{"id":282,"date":"2020-08-21T20:41:12","date_gmt":"2020-08-21T20:41:12","guid":{"rendered":"http:\/\/bqrcertification.com\/home\/?page_id=282"},"modified":"2020-09-27T06:49:32","modified_gmt":"2020-09-27T06:49:32","slug":"iso-13485-certification","status":"publish","type":"page","link":"https:\/\/bqrcertification.com\/home\/iso-13485-certification\/","title":{"rendered":"ISO 13485 Certification"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"282\" class=\"elementor elementor-282\" data-elementor-settings=\"[]\">\n\t\t\t\t\t\t<div class=\"elementor-inner\">\n\t\t\t\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-fc5c326 elementor-section-stretched elementor-section-full_width elementor-section-height-min-height elementor-section-height-default elementor-section-items-middle\" data-id=\"fc5c326\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1075169\" data-id=\"1075169\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3f04ab3 elementor-widget elementor-widget-heading\" data-id=\"3f04ab3\" 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-default\">ISO 13485 Certification :<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\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-bec9052 elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bec9052\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-cfb87df\" data-id=\"cfb87df\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fd0f692 elementor-widget elementor-widget-html\" data-id=\"fd0f692\" data-element_type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<div style=\"display:inline; color:#AE0110; font-size:12px; text-transform: capitalize;\"> \n<a href=\"http:\/\/bqrcertification.com\/home\/\"> <i class=\"fa fa-home fa-2x\" aria-hidden=\"true\"><\/i> <\/a> >> \n<a style=\"color:#AE0110; \" href=\"http:\/\/bqrcertification.com\/home\/iso-13485-certification\/\"> &nbsp; ISO 13485 Certification <\/a> <\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26d68d2 elementor-widget elementor-widget-text-editor\" data-id=\"26d68d2\" 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<div class=\"elementor-text-editor elementor-clearfix\"><div class=\"elementor-element elementor-element-ff4e280 elementor-widget elementor-widget-text-editor\" data-id=\"ff4e280\" data-element_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-text-editor elementor-clearfix\"><p>ISO 13485:2016 specifies requirements for a medical device quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As result, it includes some requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 All requirements of ISO 13485:2016 are specific to organizations providing medical devices, regardless of the type or size of the organization<\/p><\/div><\/div><\/div><div class=\"elementor-element elementor-element-1f2d7cf elementor-widget elementor-widget-heading\" data-id=\"1f2d7cf\" data-element_type=\"heading.default\"><div class=\"elementor-widget-container\"><h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"color: #808080;\">Benefits of ISO 13485:2016 (MDQMS)<\/span><\/h2><\/div><\/div><div class=\"elementor-element elementor-element-60ad1bc elementor-widget elementor-widget-text-editor\" data-id=\"60ad1bc\" data-element_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-text-editor elementor-clearfix\"><ul><li>Increase access to more markets worldwide with certification.<\/li><li>Outline how to review and improve processes across your organization.<\/li><li>Increase efficiency, cut costs and monitor supply chain performance.<\/li><li>Demonstrate that you produce safer and more effective medical devices.<\/li><\/ul><\/div><\/div><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\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-e84c4b5\" data-id=\"e84c4b5\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-72b96b4 elementor-position-left elementor-view-default elementor-vertical-align-top elementor-widget elementor-widget-icon-box\" data-id=\"72b96b4\" data-element_type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a class=\"elementor-icon elementor-animation-\" href=\"#\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-phone-alt\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t<a href=\"#\">+91 - 9999229689<\/a>\n\t\t\t\t<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b6d4c5 elementor-widget elementor-widget-heading\" data-id=\"3b6d4c5\" 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-default\">Request Callback<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-acb85c3 eael-contact-form-7-button-custom elementor-widget elementor-widget-eael-contact-form-7\" data-id=\"acb85c3\" data-element_type=\"widget\" data-widget_type=\"eael-contact-form-7.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<div class=\"eael-contact-form-7-wrapper\">\n                <div class=\"eael-contact-form eael-contact-form-7 eael-contact-form-acb85c3 placeholder-show eael-contact-form-align-default\"><div role=\"form\" class=\"wpcf7\" id=\"wpcf7-f94-o1\" lang=\"en-US\" dir=\"ltr\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/home\/wp-json\/wp\/v2\/pages\/282#wpcf7-f94-o1\" method=\"post\" class=\"wpcf7-form init\" novalidate=\"novalidate\" data-status=\"init\">\n<div style=\"display: none;\">\n<input type=\"hidden\" name=\"_wpcf7\" value=\"94\" \/>\n<input type=\"hidden\" name=\"_wpcf7_version\" value=\"5.4\" \/>\n<input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/>\n<input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f94-o1\" \/>\n<input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/>\n<input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/>\n<\/div>\n<p><span class=\"wpcf7-form-control-wrap Name\"><input type=\"text\" name=\"Name\" value=\"\" size=\"40\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Name\" \/><\/span> <br\/><\/p>\n<p><span class=\"wpcf7-form-control-wrap Email\"><input type=\"email\" name=\"Email\" value=\"\" size=\"40\" class=\"wpcf7-form-control wpcf7-text wpcf7-email wpcf7-validates-as-required wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Email\" \/><\/span> <br\/><\/p>\n<p><span class=\"wpcf7-form-control-wrap Phone\"><input type=\"text\" name=\"Phone\" value=\"\" size=\"40\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Phone\" \/><\/span> <br\/><\/p>\n<p><span class=\"wpcf7-form-control-wrap City\"><input type=\"text\" name=\"City\" value=\"\" size=\"40\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"City\" \/><\/span> <br\/><\/p>\n<p><span class=\"wpcf7-form-control-wrap LookingFor\"><select name=\"LookingFor\" class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\"><option value=\"Looking For\">Looking For<\/option><option value=\"ISO 9001:2015\">ISO 9001:2015<\/option><option value=\"ISO 14001:2015\">ISO 14001:2015<\/option><option value=\"ISO 27001:20015\">ISO 27001:20015<\/option><option value=\"ISO 22000:2015\">ISO 22000:2015<\/option><option value=\"OHSAS 18001:2015\">OHSAS 18001:2015<\/option><option value=\"CE MARKING\">CE MARKING<\/option><option value=\"OTHER\">OTHER<\/option><\/select><\/span><br\/><\/p>\n<p><input type=\"submit\" value=\"Send\" class=\"wpcf7-form-control wpcf7-submit\" \/><\/p>\n<div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div><\/form><\/div><\/div>\n            <\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>ISO 13485 Certification : >> &nbsp; ISO 13485 Certification ISO 13485:2016 specifies requirements for a medical device quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":[],"_links":{"self":[{"href":"https:\/\/bqrcertification.com\/home\/wp-json\/wp\/v2\/pages\/282"}],"collection":[{"href":"https:\/\/bqrcertification.com\/home\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/bqrcertification.com\/home\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/bqrcertification.com\/home\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bqrcertification.com\/home\/wp-json\/wp\/v2\/comments?post=282"}],"version-history":[{"count":3,"href":"https:\/\/bqrcertification.com\/home\/wp-json\/wp\/v2\/pages\/282\/revisions"}],"predecessor-version":[{"id":976,"href":"https:\/\/bqrcertification.com\/home\/wp-json\/wp\/v2\/pages\/282\/revisions\/976"}],"wp:attachment":[{"href":"https:\/\/bqrcertification.com\/home\/wp-json\/wp\/v2\/media?parent=282"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}