{"id":76246,"date":"2025-05-27T12:42:34","date_gmt":"2025-05-27T10:42:34","guid":{"rendered":"https:\/\/skrivanek.cz\/?p=76246"},"modified":"2025-05-27T12:49:57","modified_gmt":"2025-05-27T10:49:57","slug":"iso-13485-certifikace-ktera-garantuje-nejvyssi-standardy-v-prekladech-zdravotnicke-dokumentace","status":"publish","type":"post","link":"https:\/\/skrivanek.cz\/cz\/novinky\/iso-13485-certifikace-ktera-garantuje-nejvyssi-standardy-v-prekladech-zdravotnicke-dokumentace\/","title":{"rendered":"ISO 13485: Certifikace, kter\u00e1 garantuje nejvy\u0161\u0161\u00ed standardy v&nbsp;p\u0159ekladech zdravotnick\u00e9 dokumentace"},"content":{"rendered":"<p data-start=\"249\" data-end=\"629\">Ve spole\u010dnosti Sk\u0159iv\u00e1nek jsme ud\u011blali dal\u0161\u00ed d\u016fle\u017eit\u00fd krok ke zkvalitn\u011bn\u00ed na\u0161ich jazykov\u00fdch slu\u017eeb. Z\u00edsk\u00e1n\u00edm certifikace <strong data-start=\"410\" data-end=\"423\">ISO 13485<\/strong> jsme ofici\u00e1ln\u011b potvrdili, \u017ee procesy p\u0159i&nbsp;zpracov\u00e1n\u00ed p\u0159eklad\u016f pro oblast zdravotnick\u00fdch prost\u0159edk\u016f odpov\u00eddaj\u00ed nejp\u0159\u00edsn\u011bj\u0161\u00edm mezin\u00e1rodn\u00edm standard\u016fm.<\/p>\n<h3 data-start=\"631\" data-end=\"681\">Co je ISO 13485 a&nbsp;pro\u010d je d\u016fle\u017eit\u00e1?<\/h3>\n<p data-start=\"614\" data-end=\"966\"><strong data-start=\"614\" data-end=\"627\">ISO 13485<\/strong> je mezin\u00e1rodn\u00ed norma pro syst\u00e9m managementu kvality specificky navr\u017een\u00e1 pro v\u00fdrobce, distributory a&nbsp;dodavatele <strong data-start=\"739\" data-end=\"768\">zdravotnick\u00fdch prost\u0159edk\u016f<\/strong>. Certifikace zaru\u010duje, \u017ee organizace spl\u0148uje legislativn\u00ed po\u017eadavky a&nbsp;uplat\u0148uje p\u0159\u00edsn\u00e9 kontroln\u00ed a&nbsp;dokumenta\u010dn\u00ed procesy, kter\u00e9 jsou kl\u00ed\u010dov\u00e9 pro bezpe\u010dnost a&nbsp;kvalitu produkt\u016f a&nbsp;souvisej\u00edc\u00edch slu\u017eeb.<\/p>\n<p data-start=\"968\" data-end=\"1215\">V kontextu jazykov\u00fdch slu\u017eeb tato certifikace potvrzuje, \u017ee <strong data-start=\"1028\" data-end=\"1111\">p\u0159eklady medic\u00ednsk\u00fdch dokument\u016f, n\u00e1vod\u016f, p\u0159\u00edbalov\u00fdch let\u00e1k\u016f \u010di&nbsp;klinick\u00fdch studi\u00ed<\/strong> prob\u00edhaj\u00ed podle p\u0159esn\u011b stanoven\u00fdch pravidel, s&nbsp;d\u016frazem na p\u0159esnost, konzistenci a&nbsp;plnou dohledatelnost.