{"id":10221,"date":"2023-08-11T01:47:47","date_gmt":"2023-08-11T01:47:47","guid":{"rendered":"https:\/\/china-maching.com\/?p=10221"},"modified":"2023-08-29T01:56:50","modified_gmt":"2023-08-29T01:56:50","slug":"understanding-iso-13485","status":"publish","type":"post","link":"https:\/\/china-maching.com\/ko\/\uc774\ud574-iso-13485\/","title":{"rendered":"ISO 13485 \uc774\ud574: \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \ud488\uc9c8 \ubcf4\uc7a5"},"content":{"rendered":"

ISO 13485\ub780 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h2>\n

ISO 13485\ub294 \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc5d0 \ud2b9\ud654\ub41c \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c(QMS)\uc5d0 \ub300\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \uc124\uba85\ud558\ub294 \uad6d\uc81c\uc801\uc73c\ub85c \uc778\uc815\ub41c \ud45c\uc900\uc785\ub2c8\ub2e4. \uc774\ub294 \uc870\uc9c1\uc774 \ud488\uc9c8 \uad00\ub9ac\uc5d0 \ub300\ud55c \uad6c\uc870\ud654\ub41c \uc811\uadfc \ubc29\uc2dd\uc744 \uc218\ub9bd\ud558\uace0 \uc720\uc9c0\ud560 \uc218 \uc788\ub294 \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud558\uc5ec \uc81c\ud488\uc774 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uacfc \uace0\uac1d \uae30\ub300\uce58\ub97c \uc77c\uad00\ub418\uac8c \ucda9\uc871\ud558\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>\n

\uad8c\uc7a5 \uc77d\uae30: CNC \ud488\uc9c8 \uad00\ub9ac\uc5d0 \uad00\ud55c \ubaa8\ub4e0 \uac83<\/a><\/strong><\/p>\n

ISO 13485 \uc18c\uac1c<\/h3>\n

ISO 13485\ub294 \uc81c\uc870\uc5c5\uccb4, \uacf5\uae09\uc5c5\uccb4 \ubc0f \uc11c\ube44\uc2a4 \uc81c\uacf5\uc5c5\uccb4\ub97c \ud3ec\ud568\ud55c \uc758\ub8cc\uae30\uae30 \uc0b0\uc5c5\uc758 \ubaa8\ub4e0 \uc870\uc9c1\uc5d0 \uc801\uc6a9\ub429\ub2c8\ub2e4. \uc758\ub8cc\uae30\uae30 \uc0b0\uc5c5\uc758 \uc694\uad6c\uc5d0 \ub9de\ub294 QMS\uc758 \uac1c\ubc1c \ubc0f \uad6c\ud604\uc744 \uc9c0\uc6d0\ud558\ub3c4\ub85d \uc124\uacc4\ub418\uc5b4 \uc870\uc9c1\uc774 \uc548\uc804\ud558\uace0 \ud6a8\uacfc\uc801\uc778 \uc758\ub8cc\uae30\uae30\ub97c \uc9c0\uc18d\uc801\uc73c\ub85c \uc0dd\uc0b0\ud560 \uc218 \uc788\ub3c4\ub85d \ud569\ub2c8\ub2e4.<\/p>\n

\uc8fc\uc694 \uc694\uad6c \uc0ac\ud56d Essentials 13485<\/h3>\n

ISO 13485\ub294 \uc870\uc9c1\uc774 \uc778\uc99d\uc744 \ud68d\ub4dd\ud558\uae30 \uc704\ud574 \ucda9\uc871\ud574\uc57c \ud558\ub294 \uba87 \uac00\uc9c0 \uc911\uc694\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \uc124\uba85\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc694\uad6c \uc0ac\ud56d\uc5d0\ub294 \uad00\ub9ac \ucc45\uc784, \ubb38\uc11c\ud654, \uc704\ud5d8 \uad00\ub9ac \ubc0f \uc81c\ud488 \uc2e4\ud604\uc744 \ube44\ub86f\ud55c \ub2e4\uc591\ud55c \uc8fc\uc81c\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n

ISO 13485\uc758 \uac00\uc7a5 \uc911\uc694\ud55c \uc694\uad6c \uc0ac\ud56d \uc911 \ud558\ub098\ub294 \uc870\uc9c1\uc774 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d \uc900\uc218\uc5d0 \uc911\uc810\uc744 \ub454 \ud6a8\uacfc\uc801\uc778 QMS\ub97c \uc218\ub9bd\ud558\uace0 \uc720\uc9c0\ud574\uc57c \ud55c\ub2e4\ub294 \uac83\uc785\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \uc758\ub8cc \uae30\uae30\uc758 \uc124\uacc4, \uac1c\ubc1c, \uc81c\uc870 \ubc0f \uc720\ud1b5\uacfc \uad00\ub828\ub41c \ubaa8\ub4e0 \ud65c\ub3d9\uc774 \ud1b5\uc81c\ub418\ub3c4\ub85d \ub2e4\uc591\ud55c \ud504\ub85c\uc138\uc2a4 \ubc0f \uc808\ucc28\ub97c \uad6c\ud604\ud558\ub294 \uac83\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n

13485\uc5d0 \ub300\ud55c \uae30\ud0c0 \uc911\uc694\ud55c \uc694\uad6c \uc0ac\ud56d\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<\/h3>\n

\uc774\ub294 \uba85\ud655\ud55c \ud488\uc9c8 \ubaa9\ud45c\uc640 \uc870\uc9c1\uc758 \uc804\ubc18\uc801\uc778 \ubaa9\ud45c\uc5d0 \ubd80\ud569\ud558\ub294 \ud488\uc9c8 \uc815\ucc45\uc744 \uc218\ub9bd\ud558\ub294 \uac83\uc785\ub2c8\ub2e4.
\n\ud488\uc9c8 \uad00\ub9ac \uc6d0\uce59\uc774 \uc870\uc9c1 \ub0b4\uc5d0\uc11c \uc5b4\ub5bb\uac8c \uc801\uc6a9\ub418\ub294\uc9c0 \uc124\uba85\ud558\ub294 \uc815\ucc45, \uc808\ucc28 \ubc0f \uc791\uc5c5 \uc9c0\uce68\uc744 \ubb38\uc11c\ud654\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.
\n\uc6b0\ub9ac\ub294 \ud658\uc790 \uc548\uc804\uacfc \uc81c\ud488 \uc131\ub2a5\uc5d0 \ub300\ud55c \uc7a0\uc7ac\uc801\uc778 \uc704\ud5d8\uc744 \uc2dd\ubcc4\ud558\uace0 \uc644\ud654\ud558\uae30 \uc704\ud574 \uc81c\ud488 \uc218\uba85 \uc8fc\uae30 \uc804\ubc18\uc5d0 \uac78\uccd0 \uc704\ud5d8 \ud3c9\uac00\ub97c \uc218\ud589\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.
\n\uadf8\ub4e4\uc740 \uc758\ub8cc \uae30\uae30\ub97c \uc81c\uc870 \ubc0f \uc720\ud1b5\ud558\ub294 \ubaa8\ub4e0 \uc9c1\uc6d0\uc774 \uc801\uc808\ud558\uac8c \uad50\uc721\uc744 \ubc1b\uace0 \uc790\uc2e0\uc758 \ucc45\uc784\uc744 \uc644\uc804\ud788 \uc778\uc2dd\ud558\ub3c4\ub85d \ud569\ub2c8\ub2e4.
\n\uc6b0\ub9ac\ub294 \uaddc\uc81c \uc694\uac74 \uc900\uc218 \ubc0f QMS\uc758 \ud6a8\uc728\uc131\uc744 \uc785\uc99d\ud558\uae30 \uc704\ud574 \uc801\uc808\ud55c \uae30\ub85d\uc744 \uc720\uc9c0\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

