{"id":1883,"date":"2026-04-08T03:04:46","date_gmt":"2026-04-08T03:04:46","guid":{"rendered":"https:\/\/qtc.gov.vn\/?p=1883"},"modified":"2026-04-08T03:04:46","modified_gmt":"2026-04-08T03:04:46","slug":"lead-auditor-iso-134852016-tieu-chuan-vang-cho-he-thong-quan-ly-chat-luong-trang-thiet-bi-y-te-tu-ngay-13-17-04-2026","status":"publish","type":"post","link":"https:\/\/qtc.gov.vn\/lead-auditor-iso-134852016-tieu-chuan-vang-cho-he-thong-quan-ly-chat-luong-trang-thiet-bi-y-te-tu-ngay-13-17-04-2026\/","title":{"rendered":"LEAD AUDITOR ISO 13485:2016 \u2013 Ti\u00eau Chu\u1ea9n V\u00e0ng Cho H\u1ec7 Th\u1ed1ng Qu\u1ea3n L\u00fd Ch\u1ea5t L\u01b0\u1ee3ng Trang Thi\u1ebft B\u1ecb Y T\u1ebf (t\u1eeb ng\u00e0y 13-17\/04\/2026)"},"content":{"rendered":"<p data-path-to-node=\"16\">Trong b\u1ed1i c\u1ea3nh ng\u00e0nh s\u1ea3n xu\u1ea5t v\u00e0 kinh doanh thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f2i h\u1ecfi s\u1ef1 tu\u00e2n th\u1ee7 nghi\u00eam ng\u1eb7t c\u00e1c quy chu\u1ea9n qu\u1ed1c t\u1ebf, vai tr\u00f2 c\u1ee7a m\u1ed9t \u0110\u00e1nh gi\u00e1 vi\u00ean tr\u01b0\u1edfng (Lead Auditor) l\u00e0 v\u00f4 c\u00f9ng quan tr\u1ecdng. H\u1ecd kh\u00f4ng ch\u1ec9 ki\u1ec3m tra s\u1ef1 tu\u00e2n th\u1ee7 m\u00e0 c\u00f2n l\u00e0 nh\u1eefng ng\u01b0\u1eddi d\u1eabn d\u1eaft, gi\u00fap doanh nghi\u1ec7p li\u00ean t\u1ee5c c\u1ea3i ti\u1ebfn h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QMS)<img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-1884\" src=\"http:\/\/qtc.gov.vn\/wp-content\/uploads\/2026\/04\/13585.jpeg\" alt=\"\" width=\"1024\" height=\"559\" srcset=\"https:\/\/qtc.gov.vn\/wp-content\/uploads\/2026\/04\/13585.jpeg 1024w, https:\/\/qtc.gov.vn\/wp-content\/uploads\/2026\/04\/13585-768x419.jpeg 768w, https:\/\/qtc.gov.vn\/wp-content\/uploads\/2026\/04\/13585-1000x546.jpeg 1000w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/p>\n<p data-path-to-node=\"17\"><b data-path-to-node=\"17\" data-index-in-node=\"0\">Trung t\u00e2m \u0110\u00e0o t\u1ea1o (QTC)<\/b> kh\u1eb3ng \u0111\u1ecbnh v\u1ecb th\u1ebf l\u00e0 \u0111\u01a1n v\u1ecb \u0111\u00e0o t\u1ea1o h\u00e0ng \u0111\u1ea7u, cung c\u1ea5p ch\u01b0\u01a1ng tr\u00ecnh <b data-path-to-node=\"17\" data-index-in-node=\"118\">\u0110\u00e0o t\u1ea1o \u0110\u00e1nh gi\u00e1 vi\u00ean tr\u01b0\u1edfng ISO 13485:2016<\/b> theo chu\u1ea9n qu\u1ed1c t\u1ebf.<\/p>\n<h3 data-path-to-node=\"18\">T\u1ea1i sao n\u00ean ch\u1ecdn QTC l\u00e0m \u0111\u1ed1i t\u00e1c \u0111\u00e0o t\u1ea1o Lead Auditor?