{"id":93,"date":"2021-03-24T09:41:13","date_gmt":"2021-03-24T08:41:13","guid":{"rendered":"http:\/\/www.meliora-compliance.com\/?page_id=93"},"modified":"2023-09-25T16:46:27","modified_gmt":"2023-09-25T14:46:27","slug":"auditing","status":"publish","type":"page","link":"https:\/\/www.meliora-compliance.com\/czech\/auditing\/","title":{"rendered":"Audity"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"93\" class=\"elementor elementor-93\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-781916eb elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"781916eb\" 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-2b786e27\" data-id=\"2b786e27\" 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-40cf7a4 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget elementor-widget-image\" data-id=\"40cf7a4\" 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\/07_AUDIT-300x300.png\" class=\"elementor-animation-push attachment-medium size-medium wp-image-824\" alt=\"\" srcset=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/07_AUDIT-300x300.png 300w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/07_AUDIT-150x150.png 150w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/07_AUDIT-12x12.png 12w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/07_AUDIT.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-6af4c76d\" data-id=\"6af4c76d\" 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-dabb643 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"dabb643\" 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\">Audity<\/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-6033a9be elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6033a9be\" 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-72f7c4bf\" data-id=\"72f7c4bf\" 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-25594f83 elementor-widget elementor-widget-heading\" data-id=\"25594f83\" 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 audity?<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c5021d7 elementor-widget elementor-widget-text-editor\" data-id=\"1c5021d7\" 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>Audity a inspekce jsou nezbytn\u00e9 pro v\u0161echny v\u00fdrobce zdravotnick\u00fdch prost\u0159edk\u016f i jin\u00e9 oborov\u00e9 hospod\u00e1\u0159sk\u00e9 subjekty.<\/p><p>Spole\u010dnost Meliora Compliance nab\u00edz\u00ed sv\u00e9 odborn\u00e9 znalosti v oblasti poskytov\u00e1n\u00ed auditorsk\u00fdch slu\u017eeb sv\u00fdm z\u00e1kazn\u00edk\u016fm. Tyto slu\u017eby zahrnuj\u00ed jak audity prov\u00e1d\u011bn\u00e9 u z\u00e1kazn\u00edka, tak i audity na d\u00e1lku.<\/p><p>Rozsah slu\u017eeb<\/p><p>Prov\u00e1d\u00edme n\u00e1sleduj\u00edc\u00ed typy audit\u016f:<\/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-244943c1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"244943c1\" 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-671e2dec\" data-id=\"671e2dec\" 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-3962a834 elementor-widget elementor-widget-text-editor\" data-id=\"3962a834\" 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><span style=\"font-weight: 400;\">Po\u010d\u00e1te\u010dn\u00ed audity k hodnocen\u00ed stavu z\u00e1kazn\u00edkova syst\u00e9mu jakosti<\/span><\/li><li><span style=\"font-weight: 400;\">Intern\u00ed audity<\/span><\/li><li><span style=\"font-weight: 400;\">Fale\u0161n\u00e9 audity (mock audits) k ov\u011b\u0159en\u00ed p\u0159ipravenosti na neohl\u00e1\u0161en\u00e9 audity<\/span><\/li><li><span style=\"font-weight: 400;\">Audity u kritick\u00fdch subdodavatel\u016f<\/span><\/li><li><span style=\"font-weight: 400;\">P\u0159edb\u011b\u017en\u00e9 audity a inspekce p\u0159ed audity prov\u00e1d\u011bn\u00fdmi regulatorn\u00edmi org\u00e1ny<\/span><\/li><li><span style=\"font-weight: 400;\">Audity k ov\u011b\u0159en\u00ed implementace konkr\u00e9tn\u00edch n\u00e1pravn\u00fdch a preventivn\u00edch opat\u0159en\u00ed<\/span><\/li><li><span style=\"font-weight: 400;\">P\u0159edb\u011b\u017en\u00e9 kontroly ze specifick\u00e9ho d\u016fvodu (for-cause audits)<\/span><\/li><li><span style=\"font-weight: 400;\">Speci\u00e1ln\u00ed audity k ov\u011b\u0159en\u00ed souladu s konkr\u00e9tn\u00ed normou \/ p\u0159edpisem<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">\u00a0 \u00a0 \u00a0Rozsah na\u0161ich auditorsk\u00fdch slu\u017eeb zahrnuje tyto regulatorn\u00ed po\u017eadavky:<\/span><\/p><ul><li><span style=\"font-weight: 400;\">ISO 13485<\/span><\/li><li><span style=\"font-weight: 400;\">EU MDR a IVDR<\/span><\/li><li><span style=\"font-weight: 400;\">US FDA QSR (21 CFR Part 820)<\/span><\/li><li><span style=\"font-weight: 400;\">MDSAP<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">\u00a0 \u00a0 \u00a0Z\u00e1rove\u0148 tak\u00e9 poskytujeme podporu z\u00e1kazn\u00edk\u016fm v n\u00e1sleduj\u00edc\u00edch \u010dinnostech souvisej\u00edc\u00edch s audity:<\/span><\/p><ul><li><span style=\"font-weight: 400;\">Tvorba pl\u00e1n\u016f n\u00e1pravn\u00fdch a preventivn\u00edch opat\u0159en\u00ed k odstran\u011bn\u00ed p\u0159\u00ed\u010din neshod z audit\u016f<\/span><\/li><li><span style=\"font-weight: 400;\">Zastoupen\u00ed z\u00e1kazn\u00edk\u016f p\u0159i auditech \/ inspekc\u00edch prov\u00e1d\u011bn\u00fdch jejich klienty, certifika\u010dn\u00edmi \/ notifikovan\u00fdmi org\u00e1ny EU, auditorsk\u00fdmi organizacemi pro MDSAP, a americk\u00fdm \u00fa\u0159adem FDA<\/span><\/li><li><span style=\"font-weight: 400;\">Kombinace audit\u016f s n\u00e1sledn\u00fdmi poradensk\u00fdmi slu\u017ebami<\/span><\/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-717fe19b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"717fe19b\" 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-425b4eb6\" data-id=\"425b4eb6\" 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-1d0c6405 elementor-widget elementor-widget-heading\" data-id=\"1d0c6405\" 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-64828edf elementor-align-center elementor-widget elementor-widget-button\" data-id=\"64828edf\" 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>Auditing Why audits? Audits and inspections are essential for all medical device manufacturers and other economic operators. Meliora Compliance offers its expertise to provide second-party auditing services to its customers. These services cover on-site and remote audits. Scope We perform the following types of audits: Initial QMS assessment audits Internal audits Mock audits to verify &#8230; <a title=\"Audity\" class=\"read-more\" href=\"https:\/\/www.meliora-compliance.com\/czech\/auditing\/\" aria-label=\"V\u00edce na Auditing\">\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-93","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/93","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=93"}],"version-history":[{"count":68,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/93\/revisions"}],"predecessor-version":[{"id":1487,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/93\/revisions\/1487"}],"wp:attachment":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/media?parent=93"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}