{"id":1437,"date":"2022-08-15T05:32:30","date_gmt":"2022-08-15T05:32:30","guid":{"rendered":"https:\/\/www.mandreel.com\/vietnam\/?page_id=1437"},"modified":"2022-08-15T05:43:18","modified_gmt":"2022-08-15T05:43:18","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/www.mandreel.com\/vietnam\/iso-13485\/","title":{"rendered":"ISO 13485 l\u00e0 g\u00ec? Gi\u1ea3i Th\u00edch D\u1ec5 Hi\u1ec3u"},"content":{"rendered":"

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\r\n T\u00ecm hi\u1ec3u c\u00e1c ti\u00eau chu\u1ea9n v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf<\/span>\r\n

H\u01b0\u1edbng d\u1eabn ISO 13485<\/h2>\r\n
<\/div>\r\n <\/div>\r\n\r\n
\r\n Trong tr\u01b0\u1eddng h\u1ee3p b\u1ea1n ch\u01b0a nghe, c\u00e1c ti\u00eau chu\u1ea9n v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf g\u1ea7n \u0111\u00e2y \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1eadp nh\u1eadt. B\u1ea3n c\u1eadp nh\u1eadt n\u00e0y \u0111\u1ed1i v\u1edbi c\u00e1c ti\u00eau chu\u1ea9n y t\u1ebf do ISO 13485 \u0111\u1eb7t ra r\u1ea5t kh\u00e1c so v\u1edbi c\u00e1c b\u1ea3n s\u1eeda \u0111\u1ed5i tr\u01b0\u1edbc \u0111\u00f3 v\u00e0 c\u00f4ng ty c\u1ee7a b\u1ea1n c\u1ea7n ph\u1ea3i chu\u1ea9n b\u1ecb \u0111\u1ea7y \u0111\u1ee7.<\/p>\n

N\u1ebfu \u0111\u00e2y l\u00e0 t\u00ecnh hu\u1ed1ng c\u1ee7a b\u1ea1n, b\u00e0i vi\u1ebft n\u00e0y s\u1ebd l\u00e0 h\u01b0\u1edbng d\u1eabn c\u01a1 b\u1ea3n \u0111\u1ec3 b\u1ea1n hi\u1ec3u \u0111\u01b0\u1ee3c nh\u1eefng thay \u0111\u1ed5i n\u00e0y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn doanh nghi\u1ec7p c\u1ee7a b\u1ea1n nh\u01b0 th\u1ebf n\u00e0o.\r\n\r\n

\r\n \r\n \"T\u00ecm\r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n\r\n
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\r\n \r\n \"about-img\"\r\n \r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>[\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column]\r\n
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ISO 13485 l\u00e0 g\u00ec?<\/h2>\r\n
<\/div>\r\n <\/div>\r\n\r\n
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\r\n <\/i>\r\n <\/div>\r\n ISO 13485:2013 l\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf cho bi\u1ebft nh\u1eefng vi\u1ec7c c\u1ea7n l\u00e0m \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

ISO 13485 d\u1ef1a tr\u00ean thi\u1ebft k\u1ebf d\u1ef1a tr\u00ean r\u1ee7i ro v\u00e0 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3. N\u00f3 thi\u1ebft l\u1eadp c\u00e1c y\u00eau c\u1ea7u t\u1ed1i thi\u1ec3u \u0111\u1ed1i v\u1edbi thi\u1ebft k\u1ebf, s\u1ea3n xu\u1ea5t, th\u1eed nghi\u1ec7m v\u00e0 t\u00e0i li\u1ec7u y t\u1ebf.<\/p>\n

C\u00e1c l\u1ee3i \u00edch c\u1ee7a vi\u1ec7c th\u1ef1c hi\u1ec7n ISO 13485 bao g\u1ed3m c\u1ea3i thi\u1ec7n \u0111\u1ed9 tin c\u1eady, an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf. B\u1eb1ng c\u00e1ch tu\u00e2n theo c\u00e1c ti\u00eau chu\u1ea9n n\u00e0y, b\u1ea1n c\u00f3 th\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a m\u00ecnh \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t m\u1ed9t c\u00e1ch \u0111\u00e1ng tin c\u1eady v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng cao nh\u1ea5t.\r\n\r\n

\r\n \r\n \"\"\r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n
\r\n \r\n \"shape\"\r\n \r\n <\/div>\r\n\r\n <\/div>\r\n [\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column]\r\n
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Nh\u1eefng Thi\u1ebft B\u1ecb Y T\u1ebf N\u00e0o C\u00f3 Th\u1ec3 Y\u00eau C\u1ea7u Ch\u1ee9ng Nh\u1eadn ISO 13485?<\/h2>\r\n
<\/div>\r\n <\/div>\r\n\r\n
\r\n \u0110\u1ed1i v\u1edbi m\u1ed9t s\u1ed1 lo\u1ea1i thi\u1ebft b\u1ecb y t\u1ebf, bao g\u1ed3m m\u00e1y kh\u1eed rung tim, m\u00e1y th\u1edf v\u00e0 \u1ed1ng th\u00f4ng<\/u>, b\u1eaft bu\u1ed9c ph\u1ea3i c\u00f3 ch\u1ee9ng nh\u1eadn ISO 13485. N\u1ebfu b\u1ea1n \u0111ang ph\u00e1t tri\u1ec3n m\u1ed9t thi\u1ebft b\u1ecb y t\u1ebf m\u1edbi, \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 ph\u1ea3i hi\u1ec3u c\u00e1c y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi ch\u1ee9ng nh\u1eadn ISO 13485.<\/p>\n

Ti\u00eau chu\u1ea9n ISO 13485 \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n \u0111\u1ec3 gi\u00fap \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng cao v\u00e0 \u0111\u00e1p \u1ee9ng t\u1ea5t c\u1ea3 c\u00e1c y\u00eau c\u1ea7u quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh.<\/p>\n