\"ISO\"<\/p>\n

ISO 13485 \uc778\uc99d\uc758 \uc774\uc810<\/h3>\n

ISO 13485 \uc778\uc99d\uc744 \uad6c\ud604\ud558\uace0 \ub2ec\uc131\ud558\uba74 \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \uc870\uc9c1\uc5d0 \ub2e4\uc591\ud55c \uc774\uc810\uc774 \uc81c\uacf5\ub429\ub2c8\ub2e4. \uac00\uc7a5 \uc911\uc694\ud55c \uc774\uc810\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<\/p>\n

\ud5a5\uc0c1\ub41c \uace0\uac1d \uc2e0\ub8b0: ISO 13485 \uc778\uc99d\uc740 \uc870\uc9c1\uc774 \uace0\uac1d\uacfc \uc774\ud574 \uad00\uacc4\uc790 \uac04\uc758 \uc2e0\ub8b0\ub97c \uad6c\ucd95\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub418\ub294 \ud488\uc9c8 \ub9c8\ud06c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774\ub294 \ubc1c\ud310\uc744 \ub9c8\ub828\ud558\ub824\ub294 \uc18c\uaddc\ubaa8 \ub610\ub294 \uc2e0\uc0dd \uae30\uc5c5\uc5d0 \ud2b9\ud788 \uc720\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.
\n\ud5a5\uc0c1\ub41c \uc6b4\uc601 \ud6a8\uc728\uc131: ISO 13485\ub294 \uc870\uc9c1\uc774 \uc6b4\uc601\uc744 \ud569\ub9ac\ud654\ud558\uace0 \ub0ad\ube44\ub97c \uc904\uc774\uba70 \uc804\ubc18\uc801\uc778 \ud6a8\uc728\uc131\uc744 \uac1c\uc120\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub418\ub294 \ud488\uc9c8 \uad00\ub9ac\uc5d0 \ub300\ud55c \uad6c\uc870\ud654\ub41c \uc811\uadfc \ubc29\uc2dd\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.
\n\uaddc\uc81c \uc694\uad6c \uc0ac\ud56d \uc900\uc218 \ud5a5\uc0c1: ISO 13485 \uc900\uc218\ub294 \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d \uc900\uc218\uc640 \ubc00\uc811\ud55c \uad00\ub828\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uc778\uc99d\uc740 \uc870\uc9c1\uc774 \ud488\uc9c8 \ubc0f \uaddc\uc815 \uc900\uc218\uc5d0 \ub300\ud55c \uc758\uc9c0\ub97c \uc785\uc99d\ud558\uc5ec \ube44\uc900\uc218 \uad00\ub828 \ucc98\ubc8c \ub610\ub294 \ubc8c\uae08\uc758 \uc704\ud5d8\uc744 \uc904\uc774\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.
\n\uc81c\ud488 \ub9ac\ucf5c \uc704\ud5d8 \uac10\uc18c: ISO 13485\ub97c \uae30\ubc18\uc73c\ub85c QMS\ub97c \uad6c\ud604\ud558\uba74 \uc870\uc9c1\uc774 \uc81c\ud488 \uc218\uba85 \uc8fc\uae30 \ucd08\uae30\uc5d0 \uc7a0\uc7ac\uc801 \uc704\ud5d8\uc744 \uc2dd\ubcc4\ud558\uc5ec \uac1c\ubc1c \ub9ac\ucf5c \ubc0f \uad00\ub828 \ube44\uc6a9\uc758 \uc704\ud5d8\uc744 \uc904\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

ISO 13485\uc640 ISO 9001\uc758 \ucc28\uc774\uc810<\/h3>\n

ISO 13485\uc640 ISO 9001<\/a> QMS \uad6c\ud604 \uac00\uc774\ub4dc\uc5d0 \ub530\ub974\uba74 \ub450 \ud45c\uc900\uc5d0\ub294 \uba87 \uac00\uc9c0 \uc8fc\uc694 \ucc28\uc774\uc810\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

ISO 9001\uc740 \ubaa8\ub4e0 \uc0b0\uc5c5\uc744 \uc704\ud574 \uc124\uacc4\ub41c \uc77c\ubc18\uc801\uc778 \ud488\uc9c8 \uad00\ub9ac \ud45c\uc900\uc785\ub2c8\ub2e4. \uc870\uc9c1 \ud504\ub85c\uc138\uc2a4\uc758 \uc804\ubc18\uc801\uc778 \ud6a8\uc728\uc131\uc744 \uac1c\uc120\ud558\uc5ec \uace0\uac1d \ub9cc\uc871\uc744 \ubcf4\uc7a5\ud558\ub294 \ub370 \uc911\uc810\uc744 \ub461\ub2c8\ub2e4. \ubc18\uba74\uc5d0 ISO 13485\ub294 \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc5d0 \ud2b9\ud654\ub418\uc5b4 \uc788\uc73c\uba70 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d \ubc0f \uc704\ud5d8 \uad00\ub9ac \uc900\uc218\ub97c \ub354 \uac15\uc870\ud569\ub2c8\ub2e4.<\/p>\n

ISO 13485 \uc900\uc218: \uaddc\uc81c \ubc0f \ubc95\uc801 \uc758\ubb34<\/h3>\n

\uc778\uc99d\uc758 \uc774\uc810 \uc678\uc5d0\ub3c4 ISO 13485\ub97c \uc900\uc218\ud558\uba74 \uc870\uc9c1\uc774 \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5 \ubc0f \uadf8 \uc678 \ubd84\uc57c\uc5d0\uc11c \ubc95\uc801 \ubc0f \uaddc\uc81c \uc758\ubb34\ub97c \ucda9\uc871\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\uac83\uc740 \uc0b0\uc5c5\uc758 \uaddc\uc81c\uac00 \uc2ec\ud55c \ud2b9\uc131\uacfc \uc758\ub8cc \uae30\uae30 \uc0ac\uc6a9\uacfc \uad00\ub828\ub41c \uc7a0\uc7ac\uc801 \uc704\ud5d8\uc744 \uace0\ub824\ud560 \ub54c \ud2b9\ud788 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n

\"CNC
\ub354 \ubcf4\uae30<\/strong>CNC \uae30\uacc4\uc6a9 CAD \ub3c4\uba74 \uc885\ud569 \uc548\ub0b4\uc11c<\/span><\/div><\/a><\/div>

