{"id":3783,"date":"2023-03-21T20:47:48","date_gmt":"2023-03-21T13:47:48","guid":{"rendered":"https:\/\/sci.edu.vn\/?post_type=blog_post&p=2587"},"modified":"2024-11-24T08:01:44","modified_gmt":"2024-11-24T01:01:44","slug":"vien-te-bao-goc-dat-chung-nhan-iso-134852016-cho-san-xuat-thiet-bi-y-te","status":"publish","type":"post","link":"https:\/\/sci.edu.vn\/home\/blog\/2023\/03\/21\/vien-te-bao-goc-dat-chung-nhan-iso-134852016-cho-san-xuat-thiet-bi-y-te\/","title":{"rendered":"Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c \u0111\u1ea1t Ch\u1ee9ng nh\u1eadn ISO 13485:2016 cho s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf"},"content":{"rendered":"\n

Ng\u00e0y 17.03.2023, Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p Ch\u1ee9ng nh\u1eadn ISO 13485:2016 cho d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t v\u1eadt t\u01b0 y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ea1i Trung t\u00e2m \u0110\u1ed5i m\u1edbi S\u00e1ng t\u1ea1o v\u00e0 S\u1ea3n xu\u1ea5t Th\u1ef1c nghi\u1ec7m (CIPP) c\u1ee7a Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c (SCI), Tr\u01b0\u1eddng \u0110\u1ea1i h\u1ecdc Khoa h\u1ecdc T\u1ef1 nhi\u00ean, \u0110HQG Tp.HCM<\/em><\/strong>.<\/p>\n\n\n\n

Ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e1nh gi\u00e1 gi\u00e1m s\u00e1t h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng theo ISO 13485 cho v\u1eadt t\u01b0 y t\u1ebf s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n cho Trung t\u00e2m \u0110\u1ed5i m\u1edbi S\u00e1ng t\u1ea1o v\u00e0 S\u1ea3n xu\u1ea5t Th\u1ef1c nghi\u1ec7m c\u1ee7a Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c b\u1edfi Trung t\u00e2m Ki\u1ec3m nghi\u1ec7m v\u00e0 Ch\u1ee9ng nh\u1eadn ch\u1ea5t l\u01b0\u1ee3ng TQC. TQC l\u00e0 \u0111\u01a1n v\u1ecb \u0111\u01b0\u1ee3c T\u1ed5ng c\u1ee5c Ti\u00eau chu\u1ea9n \u0110o l\u01b0\u1eddng Ch\u1ea5t l\u01b0\u1ee3ng ch\u1ec9 \u0111\u1ecbnh \u0111\u01b0\u1ee3c ph\u00e9p ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1, cung c\u1ea5p D\u1ecbch v\u1ee5 ch\u1ee9ng nh\u1eadn ISO 13485<\/strong> ch\u1ee9ng nh\u1eadn H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng cho l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, v\u1eadt t\u01b0 y t\u1ebf ph\u00f9 h\u1ee3p theo Ti\u00eau chu\u1ea9n Qu\u1ed1c t\u1ebf ISO 13485. <\/p>\n\n\n\n

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Ch\u1ee9ng nh\u1eadn ISO 13485:2016 (b\u1ea3n ti\u1ebfng Vi\u1ec7t)<\/figcaption><\/figure>\n\n\n\n
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Ch\u1ee9ng nh\u1eadn ISO 13485:2016 (b\u1ea3n ti\u1ebfng Anh)<\/figcaption><\/figure>\n\n\n\n

K\u1ebft th\u00fac qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1, TQC \u0111\u00e1nh gi\u00e1 cao vi\u1ec7c thi\u1ebft l\u1eadp quy ch\u1ebf v\u00e0 c\u00e1c quy tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng nh\u1eb1m ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m \u0111\u1ea1t y\u00eau c\u1ea7u theo ti\u00eau chu\u1ea9n ISO 13485. V\u1edbi \u0111\u1ed9i ng\u0169 nh\u00e2n s\u1ef1 c\u00f3 tr\u00ecnh \u0111\u1ed9 chuy\u00ean m\u00f4n cao, \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o b\u00e0i b\u1ea3n v\u00e0 nghi\u00eam t\u00fac, h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m theo ISO13485 m\u00e0 CIPP-SCI \u0111\u00e3 v\u00e0 \u0111ang x\u00e2y d\u1ef1ng \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 ch\u1ea5p h\u00e0nh t\u1ed1t c\u00e1c quy \u0111\u1ecbnh c\u00f3 li\u00ean quan v\u00e0 g\u1eb7p r\u1ea5t \u00edt l\u1ed7i quan s\u00e1t. Do \u0111\u00f3, Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c \u0111\u00e3 r\u1ea5t nhanh ch\u00f3ng \u0111\u01b0\u1ee3c c\u1ea5p ch\u1ee9ng nh\u1eadn ISO 13485:2016 cho thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n

Ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf ISO 13485:2016 \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn t\u1ea1i Vi\u1ec7n T\u1ebf b\u00e0o cho 5 l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t v\u00e0 kinh doanh, bao g\u1ed3m: (1) kit ph\u00e2n l\u1eadp t\u1ebf b\u00e0o<\/strong>, (2) kit thu nh\u1eadn ch\u1ebf ph\u1ea9m t\u1eeb m\u00e1u<\/strong>, (3) m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u0103ng sinh t\u1ebf b\u00e0o<\/strong>, (4) m\u00f4i tr\u01b0\u1eddng b\u1ea3o qu\u1ea3n t\u1ebf b\u00e0o<\/strong>, (5) m\u00f4i tr\u01b0\u1eddng bi\u1ebfn \u0111\u1ed5i t\u1ebf b\u00e0o<\/strong>.<\/p>\n\n\n\n

