{"id":160,"date":"2024-04-19T16:39:28","date_gmt":"2024-04-19T07:39:28","guid":{"rendered":"https:\/\/cm-plus.co.jp\/vn\/?page_id=160"},"modified":"2025-09-25T15:05:43","modified_gmt":"2025-09-25T06:05:43","slug":"qms_consulting","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/qms_consulting\/","title":{"rendered":"QMS for Medical Devices"},"content":{"rendered":"<div id=\"qms_consulting\">\n<div id=\"pagePath\">\n<ul>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/\">Trang ch\u1ee7<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/\">D\u1ecbch v\u1ee5<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/\">T\u01b0 v\u1ea5n<\/a>\/<\/li>\n<li>QMS cho thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">T\u01b0 v\u1ea5n<\/span><br class=\"wpTag\">QMS cho thi\u1ebft b\u1ecb y t\u1ebf<br \/>\n<span class=\"h1Photo\"><br \/>\n<span class=\"maskBox\"><br \/>\n<span class=\"topCover\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\" alt=\"Consulting QMS for Medical Devices\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg01\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/image-service10.webp\" alt=\"Consulting QMS for Medical Devices\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg02\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/image-service10.webp\" alt=\"Consulting QMS for Medical Devices\"><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/h1>\n<\/div>\n<\/div>\n<div class=\"content\">\n<div class=\"mainBox\">\n<article id=\"conts\">\n<section class=\"secBox supportBox\">\n<h2 class=\"headLine05\">H\u1ed7 tr\u1ee3 Doanh Nghi\u1ec7p M\u1edbi Gia Nh\u1eadp Ng\u00e0nh Thi\u1ebft B\u1ecb Y T\u1ebf<\/h2>\n<p class=\"wpTag\">TQuy m\u00f4 th\u1ecb tr\u01b0\u1eddng thi\u1ebft b\u1ecb y t\u1ebf to\u00e0n c\u1ea7u \u01b0\u1edbc t\u00ednh v\u00e0o kho\u1ea3ng 30 ngh\u00ecn t\u1ef7 y\u00ean, trong \u0111\u00f3 ri\u00eang Nh\u1eadt B\u1ea3n chi\u1ebfm kho\u1ea3ng 2,8 ngh\u00ecn t\u1ef7 y\u00ean.<\/p>\n<p class=\"wpTag\">Th\u1ecb tr\u01b0\u1eddng n\u00e0y l\u1edbn v\u00e0 h\u1ea5p d\u1eabn \u0111\u1ed1i v\u1edbi nh\u1eefng doanh nghi\u1ec7p m\u1edbi tham gia; tuy nhi\u00ean, c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i tu\u00e2n theo c\u00e1c quy \u0111\u1ecbnh nghi\u00eam ng\u1eb7t theo \u201c\u0110\u1ea1o lu\u1eadt \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng, hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m bao g\u1ed3m d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf\u201d (vi\u1ebft t\u1eaft l\u00e0 \u0110\u1ea1o lu\u1eadt d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c \u0110\u1ea1o lu\u1eadt PMD). Ngay c\u1ea3 khi m\u1ed9t v\u1eadt li\u1ec7u ho\u1eb7c c\u00f4ng ngh\u1ec7 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c \u1ee9ng d\u1ee5ng v\u00e0o y h\u1ecdc th\u00ec v\u1eabn c\u00f2n nhi\u1ec1u r\u00e0o c\u1ea3n \u0111\u00e1ng k\u1ec3 c\u1ea7n ph\u1ea3i v\u01b0\u1ee3t qua \u0111\u1ec3 \u0111\u01b0a n\u00f3 ra th\u1ecb tr\u01b0\u1eddng nh\u01b0 m\u1ed9t thi\u1ebft b\u1ecb y t\u1ebf.\n<\/p>\n<p class=\"text01\">CM Plus h\u1ed7 tr\u1ee3 doanh nghi\u1ec7p m\u1edbi tham gia b\u1eb1ng c\u00e1ch x\u00e2y d\u1ef1ng h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QMS) d\u1ef1a tr\u00ean Ph\u00e1p l\u1ec7nh QMS (ISO 13485) v\u00e0 ti\u1ebfn h\u00e0nh thi\u1ebft k\u1ebf v\u00e0 ph\u00e1t tri\u1ec3n s\u1ea3n ph\u1ea9m theo QMS ngay t\u1eeb giai \u0111o\u1ea1n l\u1eadp k\u1ebf ho\u1ea1ch ban \u0111\u1ea7u c\u1ee7a c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf, \u0111\u1ea3m b\u1ea3o s\u1ef1 gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng su\u00f4n s\u1ebb v\u00e0 kh\u00f4ng th\u1ec3 \u0111\u1ea3o ng\u01b0\u1ee3c.<\/p>\n<h3 class=\"headLine11\">L\u1ed9 tr\u00ecnh t\u1eeb Ph\u00e1t tri\u1ec3n \u0111\u1ebfn Ra m\u1eaft Th\u1ecb tr\u01b0\u1eddng Thi\u1ebft b\u1ecb Y t\u1ebf<\/h3>\n<div class=\"bigPhoto\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo01.webp\" alt=\"\u201cS\u1ed5 tay H\u1ed7 tr\u1ee3 Ph\u00e1t tri\u1ec3n Thi\u1ebft b\u1ecb Y t\u1ebf\u201d \u0110\u00e3 s\u1eeda \u0111\u1ed5i v\u00e0o th\u00e1ng 10 n\u0103m 2023\"><br \/>\n<span class=\"photoIco\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo01.webp\" class=\"popImg\">&nbsp;<\/a><\/span><\/div>\n<p class=\"smlText\">\u201cS\u1ed5 tay H\u1ed7 tr\u1ee3 Ph\u00e1t tri\u1ec3n Thi\u1ebft b\u1ecb Y t\u1ebf\u201d \u0110\u00e3 s\u1eeda \u0111\u1ed5i v\u00e0o th\u00e1ng 10 n\u0103m 2023<\/p>\n<p class=\"smlText\">T\u1eeb V\u0103n ph\u00f2ng N\u1ed9i c\u00e1c (V\u0103n ph\u00f2ng Chi\u1ebfn l\u01b0\u1ee3c Y t\u1ebf v\u00e0 Ch\u0103m s\u00f3c S\u1ee9c kh\u1ecfe), B\u1ed9 Gi\u00e1o d\u1ee5c, V\u0103n h\u00f3a, Th\u1ec3 thao, Khoa h\u1ecdc v\u00e0 C\u00f4ng ngh\u1ec7, B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i, v\u00e0 B\u1ed9 Kinh t\u1ebf, Th\u01b0\u01a1ng m\u1ea1i v\u00e0 C\u00f4ng nghi\u1ec7p<\/p>\n<p class=\"note\">\u203b<span class=\"strip\"><\/span>ch\u1ec9 ra ph\u1ea1m vi d\u1ecbch v\u1ee5 t\u01b0 v\u1ea5n thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a CM Plus.