ISO 13485\ub294 \uc870\uc9c1\uc774 \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \uaddc\uc81c \uc694\uac74\uc744 \uc644\uc804\ud788 \uc900\uc218\ud558\ub294 QMS\ub97c \uc218\ub9bd\ud558\uace0 \uc720\uc9c0\ud558\uae30 \uc704\ud55c \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \ud45c\uc900\uc744 \uc900\uc218\ud558\uba74 \uc870\uc9c1\uc774 \ud488\uc9c8, \uaddc\uc815 \uc900\uc218 \ubc0f \ud658\uc790 \uc548\uc804\uc5d0 \ub300\ud55c \uc57d\uc18d\uc744 \uc785\uc99d\ud558\uc5ec \ube44\uc900\uc218 \uad00\ub828 \ucc98\ubc8c \ub610\ub294 \ubc8c\uae08\uc758 \uc704\ud5d8\uc744 \uc904\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

\ub610\ud55c \uacbd\uc6b0\uc5d0 \ub530\ub77c \uaddc\uc81c \uae30\uad00\uc5d0\uc11c \uc758\ub8cc \uae30\uae30 \ud310\ub9e4 \ub610\ub294 \uc720\ud1b5 \uc2b9\uc778\uc744 \uc5bb\uae30 \uc704\ud55c \uc870\uac74\uc73c\ub85c ISO 13485 \uc900\uc218\ub97c \uc694\uad6c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub530\ub77c\uc11c \uc778\uc99d\uc744 \ud68d\ub4dd\ud558\uba74 \uc870\uc9c1\uc774 \ubaa8\ub4e0 \uad00\ub828 \uaddc\uc815 \ubc0f \ud45c\uc900\uc744 \uc644\uc804\ud788 \uc900\uc218\ud558\uba74\uc11c \uc0c8\ub85c\uc6b4 \uc2dc\uc7a5\uc5d0 \uc811\uadfc\ud558\uace0 \uc6b4\uc601\uc744 \ud655\uc7a5\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

\uac15\ub825\ud55c \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c \uad6c\ucd95<\/h2>\n

\uac15\ub825\ud55c QMS\ub294 \uc124\uacc4 \ubc0f \uac1c\ubc1c\uc5d0\uc11c \uc720\ud1b5 \ubc0f \uc2dc\ud310 \ud6c4 \uac10\uc2dc\uc5d0 \uc774\ub974\uae30\uae4c\uc9c0 \uc758\ub8cc \uae30\uae30 \ud68c\uc0ac \uc6b4\uc601\uc758 \ubaa8\ub4e0 \uce21\uba74\uc744 \ud3ec\uad04\ud558\ub294 \ud488\uc9c8 \uad00\ub9ac\uc5d0 \ub300\ud55c \uccb4\uacc4\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc785\ub2c8\ub2e4. \uc798 \uad6c\uc131\ub41c QMS\ub294 \uc7a0\uc7ac\uc801\uc778 \uc704\ud5d8\uc744 \uc2dd\ubcc4 \ubc0f \ud574\uacb0\ud558\uace0 \uace0\uac1d, \ud658\uc790 \ubc0f \uaddc\uc81c \uae30\uad00\uc758 \uc694\uad6c\ub97c \ucda9\uc871\ud558\uae30 \uc704\ud574 \uc9c0\uc18d\uc801\uc73c\ub85c \ud6a8\uc728\uc131\uc744 \uac1c\uc120\ud558\ub3c4\ub85d \uc124\uacc4\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

\uc758\ub8cc\uae30\uae30 \uae30\uc5c5\uc744 \uc704\ud55c \ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c \uad6c\ucd95<\/h3>\n

\ud488\uc9c8 \ubaa9\ud45c, \uc704\ud5d8 \uad00\ub9ac, \uaddc\uc815 \uc694\uad6c \uc0ac\ud56d \uc900\uc218, \uad00\ub9ac \ucc45\uc784 \ubc0f ISO 13485\uc640 \uac19\uc740 \uc5ec\ub7ec \uad6c\uc131 \uc694\uc18c\uac00 \uac15\ub825\ud55c QMS\ub97c \uad6c\uc131\ud569\ub2c8\ub2e4.<\/p>\n

\uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \ud488\uc9c8 \ubaa9\ud45c<\/h3>\n

\ud488\uc9c8 \ubaa9\ud45c\ub294 \uace0\uac1d \ubc0f \uaddc\uc815 \uae30\ub300\uce58\ub97c \ucda9\uc871\ud558\ub294 \uace0\ud488\uc9c8 \uc81c\ud488\uc744 \uc81c\uacf5\ud558\ub294 \ub370 \uc911\uc810\uc744 \ub461\ub2c8\ub2e4. \ubaa9\ud45c\ub294 SMART(\uad6c\uccb4\uc801, \uce21\uc815 \uac00\ub2a5, \ub2ec\uc131 \uac00\ub2a5, \uad00\ub828\uc131 \ubc0f \uc2dc\uac04 \ud55c\uc815)\uc5ec\uc57c \ud558\uba70 \ube44\uc988\ub2c8\uc2a4\uc640 \uc9c1\uc6d0\uc5d0 \ub300\ud55c \uba85\ud655\ud55c \uae30\ub300\uce58\ub97c \uc81c\uacf5\ud574\uc57c \ud569\ub2c8\ub2e4. \ubaa9\ud45c\ub294 \uc81c\ud488 \uc124\uacc4, \uc81c\uc870 \ud6a8\uc728\uc131 \uac1c\uc120 \ubc0f \ud658\uc790 \uc548\uc804 \uc704\ud5d8 \ucd5c\uc18c\ud654\uc5d0 \ucd08\uc810\uc744 \ub9de\ucdb0\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

\uc704\ud5d8 \uad00\ub9ac \ubc0f ISO 13485<\/h3>\n

\uc704\ud5d8 \uad00\ub9ac\ub294 \uc7a0\uc7ac\uc801\uc778 \uc704\ud5d8\uc744 \uc2dd\ubcc4 \ubc0f \uc644\ud654\ud558\uace0 \uc9c0\uc18d\uc801\uc778 \uc81c\ud488 \uac1c\uc120\uc744 \ubcf4\uc7a5\ud558\uae30 \ub54c\ubb38\uc5d0 QMS\uc5d0 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. ISO 13485 \u2013 \uc758\ub8cc \uae30\uae30 \u2013 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc740 \uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\ub97c \uc704\ud55c \uc2e4\uc6a9\uc801\uc778 \uc9c0\uce68\uc73c\ub85c, \uc870\uc9c1 \ub0b4 \uc704\ud5d8 \uad00\ub9ac \ud504\ub85c\uc138\uc2a4\ub97c \uac04\ub7b5\ud558\uac8c \uc124\uba85\ud569\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc5d0\ub294 \uc801\uc808\ud55c \uc704\ud5d8 \uad00\ub9ac \uacc4\ud68d\uc744 \uc791\uc131\ud558\uc5ec \uc7a0\uc7ac\uc801 \ubd80\uc791\uc6a9\uc744 \ud3c9\uac00, \ud3c9\uac00 \ubc0f \ubaa8\ub2c8\ud130\ub9c1\ud558\ub294 \uac83\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uc798 \uad6c\ud604\ub41c ISO 13485 \uc2dc\uc2a4\ud15c\uc740 FDA(Food and Drug Administration)\uc640 \uac19\uc740 \uaddc\uc81c \uae30\uad00\uc744 \ud6a8\uacfc\uc801\uc73c\ub85c \uc900\uc218\ud558\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>\n

