{"id":232,"date":"2023-07-24T01:45:12","date_gmt":"2023-07-24T01:45:12","guid":{"rendered":"https:\/\/srtub.com\/?p=232"},"modified":"2023-07-24T01:45:12","modified_gmt":"2023-07-24T01:45:12","slug":"proc-chteji-vyrobci-lekarskych-silikonovych-hadicek-ziskat-certifikaci-iso-13485","status":"publish","type":"post","link":"https:\/\/srtub.com\/cs\/proc-chteji-vyrobci-lekarskych-silikonovych-hadicek-ziskat-certifikaci-iso-13485\/","title":{"rendered":"Pro\u010d cht\u011bj\u00ed v\u00fdrobci l\u00e9ka\u0159sk\u00fdch silikonov\u00fdch hadi\u010dek z\u00edskat certifikaci ISO 13485?"},"content":{"rendered":"<p>Nejprve stru\u010dn\u00fd \u00favod k certifikaci ISO 13485, ISO13485 \u010c\u00ednsk\u00fd n\u00e1zev \"syst\u00e9m \u0159\u00edzen\u00ed kvality zdravotnick\u00fdch prost\u0159edk\u016f pro regula\u010dn\u00ed po\u017eadavky\" Vzhledem k tomu, \u017ee zdravotnick\u00e9 prost\u0159edky jsou speci\u00e1ln\u00ed v\u00fdrobky pro z\u00e1chranu \u017eivot\u016f a prevenci nemoc\u00ed, pouze podle obecn\u00fdch po\u017eadavk\u016f normy ISO9000 k regulaci nesta\u010d\u00ed, z tohoto d\u016fvodu organizace ISO vyhl\u00e1sila normu ISO13485: 1996 verze normy (YY\/T0287 a YY\/T0288) pro v\u00fdrobce zdravotnick\u00fdch prost\u0159edk\u016f, aby p\u0159edlo\u017eila zvl\u00e1\u0161tn\u00ed po\u017eadavky na kvalitu bezpe\u010dnosti a \u00fa\u010dinnosti, kter\u00e9 hraj\u00ed roli v kvalit\u011b zdravotnick\u00fdch prost\u0159edk\u016f. ISO13485: 1996 verze normy (YY\/T0287 a YY\/T0288), kter\u00e1 p\u0159edkl\u00e1d\u00e1 zvl\u00e1\u0161tn\u00ed po\u017eadavky na syst\u00e9m \u0159\u00edzen\u00ed kvality v\u00fdrobc\u016f zdravotnick\u00fdch prost\u0159edk\u016f a hraje dobrou roli p\u0159i podpo\u0159e kvality zdravotnick\u00fdch prost\u0159edk\u016f k dosa\u017een\u00ed bezpe\u010dnosti a \u00fa\u010dinnosti.<\/p>\n<p>V\u00fdkonnou verz\u00ed do listopadu 2017 je norma ISO13485:2016 \"Po\u017eadavky na pou\u017e\u00edv\u00e1n\u00ed syst\u00e9m\u016f managementu kvality pro zdravotnick\u00e9 prost\u0159edky pro regula\u010dn\u00ed \u00fa\u010dely\". Oproti p\u0159edchoz\u00ed verzi do\u0161lo ke zm\u011bn\u011b n\u00e1zvu a obsahu.<\/p>\n<div id=\"attachment_225\" style=\"width: 1478px\" class=\"wp-caption alignnone\"><img fetchpriority=\"high\" decoding=\"async\" aria-describedby=\"caption-attachment-225\" class=\"wp-image-225\" src=\"https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-300x186.jpg\" alt=\"V\u00fdhody silikonov\u00fdch trubek\" width=\"1468\" height=\"910\" srcset=\"https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-18x12.jpg 18w, https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-200x124.jpg 200w, https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-300x186.jpg 300w, https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-400x248.jpg 400w, https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages.jpg 450w\" sizes=\"(max-width: 1468px) 100vw, 1468px\" \/><p id=\"caption-attachment-225\" class=\"wp-caption-text\">V\u00fdhody silikonov\u00fdch trubek<\/p><\/div>\n<p>Certifikace