<\/p>\n<section>\n<h3 class=\"headLine06\">C\u00e1c B\u01b0\u1edbc Tri\u1ec3n Khai \u0110i\u1ec3n H\u00ecnh t\u1ea1i Nh\u1eadt B\u1ea3n<\/h3>\n<div class=\"comStepBox comStepBox02\">\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">B\u01af\u1edaC<span class=\"txtSpan\">01<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<h4 class=\"headLine09\"><span class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon_img14.webp\" alt=\"AMua l\u1ea1i Gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 \u0110\u0103ng k\u00fd kinh doanh s\u1ea3n xu\u1ea5t\"><\/span><span class=\"ttl\">Mua l\u1ea1i Gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 \u0110\u0103ng k\u00fd kinh doanh s\u1ea3n xu\u1ea5t<\/span><\/h4>\n<p class=\"wpTag\">Vi\u1ec7c s\u1ea3n xu\u1ea5t v\u00e0 l\u01b0u h\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i Nh\u1eadt B\u1ea3n ph\u1ea3i tu\u00e2n th\u1ee7 \u0110\u1ea1o lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb Y t\u1ebf (\u0110\u1ea1o lu\u1eadt PMD). \u0110\u1ec3 ti\u1ebfn h\u00e0nh s\u1ea3n xu\u1ea5t v\u00e0 ti\u1ebfp th\u1ecb, c\u1ea7n ph\u1ea3i c\u00f3 gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 \u0111\u1ec3 ti\u1ebfn h\u00e0nh s\u1ea3n xu\u1ea5t, c\u1ea7n ph\u1ea3i \u0111\u0103ng k\u00fd l\u00e0 doanh nghi\u1ec7p s\u1ea3n xu\u1ea5t.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">B\u01af\u1edaC<span class=\"txtSpan\">02<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<h4 class=\"headLine09\"><span class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon_img02.webp\" alt=\"Thi\u1ebft l\u1eadp QMS (H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng)\"><\/span><span class=\"ttl\">Thi\u1ebft l\u1eadp QMS (H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng)<\/span><\/h4>\n<p class=\"wpTag\">\u0110\u1ec3 th\u1ef1c hi\u1ec7n chu\u1ed7i quy tr\u00ecnh thi\u1ebft k\u1ebf, ph\u00e1t tri\u1ec3n, s\u1ea3n xu\u1ea5t, v\u1eadn chuy\u1ec3n v\u00e0 b\u00e1n c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf, y\u00eau c\u1ea7u ph\u1ea3i c\u00f3 H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QMS) v\u00e0 tr\u01b0\u1edbc ti\u00ean, QMS ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp. T\u1ea1i Nh\u1eadt B\u1ea3n, \u0111i\u1ec1u n\u00e0y \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong S\u1eafc l\u1ec7nh s\u1ed1 169 c\u1ee7a B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i (S\u1eafc l\u1ec7nh QMS). S\u1eafc l\u1ec7nh s\u1ed1 169 n\u00e0y ph\u1ea7n l\u1edbn ph\u00f9 h\u1ee3p v\u1edbi ISO 13485 (phi\u00ean b\u1ea3n 2016).<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">B\u01af\u1edaC<span class=\"txtSpan\">03<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<h4 class=\"headLine09\"><span class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon_img15.webp\" alt=\"Th\u00f4ng b\u00e1o, \u0110\u01a1n xin c\u1ea5p ch\u1ee9ng nh\u1eadn v\u00e0 \u0110\u01a1n xin ph\u00ea duy\u1ec7t cho Thi\u1ebft b\u1ecb y t\u1ebf\"><\/span><span class=\"ttl\">Th\u00f4ng b\u00e1o, \u0110\u01a1n xin c\u1ea5p ch\u1ee9ng nh\u1eadn v\u00e0 \u0110\u01a1n xin ph\u00ea duy\u1ec7t cho Thi\u1ebft b\u1ecb y t\u1ebf<\/span><\/h4>\n<p class=\"wpTag\">Sau khi thi\u1ebft k\u1ebf, ph\u00e1t tri\u1ec3n v\u00e0 s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c chu\u1ea9n b\u1ecb \u0111\u1ec3 th\u1ef1c hi\u1ec7n s\u1ea3n ph\u1ea9m, c\u1ea7n ph\u1ea3i th\u00f4ng b\u00e1o, n\u1ed9p \u0111\u01a1n xin c\u1ea5p ch\u1ee9ng nh\u1eadn ho\u1eb7c \u0111\u01a1n xin ph\u00ea duy\u1ec7t cho thi\u1ebft b\u1ecb y t\u1ebf. Vi\u1ec7c l\u1ef1a ch\u1ecdn trong s\u1ed1 nh\u1eefng \u0111i\u1ec1u n\u00e0y ph\u1ee5 thu\u1ed9c v\u00e0o m\u1ee9c \u0111\u1ed9 r\u1ee7i ro li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf.<br class=\"wpTag\"><br \/>\nV\u00ed d\u1ee5, \u1ed1ng ti\u00eam kh\u00f4ng c\u00f3 kim \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i l\u00e0 Lo\u1ea1i I v\u00e0 c\u1ea7n ph\u1ea3i th\u00f4ng b\u00e1o, trong khi \u1ed1ng ti\u00eam c\u00f3 kim \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i l\u00e0 Lo\u1ea1i II v\u00e0 c\u1ea7n ph\u1ea3i n\u1ed9p \u0111\u01a1n xin c\u1ea5p ch\u1ee9ng nh\u1eadn. Ngo\u00e0i ra, c\u00e1c thi\u1ebft b\u1ecb nh\u01b0 \u1ed1ng th\u00f4ng \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o m\u1ea1ch m\u00e1u c\u1ea7n ph\u1ea3i n\u1ed9p \u0111\u01a1n xin ph\u00ea duy\u1ec7t.