{"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\/lv\/certyfikacja-systemow\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<p>&nbsp;<\/p>\n<h4>Kas ir ISO 13485?<\/h4>\n<p>Starptautiskais standarts ISO 13485 \"Medic\u012bnisk\u0101s ier\u012bces - Kvalit\u0101tes vad\u012bbas sist\u0113mas - Pras\u012bbas regulat\u012bviem m\u0113r\u0137iem\" attiecas uz kvalit\u0101tes vad\u012bbas sist\u0113m\u0101m medic\u012bnisko ier\u012b\u010du ra\u017eo\u0161anai. Tas nosaka kvalit\u0101tes vad\u012bbas sist\u0113mas pras\u012bbas, kas j\u0101iev\u0113ro organiz\u0101cijai vis\u0101 ra\u017eo\u0161anas cikl\u0101. ISO 13485 pras\u012bbas attiecas uz organiz\u0101cij\u0101m neatkar\u012bgi no to lieluma vai veida.<\/p>\n<h4>Standarta darb\u012bbas joma:<\/h4>\n<p>ISO 13485 ietver QMS pras\u012bbas, ja organiz\u0101cijai ir j\u0101pier\u0101da, ka t\u0101 sp\u0113j nodro\u0161in\u0101t medic\u012bnas ier\u012bces un saist\u012btos pakalpojumus, past\u0101v\u012bgi izpildot klientu un piem\u0113rojam\u0101s normat\u012bv\u0101s pras\u012bbas. \u0160\u0101das organiz\u0101cijas var b\u016bt iesaist\u012btas vien\u0101 vai vair\u0101kos produkta dz\u012bves cikla posmos, tostarp medic\u012bnisk\u0101s ier\u012bces projekt\u0113\u0161an\u0101 un izstr\u0101d\u0113, ra\u017eo\u0161an\u0101, uzglab\u0101\u0161an\u0101 un izplat\u012b\u0161an\u0101, uzst\u0101d\u012b\u0161an\u0101 vai apkalpo\u0161an\u0101, k\u0101 ar\u012b saist\u012bto pakalpojumu (piem\u0113ram, tehnisk\u0101 atbalsta) izstr\u0101d\u0113 un att\u012bst\u012bb\u0101 vai snieg\u0161an\u0101.<\/p>\n<p>\u0160o standartu var izmantot ar\u012b pieg\u0101d\u0101t\u0101ji vai \u0101r\u0113j\u0101s puses, kas \u0161\u0101dai organiz\u0101cijai pieg\u0101d\u0101 produktu, tostarp ar QMS saist\u012btus pakalpojumus.<\/p>\n<h4>Visp\u0101r\u012bg\u0101s pras\u012bbas:<\/h4>\n<p>Katrai organiz\u0101cijai vajadz\u0113tu:<\/p>\n<ul>\n<li>dokument\u0113t kvalit\u0101tes vad\u012bbas sist\u0113mu un uztur\u0113t t\u0101s efektivit\u0101ti;<\/li>\n<li>Izstr\u0101d\u0101t, ieviest un uztur\u0113t sp\u0113k\u0101 visas standart\u0101 ietvert\u0101s pras\u012bbas, proced\u016bras un darb\u012bbas;<\/li>\n<li>Noteikt procesus, kas nepiecie\u0161ami QMS, un to piem\u0113ro\u0161anu organiz\u0101cij\u0101;<\/li>\n<li>Uz risku balst\u012btas pieejas izmanto\u0161ana attiec\u012bgo procesu p\u0101rraudz\u012bbai;<\/li>\n<li>Nosakiet \u0161o procesu sec\u012bbu un to mijiedarb\u012bbu;<\/li>\n<li>Pien\u0101c\u012bgi p\u0101rvaldiet \u0161os procesus<\/li>\n<li>Dokument\u0113jiet proced\u016bras, kas paredz\u0113tas QMS izmantot\u0101s datoru programmat\u016bras lieto\u0161anas apstiprin\u0101\u0161anai;<\/li>\n<\/ul>\n<h4>ISO 13485 priek\u0161roc\u012bbas:<\/h4>\n<ul>\n<li>Uz\u0146\u0113muma uzticam\u012bbas palielin\u0101\u0161ana;<\/li>\n<li>Iesp\u0113ja piek\u013c\u016bt viet\u0113jiem un \u0101rvalstu tirgiem;<\/li>\n<li>Organiz\u0101cijas konkur\u0113tsp\u0113jas palielin\u0101\u0161ana;<\/li>\n<li>Organiz\u0101cijas procesi k\u013c\u016bst p\u0101rredzam\u0101ki;<\/li>\n<li>Samazin\u0101t boj\u0101ta produkta risku;<\/li>\n<li>S\u016bdz\u012bbu skaita samazin\u0101\u0161ana.<\/li>\n<\/ul>\n<h4>Kam j\u0101b\u016bt sertific\u0113tam saska\u0146\u0101 ar ISO 13485?<\/h4>\n<p>Kvalit\u0101tes vad\u012bbas sist\u0113mu saska\u0146\u0101 ar ISO 13485 ievie\u0161 medic\u012bnas ier\u012b\u010du ra\u017eot\u0101ji un citi uz\u0146\u0113mumi, kas iesaist\u012bti medic\u012bnas ier\u012b\u010du biznes\u0101 (piem\u0113ram, medic\u012bnas iek\u0101rtu servisa uz\u0146\u0113mumi).<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; Kas ir ISO 13485? Starptautiskais standarts ISO 13485 \"Medic\u012bnisk\u0101s ier\u012bces - Kvalit\u0101tes vad\u012bbas sist\u0113mas - Pras\u012bbas regulat\u012bviem m\u0113r\u0137iem\" attiecas uz kvalit\u0101tes vad\u012bbas sist\u0113m\u0101m medic\u012bnisko ier\u012b\u010du ra\u017eo\u0161anai. Tas nosaka kvalit\u0101tes vad\u012bbas sist\u0113mas pras\u012bbas, kas j\u0101iev\u0113ro organiz\u0101cijai vis\u0101 ra\u017eo\u0161anas cikl\u0101. ISO 13485 pras\u012bbas attiecas uz organiz\u0101cij\u0101m neatkar\u012bgi no...&nbsp;<a href=\"https:\/\/icr.you2.pl\/lv\/certyfikacja-systemow\/iso-13485\/\" rel=\"bookmark\">Las\u012bt vair\u0101k \"<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\/lv\/certyfikacja-systemow\/iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"lv_LV\" \/>\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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