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(H) ISO u Hrvatskoj - Dr. Vedran Deletis
By Nenad N. Bach | Published  05/22/2002 | Business | Unrated
(H) ISO u Hrvatskoj - Dr. Vedran Deletis
Obavljena prva certifikacija prema ISO 13488:2000 u Hrvatskoj

First 13488:2000 ISO certification in Croatia

Dragi Nenade,

Ova vijest spada u privredna dostignuca Hrvatske. Mada je mozda za velike zemlje bez znacaja, za Hrvate je velika jer se upisujemo u zakonski verificirane proizvodjace.

Srdacno,
Vedran

Op-ed

I added Vedran's short profile because, he was more then instrumental in thissuccess. Besides the respect that he has in Croatian community and love for artthat he supports, he is even more recognized scientist.

NB


Tvrtka za proizvodnju neurokirurskih elektroda, SGM sa sjedistem u Splitu i proizvodnim pogonom u Starom Gradu na otokuHvaru, obavila je certifikaciju prema normi ISO 13488:2000 i 93/42-EEC. Ovime je SGM postao prva tvrtka u Hrvatskoj koja posjeduje ovunormu. 

ISO 13488 koji od 2000. godine zamjenjuje normu EN 46002 obvezan je uvjet za sve proizvodjace medicinskeopreme. Isto tako za zemlje EU, obvezna je i primjena direktive 93/42-EEC koja sadrzi dodatne zahtjeve u odnosu na ISO 13488. SGM je ovom certifikacijom stvorio integrirani sustav upravljanja procesima sa certificiranim proizvodima i CEmarkicom, sto predstavlja jedini takav sustav u Hrvatskoj. Kako isticu u SGM-u, tvrtka je odlucila certificirati svoje proizvode i na taj nacin potpuno rijesiti sve prepreke okoizvoza, bez obzira u koje zemlje se proizvod izvozi. Iako je do nedavno bilo smatrano da je ISO 9001dovoljan, bez zadovoljenja svih normi poslovanje sa inozemstvom postalo binemoguce. EU sve cesce pretpostavlja primjenu njenih direktiva bilo kakvom poslovanju na njenomteritoriju. Tek se rijetke hrvatske tvrtke odlucuju na cjelovit pristup rjesavanju ovogproblema. Cesci je primjer izvoza pod imenima kupaca u zemljama u koje se izvozi. Na taj nacin hrvatske tvrtke gube bitku sa stranom konkurencijom vec na samoj hrvatskojgranici. Certifikaciju su izvrsili Drago Goic iz DNV-a Zagreb i Augusto Cerina izDNV-a Rim. Ovime je DNV Zagreb pokazao da prati najnovije europske trendove u certifikaciji i da je u stanju izvesti certifikaciju prema svim EU direktivama u zemljama koje nisu claniceEU. Hrvatske tvrtke trebale bi iskoristiti ovu priliku. (DNV News in brief)

************

VedranDeletis, M.D., Ph.D.

Director,Division of Intraoperative Neurophysiology, INN

A leading scientist in his field, Vedran Deletis, M.D., PH.D., is Director of Intraoperative Neurophysiology at the Institute for Neurology and Neurosurgery (INN) of the Beth Israel Medical Center. The INN is a state-of-the-art pediatric and adult diagnosis and treatment center for patients who have neurological disorders. Intraoperative Neurophysiology assesses and helps sustain the wellbeing and integrity of the nervous system during neurological surgery. Dr. Deletis joined the INN in 1996 from NYU where he was Director of the Intraopeartive Neurophysiology department.
A clinical neurophysiologist and neurologist by training, Dr. Deletis is known for designing and implementing new approaches and methods to intraoperative neurophysiology which have radically improve prognosis and help to minimize motor neurological deficit during neurological surgery. Dr. Deletis has created and heads a fellowship program at INN.
Dr. Deletis is an active member of the American Academy of Clinical Neurophysiology, a fellow who has served as member of the executive board of the American Society for Neurophysiological Monitoring, Chairman of the VI International Symposium on Spinal Cord Monitoring, and Chairman of the New York Symposium on Intraoperative Neurophysiological Monitoring in Neurosurgery. Dr. Deletis has received a fellowship from the Baylor College of Medicine in Houston, Texas. He is the author of 42 scientific papers and 11 book chapters in the field of intraoperative neurophysiology.
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