\uc801\uc6a9 \uac00\ub2a5\ud55c \uaddc\uc81c \uc694\uac74 \uc900\uc218 \ubcf4\uc7a5<\/h3>\n

\ud658\uc790\uc758 \uc548\uc804\uc744 \uc720\uc9c0\ud558\uae30 \uc704\ud574 \uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\ub294 FDA\uc758 21 CFR Part 820 \ubc0f GMP(Good Manufacturing Practices)\uc640 \uac19\uc740 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \uc694\uad6c \uc0ac\ud56d\uc740 \uc758\ub8cc \uae30\uae30 \uc720\ud615\uc5d0 \ub530\ub77c \ub2e4\ub974\ubbc0\ub85c \ud68c\uc0ac \uc81c\ud488\uc5d0 \uc5b4\ub5a4 \uaddc\uc81c \uae30\uad00 \ubc0f \ud45c\uc900\uc774 \uc801\uc6a9\ub418\ub294\uc9c0 \uc774\ud574\ud558\ub294 \uac83\uc774 \ud544\uc218\uc801\uc785\ub2c8\ub2e4.<\/p>\n

\uacbd\uc601 \ucc45\uc784 \ubc0f ISO 13485<\/h3>\n

\uad00\ub9ac \ucc45\uc784\uc740 \ud488\uc9c8 \uc815\ucc45\uc744 \uc218\ub9bd\ud558\uace0, \ud488\uc9c8 \ubaa9\ud45c\ub97c \uc815\uc758\ud558\uace0, \uc801\uc808\ud55c \uc790\uc6d0\uacfc \uc778\ub825\uc744 QMS\uc5d0 \ud560\ub2f9\ud558\ub294 \uac83\uacfc \uad00\ub828\ub41c QMS\uc758 \uc911\uc694\ud55c \uad6c\uc131 \uc694\uc18c\uc785\ub2c8\ub2e4. ISO 13485\ub294 \uaddc\uc81c \uae30\uad00\uc744 \uc900\uc218\ud558\uace0 \uac15\ub825\ud55c \ud488\uc9c8 \ubb38\ud654\ub97c \ud655\ub9bd\ud558\uae30 \uc704\ud574 \ud45c\uc900 \uc2dc\ud589 \ubc0f \ubb38\uc11c \uc5c5\ub370\uc774\ud2b8 \uc81c\uc5b4\uc640 \uac19\uc740 \uad00\ub9ac \ucc45\uc784\uc744 \uc124\uba85\ud569\ub2c8\ub2e4.<\/p>\n

\uad8c\uc7a5 \uc77d\uae30: \uc911\uad6d CNC \uc54c\ub8e8\ubbf8\ub284 \ubd80\ud488: \ucd5c\uace0\uc758 \uac00\uacf5 \uc11c\ube44\uc2a4 \ubc0f \uacf5\uae09\uc5c5\uccb4 \ucc3e\uae30<\/a><\/strong><\/p>\n

ISO 13485 \uc778\uc99d \ubc1b\uae30: \uac10\uc0ac \ud504\ub85c\uc138\uc2a4<\/h2>\n

ISO 13485\ub294 \uc758\ub8cc \uae30\uae30\uc5d0 \ud2b9\ud654\ub41c \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud574 \uad6d\uc81c\uc801\uc73c\ub85c \uc778\uc815\ub41c \ud45c\uc900\uc785\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc5d0 \ub300\ud55c \uc778\uc99d\uc744 \ud68d\ub4dd\ud558\uba74 \uc758\ub8cc \uae30\uae30 \ud68c\uc0ac\uac00 \uc548\uc804\ud558\uace0 \ud6a8\uacfc\uc801\uc778 \uc81c\ud488\uc744 \uc0dd\uc0b0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c \uace0\uac1d\uc774 \uad6c\ub9e4\ud558\ub294 \uc81c\ud488\uc758 \ud488\uc9c8\uc5d0 \ub300\ud55c \ud655\uc2e0\uc744 \uc90d\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uc778\uc99d\uc744 \ubc1b\ub294 \uac83\uc740 \uc5b4\ub824\uc6b4 \uc791\uc5c5\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774 \uac00\uc774\ub4dc\ub294 \uc2ec\uc0ac \uc900\ube44, \uc2ec\uc0ac \uae30\uc900 \uc774\ud574, \uaddc\uc815 \uc900\uc218 \ub2ec\uc131, \uad00\ub9ac \uac80\ud1a0 \ubc0f \ub9ac\uc18c\uc2a4 \uad00\ub9ac\ub97c \ud1b5\ud55c \uc778\uc99d \uc720\uc9c0\ub97c \ud3ec\ud568\ud558\uc5ec ISO 13485 \uc778\uc99d \ud504\ub85c\uc138\uc2a4\uc5d0 \ub300\ud55c \ud3ec\uad04\uc801\uc778 \uac1c\uc694\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n

ISO 13485 \uc778\uc99d \uc2ec\uc0ac \uc900\ube44<\/h3>\n

ISO 13485 \uc778\uc99d\uc744 \ud5a5\ud55c \uccab \ubc88\uc9f8 \ub2e8\uacc4\ub294 \uac10\uc0ac\ub97c \uc900\ube44\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \ud45c\uc900\uc744 \uac80\ud1a0\ud558\uace0 \ud604\uc7ac \ud504\ub85c\uc138\uc2a4\uc758 \ucc28\uc774\ub97c \uc2dd\ubcc4\ud558\ub294 \uc791\uc5c5\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. \ucee8\uc124\ud134\ud2b8\ub97c \uace0\uc6a9\ud558\uac70\ub098 \uacbd\ud5d8\uc774 \ud48d\ubd80\ud55c \ud488\uc9c8 \ubcf4\uc99d \uad00\ub9ac\uc790\uc758 \uc9c0\ub3c4\ub97c \ubc1b\ub294 \uac83\uc774 \uc88b\uc2b5\ub2c8\ub2e4. \ud68c\uc0ac\ub294 \ub610\ud55c \ud45c\uc900\uc758 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c(QMS)\uc744 \uc218\ub9bd\ud574\uc57c \ud569\ub2c8\ub2e4. QMS\uc5d0\ub294 \ud68c\uc0ac\uac00 \uc81c\ud488 \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud558\ub294 \ubc29\ubc95\uc744 \uc124\uba85\ud558\ub294 \uc815\ucc45, \uc808\ucc28 \ubc0f \uc791\uc5c5 \uc9c0\uce68\uc774 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc9c1\uc6d0\uc740 QMS\uc5d0 \ub300\ud55c \uad50\uc721\uc744 \ubc1b\uc544\uc57c \ud558\uba70 \uad50\uc721 \uae30\ub85d\uc744 \ubcf4\uad00\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

