »quality manual«introduction of a system of internal estimation. Clinical pathways and clinical guidelines were identified to be of a major importance for processes` listing and identifying their proprietorship as well as their execution. In addition, analysis of the present state in comparison to the ISO 9001:2008 requirements was performed, as well. If discordance to the requirements was identified, measures for their solution were given according to the IWA1 guidelines for ISO 9001 standard implementation