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">B\u01af\u1edaC<span class=\"txtSpan\">04<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<h4 class=\"headLine09\"><span class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon_img16.webp\" alt=\"QMS Conformity Assessment\"><\/span><span class=\"ttl\">\u0110\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p c\u1ee7a QMS<\/span><\/h4>\n<p class=\"wpTag\">Trong tr\u01b0\u1eddng h\u1ee3p \u0111\u01a1n xin c\u1ea5p ch\u1ee9ng nh\u1eadn ho\u1eb7c \u0111\u01a1n xin ph\u00ea duy\u1ec7t, \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p c\u1ee7a QMS s\u1ebd \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh sau khi \u0111\u01a1n \u0111\u01b0\u1ee3c n\u1ed9p. \u0110\u00e1nh gi\u00e1 n\u00e0y x\u00e1c \u0111\u1ecbnh li\u1ec7u c\u00e1c ho\u1ea1t \u0111\u1ed9ng qu\u1ea3n l\u00fd s\u1ea3n xu\u1ea5t v\u00e0 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u00f3 th\u1ef1c s\u1ef1 \u0111\u01b0\u1ee3c tri\u1ec3n khai theo \u0111\u00fang Ph\u00e1p l\u1ec7nh QMS v\u00e0 ISO 13485 (phi\u00ean b\u1ea3n 2016) hay kh\u00f4ng. \u0110\u1ed1i v\u1edbi ch\u1ee9ng nh\u1eadn, \u0111\u00e1nh gi\u00e1 n\u00e0y \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi C\u01a1 quan ch\u1ee9ng nh\u1eadn \u0111\u00e3 \u0111\u0103ng k\u00fd v\u00e0 \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t, \u0111\u00e1nh gi\u00e1 n\u00e0y \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi PMDA (C\u01a1 quan d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf).<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">B\u01af\u1edaC<span class=\"txtSpan\">05<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<h4 class=\"headLine09\"><span class=\"mark\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/icon_img17.webp\" alt=\"Gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh\"><\/span><span class=\"ttl\">Gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh<\/span><\/h4>\n<p class=\"wpTag\">Trong tr\u01b0\u1eddng h\u1ee3p c\u00e1c \u0111\u01a1n xin c\u1ea5p ch\u1ee9ng nh\u1eadn v\u00e0 ph\u00ea duy\u1ec7t, vi\u1ec7c s\u1ea3n xu\u1ea5t v\u00e0 ti\u1ebfp th\u1ecb ch\u1ec9 c\u00f3 th\u1ec3 th\u1ef1c hi\u1ec7n \u0111\u01b0\u1ee3c sau khi \u0111\u01a1n \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng qua v\u00e0 \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p c\u1ee7a QMS \u0111\u00e3 ho\u00e0n t\u1ea5t th\u00e0nh c\u00f4ng.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section>\n<h3 class=\"headLine06 spTtl\">D\u1ecbch V\u1ee5 H\u1ed7 Tr\u1ee3 Gia Nh\u1eadp Th\u1ecb Tr\u01b0\u1eddng M\u1edbi c\u1ee7a CM Plus<\/h3>\n<p class=\"text02\">Nh\u01b0 \u0111\u00e3 tr\u00ecnh b\u00e0y trong c\u00e1c v\u00ed d\u1ee5 tr\u00ean, nhi\u1ec1u nhi\u1ec7m v\u1ee5 kh\u00e1c nhau ph\u00e1t sinh d\u1ef1a tr\u00ean c\u00e1c y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh trong c\u00e1c b\u01b0\u1edbc th\u00e2m nh\u1eadp th\u1ecb tr\u01b0\u1eddng m\u1edbi. CM Plus h\u1ed7 tr\u1ee3 th\u1ef1c hi\u1ec7n c\u00e1c nhi\u1ec7m v\u1ee5 n\u00e0y. Ch\u00fang t\u00f4i cung c\u1ea5p c\u00e1c d\u1ecbch v\u1ee5 \u0111\u00e1p \u1ee9ng nhu c\u1ea7u c\u1ee7a b\u1ea1n, t\u1eeb h\u1ed7 tr\u1ee3 to\u00e0n b\u1ed9 d\u1ef1 \u00e1n \u0111\u1ebfn h\u1ed7 tr\u1ee3 m\u1ed9t ph\u1ea7n, ch\u1eb3ng h\u1ea1n nh\u01b0 ch\u1ec9 th\u1ea9m \u0111\u1ecbnh. N\u1ed9i dung h\u1ed7 tr\u1ee3 c\u1ee5 th\u1ec3 nh\u01b0 sau:<\/p>\n<div class=\"imgInner\">\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<h4 class=\"headLine10\">Thi\u1ebft l\u1eadp QMS<\/h4>\n<p class=\"wpTag\">Ch\u00fang t\u00f4i h\u1ed7 tr\u1ee3 thi\u1ebft l\u1eadp H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QMS) c\u00e0ng nh\u1ecf g\u1ecdn c\u00e0ng t\u1ed1t, ph\u00f9 h\u1ee3p v\u1edbi quy m\u00f4 ho\u1ea1t \u0111\u1ed9ng c\u1ee7a b\u1ea1n. \u0110i\u1ec1u n\u00e0y bao g\u1ed3m h\u1ed7 tr\u1ee3 chu\u1ea9n b\u1ecb t\u00e0i li\u1ec7u c\u1ea7n thi\u1ebft v\u00e0 tri\u1ec3n khai th\u1ef1c t\u1ebf h\u1ec7 th\u1ed1ng.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo02.webp\" alt=\"Establishment of QMS\"><\/div>\n<\/div>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<h4 class=\"headLine10\">H\u1ed7 tr\u1ee3 Ki\u1ec3m so\u00e1t Thi\u1ebft k\u1ebf<\/h4>\n<p class=\"wpTag\">Ch\u00fang t\u00f4i h\u1ed7 tr\u1ee3 thi\u1ebft k\u1ebf c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf m\u1edbi ph\u00e1t tri\u1ec3n b\u1eb1ng c\u00e1ch gi\u00fap l\u00e0m r\u00f5 c\u00e1c y\u00eau c\u1ea7u, chuy\u1ec3n \u0111\u1ed5i ch\u00fang th\u00e0nh d\u1eef li\u1ec7u \u0111\u1ea7u v\u00e0o, ti\u1ebfn h\u00e0nh c\u00f4ng vi\u1ec7c thi\u1ebft k\u1ebf v\u00e0 ph\u00e1t tri\u1ec3n th\u1ef1c t\u1ebf, t\u1ea1o ra \u0111\u1ea7u ra, x\u00e1c minh \u0111\u1ea7u ra, th\u1ea9m \u0111\u1ecbnh \u0111\u1ea7u ra v\u00e0 th\u1ef1c hi\u1ec7n c\u00e1c nhi\u1ec7m v\u1ee5 qu\u1ea3n l\u00fd r\u1ee7i ro t\u1ea1i c\u00e1c th\u1eddi \u0111i\u1ec3m quan tr\u1ecdng.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo03.webp\" alt=\"Support for Design Control\"><\/div>\n<\/div>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<h4 class=\"headLine10\">H\u1ed7 Tr\u1ee3 \u0110\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n H\u1ec7 Th\u1ed1ng Qu\u1ea3n L\u00fd Ch\u1ea5t L\u01b0\u1ee3ng (QMS)<\/h4>\n<p class=\"wpTag\">Ch\u00fang t\u00f4i cung c\u1ea5p h\u1ed7 tr\u1ee3 cho c\u00f4ng t\u00e1c chu\u1ea9n b\u1ecb v\u00e0 c\u00e1c d\u1ecbch v\u1ee5 nh\u01b0 ki\u1ec3m tra gi\u1ea3 \u0111\u1ecbnh \u0111\u1ec3 chu\u1ea9n b\u1ecb cho c\u00e1c cu\u1ed9c ki\u1ec3m tra c\u1ee7a c\u00e1c t\u1ed5 ch\u1ee9c ch\u1ee9ng nh\u1eadn v\u00e0 PMDA.