C\u00e1c thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn \u0111\u1ec3 \u0111\u01b0\u1ee3c b\u00e1n \u1edf Ch\u00e2u \u00c2u v\u00e0 c\u00e1c n\u01a1i kh\u00e1c tr\u00ean th\u1ebf gi\u1edbi. Ch\u1ee9ng nh\u1eadn ISO 13485 l\u00e0 c\u1ea7n thi\u1ebft \u0111\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c d\u1ea5u CE.\r\n\r\n

\r\n \r\n \"\"\r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n\r\n
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\r\n \r\n \"about-img\"\r\n \r\n \r\n \r\n \"shape\"\r\n \r\n \r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n
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<\/div>\r\n <\/div>[vc_empty_space height=”20″][vc_column_text css=”.vc_custom_1660542193157{margin-right: 100px !important;margin-left: 100px !important;}”]<\/p>\n

Kh\u00e1i Ni\u1ec7m C\u01a1 B\u1ea3n V\u1ec1 ISO 13485<\/h2>\n

ISO 13485 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ec3 gi\u00fap gi\u1ea3m nguy c\u01a1 tai n\u1ea1n do thi\u1ebft b\u1ecb y t\u1ebf g\u00e2y ra v\u00e0 c\u1ea3i thi\u1ec7n ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

ISO 13485 gi\u1ea3i quy\u1ebft nhi\u1ec1u v\u1ea5n \u0111\u1ec1, bao g\u1ed3m:<\/p>\n

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  • \u0110\u00e1nh gi\u00e1 an to\u00e0n v\u00e0 thi\u1ebft k\u1ebf c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n
  • Ph\u00e2n t\u00edch l\u1ed7i thi\u1ebft b\u1ecb<\/li>\n
  • H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng cho c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n<\/ul>\n

    \u00dd Ngh\u0129a Thi\u1ebft Th\u1ef1c c\u1ee7a ISO 13485<\/h2>\n

    C\u00e1c c\u00f4ng ty thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i hi\u1ec3u c\u00e1c y\u00eau c\u1ea7u c\u1ee7a ISO 13485 \u0111\u1ec3 thi\u1ebft k\u1ebf, s\u1ea3n xu\u1ea5t v\u00e0 cung c\u1ea5p c\u00e1c s\u1ea3n ph\u1ea9m ch\u1ea5t l\u01b0\u1ee3ng cao. H\u1ecd c\u0169ng ph\u1ea3i \u0111\u1ea3m b\u1ea3o r\u1eb1ng nh\u00e2n vi\u00ean c\u1ee7a h\u1ecd \u0111\u00e3 quen thu\u1ed9c v\u1edbi c\u00e1c ti\u00eau chu\u1ea9n n\u00e0y.<\/p>\n

    ISO 13485 thi\u1ebft l\u1eadp c\u00e1c y\u00eau c\u1ea7u c\u1ee5 th\u1ec3 \u0111\u1ed1i v\u1edbi vi\u1ec7c thi\u1ebft k\u1ebf, s\u1ea3n xu\u1ea5t, l\u1eadp t\u00e0i li\u1ec7u, ki\u1ec3m so\u00e1t qu\u00e1 tr\u00ecnh v\u00e0 \u0111\u1ea3m b\u1ea3o. C\u00e1c c\u00f4ng ty thi\u1ebft b\u1ecb y t\u1ebf tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n n\u00e0y c\u00f3 th\u1ec3 kh\u1eb3ng \u0111\u1ecbnh m\u1ed9t c\u00e1ch \u0111\u00e1ng tin c\u1eady r\u1eb1ng s\u1ea3n ph\u1ea9m c\u1ee7a h\u1ecd c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng cao.<\/p>\n

    \u0110\u00e2y l\u00e0 m\u1ed9t ph\u1ea7n quan tr\u1ecdng c\u1ee7a H\u1ec7 th\u1ed1ng Qu\u1ea3n l\u00fd Ch\u1ea5t l\u01b0\u1ee3ng cho c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf. N\u00f3 cung c\u1ea5p m\u1ed9t khu\u00f4n kh\u1ed5 ti\u00eau chu\u1ea9n \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 \u0111\u1ed9 tin c\u1eady c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m tr\u00ean to\u00e0n th\u1ebf gi\u1edbi.<\/p>\n

    ISO 13485 li\u00ean quan \u0111\u1ebfn t\u00f4i nh\u01b0 th\u1ebf n\u00e0o?<\/strong><\/h2>\n

    ISO 13485 t\u1ed3n t\u1ea1i b\u1edfi v\u00ec m\u1ecdi ng\u01b0\u1eddi lo l\u1eafng v\u1ec1 m\u1ee9c \u0111\u1ed9 an to\u00e0n v\u00e0 c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ed1t.<\/p>\n

    C\u00f3 nhi\u1ec1u y\u00eau c\u1ea7u kh\u00e1c nhau ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng \u0111\u1ec3 ph\u00f9 h\u1ee3p v\u1edbi ISO 13485. \u0110i\u1ec1u n\u00e0y c\u00f3 ngh\u0129a l\u00e0 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf v\u00e0 ch\u1ebf t\u1ea1o b\u1eb1ng c\u00e1c ph\u01b0\u01a1ng ph\u00e1p s\u1ea1ch, \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n v\u00e0 ch\u00fang c\u00f3 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng t\u1ed1t.<\/p>\n

    \u0110i\u1ec1u quan tr\u1ecdng l\u00e0 ph\u1ea3i hi\u1ec3u ISO 13485 \u1ea3nh h\u01b0\u1edfng nh\u01b0 th\u1ebf n\u00e0o \u0111\u1ebfn b\u1ea1n v\u1edbi t\u01b0 c\u00e1ch l\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf. N\u1ebfu b\u1ea1n \u0111\u00e1p \u1ee9ng t\u1ea5t c\u1ea3 c\u00e1c ti\u00eau chu\u1ea9n b\u1eaft bu\u1ed9c, th\u00ec thi\u1ebft b\u1ecb c\u1ee7a b\u1ea1n c\u00f3 th\u1ec3 s\u1ebd tu\u00e2n th\u1ee7 ISO 13485. Tuy nhi\u00ean, n\u1ebfu b\u1ea1n kh\u00f4ng \u0111\u00e1p \u1ee9ng t\u1ea5t c\u1ea3 c\u00e1c ti\u00eau chu\u1ea9n b\u1eaft bu\u1ed9c, thi\u1ebft b\u1ecb c\u1ee7a b\u1ea1n c\u00f3 th\u1ec3 v\u1eabn an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3, nh\u01b0ng ch\u00fang c\u00f3 th\u1ec3 kh\u00f4ng \u0111\u00e1p \u1ee9ng mong \u0111\u1ee3i c\u1ee7a kh\u00e1ch h\u00e0ng.<\/p>\n

