{"id":85950,"date":"2025-07-10T14:33:45","date_gmt":"2025-07-10T07:33:45","guid":{"rendered":"https:\/\/tcvn.gov.vn\/?p=85950"},"modified":"2026-05-14T11:01:41","modified_gmt":"2026-05-14T04:01:41","slug":"cai-thien-nang-suat-giam-sai-loi-va-tang-do-tin-cay-cua-san-pham-voi-tieu-chuan-iso-13485","status":"publish","type":"post","link":"https:\/\/tcvn.gov.vn\/cai-thien-nang-suat-giam-sai-loi-va-tang-do-tin-cay-cua-san-pham-voi-tieu-chuan-iso-13485\/10\/07\/2025\/","title":{"rendered":"C\u1ea3i thi\u1ec7n n\u0103ng su\u1ea5t, gi\u1ea3m sai l\u1ed7i v\u00e0 t\u0103ng \u0111\u1ed9 tin c\u1eady c\u1ee7a s\u1ea3n ph\u1ea9m v\u1edbi ti\u00eau chu\u1ea9n ISO 13485"},"content":{"rendered":"\n

Vi\u1ec7c tri\u1ec3n khai ISO 13485 kh\u00f4ng ch\u1ec9 l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c \u0111\u1ec3 ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng qu\u1ed1c t\u1ebf m\u00e0 c\u00f2n gi\u00fap doanh nghi\u1ec7p c\u1ea3i thi\u1ec7n n\u0103ng su\u1ea5t, gi\u1ea3m sai l\u1ed7i v\u00e0 t\u0103ng \u0111\u1ed9 tin c\u1eady c\u1ee7a s\u1ea3n ph\u1ea9m.<\/strong><\/p>\n\n\n

ISO 13485 l\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf v\u1ec1 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng d\u00e0nh ri\u00eang cho l\u0129nh v\u1ef1c thi\u1ebft b\u1ecb y t\u1ebf. Vi\u1ec7c tri\u1ec3n khai ISO 13485 kh\u00f4ng ch\u1ec9 l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c \u0111\u1ec3 ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng qu\u1ed1c t\u1ebf m\u00e0 c\u00f2n gi\u00fap doanh nghi\u1ec7p c\u1ea3i thi\u1ec7n n\u0103ng su\u1ea5t, gi\u1ea3m sai l\u1ed7i v\u00e0 t\u0103ng \u0111\u1ed9 tin c\u1eady c\u1ee7a s\u1ea3n ph\u1ea9m. \u0110\u1ec3 doanh nghi\u1ec7p tri\u1ec3n khai h\u1ec7 th\u1ed1ng ISO 13485 hi\u1ec7u qu\u1ea3 c\u1ea7n 6 b\u01b0\u1edbc.<\/p>\n

B\u01b0\u1edbc 1: \u0110\u1ecbnh h\u01b0\u1edbng ph\u1ea1m vi \u00e1p d\u1ee5ng c\u1ee7a h\u1ec7 th\u1ed1ng<\/strong><\/p>\n

Doanh nghi\u1ec7p c\u1ea7n x\u00e1c \u0111\u1ecbnh r\u00f5 ph\u1ea1m vi \u00e1p d\u1ee5ng c\u1ee7a h\u1ec7 th\u1ed1ng ISO 13485. Ph\u1ea1m vi n\u00e0y c\u00f3 th\u1ec3 bao g\u1ed3m to\u00e0n b\u1ed9 quy tr\u00ecnh s\u1ea3n xu\u1ea5t, thi\u1ebft k\u1ebf, ph\u00e2n ph\u1ed1i ho\u1eb7c ch\u1ec9 m\u1ed9t ph\u1ea7n c\u1ee5 th\u1ec3. \u0110i\u1ec1u n\u00e0y gi\u00fap t\u1ed5 ch\u1ee9c x\u00e2y d\u1ef1ng h\u1ec7 th\u1ed1ng ph\u00f9 h\u1ee3p v\u1edbi th\u1ef1c t\u1ebf ho\u1ea1t \u0111\u1ed9ng, tr\u00e1nh l\u00e3ng ph\u00ed t\u00e0i nguy\u00ean v\u00e0 \u0111\u00e1p \u1ee9ng \u0111\u00fang c\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd li\u00ean quan.<\/p>\n

B\u01b0\u1edbc 2: \u0110\u00e0o t\u1ea1o nh\u1eadn th\u1ee9c v\u1ec1 ISO 13485<\/strong><\/p>\n