<\/p>\n<p data-start=\"1073\" data-end=\"1135\">Z\u00edsk\u00e1n\u00edm certifikace ISO 13485 prokazujeme, \u017ee p\u0159i&nbsp;p\u0159ekladech:<\/p>\n<ul data-start=\"1137\" data-end=\"1475\">\n<li data-start=\"1137\" data-end=\"1199\">\n<p data-start=\"1139\" data-end=\"1199\">dodr\u017eujeme <strong data-start=\"1150\" data-end=\"1188\">procesn\u00ed \u0159\u00edzen\u00ed a&nbsp;kontrolu kvality<\/strong> dle normy,<\/p>\n<\/li>\n<li data-start=\"1200\" data-end=\"1290\">\n<p data-start=\"1202\" data-end=\"1290\">sledujeme a&nbsp;dokumentujeme ka\u017edou f\u00e1zi projektu (od p\u0159\u00edjmu zad\u00e1n\u00ed a\u017e po&nbsp;dod\u00e1n\u00ed p\u0159ekladu),<\/p>\n<\/li>\n<li data-start=\"1291\" data-end=\"1364\">\n<p data-start=\"1293\" data-end=\"1364\"><strong data-start=\"1293\" data-end=\"1312\">\u0161kol\u00edme n\u00e1\u0161 t\u00fdm<\/strong> ve specifick\u00fdch po\u017eadavc\u00edch zdravotnick\u00e9ho sektoru,<\/p>\n<\/li>\n<li data-start=\"1365\" data-end=\"1475\">\n<p data-start=\"1367\" data-end=\"1475\">uplat\u0148ujeme <strong data-start=\"1379\" data-end=\"1400\">rizikovou anal\u00fdzu<\/strong>, nap\u0159.&nbsp;pro identifikaci potenci\u00e1ln\u00edch bod\u016f selh\u00e1n\u00ed v&nbsp;p\u0159ekladu nebo revizi.<\/p>\n<\/li>\n<\/ul>\n<h3 data-start=\"1771\" data-end=\"1818\">Pro koho je certifikace nejv\u011bt\u0161\u00edm p\u0159\u00ednosem?<\/h3>\n<div class=\"columns columns-2\" data-columns=\"2\">\n<div class=\"column column-1\">\n<p data-start=\"1820\" data-end=\"1873\">Certifikace ISO 13485 je z\u00e1sadn\u00ed v\u00fdhodou zejm\u00e9na pro:<\/p>\n<ul>\n<li><strong>v\u00fdrobce zdravotnick\u00fdch prost\u0159edk\u016f,<\/strong><\/li>\n<li><strong>farmaceutick\u00e9 spole\u010dnosti,<\/strong><\/li>\n<li><strong>dodavatele do nemocnic a\u00a0laborato\u0159\u00ed,<\/strong><\/li>\n<li><strong>v\u00fdvoj\u00e1\u0159e zdravotnick\u00e9ho software,<\/strong><\/li>\n<li><strong>klinick\u00e9 v\u00fdzkumn\u00e9 organizace.<\/strong><\/li>\n<\/ul>\n<\/div>\n<div class=\"column column-2\">\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-76278\" src=\"https:\/\/skrivanek.cz\/wp-content\/uploads\/2025\/05\/medicinske-preklady-iso-13485-948x520.jpg\" alt=\"medic\u00ednsk\u00e9 p\u0159eklady - certifikovan\u00e1 spole\u010dnost iso 13485\" width=\"948\" height=\"520\" data-wp-editing=\"1\" \/><\/p>\n<\/div>\n<\/div>\n<p data-start=\"2064\" data-end=\"2203\">\u00a0<\/p>\n<p data-start=\"2064\" data-end=\"2203\">D\u00edky t\u00e9to certifikaci m\u00e1te jistotu, \u017ee va\u0161e jazykov\u00e9 partnerstv\u00ed s&nbsp;n\u00e1mi odpov\u00edd\u00e1 po\u017eadavk\u016fm regul\u00e1tor\u016f nejen v&nbsp;EU, ale i&nbsp;na glob\u00e1ln\u00edm trhu.<\/p>\n<h3 data-start=\"1217\" data-end=\"1270\">Jak\u00e9 v\u00fdhody p\u0159in\u00e1\u0161\u00ed ISO 13485 klient\u016fm Sk\u0159iv\u00e1nka?