    N\u1ebfu b\u1ea1n tham gia v\u00e0o ng\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf, \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 ph\u1ea3i hi\u1ec3u ISO 13485 v\u00e0 c\u00e1ch n\u00f3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ho\u1ea1t \u0111\u1ed9ng kinh doanh c\u1ee7a b\u1ea1n. B\u1ea1n c\u00f3 th\u1ec3 t\u00ecm th\u00eam th\u00f4ng tin v\u1ec1 ISO 13485 tr\u00ean trang web c\u1ee7a ch\u00fang t\u00f4i ho\u1eb7c li\u00ean h\u1ec7 v\u1edbi ch\u00fang t\u00f4i \u0111\u1ec3 bi\u1ebft th\u00eam th\u00f4ng tin.<\/p>\n

    Nh\u1eefng \u0111i\u1ec1u c\u1ea7n c\u00e2n nh\u1eafc khi theo \u0111u\u1ed5i ch\u1ee9ng nh\u1eadn thi\u1ebft b\u1ecb y t\u1ebf<\/strong><\/h2>\n

    Khi t\u00ecm ki\u1ebfm ch\u1ee9ng nh\u1eadn thi\u1ebft b\u1ecb y t\u1ebf, c\u00f3 m\u1ed9t s\u1ed1 \u0111i\u1ec1u c\u1ea7n l\u01b0u \u00fd.<\/p>\n

      \n
    • \u0110\u1ea7u ti\u00ean v\u00e0 quan tr\u1ecdng nh\u1ea5t, c\u00e1c ti\u00eau chu\u1ea9n ISO r\u1ea5t quan tr\u1ecdng. H\u1ec7 th\u1ed1ng ISO cung c\u1ea5p m\u1ed9t h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ec3 ki\u1ec3m tra c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf. H\u1ecd cho bi\u1ebft c\u00e1c thi\u1ebft b\u1ecb n\u00ean \u0111\u01b0\u1ee3c ki\u1ec3m tra nh\u01b0 th\u1ebf n\u00e0o v\u00e0 \u0111\u1ea3m b\u1ea3o r\u1eb1ng ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a c\u00e1c thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c ki\u1ec3m tra trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t.<\/li>\n
    • Th\u1ee9 hai, \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn b\u1edfi m\u1ed9t t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn. \u0110i\u1ec1u n\u00e0y s\u1ebd \u0111\u1ea3m b\u1ea3o r\u1eb1ng thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a b\u1ea1n \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n do c\u01a1 quan c\u00f4ng nh\u1eadn \u0111\u1eb7t ra.<\/li>\n
    • Cu\u1ed1i c\u00f9ng, \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 ph\u1ea3i hi\u1ec3u r\u00f5 v\u1ec1 c\u00e1c quy \u0111\u1ecbnh v\u00e0 h\u01b0\u1edbng d\u1eabn li\u00ean quan. \u0110i\u1ec1u n\u00e0y s\u1ebd gi\u00fap b\u1ea1n \u0111i\u1ec1u h\u01b0\u1edbng th\u00f4ng qua b\u1ed1i c\u1ea3nh ph\u00e1p l\u00fd ph\u1ee9c t\u1ea1p. th\u1eadt<\/li>\n<\/ul>\n

      Quy tr\u00ecnh c\u1ee7a Quy \u0111\u1ecbnh ISO 13485<\/strong><\/h2>\n

      ISO 13485 l\u00e0 ti\u00eau chu\u1ea9n to\u00e0n c\u1ea7u cho c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1eb7t ra c\u00e1c quy t\u1eafc v\u1ec1 c\u00e1ch ch\u00fang \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf, ch\u1ebf t\u1ea1o v\u00e0 \u0111\u0103ng k\u00fd.<\/p>\n

      Thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i tu\u00e2n th\u1ee7 ISO 13485 \u0111\u1ec3 \u0111\u01b0\u1ee3c b\u00e1n \u1edf Li\u00ean minh Ch\u00e2u \u00c2u v\u00e0 c\u00e1c khu v\u1ef1c ph\u00e1p l\u00fd kh\u00e1c. Ti\u00eau chu\u1ea9n c\u00f3 ba ph\u1ea7n: y\u00eau c\u1ea7u, h\u01b0\u1edbng d\u1eabn v\u00e0 khuy\u1ebfn ngh\u1ecb.<\/p>\n

      C\u00e1c \u0111i\u1ec1u ki\u1ec7n x\u00e1c \u0111\u1ecbnh nh\u1eefng y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m v\u00e0 h\u1ec7 th\u1ed1ng, bao g\u1ed3m lo\u1ea1i s\u1ea3n ph\u1ea9m v\u00e0 c\u00e1c \u0111\u1eb7c t\u00ednh ho\u1ea1t \u0111\u1ed9ng. C\u00e1c h\u01b0\u1edbng d\u1eabn cho b\u1ea1n bi\u1ebft c\u00e1ch \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u c\u1ee7a s\u1ea3n ph\u1ea9m, trong khi c\u00e1c khuy\u1ebfn ngh\u1ecb cho b\u1ea1n bi\u1ebft c\u00e1ch ch\u1ebf t\u1ea1o v\u00e0 s\u1eed d\u1ee5ng c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf theo c\u00e1ch t\u1ed1t nh\u1ea5t c\u00f3 th\u1ec3.<\/p>\n