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo04.webp\" alt=\"Support for QMS Conformity Assessment Preparation\"><\/div>\n<\/div>\n<div class=\"comImgBox\">\n<div class=\"textBox\">\n<h4 class=\"headLine10\">H\u1ed7 tr\u1ee3 Th\u1ea9m \u0111\u1ecbnh <\/h4>\n<p class=\"wpTag\">Khi thi\u1ebft l\u1eadp quy tr\u00ecnh s\u1ea3n xu\u1ea5t t\u1ea1i c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, ch\u00fang t\u00f4i cung c\u1ea5p h\u1ed7 tr\u1ee3 to\u00e0n di\u1ec7n, t\u1eeb vi\u1ec7c l\u1eadp k\u1ebf ho\u1ea1ch th\u1ea9m \u0111\u1ecbnh \u0111\u1ebfn t\u00f3m t\u1eaft b\u00e1o c\u00e1o.<\/p>\n<\/div>\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo05.webp\" alt=\"Validation Support\"><\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/section>\n<section class=\"secBox improveBox\">\n<h2 class=\"headLine05\">H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng: C\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c QMS<\/h2>\n<p class=\"wpTag\">Thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 c\u00f4ng c\u1ee5 \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb v\u00e0 ch\u1ea9n \u0111o\u00e1n, \u0111\u00f2i h\u1ecfi ph\u1ea3i c\u1ea3i ti\u1ebfn hi\u1ec7u su\u1ea5t li\u00ean t\u1ee5c, t\u0103ng c\u01b0\u1eddng an to\u00e0n v\u00e0 c\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QMS). \u0110\u1ec3 h\u1ed7 tr\u1ee3 c\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c n\u00e0y, CM Plus cung c\u1ea5p c\u00e1c d\u1ecbch v\u1ee5 sau.<\/p>\n<p class=\"text01\">Ngo\u00e0i ra, nhi\u1ec1u nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng ch\u1ec9 nh\u1eafm t\u1edbi th\u1ecb tr\u01b0\u1eddng trong n\u01b0\u1edbc m\u00e0 c\u00f2n xu\u1ea5t kh\u1ea9u sang nhi\u1ec1u n\u01b0\u1edbc tr\u00ean th\u1ebf gi\u1edbi. C\u00e1c y\u00eau c\u1ea7u v\u1ec1 quy \u0111\u1ecbnh kh\u00f4ng ch\u1ec9 bao g\u1ed3m c\u00e1c quy \u0111\u1ecbnh v\u1ec1 QMS c\u1ee7a Nh\u1eadt B\u1ea3n m\u00e0 c\u00f2n bao g\u1ed3m c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf nh\u01b0 ISO 13485 v\u00e0 Quy \u0111\u1ecbnh v\u1ec1 h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng (QSR) c\u1ee7a FDA Hoa K\u1ef3. Vi\u1ec7c xu\u1ea5t kh\u1ea9u \u0111\u00f2i h\u1ecfi ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh c\u1ee7a qu\u1ed1c gia \u0111\u00f3.<\/p>\n<h3 class=\"headLine11\">C\u1ea3i ti\u1ebfn li\u00ean t\u1ee5c h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng<\/h3>\n<div class=\"bigPhoto bigPhoto02\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo06.webp\" alt=\"Continuous Improvement of the Quality Management System\"><span class=\"photoIco\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo06.webp\" class=\"popImg\">&nbsp;<\/a><\/span><\/div>\n<section>\n<h3 class=\"headLine06\">T\u1ed1i \u01b0u h\u00f3a H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QMS)<\/h3>\n<p class=\"wpTag\">Ch\u00fang t\u00f4i th\u01b0\u1eddng th\u1ea5y nh\u1eefng tr\u01b0\u1eddng h\u1ee3p m\u00e0 b\u1ea3n th\u00e2n H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng tr\u1edf n\u00ean c\u1ed3ng k\u1ec1nh v\u00e0 kh\u00f3 qu\u1ea3n l\u00fd, bi\u1ebfn th\u00e0nh m\u1ed9t n\u00fai t\u00e0i li\u1ec7u do ph\u1ea3i s\u1eeda ch\u1eefa nhi\u1ec1u l\u1ea7n c\u00e1c v\u1ea5n \u0111\u1ec1 \u0111\u01b0\u1ee3c n\u00eau trong c\u00e1c cu\u1ed9c thanh tra \u0111\u1ecbnh k\u1ef3 ISO 13485 tr\u01b0\u1edbc \u0111\u00e2y. Ch\u00fang t\u00f4i h\u1ed7 tr\u1ee3 vi\u1ec7c t\u00e1i thi\u1ebft H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng nh\u1ecf g\u1ecdn v\u00e0 d\u1ec5 v\u1eadn h\u00e0nh d\u1ef1a tr\u00ean chu tr\u00ecnh PDCA, ph\u00f9 h\u1ee3p v\u1edbi quy m\u00f4 c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u00e0 s\u1ed1 l\u01b0\u1ee3ng m\u1eb7t h\u00e0ng \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t ho\u1eb7c b\u00e1n ra.<\/p>\n<\/section>\n<section>\n<h3 class=\"headLine06\">H\u1ed7 tr\u1ee3 x\u00e2y d\u1ef1ng H\u1ec7 th\u1ed1ng \u0110\u00e1nh gi\u00e1 Qu\u1ea3n l\u00fd<\/h3>\n<p class=\"wpTag\">C\u1ed1t l\u00f5i c\u1ee7a QMS l\u00e0 \u0111\u00e1nh gi\u00e1 qu\u1ea3n l\u00fd m\u00e0 ban qu\u1ea3n l\u00fd c\u1ea5p cao tr\u1ef1c ti\u1ebfp tham gia. CM Plus gi\u00fap t\u1ed1i \u01b0u h\u00f3a n\u1ed9i dung \u0111\u00e1nh gi\u00e1 qu\u1ea3n l\u00fd v\u00e0 \u0111\u1ecbnh d\u1ea1ng c\u1ee7a ch\u00fang \u0111\u1ec3 gi\u00fap ban qu\u1ea3n l\u00fd c\u1ea5p cao d\u1ec5 d\u00e0ng \u0111\u01b0a ra quy\u1ebft \u0111\u1ecbnh h\u01a1n.