{"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:\/\/icr.you2.pl\/est\/certyfikacja-systemow\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<p>&nbsp;<\/p>\n<h4>Mis on ISO 13485?<\/h4>\n<p>Rahvusvaheline standard ISO 13485 \"Meditsiiniseadmed - Kvaliteedijuhtimiss\u00fcsteemid - N\u00f5uded regulatiivsetel eesm\u00e4rkidel\" k\u00e4sitleb meditsiiniseadmete tootmise kvaliteedijuhtimiss\u00fcsteeme. Selles on m\u00e4\u00e4ratletud kvaliteedijuhtimiss\u00fcsteemi n\u00f5uded, mida organisatsioon peaks t\u00e4itma kogu tootmists\u00fckli jooksul. ISO 13485 n\u00f5uded kehtivad organisatsioonidele olenemata nende suurusest v\u00f5i t\u00fc\u00fcbist.<\/p>\n<h4>Standardi reguleerimisala:<\/h4>\n<p>ISO 13485 sisaldab kvaliteedijuhtimise s\u00fcsteemi n\u00f5udeid, kui organisatsioon peab t\u00f5endama oma v\u00f5imet pakkuda meditsiiniseadmeid ja nendega seotud teenuseid, mis vastavad pidevalt klientide ja kehtivate \u00f5igusaktide n\u00f5uetele. Sellised organisatsioonid v\u00f5ivad olla seotud toote eluts\u00fckli \u00fches v\u00f5i mitmes etapis, sealhulgas meditsiiniseadme projekteerimise ja arendamise, tootmise, ladustamise ja levitamise, paigaldamise v\u00f5i hoolduse ning sellega seotud teenuste (nt tehniline tugi) projekteerimise ja arendamise v\u00f5i osutamisega.<\/p>\n<p>Seda standardit v\u00f5ivad kasutada ka tarnijad v\u00f5i v\u00e4lised osapooled, kes tarnivad sellisele organisatsioonile toodet, sealhulgas QMSiga seotud teenuseid.<\/p>\n<h4>\u00dcldised n\u00f5uded:<\/h4>\n<p>Iga organisatsioon peaks:<\/p>\n<ul>\n<li>dokumenteerida kvaliteedijuhtimiss\u00fcsteem ja s\u00e4ilitada selle t\u00f5husus;<\/li>\n<li>kehtestab, rakendab ja s\u00e4ilitab k\u00f5ik standardis sisalduvad n\u00f5uded, menetlused ja tegevused;<\/li>\n<li>M\u00e4\u00e4rake kindlaks kvaliteedijuhtimise s\u00fcsteemis vajalikud protsessid ja nende rakendamine organisatsioonis;<\/li>\n<li>Kasutage riskip\u00f5hist l\u00e4henemisviisi asjakohaste protsesside j\u00e4relevalveks;<\/li>\n<li>M\u00e4\u00e4rake kindlaks nende protsesside ja nende koostoimete j\u00e4rjestus;<\/li>\n<li>Haldage neid protsesse asjakohaselt<\/li>\n<li>dokumenteerida kvaliteedijuhtimise s\u00fcsteemis kasutatava arvutitarkvara kasutamise valideerimise menetlused;<\/li>\n<\/ul>\n<h4>ISO 13485 eelised:<\/h4>\n<ul>\n<li>Ettev\u00f5tte usaldusv\u00e4\u00e4rsuse suurendamine;<\/li>\n<li>V\u00f5imalus p\u00e4\u00e4seda kodu- ja v\u00e4listurgudele;<\/li>\n<li>Organisatsiooni konkurentsiv\u00f5ime suurendamine;<\/li>\n<li>Organisatsiooni protsessid muutuvad l\u00e4bipaistvamaks;<\/li>\n<li>Minimeerige defektse toote riski;<\/li>\n<li>Kaebuste arvu v\u00e4hendamine.<\/li>\n<\/ul>\n<h4>Kes peaks olema ISO 13485 sertifitseeritud?<\/h4>\n<p>ISO 13485 kohast kvaliteedijuhtimiss\u00fcsteemi rakendavad meditsiiniseadmete tootjad ja muud meditsiiniseadmete \u00e4riga tegelevad ettev\u00f5tted (nt meditsiiniseadmete teenindusettev\u00f5tted).<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; Mis on ISO 13485? Rahvusvaheline standard ISO 13485 \"Meditsiiniseadmed - Kvaliteedijuhtimiss\u00fcsteemid - N\u00f5uded regulatiivsetel eesm\u00e4rkidel\" k\u00e4sitleb meditsiiniseadmete tootmise kvaliteedijuhtimiss\u00fcsteeme. Selles on m\u00e4\u00e4ratletud kvaliteedijuhtimiss\u00fcsteemi n\u00f5uded, mida organisatsioon peaks t\u00e4itma kogu tootmists\u00fckli jooksul. ISO 13485 n\u00f5uded kehtivad organisatsioonidele s\u00f5ltumata...&nbsp;<a href=\"https:\/\/icr.you2.pl\/est\/certyfikacja-systemow\/iso-13485\/\" rel=\"bookmark\">Loe edasi \"<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 v26.8 - 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:\/\/icr.you2.pl\/est\/certyfikacja-systemow\/iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"et_EE\" \/>\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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