{"id":91,"date":"2021-03-24T09:40:59","date_gmt":"2021-03-24T08:40:59","guid":{"rendered":"http:\/\/www.meliora-compliance.com\/?page_id=91"},"modified":"2023-09-20T21:13:11","modified_gmt":"2023-09-20T19:13:11","slug":"quality-management-system","status":"publish","type":"page","link":"https:\/\/www.meliora-compliance.com\/czech\/quality-management-system\/","title":{"rendered":"Syst\u00e9m \u0159\u00edzen\u00ed kvality (QMS)"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"91\" class=\"elementor elementor-91\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-615771e0 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"615771e0\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;triangle&quot;,&quot;shape_divider_bottom_negative&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" data-negative=\"true\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 1000 100\" preserveaspectratio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M500.2,94.7L0,0v100h1000V0L500.2,94.7z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-531dcfb0\" data-id=\"531dcfb0\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-17972f59 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget elementor-widget-image\" data-id=\"17972f59\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/04_QMS-300x300.png\" class=\"elementor-animation-push attachment-medium size-medium wp-image-827\" alt=\"\" srcset=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/04_QMS-300x300.png 300w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/04_QMS-150x150.png 150w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/04_QMS-12x12.png 12w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/04_QMS.png 512w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-948a249\" data-id=\"948a249\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2780a443 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"2780a443\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Syst\u00e9m \u0159\u00edzen\u00ed kvality (QMS)<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-211c4113 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"211c4113\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4e781e2f\" data-id=\"4e781e2f\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-54568748 elementor-widget elementor-widget-heading\" data-id=\"54568748\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Pro\u010d zav\u00e9st QMS?<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-160eb5c2 elementor-widget elementor-widget-text-editor\" data-id=\"160eb5c2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Zaveden\u00ed a \u00fadr\u017eba syst\u00e9mu \u0159\u00edzen\u00ed kvality (QMS) je z\u00e1kladn\u00ed podm\u00ednkou shody s regulatorn\u00edmi po\u017eadavky pro vstup na v\u011bt\u0161inu sv\u011btov\u00fdch trh\u016f.<\/span><\/p><p><span style=\"font-weight: 400;\">Zaveden\u00fd QMS z\u00e1rove\u0148 pom\u016f\u017ee spole\u010dnostem zlep\u0161it a podpo\u0159it obchodn\u00ed praktiky jak v p\u0159edprodejn\u00ed f\u00e1zi, tak i po uveden\u00ed na trh, jako je nap\u0159\u00edklad proces \u0159\u00edzen\u00ed n\u00e1vrhu, a obecn\u011b bezpe\u010dnost va\u0161eho zdravotnick\u00e9ho prost\u0159edku.<\/span><\/p><p>Nab\u00edz\u00edme v\u00e1m n\u00e1sleduj\u00edc\u00ed slu\u017eby QMS:<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-680a1dc7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"680a1dc7\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-521be296\" data-id=\"521be296\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4b7cfdc4 elementor-widget elementor-widget-text-editor\" data-id=\"4b7cfdc4\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li aria-level=\"1\">Pom\u016f\u017eeme v\u00e1m ur\u010dit po\u017eadovan\u00fd rozsah va\u0161eho QMS na z\u00e1klad\u011b va\u0161\u00ed obchodn\u00ed a marketingov\u00e9 strategie<\/li><li aria-level=\"1\">Pokud ji\u017e m\u00e1te QMS, provedeme zji\u0161t\u011bn\u00ed nedostatk\u016f podle nejnov\u011bj\u0161\u00edch p\u0159\u00edslu\u0161n\u00fdch po\u017eadavk\u016f, abychom vyhodnotili stav va\u0161eho QMS<\/li><li aria-level=\"1\">Pokud chcete prod\u00e1vat v USA, implementujeme nebo dopln\u00edme v\u00e1\u0161 QMS tak, aby byl v souladu s na\u0159\u00edzen\u00edm FDA QSR (21 CFR \u010d\u00e1st 820)<\/li><li aria-level=\"1\">Pokud chcete prod\u00e1vat v Kanad\u011b a v dal\u0161\u00edch \u00fa\u010dastnick\u00fdch zem\u00edch \u00fazem\u00edch, implementujeme nebo dopln\u00edme v\u00e1\u0161 QMS tak, aby byl v souladu s programem MDSAP (Medical Device Single Audit Program)<\/li><li aria-level=\"1\">Pokud chcete prod\u00e1vat v EU nebo v jin\u00fdch \u010d\u00e1stech sv\u011bta, implementujeme nebo dopln\u00edme v\u00e1\u0161 QMS tak, aby vyhovoval mezin\u00e1rodn\u00ed norm\u011b ISO 13485<\/li><li aria-level=\"1\">Zastoup\u00edme v\u00e1s p\u0159i kontaktu s va\u0161\u00edm certifika\u010dn\u00edm org\u00e1nem \/ auditorskou organizac\u00ed \/ registr\u00e1torem, od po\u010d\u00e1te\u010dn\u00ed f\u00e1ze implementace a\u017e po \u00fasp\u011b\u0161nou certifikaci, v\u010detn\u011b veden\u00ed audit\u016f a inspekc\u00ed<\/li><li aria-level=\"1\">Pom\u016f\u017eeme v\u00e1m nastavit va\u0161e QMS procesy, vytvo\u0159it manu\u00e1l kvality, standardn\u00ed opera\u010dn\u00ed p\u0159edpisy, formul\u00e1\u0159e, nastavit syst\u00e9m \u0159\u00edzen\u00ed rizik podle normy ISO 14971, nastavit syst\u00e9m n\u00e1pravn\u00fdch a preventivn\u00edch opat\u0159en\u00ed (CAPA), syst\u00e9m z\u00e1kaznick\u00fdch st\u00ed\u017enost\u00ed, a dal\u0161\u00edch sou\u010d\u00e1st\u00ed QMS<\/li><li aria-level=\"1\">Pom\u016f\u017eeme v\u00e1m zav\u00e9st opat\u0159en\u00ed v reakci na n\u00e1lezy z p\u0159edchoz\u00edch audit\u016f a inspekc\u00ed<\/li><li aria-level=\"1\">Provedeme pro v\u00e1s intern\u00ed audity, p\u0159edb\u011b\u017en\u00e9 audity a fale\u0161n\u00e9 audity (mock audits)<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5c678c12 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5c678c12\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4dbc32da\" data-id=\"4dbc32da\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-525e4623 elementor-widget elementor-widget-heading\" data-id=\"525e4623\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-medium\">Dotazy?<br>\nNapi\u0161te n\u00e1m!<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4daca0d2 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"4daca0d2\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.meliora-compliance.com\/czech\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-right\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-long-arrow-alt-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Kontakt<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Quality management system Why to have QMS? To implement and maintain a quality management system (QMS) is an essential condition of regulatory compliance for the entry to the majority of world markets. At the same time an implemented QMS will help companies to improve and support business practices in both the pre- and post-market phases, &#8230; <a title=\"Syst\u00e9m \u0159\u00edzen\u00ed kvality (QMS)\" class=\"read-more\" href=\"https:\/\/www.meliora-compliance.com\/czech\/quality-management-system\/\" aria-label=\"V\u00edce na Quality management system\">\u010c\u00edst d\u00e1l<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-91","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/91","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/comments?post=91"}],"version-history":[{"count":47,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/91\/revisions"}],"predecessor-version":[{"id":1435,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/91\/revisions\/1435"}],"wp:attachment":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/media?parent=91"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}