{"id":5291,"date":"2026-03-13T09:40:35","date_gmt":"2026-03-13T02:40:35","guid":{"rendered":"https:\/\/sci.edu.vn\/home\/?p=5291"},"modified":"2026-04-02T08:59:26","modified_gmt":"2026-04-02T01:59:26","slug":"vien-te-bao-goc-tai-danh-gia-toan-dien-he-thong-quan-ly-chat-luong-iso-134852016","status":"publish","type":"post","link":"https:\/\/sci.edu.vn\/home\/blog\/2026\/03\/13\/vien-te-bao-goc-tai-danh-gia-toan-dien-he-thong-quan-ly-chat-luong-iso-134852016\/","title":{"rendered":"Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c t\u00e1i \u0111\u00e1nh gi\u00e1 to\u00e0n di\u1ec7n h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 13485:2016"},"content":{"rendered":"\n<p>Trong hai ng\u00e0y 11-12\/3\/2026, Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c \u0111\u00e3 ti\u1ebfn h\u00e0nh t\u00e1i \u0111\u00e1nh gi\u00e1 to\u00e0n di\u1ec7n h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng theo ti\u00eau chu\u1ea9n ISO 13485:2016. Ho\u1ea1t \u0111\u1ed9ng n\u00e0y nh\u1eb1m r\u00e0 so\u00e1t m\u1ee9c \u0111\u1ed9 tu\u00e2n th\u1ee7, hi\u1ec7u qu\u1ea3 v\u1eadn h\u00e0nh v\u00e0 kh\u1ea3 n\u0103ng c\u1ea3i ti\u1ebfn c\u1ee7a h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng \u0111ang \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng t\u1ea1i Vi\u1ec7n trong c\u00e1c ho\u1ea1t \u0111\u1ed9ng nghi\u00ean c\u1ee9u, ph\u00e1t tri\u1ec3n v\u00e0 ch\u1ebf t\u1ea1o s\u1ea3n ph\u1ea9m sinh h\u1ecdc.<\/p>\n\n\n\n<p>ISO 13485:2016 l\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf d\u00e0nh cho c\u00e1c t\u1ed5 ch\u1ee9c tham gia v\u00e0o thi\u1ebft k\u1ebf, ph\u00e1t tri\u1ec3n, s\u1ea3n xu\u1ea5t v\u00e0 cung c\u1ea5p c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 c\u00f4ng ngh\u1ec7 y sinh, v\u1edbi y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t v\u1ec1 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng, truy xu\u1ea5t ngu\u1ed3n g\u1ed1c, qu\u1ea3n l\u00fd r\u1ee7i ro v\u00e0 h\u1ec7 th\u1ed1ng t\u00e0i li\u1ec7u.<\/p>\n\n\n\n<p>Trong qu\u00e1 tr\u00ecnh t\u00e1i \u0111\u00e1nh gi\u00e1, c\u00e1c n\u1ed9i dung tr\u1ecdng t\u00e2m \u0111\u01b0\u1ee3c xem x\u00e9t bao g\u1ed3m:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>H\u1ec7 th\u1ed1ng t\u00e0i li\u1ec7u v\u00e0 quy tr\u00ecnh qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng<\/li>\n\n\n\n<li>Quy tr\u00ecnh ki\u1ec3m so\u00e1t r\u1ee7i ro trong nghi\u00ean c\u1ee9u v\u00e0 s\u1ea3n xu\u1ea5t<\/li>\n\n\n\n<li>Ho\u1ea1t \u0111\u1ed9ng ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c<\/li>\n\n\n\n<li>C\u01a1 ch\u1ebf gi\u00e1m s\u00e1t, \u0111\u00e1nh gi\u00e1 n\u1ed9i b\u1ed9 v\u00e0 c\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c<\/li>\n<\/ul>\n\n\n\n<p>Vi\u1ec7c t\u00e1i \u0111\u00e1nh gi\u00e1 \u0111\u1ecbnh k\u1ef3 h\u1ec7 th\u1ed1ng ISO 13485:2016 kh\u00f4ng ch\u1ec9 gi\u00fap duy tr\u00ec s\u1ef1 tu\u00e2n th\u1ee7 c\u00e1c chu\u1ea9n m\u1ef1c qu\u1ed1c t\u1ebf, m\u00e0 c\u00f2n g\u00f3p ph\u1ea7n n\u00e2ng cao t\u00ednh minh b\u1ea1ch, \u0111\u1ed9 tin c\u1eady v\u00e0 t\u00ednh h\u1ec7 th\u1ed1ng trong c\u00e1c ho\u1ea1t \u0111\u1ed9ng khoa h\u1ecdc \u2013 c\u00f4ng ngh\u1ec7 t\u1ea1i Vi\u1ec7n.<\/p>\n\n\n\n<p>Th\u00f4ng qua vi\u1ec7c v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng theo chu\u1ea9n ISO 13485, Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c ti\u1ebfp t\u1ee5c kh\u1eb3ng \u0111\u1ecbnh cam k\u1ebft ph\u00e1t tri\u1ec3n c\u00e1c c\u00f4ng ngh\u1ec7 v\u00e0 s\u1ea3n ph\u1ea9m sinh h\u1ecdc trong l\u0129nh v\u1ef1c y h\u1ecdc t\u00e1i t\u1ea1o theo ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf, h\u01b0\u1edbng \u0111\u1ebfn kh\u1ea3 n\u0103ng \u1ee9ng d\u1ee5ng v\u00e0 chuy\u1ec3n giao c\u00f4ng ngh\u1ec7 b\u1ec1n v\u1eefng trong t\u01b0\u01a1ng lai.<\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/sci.edu.vn\/home\/wp-content\/uploads\/2026\/03\/Ban-tieng-viet-ISO-13485-2016.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of K\u1ebft qu\u1ea3 t\u00e1i \u0111\u00e1nh gi\u00e1 to\u00e0n di\u1ec7n ISO 13485-2016 c\u1ee7a Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c cho giai \u0111o\u1ea1n 2026-2029.\"><\/object><a id=\"wp-block-file--media-11437e4a-8d9f-42af-9c8c-5abe22889681\" href=\"https:\/\/sci.edu.vn\/home\/wp-content\/uploads\/2026\/03\/Ban-tieng-viet-ISO-13485-2016.pdf\">K\u1ebft qu\u1ea3 t\u00e1i \u0111\u00e1nh gi\u00e1 to\u00e0n di\u1ec7n ISO 13485-2016 c\u1ee7a Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c cho giai \u0111o\u1ea1n 2026-2029<\/a><a href=\"https:\/\/sci.edu.vn\/home\/wp-content\/uploads\/2026\/03\/Ban-tieng-viet-ISO-13485-2016.