<\/p>\n<\/section>\n<section>\n<h3 class=\"headLine06\">H\u1ed7 tr\u1ee3 \u0110\u00e1nh gi\u00e1 H\u1ec7 th\u1ed1ng H\u00e0nh \u0111\u1ed9ng Kh\u1eafc ph\u1ee5c v\u00e0 Ph\u00f2ng ng\u1eeba<\/h3>\n<p class=\"wpTag\">C\u00e1c v\u1ea5n \u0111\u1ec1 th\u01b0\u1eddng \u0111\u01b0\u1ee3c ch\u1ec9 ra nh\u1ea5t trong c\u00e1c cu\u1ed9c thanh tra QMS b\u00ean ngo\u00e0i li\u00ean quan \u0111\u1ebfn c\u00e1c h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 ph\u00f2ng ng\u1eeba. H\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c th\u1ef1c s\u1ef1 l\u00e0 g\u00ec? C\u00e1c ph\u01b0\u01a1ng ph\u00e1p hi\u1ec7u qu\u1ea3 cho c\u00e1c h\u00e0nh \u0111\u1ed9ng ph\u00f2ng ng\u1eeba l\u00e0 g\u00ec? T\u1eeb nh\u1eefng g\u00f3c nh\u00ecn n\u00e0y, ch\u00fang t\u00f4i \u0111\u1ec1 xu\u1ea5t \u0111\u00e1nh gi\u00e1 h\u1ec7 th\u1ed1ng hi\u1ec7n t\u1ea1i.<\/p>\n<\/section>\n<section>\n<h3 class=\"headLine06\">H\u1ed7 tr\u1ee3 ki\u1ec3m so\u00e1t thi\u1ebft k\u1ebf<\/h3>\n<p class=\"wpTag\">Khi thi\u1ebft k\u1ebf c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf m\u1edbi, CM Plus h\u1ed7 tr\u1ee3 c\u00e1c n\u1ed9i dung sau:<\/p>\n<div class=\"awareness\">\n<ul class=\"comRaiList\">\n<li>L\u00e0m r\u00f5 c\u00e1c y\u00eau c\u1ea7u<\/li>\n<li>Chuy\u1ec3n \u0111\u1ed5i th\u00e0nh d\u1eef li\u1ec7u \u0111\u1ea7u v\u00e0o<\/li>\n<li>Ti\u1ebfn tr\u00ecnh c\u00f4ng vi\u1ec7c thi\u1ebft k\u1ebf v\u00e0 ph\u00e1t tri\u1ec3n th\u1ef1c t\u1ebf<\/li>\n<li>T\u1ea1o \u0111\u1ea7u ra<\/li>\n<li>X\u00e1c minh \u0111\u1ea7u ra<\/li>\n<li>Th\u1ea9m \u0111\u1ecbnh \u0111\u1ea7u ra<\/li>\n<li>Qu\u1ea3n l\u00fd r\u1ee7i ro t\u1ea1i c\u00e1c \u0111i\u1ec3m quan tr\u1ecdng<\/li>\n<\/ul>\n<\/div>\n<p class=\"wpTag\">Ngo\u00e0i ra, CM Plus cung c\u1ea5p h\u1ed7 tr\u1ee3 to\u00e0n di\u1ec7n cho vi\u1ec7c l\u1eadp t\u00e0i li\u1ec7u, t\u1eeb vi\u1ec7c t\u1ea1o \u0111\u1ec1 c\u01b0\u01a1ng d\u1ef1a tr\u00ean chu tr\u00ecnh PDCA \u0111\u1ebfn vi\u1ec7c chu\u1ea9n b\u1ecb b\u00e1o c\u00e1o.<\/p>\n<\/section>\n<section>\n<h3 class=\"headLine06\">H\u1ed7 tr\u1ee3 CSV (Th\u1ea9m \u0111\u1ecbnh h\u1ec7 th\u1ed1ng m\u00e1y t\u00ednh)<\/h3>\n<p class=\"wpTag\">V\u1edbi s\u1ef1 t\u00edch h\u1ee3p ph\u1ea7n m\u1ec1m v\u00e0o c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf, vi\u1ec7c b\u00e1n ph\u1ea7n m\u1ec1m \u0111\u1ed9c l\u1eadp v\u00e0 vi\u1ec7c s\u1eed d\u1ee5ng ph\u1ea7n m\u1ec1m chuy\u00ean d\u1ee5ng trong H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng, CSV (Th\u1ea9m \u0111\u1ecbnh h\u1ec7 th\u1ed1ng m\u00e1y t\u00ednh) hi\u1ec7n l\u00e0 \u0111i\u1ec1u kh\u00f4ng th\u1ec3 thi\u1ebfu. Ch\u00fang t\u00f4i h\u1ed7 tr\u1ee3 to\u00e0n b\u1ed9 quy tr\u00ecnh, t\u1eeb l\u1eadp k\u1ebf ho\u1ea1ch CSV \u0111\u1ebfn t\u1ea1o b\u00e1o c\u00e1o.<\/p>\n<\/section>\n<section>\n<h3 class=\"headLine06\">H\u1ed7 tr\u1ee3 chu\u1ea9n b\u1ecb cho Thanh tra tu\u00e2n th\u1ee7 QMS<\/h3>\n<p class=\"wpTag\">Ch\u00fang t\u00f4i cung c\u1ea5p c\u00e1c d\u1ecbch v\u1ee5 h\u1ed7 tr\u1ee3 chu\u1ea9n b\u1ecb tr\u01b0\u1edbc cho c\u00e1c cu\u1ed9c thanh tra tu\u00e2n th\u1ee7 QMS c\u1ee7a c\u00e1c t\u1ed5 ch\u1ee9c ch\u1ee9ng nh\u1eadn v\u00e0 PMDA, bao g\u1ed3m c\u1ea3 c\u00e1c cu\u1ed9c thanh tra gi\u1ea3 \u0111\u1ecbnh.<\/p>\n<\/section>\n<section>\n<h3 class=\"headLine06\">H\u1ed7 tr\u1ee3 Th\u1ea9m \u0111\u1ecbnh<\/h3>\n<p class=\"wpTag\">Khi thi\u1ebft l\u1eadp quy tr\u00ecnh s\u1ea3n xu\u1ea5t t\u1ea1i c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, ch\u00fang t\u00f4i cung c\u1ea5p h\u1ed7 tr\u1ee3 to\u00e0n di\u1ec7n cho vi\u1ec7c th\u1ea9m \u0111\u1ecbnh, t\u1eeb kh\u00e2u l\u1eadp k\u1ebf ho\u1ea1ch \u0111\u1ebfn kh\u00e2u bi\u00ean so\u1ea1n b\u00e1o c\u00e1o. C\u00e1c d\u1ecbch v\u1ee5 c\u1ee7a ch\u00fang t\u00f4i \u0111\u1eb7c bi\u1ec7t bao g\u1ed3m th\u1ea9m \u0111\u1ecbnh c\u00e1c ti\u1ec7n \u00edch li\u00ean quan cho quy tr\u00ecnh kh\u1eed tr\u00f9ng.<\/p>\n<\/section>\n<div class=\"comTextArea\">\n<div class=\"area\">\n<p class=\"wpTag\">\u0110\u1ec3 th\u1ea9m \u0111\u1ecbnh nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t v\u00e0 thi\u1ebft b\u1ecb x\u00e2y d\u1ef1ng, vui l\u00f2ng xem chi ti\u1ebft t\u1ea1i \u0111\u00e2y.<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/qualification_validation\/\">T\u01b0 v\u1ea5n Th\u1ea9m \u0111\u1ecbnh<\/a><\/div>\n<\/div>\n<\/div>\n<p class=\"text02\">CM Plus c\u00f2n cung c\u1ea5p d\u1ecbch v\u1ee5 t\u01b0 v\u1ea5n d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng x\u1eed l\u00fd c\u00e1c s\u1ea3n ph\u1ea9m k\u1ebft h\u1ee3p (d\u01b0\u1ee3c ph\u1ea9m + thi\u1ebft b\u1ecb y t\u1ebf).<\/p>\n<div class=\"comTextArea\">\n<div class=\"area\">\n<h3 class=\"headLine06\">T\u01b0 v\u1ea5n GMP\/GDP d\u01b0\u1ee3c ph\u1ea9m<\/h3>\n<p class=\"wpTag\">C\u1ea3i ti\u1ebfn GMP\/GDP, h\u1ed7 tr\u1ee3 ki\u1ec3m tra, \u0111\u00e0o t\u1ea1o GMP\/GDP, h\u1ed7 tr\u1ee3 qu\u1ea3n l\u00fd nh\u00e0 cung c\u1ea5p\/qu\u1ea3n l\u00fd mua h\u00e0ng v\u00e0 c\u00e1c d\u1ecbch v\u1ee5 h\u1ed7 tr\u1ee3 M&#038;A kh\u00e1c.