Vi\u1ec7c \u0111\u00e0o t\u1ea1o cho \u0111\u1ed9i ng\u0169 qu\u1ea3n l\u00fd v\u00e0 nh\u00e2n vi\u00ean li\u00ean quan l\u00e0 \u0111i\u1ec1u ki\u1ec7n ti\u00ean quy\u1ebft \u0111\u1ec3 tri\u1ec3n khai th\u00e0nh c\u00f4ng h\u1ec7 th\u1ed1ng. N\u1ed9i dung \u0111\u00e0o t\u1ea1o th\u01b0\u1eddng bao g\u1ed3m: Hi\u1ec3u bi\u1ebft v\u1ec1 ti\u00eau chu\u1ea9n ISO 13485; Vai tr\u00f2, tr\u00e1ch nhi\u1ec7m c\u1ee7a t\u1eebng b\u1ed9 ph\u1eadn; C\u00e1c y\u00eau c\u1ea7u c\u1ee5 th\u1ec3 c\u1ee7a h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

\u0110\u00e0o t\u1ea1o gi\u00fap nh\u00e2n s\u1ef1 hi\u1ec3u \u0111\u00fang, l\u00e0m \u0111\u00fang ngay t\u1eeb \u0111\u1ea7u, gi\u1ea3m thi\u1ec3u sai s\u00f3t khi tri\u1ec3n khai th\u1ef1c t\u1ebf.<\/p>\n

B\u01b0\u1edbc 3: L\u1eadp k\u1ebf ho\u1ea1ch ph\u00e2n c\u00f4ng v\u00e0 x\u00e2y d\u1ef1ng t\u00e0i li\u1ec7u<\/strong><\/p>\n

Doanh nghi\u1ec7p c\u1ea7n l\u1eadp k\u1ebf ho\u1ea1ch tri\u1ec3n khai chi ti\u1ebft, ph\u00e2n c\u00f4ng ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch t\u1eebng h\u1ea1ng m\u1ee5c v\u00e0 b\u1eaft \u0111\u1ea7u x\u00e2y d\u1ef1ng t\u00e0i li\u1ec7u h\u1ec7 th\u1ed1ng, bao g\u1ed3m: S\u1ed5 tay ch\u1ea5t l\u01b0\u1ee3ng; Ch\u00ednh s\u00e1ch ch\u1ea5t l\u01b0\u1ee3ng; C\u00e1c quy tr\u00ecnh, h\u01b0\u1edbng d\u1eabn c\u00f4ng vi\u1ec7c; Bi\u1ec3u m\u1eabu, h\u1ed3 s\u01a1 ki\u1ec3m so\u00e1t.<\/p>\n

B\u01b0\u1edbc 4: Ban h\u00e0nh v\u00e0 \u00e1p d\u1ee5ng h\u1ed3 s\u01a1, t\u00e0i li\u1ec7u<\/strong><\/p>\n

Khi t\u00e0i li\u1ec7u \u0111\u00e3 \u0111\u01b0\u1ee3c ho\u00e0n thi\u1ec7n v\u00e0 ph\u00ea duy\u1ec7t, doanh nghi\u1ec7p ti\u1ebfn h\u00e0nh ban h\u00e0nh ch\u00ednh th\u1ee9c v\u00e0 tri\u1ec3n khai \u00e1p d\u1ee5ng trong to\u00e0n h\u1ec7 th\u1ed1ng. Qu\u00e1 tr\u00ecnh n\u00e0y \u0111\u00f2i h\u1ecfi s\u1ef1 ph\u1ed1i h\u1ee3p gi\u1eefa c\u00e1c ph\u00f2ng ban v\u00e0 th\u01b0\u1eddng \u0111i k\u00e8m c\u00e1c bu\u1ed5i \u0111\u00e0o t\u1ea1o h\u01b0\u1edbng d\u1eabn th\u1ef1c h\u00e0nh.<\/p>\n

Doanh nghi\u1ec7p c\u1ea7n theo d\u00f5i ch\u1eb7t ch\u1ebd vi\u1ec7c tu\u00e2n th\u1ee7 v\u00e0 ghi l\u1ea1i b\u1eb1ng ch\u1ee9ng th\u1ef1c hi\u1ec7n (bi\u1ec3u m\u1eabu, b\u00e1o c\u00e1o, log ghi nh\u1eadn\u2026).<\/p>\n

<\/p>\n\n\n

\"\"<\/figure><\/div>\n\n\n

B\u01b0\u1edbc 5: \u0110\u00e1nh gi\u00e1 n\u1ed9i b\u1ed9<\/strong><\/p>\n

Sau m\u1ed9t th\u1eddi gian v\u1eadn h\u00e0nh th\u1eed, t\u1ed5 ch\u1ee9c c\u1ea7n th\u1ef1c hi\u1ec7n \u0111\u00e1nh gi\u00e1 n\u1ed9i b\u1ed9 \u0111\u1ec3 ki\u1ec3m tra s\u1ef1 ph\u00f9 h\u1ee3p c\u1ee7a h\u1ec7 th\u1ed1ng v\u1edbi ti\u00eau chu\u1ea9n ISO 13485; Ph\u00e1t hi\u1ec7n \u0111i\u1ec3m ch\u01b0a ph\u00f9 h\u1ee3p; \u0110\u01b0a ra h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c v\u00e0 c\u1ea3i ti\u1ebfn.<\/p>\n

