{"id":1923,"date":"2019-05-22T07:56:47","date_gmt":"2019-05-22T07:56:47","guid":{"rendered":"http:\/\/icrpolska.e-ksperci.pl\/?page_id=1923"},"modified":"2022-09-07T22:58:41","modified_gmt":"2022-09-07T20:58:41","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/icrpolska.com\/lt\/certyfikacja-systemow\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<p>&nbsp;<\/p>\n<h4>Kas yra ISO 13485?<\/h4>\n<p>Tarptautinis standartas ISO 13485 \"Medicinos prietaisai - Kokyb\u0117s vadybos sistemos - Reglamentavimo reikalavimai\" skirtas medicinos prietais\u0173 gamybos kokyb\u0117s vadybos sistemoms. Jame apibr\u0117\u017eiami kokyb\u0117s vadybos sistemos reikalavimai, kuri\u0173 organizacija tur\u0117t\u0173 laikytis per vis\u0105 gamybos cikl\u0105. ISO 13485 reikalavimai taikomi organizacijoms, nepriklausomai nuo j\u0173 dyd\u017eio ar tipo.<\/p>\n<h4>Standarto taikymo sritis:<\/h4>\n<p>ISO 13485 apima QMS reikalavimus, kai organizacija turi \u012frodyti, kad sugeba nuolat teikti medicinos prietaisus ir susijusias paslaugas, atitinkan\u010dias klient\u0173 ir taikomus teis\u0117s akt\u0173 reikalavimus. Tokios organizacijos gali dalyvauti viename ar keliuose gaminio gyvavimo ciklo etapuose, \u012fskaitant medicinos prietaiso projektavim\u0105 ir k\u016brim\u0105, gamyb\u0105, saugojim\u0105 ir platinim\u0105, montavim\u0105 ar aptarnavim\u0105, taip pat susijusi\u0173 paslaug\u0173 (pvz., technin\u0117s pagalbos) projektavim\u0105 ir k\u016brim\u0105 ar teikim\u0105.<\/p>\n<p>\u0160\u012f standart\u0105 taip pat gali naudoti tiek\u0117jai arba i\u0161or\u0117s \u0161alys, kurios tiekia produkt\u0105 tokiai organizacijai, \u012fskaitant su QMS susijusias paslaugas.<\/p>\n<h4>Bendrieji reikalavimai:<\/h4>\n<p>Kiekviena organizacija tur\u0117t\u0173:<\/p>\n<ul>\n<li>dokumentuoti kokyb\u0117s valdymo sistem\u0105 ir palaikyti jos veiksmingum\u0105;<\/li>\n<li>Nustatyti, \u012fgyvendinti ir pri\u017ei\u016br\u0117ti visus standarte nurodytus reikalavimus, proced\u016bras ir veiksmus;<\/li>\n<li>Nustatyti QMS reikalingus procesus ir j\u0173 taikym\u0105 organizacijoje;<\/li>\n<li>Naudokite rizika pagr\u012fst\u0105 po\u017ei\u016br\u012f atitinkamiems procesams pri\u017ei\u016br\u0117ti;<\/li>\n<li>Nurodykite \u0161i\u0173 proces\u0173 sek\u0105 ir j\u0173 s\u0105veik\u0105;<\/li>\n<li>Tinkamai valdykite \u0161iuos procesus.<\/li>\n<li>Dokumentuoti KVS naudojamos kompiuteri\u0173 programin\u0117s \u012frangos naudojimo patvirtinimo proced\u016bras;<\/li>\n<\/ul>\n<h4>ISO 13485 privalumai:<\/h4>\n<ul>\n<li>\u012emon\u0117s patikimumo didinimas;<\/li>\n<li>Galimyb\u0117 patekti \u012f vidaus ir u\u017esienio rinkas;<\/li>\n<li>Organizacijos konkurencingumo didinimas;<\/li>\n<li>Organizacijos procesai tampa skaidresni;<\/li>\n<li>Suma\u017einkite nekokybi\u0161ko gaminio rizik\u0105;<\/li>\n<li>Skund\u0173 skai\u010diaus ma\u017einimas.<\/li>\n<\/ul>\n<h4>Kas tur\u0117t\u0173 tur\u0117ti ISO 13485 sertifikat\u0105?<\/h4>\n<p>Kokyb\u0117s vadybos sistem\u0105 pagal ISO 13485 standart\u0105 diegia medicinos prietais\u0173 gamintojai ir kitos medicinos prietais\u0173 versle dalyvaujan\u010dios \u012fmon\u0117s (pvz., medicinos \u012frangos paslaug\u0173 \u012fmon\u0117s).<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; Kas yra ISO 13485? Tarptautinis standartas ISO 13485 \"Medicinos prietaisai. Kokyb\u0117s vadybos sistemos. Reikalavimai reguliavimo tikslais\" skirtas medicinos prietais\u0173 gamybos kokyb\u0117s vadybos sistemoms. Jame apibr\u0117\u017eiami kokyb\u0117s vadybos sistemos reikalavimai, kuri\u0173 organizacija tur\u0117t\u0173 laikytis per vis\u0105 gamybos cikl\u0105. ISO 13485 reikalavimai taikomi organizacijoms, nepriklausomai nuo...&nbsp;<a href=\"https:\/\/icrpolska.com\/lt\/certyfikacja-systemow\/iso-13485\/\" rel=\"bookmark\">Skaityti daugiau \"<span class=\"screen-reader-text\">ISO 13485<\/span><\/a><\/p>","protected":false},"author":1,"featured_media":1063,"parent":162,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"off","neve_meta_content_width":70,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"","footnotes":""},"class_list":["post-1923","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 13485 - ICR POLSKA - badania i certyfikacja<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/icrpolska.com\/lt\/certyfikacja-systemow\/iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"lt_LT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - ICR POLSKA - badania i certyfikacja\" \/>\n<meta property=\"og:description\" content=\"&nbsp; Czym jest ISO 13485? 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Mi\u0119dzynarodowa norma ISO 13485 \u201eWyroby medyczne &#8212; Systemy zarz\u0105dzania jako\u015bci\u0105 &#8212; Wymagania do cel\u00f3w przepis\u00f3w prawnych&#8221; dotyczy system\u00f3w zarz\u0105dzania jako\u015bci\u0105 w produkcji wyrob\u00f3w medycznych. Okre\u015bla ona wymagania dla systemu zarz\u0105dzania jako\u015bci\u0105, kt\u00f3re powinny by\u0107 spe\u0142nione przez organizacj\u0119 w ca\u0142ym cyklu produkcji. 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