<\/p>\n<div class=\"comLink\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/gmdp_consulting\/\"><span class=\"subSpan\">T\u01b0 v\u1ea5n GMP\/GDP d\u01b0\u1ee3c ph\u1ea9m<\/span><\/a><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"secBox guideBox comBorBox\">\n<h2 class=\"headLine05\">Gi\u1edbi thi\u1ec7u v\u1ec1 D\u1ecbch v\u1ee5 h\u1ecdc tr\u1ef1c tuy\u1ebfn<\/h2>\n<section>\n<h3 class=\"headLine06\">\u201cKh\u00f3a h\u1ecdc th\u1ef1c h\u00e0nh v\u1ec1 QMS thi\u1ebft b\u1ecb y t\u1ebf theo ISO 13485:2016\u201d<\/h3>\n<p class=\"text03\">Ch\u00fang t\u00f4i cung c\u1ea5p \u0111\u00e0o t\u1ea1o tr\u1ef1c tuy\u1ebfn v\u1ec1 ISO 13485.<\/p>\n<h4 class=\"headLine10\">C\u00e1c \u0111i\u1ec3m ch\u00ednh c\u1ee7a Kh\u00f3a h\u1ecdc th\u1ef1c h\u00e0nh v\u1ec1 QMS thi\u1ebft b\u1ecb y t\u1ebf<\/h4>\n<p class=\"text01\">Kh\u00f3a h\u1ecdc n\u00e0y ph\u1ea3n h\u1ed3i b\u1ea3n s\u1eeda \u0111\u1ed5i n\u0103m 2016 c\u1ee7a ISO 13485, bao g\u1ed3m c\u00e1c n\u1ed9i dung thi\u1ebft y\u1ebfu theo y\u00eau c\u1ea7u c\u1ee7a ISO 13485 \u0111\u1ed3ng th\u1eddi gi\u1ea3i th\u00edch c\u1ea3 \u201cnh\u1eefng thay \u0111\u1ed5i trong c\u00e1c quy \u0111\u1ecbnh \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i n\u0103m 2016\u201d v\u00e0 \u201cc\u00e1c tri\u1ec3n khai th\u1ef1c t\u1ebf c\u1ee5 th\u1ec3\u201d.<\/p>\n<h3 class=\"headLine11\">\u201cB\u00ecnh lu\u1eadn v\u1ec1 S\u01a1 \u0111\u1ed3 quy tr\u00ecnh H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng\u201d<\/h3>\n<div class=\"bigPhoto\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo08.webp\" alt=\"\u201cCommentary on Quality Management System Process Diagram\u201d\"><span class=\"photoIco\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/qms_consulting\/photo08.webp\" class=\"popImg\">&nbsp;<\/a><\/span><\/div>\n<p class=\"WpTag\">(Tr\u00edch t\u1eeb kh\u00f3a h\u1ecdc tr\u1ef1c tuy\u1ebfn c\u1ee7a ch\u00fang t\u00f4i,<a href=\"https:\/\/www.gmp-platform.com\/e-learning_detail.html?id=5\" class=\"comWebLink01\" rel=\"noopener noreferrer\" target=\"_blank\"> \u201cKh\u00f3a \u0111\u00e0o t\u1ea1o h\u01b0\u1edbng th\u1ef1c h\u00e0nh v\u1ec1 QMS cho thi\u1ebft b\u1ecb y t\u1ebf theo ISO 13485: <\/a> Phi\u00ean b\u1ea3n 2.\u201d H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng) <\/p>\n<\/section>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n\t<h2 class=\"headLine04\">\u0110\u00e1nh gi\u00e1 t\u1eeb kh\u00e1ch h\u00e0ng<\/h2>\n\t<ul class=\"comFooUl comCaseListSml flex\">\n\t\t\t\t\t<li>\n\t\t\t\t<a href=\"https:\/\/cm-plus.co.jp\/vn\/portfolio\/voice\/goryo\/\">\n\t\t\t\t\t<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/uploads\/2017\/07\/thumb_goryo.jpg\" alt=\"Goryo Chemical, Inc.\"><\/span>\n\t\t\t\t\t<span class=\"textBox\">\n\t\t\t\t\t\t<span class=\"tag\"><span class=\"wpTag\" style=\"background-color: #217870;\">Engineering<\/span><span class=\"wpTag\" style=\"background-color: #2b5273;\">Consulting<\/span><\/span>\t\t\t\t\t\t<span class=\"ttl\">From Pharmaceutical Regulations to QMS and GMP Consulting: Support with Consulting That Overcomes the High Barriers to Entry from Different Industries.<br \/>\r\n<\/span>\t\t\t\t\t\t<span class=\"txt02\">Goryo Chemical, Inc.<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t<\/li>\n\t\t\t<\/ul>\n<\/section>\n\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">N\u1ed9i dung li\u00ean quan<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/portfolio\/project_details\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"D\u1ef1 \u00e1n\" \/><\/span><br \/>\n<span class=\"subSpan\">D\u1ef1 \u00e1n<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/about_cm_plus\/record\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\" \/><\/span><br \/>\n<span class=\"subSpan\">Th\u00e0nh t\u1ef1u qua c\u00e1c con s\u1ed1<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section>\n<h2 class=\"headLine04\">D\u1ecbch v\u1ee5 kh\u00e1c<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/photo01.webp\" alt=\"Engineering, Project Management\"><\/span><br \/>\n<span class=\"subSpan\">T\u01b0 v\u1ea5n k\u1ef9 thu\u1eadt, Qu\u1ea3n l\u00fd D\u1ef1 \u00e1n<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/support_for_training\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/photo03.webp\" alt=\"H\u1ed7 tr\u1ee3 \u0110\u00e0o t\u1ea1o\/ Hu\u1ea5n luy\u1ec7n\" \/><\/span><br \/>\n<span class=\"subSpan\">H\u1ed7 tr\u1ee3 \u0110\u00e0o t\u1ea1o\/ Hu\u1ea5n luy\u1ec7n<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/technology_information\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/vn\/wp-content\/themes\/cmplus\/image\/common\/photo04.webp\" alt=\"D\u1ecbch v\u1ee5 Th\u00f4ng tin K\u1ef9 thu\u1eadt\" \/><\/span><br \/>\n<span class=\"subSpan\">D\u1ecbch v\u1ee5 Th\u00f4ng tin K\u1ef9 thu\u1eadt<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<\/article>\n<aside id=\"sideBar\">\n\t<p