      ISO 13485 c\u00f3 th\u1ec3 l\u00e0 g\u00e1nh n\u1eb7ng cho c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf. Tuy nhi\u00ean, b\u1eb1ng c\u00e1ch tu\u00e2n theo ti\u00eau chu\u1ea9n m\u1ed9t c\u00e1ch ch\u00ednh x\u00e1c, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t c\u00f3 th\u1ec3 tr\u00e1nh \u0111\u01b0\u1ee3c c\u00e1c v\u1ea5n \u0111\u1ec1 ti\u1ec1m \u1ea9n v\u1ec1 an to\u00e0n v\u00e0 quy \u0111\u1ecbnh.<\/p>\n

      L\u1ee3i \u00edch c\u1ee7a ISO 13485<\/strong><\/h2>\n

      M\u1ed9t trong nh\u1eefng l\u1ee3i \u00edch c\u1ee7a ISO l\u00e0 n\u00f3 cho ph\u00e9p c\u00e1c c\u00f4ng ngh\u1ec7 y t\u1ebf \u0111\u01b0\u1ee3c ki\u1ec3m tra v\u00e0 \u0111\u00e1nh gi\u00e1 m\u1ed9t c\u00e1ch th\u1ed1ng nh\u1ea5t. \u0110i\u1ec1u n\u00e0y gi\u00fap ng\u01b0\u1eddi b\u1ec7nh d\u1ec5 d\u00e0ng t\u00ecm ra ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb t\u1ed1t nh\u1ea5t v\u00e0 b\u00e1c s\u0129 ch\u1ea9n \u0111o\u00e1n b\u1ec7nh ch\u00ednh x\u00e1c. N\u00f3 c\u0169ng gi\u00fap gi\u1ea3m chi ph\u00ed c\u1ee7a c\u00f4ng ngh\u1ec7 y t\u1ebf.<\/p>\n

      ISO 13485 l\u00e0 c\u01a1 quan ti\u00eau chu\u1ea9n h\u00f3a to\u00e0n c\u1ea7u cung c\u1ea5p m\u1ed9t h\u1ec7 th\u1ed1ng \u0111o l\u01b0\u1eddng k\u1ef9 thu\u1eadt duy nh\u1ea5t tr\u00ean to\u00e0n th\u1ebf gi\u1edbi cho c\u00e1c c\u00f4ng ngh\u1ec7 y t\u1ebf. H\u1ec7 th\u1ed1ng n\u00e0y gi\u00fap \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee7a c\u00e1c c\u00f4ng ty kh\u00e1c nhau c\u00f3 th\u1ec3 ho\u1ea1t \u0111\u1ed9ng c\u00f9ng nhau.<\/p>\n

      M\u1ed9t l\u1ee3i \u00edch kh\u00e1c c\u1ee7a ISO 13485 l\u00e0 n\u00f3 cung c\u1ea5p m\u1ed9t th\u1ecb tr\u01b0\u1eddng to\u00e0n c\u1ea7u cho c\u00e1c c\u00f4ng ngh\u1ec7 y t\u1ebf. \u0110i\u1ec1u n\u00e0y c\u00f3 ngh\u0129a l\u00e0 c\u00e1c c\u00f4ng ngh\u1ec7 y t\u1ebf t\u1eeb c\u00e1c qu\u1ed1c gia kh\u00e1c nhau c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c b\u00e1n tr\u00ean th\u1ecb tr\u01b0\u1eddng to\u00e0n c\u1ea7u m\u00e0 kh\u00f4ng c\u00f3 b\u1ea5t k\u1ef3 h\u1ea1n ch\u1ebf n\u00e0o. \u0110i\u1ec1u n\u00e0y m\u1edf ra c\u01a1 h\u1ed9i m\u1edbi cho c\u00e1c c\u00f4ng ty tham gia v\u00e0o ng\u00e0nh c\u00f4ng ngh\u1ec7 y t\u1ebf.<\/p>\n

      Nh\u00ecn chung, ISO 13485 l\u00e0 m\u1ed9t nh\u00f3m ti\u00eau chu\u1ea9n r\u1ea5t quan tr\u1ecdng gi\u00fap \u00edch cho c\u1ea3 b\u1ec7nh nh\u00e2n v\u00e0 c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t c\u00f4ng ngh\u1ec7 y t\u1ebf theo nhi\u1ec1u c\u00e1ch.<\/p>\n

      Y\u00eau c\u1ea7u ISO 13485<\/strong><\/h2>\n

      Theo ISO 13485, t\u1ea5t c\u1ea3 c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng li\u00ean quan \u0111\u1ebfn c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf m\u1edbi ph\u1ea3i tr\u1ea3i qua ki\u1ec3m tra ban \u0111\u1ea7u b\u1edfi m\u1ed9t t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u th\u1eed nghi\u1ec7m. M\u1ee5c ti\u00eau c\u1ee7a ti\u00eau chu\u1ea9n n\u00e0y l\u00e0 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb m\u1edbi c\u00e0ng an to\u00e0n c\u00e0ng t\u1ed1t.<\/p>\n

      ISO 13485 kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t y\u00eau c\u1ea7u quy \u0111\u1ecbnh nh\u01b0 FDA ho\u1eb7c CE \u0111\u00e1nh d\u1ea5u. \u0110\u00e2y l\u00e0 m\u1ed9t ti\u00eau chu\u1ea9n t\u1ef1 nguy\u1ec7n t\u1ea1o ra c\u00e1c thu\u1eadt ng\u1eef, th\u1ee7 t\u1ee5c v\u00e0 ph\u01b0\u01a1ng ph\u00e1p chung gi\u1eefa c\u00e1c qu\u1ed1c gia th\u00e0nh vi\u00ean \u0111\u1ec3 \u0111i\u1ec1u ch\u1ec9nh c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi ch\u00fang \u0111\u01b0\u1ee3c th\u01b0\u01a1ng m\u1ea1i h\u00f3a.<\/p>\n

      ISO 13845 Th\u1ef1c h\u00e0nh t\u1ed1t nh\u1ea5t<\/strong><\/h2>\n

      ISO l\u00e0 c\u01a1 quan ti\u00eau chu\u1ea9n h\u00f3a to\u00e0n c\u1ea7u \u0111\u1eb7t ra c\u00e1c ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng qu\u1ed1c t\u1ebf cho c\u00e1c s\u1ea3n ph\u1ea9m v\u00e0 d\u1ecbch v\u1ee5. ISO v\u1eadn h\u00e0nh hai c\u01a1 quan ti\u00eau chu\u1ea9n ch\u00ednh: ISO\/IEC 17025, t\u1ed5 ch\u1ee9c x\u1eed l\u00fd c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf; v\u00e0 ISO\/TS 16949, chi ph\u1ed1i h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng.<\/p>\n