ISO 13485\uc5d0 \ub300\ud55c \uac10\uc0ac \uae30\uc900 \uc774\ud574<\/h3>\n

ISO 13485 \uac10\uc0ac \uae30\uc900\uc740 \ud45c\uc900\uc758 \ud2b9\uc815 \uc694\uad6c \uc0ac\ud56d\uc744 \uae30\ubc18\uc73c\ub85c \ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc694\uad6c \uc0ac\ud56d\uc740 \uc124\uacc4 \ubc0f \uac1c\ubc1c\uc5d0\uc11c \uc0dd\uc0b0 \ubc0f \uc2dc\ud310 \ud6c4 \uac10\uc2dc\uc5d0 \uc774\ub974\ub294 \uc804\uccb4 \uc81c\ud488 \uac1c\ubc1c \uc8fc\uae30\ub97c \ud3ec\uad04\ud569\ub2c8\ub2e4. \uac10\uc0ac \ud504\ub85c\uc138\uc2a4\ub294 \ud68c\uc0ac\uc758 \ud45c\uc900 \uc900\uc218 \uc5ec\ubd80\ub97c \ud3c9\uac00\ud558\uace0 \uac1c\uc120\uc774 \ud544\uc694\ud55c \uc601\uc5ed\uc744 \uc2dd\ubcc4\ud558\ub3c4\ub85d \uc124\uacc4\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uac10\uc0ac\uc790\ub294 \uc9c1\uc6d0\uc744 \uc778\ud130\ubdf0\ud558\uace0 \ubb38\uc11c\ub97c \uac80\ud1a0\ud558\uba70 \uc808\ucc28\ub97c \uad00\ucc30\ud558\uc5ec \ud68c\uc0ac\uac00 \ud45c\uc900 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/p>\n

\"\ud544\ub81b
\ub354 \ubcf4\uae30<\/strong>\ud544\ub81b \ubc18\uacbd: \uc54c\uc544\uc57c \ud560 \ubaa8\ub4e0 \uac83<\/span><\/div><\/a><\/div>

\"ISO\"<\/p>\n

\uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc5d0\uc11c ISO 13485 \uc900\uc218 \ub2ec\uc131<\/h3>\n

ISO 13485\ub97c \uc900\uc218\ud558\ub824\uba74 \ud68c\uc0ac\ub294 \ub2e4\uc74c \ub2e8\uacc4\ub97c \ub530\ub77c\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

\ud45c\uc900 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294 QMS\ub97c \uc124\uc815\ud569\ub2c8\ub2e4.
\n\uc9c1\uc6d0\uc5d0\uac8c QMS\ub97c \uad50\uc721\ud558\uace0 \uad50\uc721 \uae30\ub85d\uc744 \ubcf4\uad00\ud558\uc2ed\uc2dc\uc624.
\n\ud45c\uc900 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\uc9c0 \uc54a\ub294 \ud504\ub85c\uc138\uc2a4\ub97c \uc2dd\ubcc4\ud558\uace0 \uc2dc\uc815 \uc870\uce58\ub97c \uad6c\ud604\ud569\ub2c8\ub2e4.
\n\uc9c0\uc18d\uc801\uc778 \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud558\uae30 \uc704\ud574 \ub0b4\ubd80 \uac10\uc0ac\ub97c \uc218\ud589\ud569\ub2c8\ub2e4.
\n\ud45c\uc900\uc744 \uac80\ud1a0\ud558\uace0 \ud504\ub85c\uc138\uc2a4 \uaca9\ucc28\ub97c \uc2dd\ubcc4\ud558\uc5ec ISO 13485 \uc778\uc99d \uac10\uc0ac\ub97c \uc900\ube44\ud558\uc2ed\uc2dc\uc624.
\n\uc219\ub828\ub41c \ud488\uc9c8 \ubcf4\uc99d \uad00\ub9ac\uc790 \ub610\ub294 \ucee8\uc124\ud134\ud2b8\uc640 \ud611\ub825\ud558\uc5ec \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>\n

ISO 13485 \uc778\uc99d \ud68d\ub4dd\uc758 \uc774\uc810\uc740 \ub9ce\uc2b5\ub2c8\ub2e4. \uc81c\ud488\uc758 \uc548\uc804\uc131\uacfc \ud6a8\ub2a5\uc744 \ubcf4\uc7a5\ud558\uace0 \uace0\uac1d\uc758 \uc2e0\ub8b0\ub3c4\ub97c \ub192\uc5ec \ub9e4\ucd9c \uc99d\ub300\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

\uacbd\uc601 \uac80\ud1a0 \ubc0f ISO 13485 \uc778\uc99d<\/h3>\n

\uad00\ub9ac \uac80\ud1a0\ub294 ISO 13485 \uc778\uc99d\uc744 \uc720\uc9c0\ud558\ub294 \ub370 \ud544\uc218\uc801\uc778 \ubd80\ubd84\uc785\ub2c8\ub2e4. \uac80\ud1a0 \ud504\ub85c\uc138\uc2a4\uc5d0\ub294 QMS\uc758 \ud6a8\uc728\uc131 \ud3c9\uac00 \ubc0f \uac1c\uc120 \uc601\uc5ed \uc2dd\ubcc4\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uacbd\uc601\uc9c4\uc740 \uc815\uae30\uc801\uc73c\ub85c QMS\ub97c \uac80\ud1a0\ud558\uace0 \ud544\uc694\ud55c \ubcc0\uacbd \uc0ac\ud56d\uc744 \uad6c\ud604\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774\ub807\uac8c \ud558\uba74 QMS\uac00 \ud45c\uc900 \uc694\uad6c \uc0ac\ud56d\uacfc \ud68c\uc0ac\uc758 \ubcc0\ud654\ud558\ub294 \uc694\uad6c \uc0ac\ud56d\uc5d0 \ub530\ub77c \ucd5c\uc2e0 \uc0c1\ud0dc\ub97c \uc720\uc9c0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

ISO 13485\ub97c \uc704\ud55c \ub9ac\uc18c\uc2a4 \uad00\ub9ac<\/h3>\n

\ub9ac\uc18c\uc2a4 \uad00\ub9ac\ub294 ISO 13485 \uc778\uc99d\uc758 \ub610 \ub2e4\ub978 \uc911\uc694\ud55c \uce21\uba74\uc785\ub2c8\ub2e4. \ud68c\uc0ac\ub294 \uc790\uaca9\uc744 \uac16\ucd98 \uc778\ub825, \uc7a5\ube44 \ubc0f \uc2dc\uc124\uacfc \uac19\uc740 \ud45c\uc900 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud560 \uc218 \uc788\ub294 \ub9ac\uc18c\uc2a4\ub97c \ubcf4\uc720\ud574\uc57c \ud569\ub2c8\ub2e4. \ub9ac\uc18c\uc2a4 \uc694\uad6c \uc0ac\ud56d\uc744 \ud30c\uc545\ud558\uace0 \uadf8\uc5d0 \ub530\ub77c \ub9ac\uc18c\uc2a4\ub97c \ud560\ub2f9\ud574\uc57c \ud569\ub2c8\ub2e4. \ud68c\uc0ac\ub294 \ub610\ud55c \uc9c0\uc18d\uc801\uc778 \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud558\uae30 \uc704\ud574 \ub9ac\uc18c\uc2a4 \uc131\ub2a5\uc744 \ubaa8\ub2c8\ud130\ub9c1\ud558\uace0 \uce21\uc815\ud558\ub294 \ud504\ub85c\uc138\uc2a4\ub97c \uac16\ucd94\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n