<\/h3>\n<p data-start=\"434\" data-end=\"670\">Z\u00edsk\u00e1n\u00edm certifikace ISO 13485 deklarujeme, \u017ee <a href=\"https:\/\/skrivanek.cz\/cz\/preklady\/medicinske-preklady\/\">p\u0159eklady pro oblast zdravotnick\u00fdch prost\u0159edk\u016f<\/a> zaji\u0161\u0165ujeme v&nbsp;souladu s&nbsp;procesy, kter\u00e9 odpov\u00eddaj\u00ed po\u017eadavk\u016fm regulovan\u00e9ho prost\u0159ed\u00ed. Pro na\u0161e klienty to znamen\u00e1 n\u00e1sleduj\u00edc\u00ed konkr\u00e9tn\u00ed p\u0159\u00ednosy:<\/p>\n<h5 data-start=\"672\" data-end=\"731\"><strong>P\u0159eklady optimalizovan\u00e9 pro regulatorn\u00ed prost\u0159ed\u00ed<\/strong><\/h5>\n<p data-start=\"732\" data-end=\"947\">Zpracov\u00e1v\u00e1me dokumentaci s&nbsp;d\u016frazem na <strong data-start=\"770\" data-end=\"845\">terminologickou p\u0159esnost, struktur\u00e1ln\u00ed konzistenci a&nbsp;form\u00e1ln\u00ed spr\u00e1vnost<\/strong> \u2013 faktory, kter\u00e9 jsou kl\u00ed\u010dov\u00e9 p\u0159i&nbsp;kontrole dokument\u016f notifikovan\u00fdmi osobami nebo regulatorn\u00edmi \u00fa\u0159ady.<\/p>\n<h5 data-start=\"949\" data-end=\"995\"><strong>D\u016fraz na bezpe\u010dnost a&nbsp;dohledatelnost<\/strong><\/h5>\n<p data-start=\"996\" data-end=\"1235\">Ka\u017ed\u00fd projekt je \u0159\u00edzen v&nbsp;souladu s&nbsp;certifikovan\u00fdmi procesy \u2013 <strong data-start=\"1057\" data-end=\"1106\">p\u0159eklad, revize, korektura i&nbsp;kontrola kvality<\/strong> jsou dokumentovan\u00e9, auditovateln\u00e9 a&nbsp;zp\u011btn\u011b dohledateln\u00e9.<br data-start=\"1163\" data-end=\"1166\" \/><br \/>\nPracujeme v&nbsp;bezpe\u010dn\u00e9m IT prost\u0159ed\u00ed odpov\u00eddaj\u00edc\u00edm norm\u011b <strong data-start=\"1221\" data-end=\"1234\">ISO 27001<\/strong>.<\/p>\n<h5 data-start=\"1237\" data-end=\"1269\"><strong>Odborn\u011b \u0161kolen\u00fd t\u00fdm<\/strong><\/h5>\n<p data-start=\"1270\" data-end=\"1475\">Va\u0161e projekty sv\u011b\u0159ujeme specialist\u016fm se zku\u0161enostmi v&nbsp;oboru zdravotnick\u00fdch prost\u0159edk\u016f, kte\u0159\u00ed rozum\u011bj\u00ed jak odborn\u00e9mu obsahu, tak specifick\u00e9mu stylu a&nbsp;jazykov\u00fdm konvenc\u00edm pou\u017e\u00edvan\u00fdm v&nbsp;regulovan\u00e9 dokumentaci.<\/p>\n<h5 data-start=\"1477\" data-end=\"1512\"><strong>Sn\u00ed\u017een\u00ed jazykov\u00e9ho rizika<\/strong><\/h5>\n<p data-start=\"1513\" data-end=\"1741\">Na\u0161e pracovn\u00ed postupy zahrnuj\u00ed kontroln\u00ed mechanismy pro identifikaci a&nbsp;eliminaci terminologick\u00fdch nep\u0159esnost\u00ed, stylistick\u00fdch odchylek nebo potenci\u00e1ln\u00edch nejednozna\u010dnost\u00ed, kter\u00e9 by mohly zkomplikovat dal\u0161\u00ed zpracov\u00e1n\u00ed dokumentace.