      \u0110\u1ec3 \u0111\u1ea3m b\u1ea3o an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf, \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 ch\u00fang ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng ph\u00f9 h\u1ee3p. ISO 13485 cung c\u1ea5p m\u1ed9t b\u1ed9 ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng \u0111\u01b0\u1ee3c qu\u1ed1c t\u1ebf c\u00f4ng nh\u1eadn, \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 “th\u1ef1c h\u00e0nh t\u1ed1t nh\u1ea5t” cho c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf. C\u00e1c ti\u00eau chu\u1ea9n n\u00e0y \u0111\u1eb7t ra c\u00e1c y\u00eau c\u1ea7u t\u1ed1i thi\u1ec3u \u0111\u1ec3 thi\u1ebft k\u1ebf, ch\u1ebf t\u1ea1o, th\u1eed nghi\u1ec7m, l\u1eadp h\u1ed3 s\u01a1 v\u00e0 theo d\u00f5i c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf sau khi ch\u00fang \u0111\u01b0\u1ee3c \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng.<\/p>\n

      C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf mu\u1ed1n b\u00e1n \u1edf Ch\u00e2u \u00c2u ho\u1eb7c c\u00e1c khu v\u1ef1c kh\u00e1c tr\u00ean th\u1ebf gi\u1edbi ph\u1ea3i tu\u00e2n th\u1ee7 Ch\u1ec9 th\u1ecb v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u (MDD). MDD \u0111\u01b0a ra c\u00e1c y\u00eau c\u1ea7u c\u1ee5 th\u1ec3 \u0111\u1ed1i v\u1edbi thi\u1ebft k\u1ebf, s\u1ea3n xu\u1ea5t, th\u1eed nghi\u1ec7m, ghi nh\u00e3n, \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng\/quy tr\u00ecnh ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 gi\u00e1m s\u00e1t sau khi \u0111\u01b0a thi\u1ebft b\u1ecb y t\u1ebf v\u00e0o th\u1ecb tr\u01b0\u1eddng.<\/p>\n

      L\u00e0m th\u1ebf n\u00e0o \u0111\u1ec3 \u0111\u01b0\u1ee3c FDA ch\u1ee9ng nh\u1eadn ho\u1eb7c c\u00e1c quy \u0111\u1ecbnh t\u01b0\u01a1ng t\u1ef1 C\u00e1c c\u01a1 h\u1ed9i kh\u00e1c li\u00ean quan \u0111\u1ebfn ISO 13485<\/strong><\/h2>\n

      ISO 13485 l\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb y t\u1ebf. ISO 13485 \u0111\u01b0a ra c\u00e1c h\u01b0\u1edbng d\u1eabn v\u00e0 quy t\u1eafc v\u1ec1 c\u00e1ch thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf, ch\u1ebf t\u1ea1o, th\u1eed nghi\u1ec7m, ki\u1ec3m so\u00e1t v\u00e0 l\u1eadp th\u00e0nh v\u0103n b\u1ea3n.<\/p>\n

      ISO 13485: 2009 l\u00e0 phi\u00ean b\u1ea3n m\u1edbi nh\u1ea5t c\u1ee7a ISO 13485, \u0111\u01b0a ra c\u00e1c y\u00eau c\u1ea7u to\u00e0n di\u1ec7n \u0111\u1ed1i v\u1edbi t\u1ea5t c\u1ea3 c\u00e1c kh\u00eda c\u1ea1nh c\u1ee7a h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      \u0110\u1ec3 \u0111\u01b0\u1ee3c FDA ch\u1ee9ng nh\u1eadn ho\u1eb7c c\u00e1c quy \u0111\u1ecbnh t\u01b0\u01a1ng t\u1ef1, tr\u01b0\u1edbc ti\u00ean b\u1ea1n c\u1ea7n t\u00ecm hi\u1ec3u v\u1ec1 ISO 13485 v\u00e0 c\u00e1ch \u00e1p d\u1ee5ng ti\u00eau chu\u1ea9n n\u00e0y cho lo\u1ea1i thi\u1ebft b\u1ecb y t\u1ebf c\u1ee5 th\u1ec3 c\u1ee7a b\u1ea1n. Khi b\u1ea1n hi\u1ec3u c\u00e1c y\u00eau c\u1ea7u v\u00e0 th\u1ee7 t\u1ee5c li\u00ean quan \u0111\u1ebfn vi\u1ec7c \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn, b\u1ea1n c\u00f3 th\u1ec3 b\u1eaft \u0111\u1ea7u \u0111\u0103ng k\u00fd \u0111\u1ec3 \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn b\u1edfi c\u00e1c t\u1ed5 ch\u1ee9c kh\u00e1c nhau nh\u01b0 FDA ho\u1eb7c CE Marking.<\/p>\n

      \u0110\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn ISO 13485 m\u1edf ra r\u1ea5t nhi\u1ec1u c\u01a1 h\u1ed9i, ch\u1eb3ng h\u1ea1n nh\u01b0 c\u00f3 th\u1ec3 l\u00e0m vi\u1ec7c v\u1edbi m\u1ed9t c\u00f4ng ty \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn v\u00e0 nh\u1eadn \u0111\u01b0\u1ee3c h\u1ee3p \u0111\u1ed3ng t\u1eeb c\u00e1c c\u00f4ng ty d\u01b0\u1ee3c ph\u1ea9m l\u1edbn.<\/p>\n