\uad8c\uc7a5 \uc77d\uae30: CMM \uac80\uc0ac: \uc54c\uc544\uc57c \ud560 \ubaa8\ub4e0 \uac83<\/a><\/strong><\/p>\n

\uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\ub97c \uc704\ud55c ISO 13485\uc758 \uc774\uc810 \ubc0f \uc2dc\uc0ac\uc810<\/h2>\n

ISO 13485\ub294 \uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uac00 \uc81c\ud488\uc774 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uacfc \uace0\uac1d \uae30\ub300\uce58\ub97c \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778\ud558\ub294 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \uad6c\ucd95\ud558\uace0 \uc6b4\uc601\ud560 \uc218 \uc788\ub294 \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \ub2e4\uc74c\uc740 ISO 13485\uc758 \uc9c0\uce68\uc744 \uc900\uc218\ud560 \ub54c \uc5bb\uc744 \uc218 \uc788\ub294 \uba87 \uac00\uc9c0 \uc911\uc694\ud55c \uc774\uc810\uacfc \uc601\ud5a5\uc785\ub2c8\ub2e4.<\/p>\n

ISO 13485\ub85c \uc758\ub8cc \uae30\uae30 \uc81c\uc870 \uac04\uc18c\ud654<\/h3>\n

ISO 13485\ub97c \uad6c\ud604\ud558\uba74 \uc81c\uc870 \ud504\ub85c\uc138\uc2a4\ub97c \uac04\uc18c\ud654\ud558\uc5ec \uc624\ub958 \uac00\ub2a5\uc131, \uc9c0\uc5f0 \ubc0f \uc81c\ud488 \uac1c\ubc1c\uacfc \uad00\ub828\ub41c \ube44\uc6a9\uc744 \uc904\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \ud45c\uc900\ud654\ud558\uba74 \uc81c\uc870 \ud504\ub85c\uc138\uc2a4\uc758 \uac01 \ub2e8\uacc4\uac00 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uacfc \uc5c5\uacc4 \ubaa8\ubc94 \uc0ac\ub840\ub97c \ucda9\uc871\ud558\ub3c4\ub85d \ubcf4\uc7a5\ud558\uba74\uc11c \ud6a8\uc728\uc131\uacfc \uc0dd\uc0b0\uc131\uc744 \ub192\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

\"ISO13485\"<\/p>\n

\uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\ub97c \uc704\ud55c ISO 13485 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c<\/h3>\n

ISO 13485 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c(QMS)\uc740 \uc124\uacc4 \ubc0f \uac1c\ubc1c, \uc0dd\uc0b0, \uc124\uce58, \uc11c\ube44\uc2a4 \ubc0f \uc0ac\uc6a9 \uc885\ub8cc\ub97c \ud3ec\ud568\ud55c \uc804\uccb4 \uc81c\ud488 \uc218\uba85 \uc8fc\uae30\ub97c \ud3ec\uad04\ud558\ub294 \uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5d0 \ub300\ud55c \uccb4\uacc4\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774 \ud3ec\uad04\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc740 \uac01 \uc81c\ud488 \uac1c\ubc1c \ub2e8\uacc4\uac00 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uacfc \uace0\uac1d \uae30\ub300\uce58\ub97c \ucda9\uc871\ud558\ub3c4\ub85d \ubcf4\uc7a5\ud558\uc5ec \uace0\ud488\uc9c8\uc758 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uc81c\ud488\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n

ISO 13485\ub85c \uace0\uac1d \uc694\uad6c \uc0ac\ud56d \ucda9\uc871<\/h3>\n

\uace0\uac1d \ub9cc\uc871\uc740 \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \uc911\uc694\ud55c \uce21\uba74\uc774\uba70 \uace0\uac1d \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294 \uac83\uc740 \uc81c\uc870\uc5c5\uccb4\uc5d0\uac8c \uc911\uc694\ud55c \uacfc\uc81c\uc785\ub2c8\ub2e4. ISO 13485\ub294 \uc81c\uc870\uc5c5\uccb4\uac00 \uace0\uac1d \uc694\uad6c \uc0ac\ud56d\uc744 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \ud1b5\ud569\ud560 \uc218 \uc788\ub294 \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. ISO 13485 \uc9c0\uce68\uc744 \uc900\uc218\ud558\uba74 \uc81c\uc870\uc5c5\uccb4\uac00 \uae30\ub300\uce58\ub97c \ucda9\uc871\ud558\uac70\ub098 \ucd08\uacfc\ud558\ub294 \uc81c\ud488\uc744 \uc81c\uacf5\ud558\uc5ec \uace0\uac1d \ub9cc\uc871\ub3c4\ub97c \ub192\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

\uc758\ub8cc \uae30\uae30 \uaddc\uc815 \ubc0f ISO 13485 \uc900\uc218<\/h3>\n

\uc758\ub8cc \uae30\uae30\ub294 \uc5c4\uaca9\ud55c \uaddc\uc81c\ub97c \ubc1b\uace0 \uc788\uc73c\uba70 \uc81c\uc870\uc5c5\uccb4\ub294 ISO 13485\ub97c \ube44\ub86f\ud55c \ub2e4\uc591\ud55c \uaddc\uc815\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uaddc\uc815\uc744 \uc900\uc218\ud568\uc73c\ub85c\uc368 \uc81c\uc870\uc5c5\uccb4\ub294 \ubc95\uc801 \ubb38\uc81c \ubc0f \ud3c9\ud310 \ud6fc\uc190\uc744 \ud53c\ud558\uba74\uc11c \uc548\uc804\ud558\uace0 \ud6a8\uacfc\uc801\uc778 \uc81c\ud488\uc744 \uc0dd\uc0b0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c ISO 13485\uc640 \uc77c\uce58\ud558\uba74 \uc81c\uc870\uc5c5\uccb4\uac00 \uaddc\uc815 \uc900\uc218 \ud45c\uc900 \uac04\uc758 \ucda9\ub3cc \ubc0f \uc911\ubcf5\uc744 \ubc29\uc9c0\ud558\uc5ec \uad81\uadf9\uc801\uc73c\ub85c \uc804\ubc18\uc801\uc778 \ud6a8\uc728\uc131\uc744 \ub192\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

ISO 13485\uc5d0 \ub300\ud55c \ucd5c\uace0 \uacbd\uc601\uc9c4\uc758 \uc57d\uc18d \ubcf4\uc7a5<\/h3>\n