<\/p>\n<h3 data-start=\"2928\" data-end=\"2994\">Sk\u0159iv\u00e1nek jako kvalifikovan\u00fd partner pro zdravotnick\u00e9 p\u0159eklady<\/h3>\n<p data-start=\"2996\" data-end=\"3234\">V\u00fdb\u011br jazykov\u00e9ho partnera pro oblast zdravotnick\u00fdch prost\u0159edk\u016f je strategick\u00fdm rozhodnut\u00edm. Kvalitn\u00ed p\u0159eklad m\u016f\u017ee urychlit vstup produktu na trh, zat\u00edmco nekvalitn\u00ed zpracov\u00e1n\u00ed m\u016f\u017ee v\u00e9st k\u00a0zam\u00edtnut\u00ed dokumentace nebo zpo\u017ed\u011bn\u00ed v\u00a0certifikaci.<\/p>\n<p data-start=\"3236\" data-end=\"3337\">Sk\u0159iv\u00e1nek nab\u00edz\u00ed jedine\u010dnou kombinaci jazykov\u00e9 odbornosti a\u00a0systematick\u00e9ho p\u0159\u00edstupu k\u00a0\u0159\u00edzen\u00ed kvality:<\/p>\n<ul data-start=\"3339\" data-end=\"3842\">\n<li data-start=\"3339\" data-end=\"3453\">\n<p data-start=\"3341\" data-end=\"3453\"><strong data-start=\"3341\" data-end=\"3399\">certifikace <a href=\"https:\/\/skrivanek.cz\/wp-content\/uploads\/2025\/04\/iso-13485-2016-cs.pdf\">ISO 13485<\/a>, <a href=\"https:\/\/skrivanek.cz\/wp-content\/uploads\/2021\/03\/certifikat-en-iso-171002015.pdf\">ISO 17100<\/a>, <a href=\"https:\/\/skrivanek.cz\/wp-content\/uploads\/2021\/03\/iso-9001-2015-1.pdf\">ISO 9001<\/a> a&nbsp;<a href=\"https:\/\/skrivanek.cz\/wp-content\/uploads\/2021\/03\/iso-27001-2015-1.pdf\">ISO 27001<\/a><\/strong> \u2013 garance kvality, procesn\u00ed bezpe\u010dnosti a\u00a0ochrany dat,<\/p>\n<\/li>\n<li data-start=\"3454\" data-end=\"3565\">\n<p data-start=\"3456\" data-end=\"3565\"><strong data-start=\"3456\" data-end=\"3471\">odborn\u00fd t\u00fdm<\/strong> se zku\u0161enost\u00ed v&nbsp;oblasti medic\u00edny, techniky a&nbsp;regula\u010dn\u00edho prost\u0159ed\u00ed,<\/p>\n<\/li>\n<li data-start=\"3566\" data-end=\"3712\">\n<p data-start=\"3568\" data-end=\"3712\"><strong data-start=\"3568\" data-end=\"3593\">prokazateln\u00e9 know-how<\/strong> z\u00a0oblasti p\u0159eklad\u016f n\u00e1vod\u016f k\u00a0pou\u017eit\u00ed, technick\u00fdch specifikac\u00ed, klinick\u00fdch hodnocen\u00ed, ozna\u010dov\u00e1n\u00ed UDI a\u00a0dal\u0161\u00edch dokument\u016f,<\/p>\n<\/li>\n<li data-start=\"3713\" data-end=\"3842\">\n<p data-start=\"3715\" data-end=\"3842\"><strong data-start=\"3715\" data-end=\"3772\">terminologick\u00e9 \u0159\u00edzen\u00ed a&nbsp;konzistentn\u00ed stylov\u00e1 politika<\/strong>, kter\u00e1 odpov\u00edd\u00e1 po\u017eadavk\u016fm na dokumentaci pro zdravotnick\u00e9 prost\u0159edky.<\/p>\n<\/li>\n<\/ul>\n<h3 data-start=\"166\" data-end=\"233\">Nepodce\u0148te s\u00edlu kvalitn\u00edho p\u0159ekladu.<\/h3>\n<p data-start=\"235\" data-end=\"545\">V regulovan\u00e9m zdravotnick\u00e9m sektoru m\u016f\u017ee \u0161pi\u010dkov\u00fd p\u0159eklad rozhodovat o&nbsp;schv\u00e1len\u00ed dokumentace i&nbsp;o&nbsp;d\u016fv\u011bryhodnosti va\u0161\u00ed zna\u010dky. Spolupr\u00e1ce se Sk\u0159iv\u00e1nkem znamen\u00e1 jistotu, \u017ee jazykov\u00e1 str\u00e1nka va\u0161ich materi\u00e1l\u016f bude spl\u0148ovat n\u00e1roky nejen na p\u0159esnost, ale i&nbsp;na plnou form\u00e1ln\u00ed, terminologickou a&nbsp;stylistickou spr\u00e1vnost.