      Hi\u1ec3u v\u1ec1 ISO 13485 l\u00e0 m\u1ed9t b\u01b0\u1edbc quan tr\u1ecdng \u0111\u1ec3 tr\u1edf th\u00e0nh nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn ho\u1eb7c qu\u1ea3n l\u00fd. N\u1ebfu b\u1ea1n \u0111ang mu\u1ed1n m\u1edf r\u1ed9ng ho\u1ea1t \u0111\u1ed9ng kinh doanh c\u1ee7a m\u00ecnh sang th\u1ecb tr\u01b0\u1eddng thi\u1ebft b\u1ecb y t\u1ebf, vi\u1ec7c t\u00ecm hi\u1ec3u v\u1ec1 ISO 13485 l\u00e0 \u0111i\u1ec1u c\u1ea7n thi\u1ebft. S\u00e1ng ki\u1ebfn \u200b\u200bISO 13485 l\u00e0 m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh to\u00e0n c\u1ea7u nh\u1eb1m qu\u1ea3n l\u00fd d\u1ef1a tr\u00ean r\u1ee7i ro c\u1ee7a c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng.<\/p>\n

      Quy tr\u00ecnh v\u00e0 ti\u00eau ch\u00ed ch\u1ee9ng nh\u1eadn m\u00e0 b\u1ea1n g\u1eb7p ph\u1ea3i c\u0169ng t\u01b0\u01a1ng t\u1ef1 nh\u01b0 quy tr\u00ecnh c\u1ee7a c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd kh\u00e1c, ch\u1eb3ng h\u1ea1n nh\u01b0 FDA ho\u1eb7c CE Marking, ch\u1ec9 \u1edf c\u1ea5p \u0111\u1ed9 qu\u1ed1c t\u1ebf v\u1edbi c\u00e1c y\u00eau c\u1ea7u kh\u00e1c li\u00ean quan \u0111\u1ebfn n\u00f3. T\u1ed5 ch\u1ee9c Ti\u00eau chu\u1ea9n h\u00f3a Qu\u1ed1c t\u1ebf n\u00f3i r\u1eb1ng nh\u1eefng ng\u01b0\u1eddi s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf n\u00ean t\u00ecm hi\u1ec3u v\u1ec1 ISO 13485 \u0111\u1ec3 h\u1ecd c\u00f3 th\u1ec3 ki\u1ec3m so\u00e1t ho\u1ea1t \u0111\u1ed9ng kinh doanh c\u1ee7a m\u00ecnh trong to\u00e0n b\u1ed9 qu\u00e1 tr\u00ecnh.<\/p>\n

      N\u1ebfu b\u1ea1n kh\u00f4ng \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u ISO 13485 th\u00ec sao?<\/strong><\/h2>\n

      C\u00e1c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c FDA quy \u0111\u1ecbnh v\u00e0 ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n v\u00e0 hi\u1ec7u su\u1ea5t nh\u1ea5t \u0111\u1ecbnh \u0111\u1ec3 \u0111\u01b0\u1ee3c b\u00e1n t\u1ea1i Hoa K\u1ef3. ISO 13485 l\u00e0 m\u1ed9t trong nh\u1eefng ti\u00eau chu\u1ea9n n\u00e0y v\u00e0 n\u00f3 l\u00e0 m\u1ed9t y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi c\u00e1c c\u00f4ng ty s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      N\u1ebfu b\u1ea1n hi\u1ec7n kh\u00f4ng s\u1ea3n xu\u1ea5t ho\u1eb7c cung c\u1ea5p thi\u1ebft b\u1ecb y t\u1ebf, kh\u00f4ng c\u1ea7n ph\u1ea3i lo l\u1eafng. B\u1ea1n v\u1eabn c\u00f3 th\u1ec3 gi\u00fap doanh nghi\u1ec7p c\u1ee7a m\u00ecnh b\u1eb1ng c\u00e1ch t\u00ecm hi\u1ec3u v\u1ec1 ISO 13485 v\u00e0 \u00e1p d\u1ee5ng c\u00e1c bi\u1ec7n ph\u00e1p an to\u00e0n v\u00e0 hi\u1ec7u su\u1ea5t c\u1ea7n thi\u1ebft.<\/p>\n

      L\u1eddi k\u1ebft<\/strong><\/h2>\n

      ISO l\u00e0 m\u1ed9t trong nh\u1eefng ti\u00eau chu\u1ea9n thi\u1ebft b\u1ecb y t\u1ebf quan tr\u1ecdng nh\u1ea5t, v\u00e0 n\u1ebfu kh\u00f4ng c\u00f3 n\u00f3, nhi\u1ec1u thi\u1ebft b\u1ecb s\u1ebd kh\u00f4ng th\u1ec3 \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn \u0111\u1ec3 \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng.<\/p>\n

      \u0110\u1ec3 tu\u00e2n th\u1ee7 ISO 13485, b\u1ea1n ph\u1ea3i c\u00f3 ch\u1ee9ng ch\u1ec9 ISO 13485 h\u1ee3p l\u1ec7. Ch\u1ee9ng ch\u1ec9 cho ph\u00e9p b\u1ea1n ch\u1ee9ng minh r\u1eb1ng s\u1ea3n ph\u1ea9m c\u1ee7a b\u1ea1n tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n \u0111\u01b0\u1ee3c n\u00eau trong \u0111\u1eb7c \u0111i\u1ec3m k\u1ef9 thu\u1eadt.<\/p>\n

      N\u1ebfu b\u1ea1n \u0111ang mu\u1ed1n tu\u00e2n th\u1ee7 ISO 13485, th\u00ec ch\u00fang t\u00f4i c\u00f3 th\u1ec3 gi\u00fap b\u1ea1n. Ch\u00fang t\u00f4i cung c\u1ea5p d\u1ecbch v\u1ee5 ch\u1ee9ng nh\u1eadn \u0111\u1ec3 \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n. Ch\u00fang t\u00f4i c\u0169ng c\u00f3 th\u1ec3 cung c\u1ea5p h\u01b0\u1edbng d\u1eabn ri\u00eang v\u1ec1 c\u00e1ch \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u.[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section el_class=”team-area uk-team uk-section”][vc_row][vc_column]\r\n