QMS\ub97c \uad6c\ud604\ud558\ub824\uba74 \uc870\uc9c1 \ucd5c\uace0 \uacbd\uc601\uc9c4\uc758 \uc0c1\ub2f9\ud55c \ub178\ub825\uc774 \ud544\uc694\ud558\uba70 ISO 13485 \uad6c\ud604\ub3c4 \uc608\uc678\ub294 \uc544\ub2d9\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \ud68c\uc0ac\uc758 \ucd5c\uace0 \uacbd\uc601\uc9c4\uc774 \uc9c0\uc18d\uc801\uc778 \uac1c\uc120, \ubd80\uc801\ud569 \ubc29\uc9c0 \ubc0f \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d \uc900\uc218 \ubcf4\uc7a5\uc744 \ud3ec\ud568\ud558\uc5ec ISO 13485\uc5d0 \uba85\uc2dc\ub41c \ud488\uc9c8 \ubaa9\ud45c\uc5d0 \uc804\ub150\ud560 \uac83\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. ISO 13485\uc5d0 \ub300\ud55c \uad81\uadf9\uc801\uc778 \uad00\ub9ac \uc57d\uc18d\uc744 \uc81c\uacf5\ud568\uc73c\ub85c\uc368 \uc81c\uc870\uc5c5\uccb4\ub294 \uc548\uc804\uacfc \uace0\uac1d \ub9cc\uc871\uc744 \uc6b0\uc120\uc2dc\ud558\ub294 \ud488\uc9c8 \ubb38\ud654\ub97c \uad6c\ucd95\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n

\uad8c\uc7a5 \uc77d\uae30: AS9100 \uc774\ud574: \ud56d\uacf5\uc6b0\uc8fc \ud488\uc9c8 \uad00\ub9ac \ud45c\uc900<\/a><\/strong><\/p>\n

\uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38:<\/h2>\n

\"ISO13485\"<\/p>\n

\uc9c8\ubb38: ISO 13485\ub780 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h3>\n

A: ISO 13485\ub294 \uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc758 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \uc9c0\uc815\ud558\ub294 \uad6d\uc81c \ud45c\uc900\uc785\ub2c8\ub2e4.<\/p>\n

\uc9c8\ubb38: ISO 13485\ub294 ISO 9001\uacfc \uc5b4\ub5bb\uac8c \ub2e4\ub978\uac00\uc694?<\/h3>\n

A: ISO 13485\ub294 \uc758\ub8cc\uae30\uae30 \uc0b0\uc5c5\uc744 \uc704\ud574 \ud2b9\ubcc4\ud788 \uace0\uc548\ub41c \ubc18\uba74 ISO 9001\uc740 \ubaa8\ub4e0 \uc0b0\uc5c5\uc5d0 \uc801\uc6a9\ud560 \uc218 \uc788\ub294 \ubcf4\ub2e4 \uc77c\ubc18\uc801\uc778 \ud488\uc9c8 \uad00\ub9ac \ud45c\uc900\uc785\ub2c8\ub2e4.<\/p>\n

Q: ISO 13485 \uc778\uc99d\uc744 \uc704\ud55c \uc694\uad6c \uc0ac\ud56d\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h3>\n

A: ISO 13485 \uc778\uc99d \uc694\uad6c \uc0ac\ud56d\uc5d0\ub294 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c \uad6c\ud604, \uad00\ub9ac \uac80\ud1a0 \uc218\ud589, \ubb38\uc11c \uad00\ub9ac \uc2dc\uc2a4\ud15c \uad6c\ucd95 \ubc0f \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d \uc900\uc218 \ubcf4\uc7a5\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n

Q: ISO 13485\uc758 \ubaa9\uc801\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h3>\n

A: ISO 13485\uc758 \ubaa9\uc801\uc740 \uc758\ub3c4\ub41c \ubaa9\uc801\uc5d0 \uc548\uc804\ud55c \uc758\ub8cc \uae30\uae30\uc758 \uc77c\uad00\ub41c \uc124\uacc4, \uac1c\ubc1c, \uc0dd\uc0b0, \uc124\uce58 \ubc0f \ubc30\uc1a1\uc744 \ubcf4\uc7a5\ud558\ub294 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \ud655\ub9bd\ud558\ub294 \uac83\uc785\ub2c8\ub2e4.<\/p>\n

Q: ISO 13485\uc5d0\uc11c \uad00\ub9ac \ucc45\uc784\uc758 \uc5ed\ud560\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h3>\n

A: \uacbd\uc601 \ucc45\uc784\uc740 ISO 13485\uc758 \uc911\uc694\ud55c \uad6c\uc131 \uc694\uc18c\uc785\ub2c8\ub2e4. \ucd5c\uace0 \uacbd\uc601\uc9c4\uc774 \ud488\uc9c8\uc5d0 \ub300\ud55c \uc758\uc9c0\ub97c \uc785\uc99d\ud558\uace0 \ud488\uc9c8 \uacbd\uc601 \uc2dc\uc2a4\ud15c\uc758 \ud6a8\uc728\uc131\uc5d0 \ub300\ud55c \ucc45\uc784\uc744 \uc838\uc57c \ud558\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/p>\n

Q: ISO 13485\ub294 \uc5b4\ub5bb\uac8c \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud569\ub2c8\uae4c?<\/h3>\n

A: ISO 13485\ub294 \uc870\uc9c1\uc774 \uc758\ub8cc \uae30\uae30\uc758 \uc124\uacc4, \uac1c\ubc1c, \uc0dd\uc0b0, \uc124\uce58 \ubc0f \ubc30\uc1a1\uc744 \ubaa8\ub2c8\ud130\ub9c1 \ubc0f \uc81c\uc5b4\ud558\uace0 \ubd80\uc801\ud569 \uc0ac\ud56d\uc744 \uad00\ub9ac\ud558\uace0 \uc815\uae30\uc801\uc778 \uac10\uc0ac\ub97c \uc218\ud589\ud558\uae30 \uc704\ud55c \ud504\ub85c\uc138\uc2a4\ub97c \uc218\ub9bd\ud558\ub3c4\ub85d \uc694\uad6c\ud568\uc73c\ub85c\uc368 \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>\n

Q: ISO 13485 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc774\ub780 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h3>\n

A: ISO 13485 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc740 \uc870\uc9c1\uc774 \ud488\uc9c8 \ubaa9\ud45c\ub97c \ub2ec\uc131\ud558\uace0 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\uae30 \uc704\ud55c \uc815\ucc45, \ubaa9\ud45c \ubc0f \ud504\ub85c\uc138\uc2a4\ub97c \uc124\uc815\ud558\ub294 \ub370 \uc0ac\uc6a9\ud558\ub294 \uc77c\ub828\uc758 \uc0c1\ud638 \uad00\ub828\ub418\uac70\ub098 \uc0c1\ud638 \uc791\uc6a9\ud558\ub294 \uc694\uc18c\uc785\ub2c8\ub2e4.<\/p>\n

\uc9c8\ubb38: ISO 13485 \uc900\uc218\ub780 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h3>\n