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-11437e4a-8d9f-42af-9c8c-5abe22889681\">Download<\/a><\/div>\n\n\n\n<h1 class=\"wp-block-heading\">Comprehensive Reassessment of ISO 13485:2016 Quality Management System at the Stem Cell Institute<\/h1>\n\n\n\n<p>On March 11\u201312, 2026, the Stem Cell Institute conducted a comprehensive reassessment of its ISO 13485:2016 quality management system. This activity aimed to review the level of compliance, operational effectiveness, and improvement capacity of the quality management framework currently implemented across the Institute\u2019s research, development, and biological product manufacturing activities.<\/p>\n\n\n\n<p>ISO 13485:2016 is an internationally recognized standard for organizations involved in the design, development, production, and supply of medical devices and biomedical technologies, emphasizing strict requirements for quality control, risk management, traceability, and documentation systems.<\/p>\n\n\n\n<p>During the reassessment process, several key aspects were systematically reviewed, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Quality documentation and management procedures<\/li>\n\n\n\n<li>Risk management processes in research and manufacturing<\/li>\n\n\n\n<li>Quality control and traceability mechanisms<\/li>\n\n\n\n<li>Internal monitoring, evaluation, and continuous improvement practices<\/li>\n<\/ul>\n\n\n\n<p>Regular reassessment of the ISO 13485:2016 system helps ensure continued compliance with international standards, while enhancing transparency, reliability, and systematic governance in scientific and technological activities at the Institute.<\/p>\n\n\n\n<p>By maintaining a quality management system aligned with ISO 13485, the Stem Cell Institute reaffirms its commitment to developing advanced biomedical technologies and biological products in regenerative medicine according to international standards, supporting future applications and technology transfer.<\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/sci.edu.vn\/home\/wp-content\/uploads\/2026\/03\/Ban-tieng-anh-ISO-13485-2016.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of Comprehensive Reassessment of ISO 13485:2016 Quality Management System at the Stem Cell Institute in the next 3 years.\"><\/object><a id=\"wp-block-file--media-3c54306d-e0d5-440c-89ad-2a5e74b66036\" href=\"https:\/\/sci.edu.vn\/home\/wp-content\/uploads\/2026\/03\/Ban-tieng-anh-ISO-13485-2016.pdf\">Comprehensive Reassessment of ISO 13485:2016 Quality Management System at the Stem Cell Institute in the next 3 years<\/a><a href=\"https:\/\/sci.edu.vn\/home\/wp-content\/uploads\/2026\/03\/Ban-tieng-anh-ISO-13485-2016.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3c54306d-e0d5-440c-89ad-2a5e74b66036\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Trong hai ng\u00e0y 11-12\/3\/2026, Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c \u0111\u00e3 ti\u1ebfn h\u00e0nh t\u00e1i \u0111\u00e1nh gi\u00e1 to\u00e0n di\u1ec7n h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng theo ti\u00eau chu\u1ea9n ISO 13485:2016. Ho\u1ea1t \u0111\u1ed9ng n\u00e0y nh\u1eb1m r\u00e0 so\u00e1t m\u1ee9c \u0111\u1ed9 tu\u00e2n th\u1ee7, hi\u1ec7u qu\u1ea3 v\u1eadn h\u00e0nh v\u00e0 kh\u1ea3 n\u0103ng c\u1ea3i ti\u1ebfn c\u1ee7a h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng \u0111ang \u0111\u01b0\u1ee3c [&hellip;]<\/p>\n","protected":false},"author":292,"featured_media":5292,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"advanced_seo_description":"","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[161],"tags":[],"class_list":["post-5291","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ban-tin"],"jetpack_featured_media_url":"https:\/\/sci.edu.vn\/home\/wp-content\/uploads\/2026\/03\/White-And-Orange-Simple-Modern-Marketing-Staff-Hiring-Linked-In-Post-1-scaled.png","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts\/5291","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/users\/292"}],"replies":[{"embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/comments?post=5291"}],"version-history":[{"count":5,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts\/5291\/revisions"}],"predecessor-version":[{"id":5343,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts\/5291\/revisions\/5343"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/media\/5292"}],"wp:attachment":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/media?parent=5291"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/categories?post=5291"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/tags?post=5291"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}