      \r\n <\/span>\r\n

      ISO 13485: C\u00c1C C\u00c2U H\u1eceI TH\u01af\u1edcNG G\u1eb6P<\/h2>\r\n
      <\/div>\r\n <\/div>[vc_tta_accordion][vc_tta_section title=”ISO l\u00e0 g\u00ec?” tab_id=”1659536326614-c459721e-5291″][vc_column_text]ISO l\u00e0 ti\u00eau chu\u1ea9n to\u00e0n c\u1ea7u v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m thi\u1ebft b\u1ecb y t\u1ebf. N\u00f3 \u0111\u1eb7t ra c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf cho m\u1ecdi th\u1ee9 t\u1eeb thi\u1ebft k\u1ebf v\u00e0 s\u1ea3n xu\u1ea5t s\u1ea3n ph\u1ea9m \u0111\u1ebfn t\u00e0i li\u1ec7u v\u00e0 th\u1eed nghi\u1ec7m.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”ISO 13485 gi\u00fap \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng trong c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf nh\u01b0 th\u1ebf n\u00e0o?” tab_id=”1659536326633-d21a3059-8a50″][vc_column_text]ISO 13485 gi\u00fap \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t ch\u00ednh x\u00e1c v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n c\u1ea7n thi\u1ebft. Ngo\u00e0i ra, n\u00f3 cung c\u1ea5p h\u01b0\u1edbng d\u1eabn v\u1ec1 c\u00e1ch ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 ki\u1ec3m tra c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf. \u0110i\u1ec1u n\u00e0y \u0111\u1ea3m b\u1ea3o r\u1eb1ng b\u1ec7nh nh\u00e2n nh\u1eadn \u0111\u01b0\u1ee3c c\u00e1c s\u1ea3n ph\u1ea9m ch\u1ea5t l\u01b0\u1ee3ng cao \u0111\u00e1p \u1ee9ng mong \u0111\u1ee3i c\u1ee7a h\u1ecd.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”L\u1ee3i \u00edch c\u1ee7a vi\u1ec7c s\u1eed d\u1ee5ng ISO 13485 trong s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 g\u00ec?” tab_id=”1659536817315-e17d9fb3-fd5f”][vc_column_text]C\u00f3 r\u1ea5t nhi\u1ec1u l\u1ee3i \u00edch khi s\u1eed d\u1ee5ng ISO 13485 trong s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf. V\u00ed d\u1ee5, s\u1eed d\u1ee5ng c\u00e1c ti\u00eau chu\u1ea9n ISO 13485 c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn ti\u1ebft ki\u1ec7m chi ph\u00ed do c\u1ea3i thi\u1ec7n vi\u1ec7c ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng.<\/p>\n

      Ngo\u00e0i ra, n\u00f3 c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn c\u00e1c m\u00f4 h\u00ecnh s\u1ea3n xu\u1ea5t nh\u1ea5t qu\u00e1n h\u01a1n, c\u00f3 th\u1ec3 l\u00e0m gi\u1ea3m nguy c\u01a1 x\u1ea3y ra l\u1ed7i ng\u1eabu nhi\u00ean. Nh\u00ecn chung, vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c ti\u00eau chu\u1ea9n ISO 13485 gi\u00fap \u0111\u1ea3m b\u1ea3o ch\u0103m s\u00f3c b\u1ec7nh nh\u00e2n t\u1ed1t h\u01a1n \u0111\u1ed3ng th\u1eddi ti\u1ebft ki\u1ec7m ti\u1ec1n b\u1ea1c v\u00e0 th\u1eddi gian cho c\u00f4ng ty c\u1ee7a b\u1ea1n.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Nh\u1eefng g\u00ec \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i l\u00e0 thi\u1ebft b\u1ecb y t\u1ebf trong quy \u0111\u1ecbnh ISO 13485?” tab_id=”1659537094245-9a0f676c-dd46″][vc_column_text]Thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 m\u1ed9t c\u00e1i g\u00ec \u0111\u00f3 gi\u1ed1ng nh\u01b0 m\u1ed9t b\u1ed9 ph\u1eadn c\u1ea5y gh\u00e9p, d\u1ee5ng c\u1ee5 ho\u1eb7c thu\u1ed1c th\u1eed trong \u1ed1ng nghi\u1ec7m. T\u1ea5t c\u1ea3 nh\u1eefng \u0111i\u1ec1u n\u00e0y \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ec3 gi\u00fap c\u00e1c b\u00e1c s\u0129 t\u00ecm ki\u1ebfm, theo d\u00f5i v\u00e0 \u0111i\u1ec1u tr\u1ecb cho nh\u1eefng b\u1ec7nh nh\u00e2n m\u1eafc c\u00e1c ch\u1ee9ng b\u1ec7nh kh\u00e1c nhau.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”T\u1ea1i sao c\u1ea7n c\u00f3 ISO 13485 v\u00e0 ai c\u1ea7n?” tab_id=”1659537098892-bf3103ab-96ee”][vc_column_text]ISO 13485 \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 s\u1eed d\u1ee5ng cho c\u00e1c doanh nghi\u1ec7p tham gia v\u00e0o vi\u1ec7c ph\u00e1t tri\u1ec3n, s\u1ea3n xu\u1ea5t, ph\u00e2n ph\u1ed1i v\u00e0 b\u1ea3o tr\u00ec c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 c\u00e1c d\u1ecbch v\u1ee5 li\u00ean quan. C\u00e1c t\u1ed5 ch\u1ee9c b\u00ean trong v\u00e0 b\u00ean ngo\u00e0i c\u00f4ng ty, ch\u1eb3ng h\u1ea1n nh\u01b0 c\u00e1c c\u01a1 quan ch\u1ee9ng nh\u1eadn, c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng n\u00f3 \u0111\u1ec3 gi\u00fap \u0111\u00e1nh gi\u00e1.<\/p>\n