<\/h3>\n<p data-path-to-node=\"19\">Ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e0o t\u1ea1o t\u1ea1i QTC \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf b\u00e0i b\u1ea3n, k\u1ebft h\u1ee3p l\u00fd thuy\u1ebft chuy\u00ean s\u00e2u v\u00e0 th\u1ef1c h\u00e0nh th\u1ef1c t\u1ebf, nh\u1eb1m mang l\u1ea1i gi\u00e1 tr\u1ecb cao nh\u1ea5t cho h\u1ecdc vi\u00ean:<\/p>\n<ol start=\"1\" data-path-to-node=\"20\">\n<li>\n<p data-path-to-node=\"20,0,0\"><b data-path-to-node=\"20,0,0\" data-index-in-node=\"0\">Ch\u01b0\u01a1ng tr\u00ecnh \u0111\u1ea1t chu\u1ea9n:<\/b> N\u1ed9i dung kh\u00f3a h\u1ecdc \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng d\u1ef1a tr\u00ean c\u00e1c y\u00eau c\u1ea7u kh\u1eaft khe\u00a0 \u0111\u1ea3m b\u1ea3o h\u1ecdc vi\u00ean \u0111\u01b0\u1ee3c trang b\u1ecb \u0111\u1ea7y \u0111\u1ee7 ki\u1ebfn th\u1ee9c v\u00e0 k\u1ef9 n\u0103ng c\u1ea7n thi\u1ebft.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"20,1,0\"><b data-path-to-node=\"20,1,0\" data-index-in-node=\"0\">Gi\u1ea3ng vi\u00ean l\u00e0 Chuy\u00ean gia th\u1ef1c chi\u1ebfn:<\/b> H\u1ecdc vi\u00ean \u0111\u01b0\u1ee3c d\u1eabn d\u1eaft b\u1edfi \u0111\u1ed9i ng\u0169 chuy\u00ean gia trong ng\u00e0nh \u0111\u00e3 c\u00f3 h\u00e0ng ch\u1ee5c n\u0103m kinh nghi\u1ec7m.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"20,2,0\"><b data-path-to-node=\"20,2,0\" data-index-in-node=\"0\">Ph\u01b0\u01a1ng ph\u00e1p \u0111\u00e0o t\u1ea1o hi\u1ec7n \u0111\u1ea1i:<\/b> T\u1eadp trung v\u00e0o c\u00e1c t\u00ecnh hu\u1ed1ng th\u1ef1c t\u1ebf (case studies), b\u00e0i t\u1eadp nh\u00f3m v\u00e0 m\u00f4 ph\u1ecfng \u0111\u00e1nh gi\u00e1 (role-play), gi\u00fap h\u1ecdc vi\u00ean \u00e1p d\u1ee5ng ki\u1ebfn th\u1ee9c ngay t\u1ea1i l\u1edbp.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"20,3,0\"><b data-path-to-node=\"20,3,0\" data-index-in-node=\"0\">Ch\u1ee9ng nh\u1eadn uy t\u00edn :<\/b> Ch\u1ee9ng nh\u1eadn <b data-path-to-node=\"20,3,0\" data-index-in-node=\"37\">ISO 13485 Lead Auditor<\/b> \u0111\u01b0\u1ee3c c\u1ea5p b\u1edfi QTC (sau khi ho\u00e0n th\u00e0nh kh\u00f3a h\u1ecdc v\u00e0 \u0111\u1ea1t k\u1ebft qu\u1ea3 ki\u1ec3m tra) l\u00e0 minh ch\u1ee9ng v\u00e0ng v\u1ec1 n\u0103ng l\u1ef1c, m\u1edf ra c\u01a1 h\u1ed9i ngh\u1ec1 nghi\u1ec7p r\u1ed9ng l\u1edbn t\u1ea1i c\u00e1c t\u1ed5 ch\u1ee9c \u0111\u00e1nh gi\u00e1 ho\u1eb7c c\u00e1c doanh nghi\u1ec7p.<\/p>\n<\/li>\n<\/ol>\n<h3 data-path-to-node=\"21\">N\u1ed9i dung ch\u00ednh c\u1ee7a kh\u00f3a h\u1ecdc<\/h3>\n<p data-path-to-node=\"22\">Ch\u01b0\u01a1ng tr\u00ecnh \u0110\u00e0o t\u1ea1o \u0110\u00e1nh gi\u00e1 vi\u00ean tr\u01b0\u1edfng ISO 13485 t\u1ea1i QTC bao g\u1ed3m c\u00e1c n\u1ed9i dung c\u1ed1t l\u00f5i:<\/p>\n<ul data-path-to-node=\"23\">\n<li>\n<p data-path-to-node=\"23,0,0\"><b data-path-to-node=\"23,0,0\" data-index-in-node=\"0\">T\u1ed5ng quan v\u00e0 ph\u00e2n t\u00edch chuy\u00ean s\u00e2u:<\/b> C\u00e1c y\u00eau c\u1ea7u c\u1ee7a ti\u00eau chu\u1ea9n ISO 13485:2016.