{"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\/kr\/certyfikacja-systemow\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<p>&nbsp;<\/p>\n<h4>ISO 13485\ub780 \ubb34\uc5c7\uc778\uac00\uc694?<\/h4>\n<p>\uad6d\uc81c \ud45c\uc900 ISO 13485 '\uc758\ub8cc\uae30\uae30 - \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c - \uaddc\uc81c \ubaa9\uc801\uc758 \uc694\uad6c \uc0ac\ud56d'\uc740 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\ub97c \uc704\ud55c \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \ub2e4\ub8f9\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \uc0dd\uc0b0 \uc8fc\uae30 \uc804\ubc18\uc5d0 \uac78\uccd0 \uc870\uc9c1\uc774 \ucda9\uc871\ud574\uc57c \ud558\ub294 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \uc815\uc758\ud569\ub2c8\ub2e4. ISO 13485\uc758 \uc694\uad6c\uc0ac\ud56d\uc740 \uaddc\ubaa8\ub098 \uc720\ud615\uc5d0 \uad00\uacc4\uc5c6\uc774 \ubaa8\ub4e0 \uc870\uc9c1\uc5d0 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>\n<h4>\ud45c\uc900\uc758 \ubc94\uc704:<\/h4>\n<p>ISO 13485\uc5d0\ub294 \uc870\uc9c1\uc774 \uc758\ub8cc \uae30\uae30 \ubc0f \uad00\ub828 \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud558\uace0 \uace0\uac1d \ubc0f \uad00\ub828 \uaddc\uc81c \uc694\uac74\uc744 \uc9c0\uc18d\uc801\uc73c\ub85c \ucda9\uc871\ud560 \uc218 \uc788\ub294 \ub2a5\ub825\uc744 \uc785\uc99d\ud574\uc57c \ud558\ub294 \uacbd\uc6b0\uc758 QMS \uc694\uad6c\uc0ac\ud56d\uc774 \ud3ec\ud568\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc870\uc9c1\uc740 \uc758\ub8cc \uae30\uae30\uc758 \uc124\uacc4 \ubc0f \uac1c\ubc1c, \uc81c\uc870, \ubcf4\uad00 \ubc0f \uc720\ud1b5, \uc124\uce58 \ub610\ub294 \uc11c\ube44\uc2a4, \uad00\ub828 \uc11c\ube44\uc2a4(\uc608: \uae30\uc220 \uc9c0\uc6d0)\uc758 \uc124\uacc4 \ubc0f \uac1c\ubc1c \ub610\ub294 \uc81c\uacf5\uc744 \ud3ec\ud568\ud558\uc5ec \uc81c\ud488 \uc218\uba85 \uc8fc\uae30\uc758 \ud558\ub098 \uc774\uc0c1\uc758 \ub2e8\uacc4\uc5d0 \uad00\uc5ec\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc774 \ud45c\uc900\uc740 \ud574\ub2f9 \uc870\uc9c1\uc5d0 \uc81c\ud488\uc744 \uc81c\uacf5\ud558\ub294 \uacf5\uae09\uc5c5\uccb4 \ub610\ub294 \uc678\ubd80 \ub2f9\uc0ac\uc790(QMS \uad00\ub828 \uc11c\ube44\uc2a4 \ud3ec\ud568)\uc5d0\uc11c\ub3c4 \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<h4>\uc77c\ubc18 \uc694\uad6c \uc0ac\ud56d:<\/h4>\n<p>\ubaa8\ub4e0 \uc870\uc9c1\uc740 \uadf8\ub798\uc57c \ud569\ub2c8\ub2e4:<\/p>\n<ul>\n<li>\ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \ubb38\uc11c\ud654\ud558\uace0 \uadf8 \ud6a8\uacfc\ub97c \uc720\uc9c0\ud558\uc138\uc694;<\/li>\n<li>\ud45c\uc900\uc5d0 \ud3ec\ud568\ub41c \ubaa8\ub4e0 \uc694\uad6c \uc0ac\ud56d, \uc808\ucc28, \ud65c\ub3d9\uc744 \uc218\ub9bd, \uad6c\ud604 \ubc0f \uc720\uc9c0\ud569\ub2c8\ub2e4;<\/li>\n<li>QMS\uc5d0 \ud544\uc694\ud55c \ud504\ub85c\uc138\uc2a4\uc640 \uc870\uc9c1 \ub0b4 \uc801\uc6a9\uc744 \ud30c\uc545\ud569\ub2c8\ub2e4;<\/li>\n<li>\uc704\ud5d8 \uae30\ubc18 \uc811\uadfc \ubc29\uc2dd\uc744 \uc0ac\uc6a9\ud558\uc5ec \uad00\ub828 \ud504\ub85c\uc138\uc2a4\ub97c \uac10\ub3c5\ud558\uc138\uc694;<\/li>\n<li>\uc774\ub7ec\ud55c \ud504\ub85c\uc138\uc2a4\uc758 \uc21c\uc11c\uc640 \uc0c1\ud638 \uc791\uc6a9\uc744 \uc2dd\ubcc4\ud569\ub2c8\ub2e4;<\/li>\n<li>\uc774\ub7ec\ud55c \ud504\ub85c\uc138\uc2a4\ub97c \uc801\uc808\ud558\uac8c \uad00\ub9ac\ud558\uc138\uc694.