      ISO 13485, gi\u1ed1ng nh\u01b0 c\u00e1c ti\u00eau chu\u1ea9n h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ISO kh\u00e1c, kh\u00f4ng b\u1eaft bu\u1ed9c ch\u1ee9ng nh\u1eadn \u0111\u1ec3 m\u1ed9t doanh nghi\u1ec7p \u0111\u01b0\u1ee3c h\u01b0\u1edfng nh\u1eefng l\u1ee3i th\u1ebf khi \u00e1p d\u1ee5ng ti\u00eau chu\u1ea9n. Tuy nhi\u00ean, vi\u1ec7c m\u1ed9t b\u00ean th\u1ee9 ba ch\u1ee9ng nh\u1eadn b\u1ea1n tu\u00e2n th\u1ee7 quy chu\u1ea9n c\u00f3 th\u1ec3 cho th\u1ea5y c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd b\u1ea1n \u0111\u00e3 l\u00e0m nh\u01b0 v\u1eady. ISO 13485 kh\u00f4ng ph\u1ea3i l\u00e0 c\u01a1 quan ch\u1ee9ng nh\u1eadn.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”ISO 13485 \u0111\u01b0\u1ee3c c\u1eadp nh\u1eadt v\u00ec l\u00fd do g\u00ec?” tab_id=”1660542068085-80acd8d7-5886″][vc_column_text]M\u1ed7i n\u0103m n\u0103m, c\u00e1c ti\u00eau chu\u1ea9n ISO 13485 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 \u0111\u1ec3 xem li\u1ec7u c\u00e1c b\u1ea3n c\u1eadp nh\u1eadt c\u00f3 c\u1ea7n thi\u1ebft \u0111\u1ec3 duy tr\u00ec ti\u1ec1n t\u1ec7 trong ng\u00e0nh hay kh\u00f4ng. ISO 13485:2016 \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n \u0111\u1ec3 ph\u1ea3n \u1ee9ng v\u1edbi c\u00e1c k\u1ef9 thu\u1eadt c\u1ee7a h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng hi\u1ec7n t\u1ea1i, bao g\u1ed3m nh\u1eefng thay \u0111\u1ed5i trong c\u00f4ng ngh\u1ec7 v\u00e0 c\u00e1c y\u00eau c\u1ea7u quy \u0111\u1ecbnh v\u00e0 k\u1ef3 v\u1ecdng.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Nh\u1eefng c\u1ea3i ti\u1ebfn ch\u00ednh l\u00e0 g\u00ec?” tab_id=”1660542094278-17af0bd1-b8cd”][vc_column_text]Nh\u1eefng thay \u0111\u1ed5i trong phi\u00ean b\u1ea3n m\u1edbi ph\u1ea3n \u00e1nh th\u1ef1c t\u1ebf l\u00e0 c\u00e1c c\u00f4ng ty trong chu\u1ed7i cung \u1ee9ng hi\u1ec7n ph\u1ea3i tu\u00e2n theo nhi\u1ec1u quy t\u1eafc h\u01a1n v\u00e0 h\u1ecd ch\u00fa tr\u1ecdng h\u01a1n v\u00e0o vi\u1ec7c qu\u1ea3n l\u00fd r\u1ee7i ro v\u00e0 \u0111\u01b0a ra quy\u1ebft \u0111\u1ecbnh d\u1ef1a tr\u00ean r\u1ee7i ro.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”C\u00f3 \u1ed5n kh\u00f4ng n\u1ebfu t\u00f4i s\u1eed d\u1ee5ng logo ISO 13485?” tab_id=”1660542115837-4a554c8c-d12d”][vc_column_text]Logo ISO l\u00e0 m\u1ed9t nh\u00e3n hi\u1ec7u \u0111\u01b0\u1ee3c b\u1ea3o h\u1ed9 b\u1edfi lu\u1eadt quy\u1ec1n s\u1edf h\u1eefu tr\u00ed tu\u1ec7, v\u00ec v\u1eady n\u00f3 ch\u1ec9 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng b\u1edfi nh\u1eefng ng\u01b0\u1eddi \u0111\u01b0\u1ee3c ISO cho ph\u00e9p l\u00e0m nh\u01b0 v\u1eady.<\/p>\n

      Li\u00ean h\u1ec7 v\u1edbi t\u1ed5 ch\u1ee9c \u0111\u00e3 c\u1ea5p cho b\u1ea1n ch\u1ee9ng ch\u1ec9 \u1ee7y quy\u1ec1n s\u1eed d\u1ee5ng bi\u1ec3u t\u01b0\u1ee3ng c\u1ee7a h\u1ecd tr\u00ean b\u1ea5t k\u1ef3 t\u00e0i li\u1ec7u qu\u1ea3ng c\u00e1o n\u00e0o.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][\/vc_column][\/vc_row][\/vc_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

      [vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][\/vc_column][\/vc_row][\/vc_section][vc_section][vc_row full_width=”stretch_row_content_no_spaces”][vc_column][vc_empty_space height=”20″][vc_column_text css=”.vc_custom_1660542193157{margin-right: 100px !important;margin-left: 100px !important;}”] Kh\u00e1i Ni\u1ec7m C\u01a1 B\u1ea3n V\u1ec1 ISO 13485 ISO 13485 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ec3 gi\u00fap gi\u1ea3m nguy c\u01a1 tai n\u1ea1n do thi\u1ebft b\u1ecb y t\u1ebf g\u00e2y ra v\u00e0 c\u1ea3i thi\u1ec7n ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf. ISO 13485 gi\u1ea3i quy\u1ebft nhi\u1ec1u v\u1ea5n \u0111\u1ec1, bao <\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"yoast_head":"\nISO 13485 l\u00e0 g\u00ec? Gi\u1ea3i Th\u00edch D\u1ec5 Hi\u1ec3u | Mandreel.com<\/title>\n<meta name=\"description\" content=\"T\u00ecm hi\u1ec3u v\u1ec1 m\u1ee5c \u0111\u00edch c\u1ee7a ISO 13485 d\u00e0nh cho c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf, \u1ea5n b\u1ea3n hi\u1ec7n t\u1ea1i, c\u00e1c y\u00eau c\u1ea7u c\u1ea7n thi\u1ebft, t\u00ednh b\u1eaft bu\u1ed9c c\u1ee7a ISO 13485, c\u00e1ch \u0111\u1ec3 \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn v\u00e0 nhi\u1ec1u th\u00f4ng tin kh\u00e1c.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.mandreel.com\/vietnam\/iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 l\u00e0 g\u00ec? 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