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"23,1,0\"><b data-path-to-node=\"23,1,0\" data-index-in-node=\"0\">K\u1ef9 n\u0103ng \u0111\u00e1nh gi\u00e1:<\/b> Ho\u1ea1ch \u0111\u1ecbnh \u0111\u00e1nh gi\u00e1, chu\u1ea9n b\u1ecb t\u00e0i li\u1ec7u (checklist), k\u1ef9 thu\u1eadt ph\u1ecfng v\u1ea5n, thu th\u1eadp b\u1eb1ng ch\u1ee9ng \u0111\u00e1nh gi\u00e1.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"23,2,0\"><b data-path-to-node=\"23,2,0\" data-index-in-node=\"0\">Quy tr\u00ecnh \u0111\u00e1nh gi\u00e1:<\/b> \u0110\u00e1nh gi\u00e1 th\u1eed, h\u1ecdp khai m\u1ea1c, th\u1ef1c hi\u1ec7n \u0111\u00e1nh gi\u00e1 t\u1ea1i hi\u1ec7n tr\u01b0\u1eddng, h\u1ecdp k\u1ebft th\u00fac.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"23,3,0\"><b data-path-to-node=\"23,3,0\" data-index-in-node=\"0\">B\u00e1o c\u00e1o v\u00e0 theo d\u00f5i:<\/b> L\u1eadp b\u00e1o c\u00e1o \u0111\u00e1nh gi\u00e1, nh\u1eadn di\u1ec7n \u0111i\u1ec3m kh\u00f4ng ph\u00f9 h\u1ee3p (NC), theo d\u00f5i h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"23,4,0\"><b data-path-to-node=\"23,4,0\" data-index-in-node=\"0\">Tr\u00e1ch nhi\u1ec7m v\u00e0 \u0111\u1ea1o \u0111\u1ee9c ngh\u1ec1 nghi\u1ec7p:<\/b> C\u1ee7a m\u1ed9t \u0110\u00e1nh gi\u00e1 vi\u00ean tr\u01b0\u1edfng chuy\u00ean nghi\u1ec7p.<\/p>\n<\/li>\n<\/ul>\n<h3 data-path-to-node=\"24\">\u0110\u1ed1i t\u01b0\u1ee3ng tham d\u1ef1<\/h3>\n<p data-path-to-node=\"25\">Kh\u00f3a h\u1ecdc l\u00fd t\u01b0\u1edfng cho c\u00e1c c\u00e1 nh\u00e2n mong mu\u1ed1n tr\u1edf th\u00e0nh \u0110\u00e1nh gi\u00e1 vi\u00ean tr\u01b0\u1edfng chuy\u00ean nghi\u1ec7p ho\u1eb7c n\u00e2ng cao n\u0103ng l\u1ef1c qu\u1ea3n l\u00fd:<\/p>\n<ul data-path-to-node=\"26\">\n<li>\n<p data-path-to-node=\"26,0,0\">Chuy\u00ean gia \u0111\u00e1nh gi\u00e1 n\u1ed9i b\u1ed9 (Internal Auditors).<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"26,1,0\">Gi\u00e1m \u0111\u1ed1c\/Tr\u01b0\u1edfng ph\u00f2ng ch\u1ea5t l\u01b0\u1ee3ng (QA\/QC Managers).<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"26,2,0\">Qu\u1ea3n l\u00fd s\u1ea3n xu\u1ea5t, R&amp;D trong ng\u00e0nh y t\u1ebf.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"26,3,0\">Chuy\u00ean gia t\u01b0 v\u1ea5n h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd.<\/p>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"27\">H\u00e3y n\u00e2ng t\u1ea7m n\u0103ng l\u1ef1c v\u00e0 \u0111\u1ecbnh h\u00ecnh t\u01b0\u01a1ng lai s\u1ef1 nghi\u1ec7p c\u1ee7a b\u1ea1n trong ng\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf c\u00f9ng QTC.