<\/li>\n<li>QMS\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ucef4\ud4e8\ud130 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc0ac\uc6a9 \uac80\uc99d \uc808\ucc28\ub97c \ubb38\uc11c\ud654\ud569\ub2c8\ub2e4;<\/li>\n<\/ul>\n<h4>ISO 13485\uc758 \uc774\uc810:<\/h4>\n<ul>\n<li>\ud68c\uc0ac\uc758 \uc2e0\ub8b0\ub3c4\ub97c \ub192\uc785\ub2c8\ub2e4;<\/li>\n<li>\uad6d\ub0b4 \ubc0f \ud574\uc678 \uc2dc\uc7a5\uc5d0 \ub300\ud55c \uc811\uadfc\uc131;<\/li>\n<li>\uc870\uc9c1\uc758 \uacbd\uc7c1\ub825\uc744 \ub192\uc785\ub2c8\ub2e4;<\/li>\n<li>\uc870\uc9c1\uc758 \ud504\ub85c\uc138\uc2a4\uac00 \ub354\uc6b1 \ud22c\uba85\ud574\uc9d1\ub2c8\ub2e4;<\/li>\n<li>\uc81c\ud488 \uacb0\ud568\uc758 \uc704\ud5d8\uc744 \ucd5c\uc18c\ud654\ud558\uc138\uc694;<\/li>\n<li>\ubd88\ub9cc \uac74\uc218 \uac10\uc18c.<\/li>\n<\/ul>\n<h4>\ub204\uac00 ISO 13485 \uc778\uc99d\uc744 \ubc1b\uc544\uc57c \ud558\ub098\uc694?<\/h4>\n<p>ISO 13485\uc5d0 \ub530\ub978 \ud488\uc9c8 \uacbd\uc601 \uc2dc\uc2a4\ud15c\uc740 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4 \ubc0f \uae30\ud0c0 \uc758\ub8cc\uae30\uae30 \uc0ac\uc5c5\uacfc \uad00\ub828\ub41c \ud68c\uc0ac(\uc608: \uc758\ub8cc\uae30\uae30 \uc11c\ube44\uc2a4 \ud68c\uc0ac)\uc5d0\uc11c \uc2dc\ud589\ud569\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; ISO 13485\ub780 \ubb34\uc5c7\uc778\uac00\uc694? \uad6d\uc81c \ud45c\uc900 ISO 13485 '\uc758\ub8cc\uae30\uae30 - \ud488\uc9c8 \uacbd\uc601 \uc2dc\uc2a4\ud15c - \uaddc\uc81c \ubaa9\uc801\uc758 \uc694\uad6c \uc0ac\ud56d'\uc740 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\ub97c \uc704\ud55c \ud488\uc9c8 \uacbd\uc601 \uc2dc\uc2a4\ud15c\uc744 \ub2e4\ub8f9\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \uc0dd\uc0b0 \uc8fc\uae30 \uc804\ubc18\uc5d0 \uac78\uccd0 \uc870\uc9c1\uc774 \ucda9\uc871\ud574\uc57c \ud558\ub294 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \uc815\uc758\ud569\ub2c8\ub2e4. ISO 13485\uc758 \uc694\uad6c\uc0ac\ud56d\uc740 \ub2e4\uc74c\uacfc \uad00\uacc4\uc5c6\uc774 \uc870\uc9c1\uc5d0 \uc801\uc6a9\ub429\ub2c8\ub2e4.&nbsp;<a href=\"https:\/\/icrpolska.com\/kr\/certyfikacja-systemow\/iso-13485\/\" rel=\"bookmark\">\uc790\uc138\ud788 \ubcf4\uae30\"<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\/kr\/certyfikacja-systemow\/iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\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? 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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