class=\"sideTtl\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/\"><span class=\"txtSpan barlow\">D\u1ecbch v\u1ee5<\/span><\/a><\/p>\n\t<ul id=\"menu-service\" class=\"sideList\"><li id=\"menu-item-238\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-238\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/\">T\u01b0 v\u1ea5n K\u1ef9 thu\u1eadt, Qu\u1ea3n l\u00fd D\u1ef1 \u00e1n<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-253\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-253\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/production_facility\/\">D\u1ecbch V\u1ee5 Tr\u1ecdn G\u00f3i Cho C\u01a1 S\u1edf S\u1ea3n Xu\u1ea5t<\/a><\/li>\n\t<li id=\"menu-item-240\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-240\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/construction_management\/\">Qu\u1ea3n L\u00fd X\u00e2y d\u1ef1ng<\/a><\/li>\n\t<li id=\"menu-item-239\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-239\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/feature\/\">D\u1ecbch V\u1ee5 Qu\u1ea3n L\u00fd X\u00e2y d\u1ef1ng c\u1ee7a CM Plus<\/a><\/li>\n\t<li id=\"menu-item-243\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-243\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/project_flow\/\">Thi c\u00f4ng C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-245\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-245\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/project_flow\/business_concept\/\">Business Concept<\/a><\/li>\n\t\t<li id=\"menu-item-246\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-246\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/project_flow\/conceptual_design\/\">Conceptual Design<\/a><\/li>\n\t\t<li id=\"menu-item-247\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-247\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/project_flow\/basic_design\/\">Basic Design<\/a><\/li>\n\t\t<li id=\"menu-item-248\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-248\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/project_flow\/purocurement\/\">Procurement<\/a><\/li>\n\t\t<li id=\"menu-item-249\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-249\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/project_flow\/detailed-design_construction\/\">Detailed Design \/ Production Management<\/a><\/li>\n\t\t<li id=\"menu-item-244\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-244\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/project_flow\/commissioning_qualification\/\">Trial Operation -Commissioning &#038; Qualification-<\/a><\/li>\n\t<\/ul>\n<\/li>\n\t<li id=\"menu-item-254\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-254\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/\">L\u0129nh V\u1ef1c Ho\u1ea1t \u0110\u1ed9ng<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-242\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-242\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/pharma_medical-device\/\">D\u01b0\u1ee3c Ph\u1ea9m v\u00e0 Thi\u1ebft B\u1ecb Y T\u1ebf<\/a>\n\t\t<ul class=\"sub-menu\">\n\t\t\t<li id=\"menu-item-263\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-263\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/pharma_medical-device\/sterile_medicine\/\">Sterile Pharmaceutical<\/a><\/li>\n\t\t\t<li id=\"menu-item-264\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-264\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/pharma_medical-device\/oral_agent\/\">Oral Drugs<\/a><\/li>\n\t\t\t<li id=\"menu-item-256\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-256\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/pharma_medical-device\/medium_molecule_drugs\/\">Medium-Molecule API<\/a><\/li>\n\t\t\t<li id=\"menu-item-257\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-257\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/pharma_medical-device\/macromolecular_drugs\/\">Large-Molecule (Biopharmaceutical) API<\/a><\/li>\n\t\t\t<li id=\"menu-item-813\" class=\"menu-item menu-item-type-custom menu-item-object-custom menu-item-813\"><a href=\"\/en\/service\/consulting\/regenerative_medicine\/\">Regenerative Medicine<\/a><\/li>\n\t\t<\/ul>\n<\/li>\n\t\t<li id=\"menu-item-265\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-265\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/food\/\">Th\u1ef1c Ph\u1ea9m<\/a><\/li>\n\t\t<li id=\"menu-item-261\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-261\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/cosmetic\/\">M\u1ef9 Ph\u1ea9m<\/a><\/li>\n\t\t<li id=\"menu-item-260\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-260\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/home-care\/\">S\u1ea3n Ph\u1ea9m Ch\u0103m S\u00f3c Gia \u0110\u00ecnh<\/a><\/li>\n\t\t<li id=\"menu-item-262\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-262\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/semiconductor\/\">B\u00e1n