<\/p>\n<p data-path-to-node=\"28\"><b data-path-to-node=\"28\" data-index-in-node=\"0\">Th\u00f4ng tin li\u00ean h\u1ec7 &amp; \u0110\u0103ng k\u00fd kh\u00f3a h\u1ecdc:<\/b><\/p>\n<ul data-path-to-node=\"29\">\n<li>\n<p data-path-to-node=\"29,0,0\"><b data-path-to-node=\"29,0,0\" data-index-in-node=\"0\">Website:<\/b> <a class=\"ng-star-inserted\" href=\"https:\/\/www.google.com\/search?q=https:\/\/qtc.gov.vn\/dao-tao\" target=\"_blank\" rel=\"noopener\" data-hveid=\"0\" data-ved=\"0CAAQ_4QMahgKEwi9m8Cdnt2TAxUAAAAAHQAAAAAQjwE\">qtc.gov.vn<\/a><\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"29,1,0\"><b data-path-to-node=\"29,1,0\" data-index-in-node=\"0\">Hotline \u0111\u0103ng k\u00ed tham gia :<\/b> Ms Huy\u1ec1n : 0913.553.434<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"29,2,0\"><b data-path-to-node=\"29,2,0\" data-index-in-node=\"0\">\u0110\u1ecba ch\u1ec9:<\/b> nh\u00e0 B s\u1ed1 8 Ho\u00e0ng Qu\u1ed1c Vi\u1ec7t, ph\u01b0\u1eddng Ngh\u0129a \u0110\u00f4, Tp. H\u00e0 N\u1ed9i<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Trong b\u1ed1i c\u1ea3nh ng\u00e0nh s\u1ea3n xu\u1ea5t v\u00e0 kinh doanh thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f2i h\u1ecfi s\u1ef1 tu\u00e2n th\u1ee7 nghi\u00eam ng\u1eb7t c\u00e1c quy chu\u1ea9n qu\u1ed1c t\u1ebf, vai tr\u00f2 c\u1ee7a m\u1ed9t \u0110\u00e1nh gi\u00e1 vi\u00ean tr\u01b0\u1edfng (Lead Auditor) l\u00e0 v\u00f4 c\u00f9ng quan tr\u1ecdng. H\u1ecd kh\u00f4ng ch\u1ec9 ki\u1ec3m tra s\u1ef1 tu\u00e2n th\u1ee7 m\u00e0 c\u00f2n l\u00e0 nh\u1eefng ng\u01b0\u1eddi d\u1eabn d\u1eaft, [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":1884,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[5,1],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.2.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>LEAD AUDITOR ISO 13485:2016 \u2013 Ti\u00eau Chu\u1ea9n V\u00e0ng Cho H\u1ec7 Th\u1ed1ng Qu\u1ea3n L\u00fd Ch\u1ea5t L\u01b0\u1ee3ng Trang Thi\u1ebft B\u1ecb Y T\u1ebf (t\u1eeb ng\u00e0y 13-17\/04\/2026) - QTC<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/qtc.gov.vn\/lead-auditor-iso-134852016-tieu-chuan-vang-cho-he-thong-quan-ly-chat-luong-trang-thiet-bi-y-te-tu-ngay-13-17-04-2026\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"LEAD AUDITOR ISO 13485:2016 \u2013 Ti\u00eau Chu\u1ea9n V\u00e0ng Cho H\u1ec7 Th\u1ed1ng Qu\u1ea3n L\u00fd Ch\u1ea5t L\u01b0\u1ee3ng Trang Thi\u1ebft B\u1ecb Y T\u1ebf (t\u1eeb ng\u00e0y 13-17\/04\/2026) - QTC\" \/>\n<meta property=\"og:description\" content=\"Trong b\u1ed1i c\u1ea3nh ng\u00e0nh s\u1ea3n xu\u1ea5t v\u00e0 kinh doanh thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f2i h\u1ecfi s\u1ef1 tu\u00e2n th\u1ee7 nghi\u00eam ng\u1eb7t c\u00e1c quy chu\u1ea9n qu\u1ed1c t\u1ebf, vai tr\u00f2 c\u1ee7a m\u1ed9t \u0110\u00e1nh gi\u00e1 vi\u00ean tr\u01b0\u1edfng (Lead Auditor) l\u00e0 v\u00f4 c\u00f9ng quan tr\u1ecdng. 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