ISO 13485 m\u00e1 p\u0159itom n\u00e1sleduj\u00edc\u00ed d\u016fle\u017eit\u00fd v\u00fdznam:<\/p>\n<p>1, zlep\u0161it a zkvalitnit \u00farove\u0148 \u0159\u00edzen\u00ed podniku, vyhnout se pr\u00e1vn\u00edm rizik\u016fm a zv\u00fd\u0161it viditelnost podniku;<br \/>\n2\u3001Zlep\u0161ovat a zaji\u0161\u0165ovat \u00farove\u0148 kvality v\u00fdrobk\u016f, aby podniky z\u00edskaly v\u011bt\u0161\u00ed ekonomick\u00fd p\u0159\u00ednos;<br \/>\n3, p\u0159isp\u00edv\u00e1 k odstran\u011bn\u00ed obchodn\u00edch p\u0159ek\u00e1\u017eek, p\u0159\u00edstup na mezin\u00e1rodn\u00ed trh proj\u00edt;<br \/>\n4, p\u0159isp\u00edv\u00e1 ke zv\u00fd\u0161en\u00ed konkurenceschopnosti v\u00fdrobk\u016f, zvy\u0161uje pod\u00edl v\u00fdrobk\u016f na trhu.<br \/>\n5\u3001Pomoc\u00ed \u00fa\u010dinn\u00e9ho \u0159\u00edzen\u00ed rizik \u00fa\u010dinn\u011b sni\u017eovat riziko nehod nebo ne\u017e\u00e1douc\u00edch ud\u00e1lost\u00ed v oblasti kvality v\u00fdrobk\u016f.<br \/>\n6\u3001Zlep\u0161ovat smysl pro odpov\u011bdnost, nad\u0161en\u00ed a oddanost zam\u011bstnanc\u016f.<\/p>\n<p>Jako v\u00fdrobci silikonov\u00fdch trubek je certifikace ISO 13485 nejen uzn\u00e1n\u00edm s\u00edly podniku, ale tak\u00e9 jak\u00fdmsi potvrzen\u00edm a z\u00e1rukou kvality v\u00fdrobk\u016f, m\u016f\u017ee d\u00e1t v\u011bt\u0161in\u011b v\u00fdrobc\u016f zdravotnick\u00fdch prost\u0159edk\u016f jist\u011bj\u0161\u00ed volbu a d\u016fv\u011bru v z\u00e1ruku.<\/p>\n<p>Pokud m\u00e1te dal\u0161\u00ed dotazy t\u00fdkaj\u00edc\u00ed se silikonov\u00fdch trubek, m\u016f\u017eete se p\u0159ihl\u00e1sit na ofici\u00e1ln\u00ed webov\u00e9 str\u00e1nky spole\u010dnosti Srtub (www.srtub.com), kde jsou k dispozici profesion\u00e1ln\u00ed odborn\u00ed a techni\u010dt\u00ed pracovn\u00edci, kte\u0159\u00ed v\u00e1m odborn\u011b zodpov\u00ed \u0159adu souvisej\u00edc\u00edch 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[&#8230;]<\/p>","protected":false},"author":1,"featured_media":181,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"_joinchat":[],"footnotes":""},"categories":[25],"tags":[],"class_list":["post-232","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-technology"],"jetpack_featured_media_url":"https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Medical-Grade-Silicone-Tube.jpg","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/posts\/232","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/comments?post=232"}],"version-history":[{"count":1,"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/posts\/232\/revisions"}],"predecessor-version":[{"id":233,"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/posts\/232\/revisions\/233"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/media\/181"}],"wp:attachment":[{"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/media?parent=232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/categories?post=232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/srtub.com\/cs\/wp-json\/wp\/v2\/tags?post=232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}