<\/p>\n<p data-start=\"547\" data-end=\"703\">\u2705 P\u0159eklady v&nbsp;souladu s&nbsp;normou ISO 13485<br data-start=\"586\" data-end=\"589\" \/><br \/>\n\u2705 T\u00fdm s&nbsp;odbornost\u00ed ve zdravotnick\u00e9 terminologii<br data-start=\"636\" data-end=\"639\" \/><br \/>\n\u2705 Bezpe\u010dnost dat dle ISO 27001<br data-start=\"669\" data-end=\"672\" \/><br \/>\n\u2705 Transparentn\u00ed \u0159\u00edzen\u00ed projekt\u016f<\/p>\n<p data-start=\"705\" data-end=\"893\"><strong data-start=\"705\" data-end=\"754\">Z\u00edskejte partnera, kter\u00fd rozum\u00ed va\u0161im v\u00fdzv\u00e1m.<\/strong><br data-start=\"754\" data-end=\"757\" \/><br \/>\n\ud83d\udce9 <a class=\"cursor-pointer\" href=\"https:\/\/skrivanek.cz\/cz\/poptavka\/preklad\/\" data-start=\"760\" data-end=\"811\">Kontaktujte n\u00e1s.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ve spole\u010dnosti Sk\u0159iv\u00e1nek jsme ud\u011blali dal\u0161\u00ed d\u016fle\u017eit\u00fd krok ke zkvalitn\u011bn\u00ed na\u0161ich jazykov\u00fdch slu\u017eeb. Z\u00edsk\u00e1n\u00edm certifikace ISO 13485 jsme ofici\u00e1ln\u011b potvrdili, \u017ee procesy p\u0159i&nbsp;zpracov\u00e1n\u00ed p\u0159eklad\u016f pro oblast zdravotnick\u00fdch prost\u0159edk\u016f odpov\u00eddaj\u00ed nejp\u0159\u00edsn\u011bj\u0161\u00edm mezin\u00e1rodn\u00edm standard\u016fm. Co je ISO 13485 a&nbsp;pro\u010d je d\u016fle\u017eit\u00e1? ISO 13485 je mezin\u00e1rodn\u00ed norma pro syst\u00e9m managementu kvality specificky navr\u017een\u00e1 pro v\u00fdrobce, distributory a&nbsp;dodavatele zdravotnick\u00fdch [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":76275,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-76246","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-novinky"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/posts\/76246","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/comments?post=76246"}],"version-history":[{"count":3,"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/posts\/76246\/revisions"}],"predecessor-version":[{"id":76304,"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/posts\/76246\/revisions\/76304"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/media\/76275"}],"wp:attachment":[{"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/media?parent=76246"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/categories?post=76246"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/skrivanek.cz\/cz\/wp-json\/wp\/v2\/tags?post=76246"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}