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CIPP-SCI s\u1edf h\u1eefu \u0111\u1ed9i ng\u0169 nh\u00e2n s\u1ef1 c\u00f3 tr\u00ecnh \u0111\u1ed9 chuy\u00ean m\u00f4n cao c\u00f9ng v\u1edbi trang thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c \u0111\u1ea7u t\u01b0 \u0111\u1ed3ng b\u1ed9<\/figcaption><\/figure>\n\n\n\n

Ti\u00eau chu\u1ea9n ISO 13485<\/strong><\/a> \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn v\u00e0 \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng r\u1ed9ng r\u00e3i cho c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean to\u00e0n th\u1ebf gi\u1edbi, v\u00e0 l\u00e0 m\u1ed9t y\u00eau c\u1ea7u c\u1ea7n ph\u1ea3i c\u00f3 trong giai \u0111o\u1ea1n hi\u1ec7n nay n\u1ebfu nh\u01b0 m\u1ed9t t\u1ed5 ch\u1ee9c s\u1ea3n xu\u1ea5t d\u1ee5ng c\u1ee5 y t\u1ebf, thi\u1ebft b\u1ecb y t\u1ebf, v\u1eadt t\u01b0 y t\u1ebf mu\u1ed1n s\u1ea3n ph\u1ea9m c\u1ee7a m\u00ecnh \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn r\u1ed9ng r\u00e3i tr\u00ean to\u00e0n th\u1ebf gi\u1edbi. M\u1ed9t doanh nghi\u1ec7p s\u1ea3n xu\u1ea5t v\u00e0 kinh doanh d\u1ee5ng c\u1ee5, v\u1eadt t\u01b0 y t\u1ebf c\u1ea7n ph\u1ea3i ho\u00e0n th\u00e0nh vi\u1ec7c \u00e1p d\u1ee5ng h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng theo ISO 13485  \u0111\u1ec3 \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh 98\/2021\/N\u0110-CP v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n

Ch\u1ee9ng nh\u1eadn ISO 13485:2016 l\u00e0 d\u1ea5u m\u1ed1c quan tr\u1ecdng ch\u1ee9ng minh cho s\u1ef1 nghi\u00eam t\u00fac trong ho\u1ea1t \u0111\u1ed9ng c\u1ee7a Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c, Tr\u01b0\u1eddng \u0110\u1ea1i h\u1ecdc Khoa h\u1ecdc T\u1ef1 nhi\u00ean, \u0110HQG Tp.HCM t\u1eeb nghi\u00ean c\u1ee9u, \u0111\u1ebfn \u0111\u1ed5i m\u1edbi s\u00e1ng t\u1ea1o v\u00e0 s\u1ea3n xu\u1ea5t th\u1ef1c nghi\u1ec7m. Ch\u1ee9ng nh\u1eadn ISO 13485:2016 cho th\u1ea5y vi\u1ec7c ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m v\u00e0 l\u00e0 b\u01b0\u1edbc ti\u1ebfn m\u1edbi trong qu\u00e1 tr\u00ecnh ph\u00e1t tri\u1ec3n, n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m c\u1ee7a Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c trong th\u1ecb tr\u01b0\u1eddng c\u00f4ng ngh\u1ec7 t\u1ebf b\u00e0o v\u00e0 t\u1ebf b\u00e0o g\u1ed1c t\u1ea1i Vi\u1ec7t Nam.<\/p>\n\n\n\n

Theo k\u1ebf ho\u1ea1ch s\u1eafp t\u1edbi, Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c ti\u1ebfp t\u1ee5c ho\u00e0n thi\u1ec7n h\u1ed3 s\u1edf \u0111\u1ec3 m\u1eddi \u0111\u00e1nh gi\u00e1 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng theo GMP, GMP FDA Part 820, h\u01b0\u1edbng \u0111\u1ebfn \u0111\u00e1nh gi\u00e1 ISO9001:2015 cho Vi\u1ec7n trong th\u1eddi gian s\u1edbm nh\u1ea5t.<\/p>\n\n\n\n

Ph\u00f2ng TTTT&TCSK, Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c<\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

Ng\u00e0y 17.03.2023, Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p Ch\u1ee9ng nh\u1eadn ISO 13485:2016 cho d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t v\u1eadt t\u01b0 y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ea1i Trung t\u00e2m \u0110\u1ed5i m\u1edbi S\u00e1ng t\u1ea1o v\u00e0 S\u1ea3n xu\u1ea5t Th\u1ef1c nghi\u1ec7m (CIPP) c\u1ee7a Vi\u1ec7n T\u1ebf b\u00e0o g\u1ed1c (SCI), Tr\u01b0\u1eddng \u0110\u1ea1i h\u1ecdc Khoa h\u1ecdc T\u1ef1 nhi\u00ean, \u0110HQG Tp.HCM<\/p>\n","protected":false},"author":291,"featured_media":2402,"comment_status":"closed","ping_status":"closed","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-3783","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\/2022\/08\/anh-bia.png","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts\/3783","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\/291"}],"replies":[{"embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/comments?post=3783"}],"version-history":[{"count":1,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts\/3783\/revisions"}],"predecessor-version":[{"id":4507,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts\/3783\/revisions\/4507"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/media\/2402"}],"wp:attachment":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/media?parent=3783"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/categories?post=3783"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/tags?post=3783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}