\u0110\u00e1nh gi\u00e1 n\u1ed9i b\u1ed9 n\u00ean do nh\u1eefng ng\u01b0\u1eddi \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o b\u00e0i b\u1ea3n th\u1ef1c hi\u1ec7n v\u00e0 \u0111\u1ed9c l\u1eadp v\u1edbi qu\u00e1 tr\u00ecnh \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1.<\/p>\n

B\u01b0\u1edbc 6: Y\u00eau c\u1ea7u t\u1ed5 ch\u1ee9c ch\u1ee9ng nh\u1eadn \u0111\u00e1nh gi\u00e1 v\u00e0 c\u1ea5p ch\u1ee9ng ch\u1ec9<\/strong><\/p>\n

Sau khi h\u1ec7 th\u1ed1ng \u0111\u00e3 v\u1eadn h\u00e0nh \u1ed5n \u0111\u1ecbnh v\u00e0 ho\u00e0n t\u1ea5t kh\u1eafc ph\u1ee5c c\u00e1c \u0111i\u1ec3m ch\u01b0a ph\u00f9 h\u1ee3p, doanh nghi\u1ec7p c\u00f3 th\u1ec3 m\u1eddi t\u1ed5 ch\u1ee9c ch\u1ee9ng nh\u1eadn (CB) \u0111\u1ebfn \u0111\u00e1nh gi\u00e1 ch\u1ee9ng nh\u1eadn. \u0110\u00e1nh gi\u00e1 n\u00e0y g\u1ed3m: \u0110\u00e1nh gi\u00e1 giai \u0111o\u1ea1n 1: ki\u1ec3m tra t\u00e0i li\u1ec7u v\u00e0 m\u1ee9c \u0111\u1ed9 s\u1eb5n s\u00e0ng; \u0110\u00e1nh gi\u00e1 giai \u0111o\u1ea1n 2: ki\u1ec3m tra th\u1ef1c t\u1ebf v\u1eadn h\u00e0nh h\u1ec7 th\u1ed1ng t\u1ea1i doanh nghi\u1ec7p.<\/p>\n

N\u1ebfu \u0111\u1ea1t y\u00eau c\u1ea7u, doanh nghi\u1ec7p s\u1ebd \u0111\u01b0\u1ee3c c\u1ea5p ch\u1ee9ng ch\u1ec9 ISO 13485 c\u00f3 hi\u1ec7u l\u1ef1c trong 3 n\u0103m, k\u00e8m \u0111\u00e1nh gi\u00e1 gi\u00e1m s\u00e1t \u0111\u1ecbnh k\u1ef3 h\u1eb1ng n\u0103m.<\/p>\n

Tri\u1ec3n khai ISO 13485 kh\u00f4ng ch\u1ec9 gi\u00fap doanh nghi\u1ec7p \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u ph\u00e1p l\u00fd v\u00e0 th\u1ecb tr\u01b0\u1eddng, m\u00e0 c\u00f2n l\u00e0 \u0111\u00f2n b\u1ea9y \u0111\u1ec3 c\u1ea3i ti\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng, gi\u1ea3m r\u1ee7i ro, n\u00e2ng cao hi\u1ec7u qu\u1ea3 qu\u1ea3n l\u00fd v\u00e0 gia t\u0103ng uy t\u00edn th\u01b0\u01a1ng hi\u1ec7u. Doanh nghi\u1ec7p n\u00ean xem \u0111\u00e2y l\u00e0 m\u1ed9t chi\u1ebfn l\u01b0\u1ee3c d\u00e0i h\u1ea1n, ch\u1ee9 kh\u00f4ng ch\u1ec9 l\u00e0 m\u1ed9t th\u1ee7 t\u1ee5c h\u00e0nh ch\u00ednh.<\/p>\n

H\u1ed3ng V\u00e2n<\/strong><\/p>","protected":false},"excerpt":{"rendered":"

Vi\u1ec7c tri\u1ec3n khai ISO 13485 kh\u00f4ng ch\u1ec9 l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c \u0111\u1ec3 ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng qu\u1ed1c t\u1ebf m\u00e0 c\u00f2n gi\u00fap doanh nghi\u1ec7p c\u1ea3i thi\u1ec7n n\u0103ng su\u1ea5t, gi\u1ea3m sai l\u1ed7i v\u00e0 t\u0103ng \u0111\u1ed9 tin c\u1eady c\u1ee7a s\u1ea3n ph\u1ea9m. ISO 13485 l\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf v\u1ec1 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng d\u00e0nh ri\u00eang […]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[59,22,27],"tags":[],"acf":{"linh-vuc":"Ti\u00eau chu\u1ea9n"},"_links":{"self":[{"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/posts\/85950"}],"collection":[{"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/comments?post=85950"}],"version-history":[{"count":4,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/posts\/85950\/revisions"}],"predecessor-version":[{"id":90817,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/posts\/85950\/revisions\/90817"}],"wp:attachment":[{"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/media?parent=85950"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/categories?post=85950"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/tags?post=85950"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}