D\u1eabn v\u00e0 Thi\u1ebft B\u1ecb \u0110i\u1ec7n T\u1eed<\/a><\/li>\n\t\t<li id=\"menu-item-259\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-259\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/data_center\/\">Trung T\u00e2m D\u1eef Li\u1ec7u<\/a><\/li>\n\t\t<li id=\"menu-item-258\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-258\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/chemical_plant\/\">Nh\u00e0 M\u00e1y H\u00f3a Ch\u1ea5t<\/a><\/li>\n\t\t<li id=\"menu-item-5871\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5871\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/logistics\/\">H\u1eadu C\u1ea7n<\/a><\/li>\n\t\t<li id=\"menu-item-5870\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5870\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/field\/halal\/\">Ti\u00eau chu\u1ea9n Halal<\/a><\/li>\n\t<\/ul>\n<\/li>\n\t<li id=\"menu-item-250\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-250\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/overseas_project_support\/\">&#8220;Qu\u1ea3n L\u00fd D\u1ef1 \u00c1n Xuy\u00ean Bi\u00ean Gi\u1edbi &#8220;<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-251\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-251\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/engineering\/overseas_project_support\/partners\/\">Alliance Partners in Southeast Asia<\/a><\/li>\n\t\t<li 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href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/qms_consulting\/\">H\u1ec7 Th\u1ed1ng Qu\u1ea3n L\u00fd Ch\u1ea5t L\u01b0\u1ee3ng (QMS) cho Thi\u1ebft B\u1ecb Y T\u1ebf<\/a><\/li>\n\t<li id=\"menu-item-274\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-274\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/regulatory_affairs\/\">T\u01b0 V\u1ea5n Ph\u00e1p L\u00fd<\/a><\/li>\n\t<li id=\"menu-item-267\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-267\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/qualification_validation\/\">T\u01b0 V\u1ea5n Th\u1ea9m \u0110\u1ecbnh<\/a><\/li>\n\t<li id=\"menu-item-270\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-270\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/regenerative_medicine\/\">T\u01b0 V\u1ea5n Y H\u1ecdc T\u00e1i T\u1ea1o<\/a><\/li>\n\t<li id=\"menu-item-273\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-273\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/contamination_control_strategy\/\">T\u01b0 V\u1ea5n Chi\u1ebfn L\u01b0\u1ee3c Ki\u1ec3m So\u00e1t \u00d4 Nhi\u1ec5m<\/a><\/li>\n\t<li id=\"menu-item-5658\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5658\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/data_integrity\/\">T\u01b0 V\u1ea5n T\u00ednh To\u00e0n V\u1eb9n D\u1eef Li\u1ec7u<\/a><\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-277\" class=\"jsLi noChild menu-item menu-item-type-post_type menu-item-object-page menu-item-277\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/support_for_training\/\">H\u1ed7 tr\u1ee3 \u0110\u00e0o t\u1ea1o\/ Hu\u1ea5n luy\u1ec7n<\/a><\/li>\n<li id=\"menu-item-275\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-275\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/technology_information\/\">D\u1ecbch v\u1ee5 Th\u00f4ng tin K\u1ef9 thu\u1eadt<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-1872\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1872\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/technology_information\/corressa\/\">CORRESSA<\/a><\/li>\n\t<li id=\"menu-item-5851\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5851\"><a href=\"https:\/\/cm-plus.co.jp\/vn\/service\/technology_information\/energy_management\/\">Gi\u1ea3i Ph\u00e1p Qu\u1ea3n L\u00fd N\u0103ng L\u01b0\u1ee3ng theo Ph\u01b0\u01a1ng Ph\u00e1p \u201cCMP Way\u201d<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul><\/aside><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Trang ch\u1ee7\/ D\u1ecbch v\u1ee5\/ T\u01b0 v\u1ea5n\/ QMS cho thi\u1ebft b\u1ecb y t\u1ebf T\u01b0 v\u1ea5nQMS cho thi\u1ebft b\u1ecb y t\u1ebf H\u1ed7 tr\u1ee3 Doanh Nghi\u1ec7p M\u1edbi Gia Nh\u1eadp [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":155,"menu_order":52,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[11,14,8],"class_list":["post-160","page","type-page","status-publish","hentry","keywords-gmpgdp","keywords-qms","keywords-audit"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>QMS for Medical Devices\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"Experienced consultants in QMS for Medical Devices support you with services tailored to your specific challenges.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cm-plus.co.jp\/vn\/service\/consulting\/qms_consulting\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" 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