A: ISO 13485 \uc900\uc218\ub294 \uc870\uc9c1\uc774 ISO 13485 \ud45c\uc900\uc5d0 \uc9c0\uc815\ub41c \uc694\uad6c \uc0ac\ud56d\uc744 \uc900\uc218\ud568\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \uc774\ub7ec\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \uad6c\ud604\ud558\uace0 \uc720\uc9c0 \uad00\ub9ac\ud558\ub294 \uac83\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n

Q: \uc758\ub8cc \uae30\uae30\uc5d0 \ub300\ud55c \uaddc\uc81c \uc694\uac74\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h3>\n

A: \uc758\ub8cc \uae30\uae30\uc5d0 \ub300\ud55c \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uc740 \uad6d\uac00\ub9c8\ub2e4 \ub2e4\ub974\uc9c0\ub9cc \uc77c\ubc18\uc801\uc73c\ub85c \uc81c\ud488 \ub4f1\ub85d, \ub77c\ubca8 \uc694\uad6c \uc0ac\ud56d, \uc548\uc804 \ubc0f \uc131\ub2a5 \ud14c\uc2a4\ud2b8, \uc2dc\ud310 \ud6c4 \uac10\uc2dc\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n

Q: ISO 13485\uc758 \ub9ac\uc18c\uc2a4 \uad00\ub9ac \uc694\uad6c \uc0ac\ud56d\uc740 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/h3>\n

A: ISO 13485\uc758 \ub9ac\uc18c\uc2a4 \uad00\ub9ac \uc694\uad6c \uc0ac\ud56d\uc5d0\ub294 \ud544\uc694\ud55c \ub9ac\uc18c\uc2a4 \uacb0\uc815 \ubc0f \uc81c\uacf5, \uc778\ud504\ub77c \uad6c\ucd95, \uc9c1\uc6d0\uc758 \uc5ed\ub7c9 \ubcf4\uc7a5 \ubc0f \uc801\uc808\ud55c \uc791\uc5c5 \ud658\uacbd \uc720\uc9c0\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>","protected":false},"excerpt":{"rendered":"

What is ISO 13485? ISO 13485 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. It provides a framework for organizations to establish and maintain a structured approach to quality management, ensuring that their products consistently meet regulatory requirements and customer expectations. Recommended […]<\/p>\n","protected":false},"author":2,"featured_media":10226,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10221","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cnc-machining-blog"],"yoast_head":"\nUnderstanding ISO 13485: Ensuring Quality in the Medical Device Industry - ETCN<\/title>\n<meta name=\"description\" content=\"Unlock the power of ISO 13485 with ETCN's ultimate guide to understanding quality management systems for medical devices.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/china-maching.com\/ko\/\uc774\ud574-iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Understanding ISO 13485: Ensuring Quality in the Medical Device Industry\" \/>\n<meta property=\"og:description\" content=\"Unlock the power of ISO 13485 with ETCN's ultimate guide to understanding quality management systems for medical devices.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/china-maching.com\/ko\/\uc774\ud574-iso-13485\/\" \/>\n<meta property=\"og:site_name\" content=\"ETCN\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-11T01:47:47+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-08-29T01:56:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/china-maching.com\/wp-content\/uploads\/2023\/08\/ISO13485-1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"512\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Johnson\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\uae00\uc4f4\uc774\" \/>\n\t<meta name=\"twitter:data1\" content=\"Johnson\" \/>\n\t<meta name=\"twitter:label2\" content=\"\uc608\uc0c1 \ub418\ub294 \ud310\ub3c5 \uc2dc\uac04\" \/>\n\t<meta name=\"twitter:data2\" content=\"11\ubd84\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/\"},\"author\":{\"name\":\"Johnson\",\"@id\":\"https:\\\/\\\/china-maching.com\\\/#\\\/schema\\\/person\\\/72d0a7fa5f1581f3e6f3dd4b93168a88\"},\"headline\":\"Understanding ISO 13485: Ensuring Quality in the Medical Device Industry\",\"datePublished\":\"2023-08-11T01:47:47+00:00\",\"dateModified\":\"2023-08-29T01:56:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/\"},\"wordCount\":2226,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/china-maching.com\\\/wp-content\\\/uploads\\\/2023\\\/08\\\/ISO13485-1.png\",\"articleSection\":[\"CNC Machining Blog\"],\"inLanguage\":\"ko-KR\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/\",\"url\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/\",\"name\":\"Understanding ISO 13485: Ensuring Quality in the Medical Device Industry - ETCN\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/china-maching.com\\\/wp-content\\\/uploads\\\/2023\\\/08\\\/ISO13485-1.png\",\"datePublished\":\"2023-08-11T01:47:47+00:00\",\"dateModified\":\"2023-08-29T01:56:50+00:00\",\"description\":\"Unlock the power of ISO 13485 with ETCN's ultimate guide to understanding quality management systems for medical devices.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/#breadcrumb\"},\"inLanguage\":\"ko-KR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"ko-KR\",\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/#primaryimage\",\"url\":\"https:\\\/\\\/china-maching.com\\\/wp-content\\\/uploads\\\/2023\\\/08\\\/ISO13485-1.png\",\"contentUrl\":\"https:\\\/\\\/china-maching.com\\\/wp-content\\\/uploads\\\/2023\\\/08\\\/ISO13485-1.png\",\"width\":512,\"height\":512,\"caption\":\"ISO13485\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/china-maching.com\\\/understanding-iso-13485\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/china-maching.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Understanding ISO 13485: Ensuring Quality in the Medical Device Industry\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/china-maching.com\\\/#website\",\"url\":\"https:\\\/\\\/china-maching.com\\\/\",\"name\":\"ETCN\",\"description\":\"China's top CNC Machining Services Supplier\",\"publisher\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/china-maching.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"ko-KR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/china-maching.com\\\/#organization\",\"name\":\"ETCN\",\"url\":\"https:\\\/\\\/china-maching.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ko-KR\",\"@id\":\"https:\\\/\\\/china-maching.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/china-maching.com\\\/wp-content\\\/uploads\\\/2024\\\/02\\\/cropped-ETCN.png\",\"contentUrl\":\"https:\\\/\\\/china-maching.com\\\/wp-content\\\/uploads\\\/2024\\\/02\\\/cropped-ETCN.png\",\"width\":511,\"height\":171,\"caption\":\"ETCN\"},\"image\":{\"@id\":\"https:\\\/\\\/china-maching.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/china-maching.com\\\/#\\\/schema\\\/person\\\/72d0a7fa5f1581f3e6f3dd4b93168a88\",\"name\":\"Johnson\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ko-KR\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c1c79a5cb5d1dcf3d18fc959f37059ad6971f7511b7ce557c60a7c40246890e5?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c1c79a5cb5d1dcf3d18fc959f37059ad6971f7511b7ce557c60a7c40246890e5?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c1c79a5cb5d1dcf3d18fc959f37059ad6971f7511b7ce557c60a7c40246890e5?s=96&d=mm&r=g\",\"caption\":\"Johnson\"},\"url\":\"https:\\\/\\\/china-maching.com\\\/ko\\\/author\\\/johnson\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"ISO 13485 \uc774\ud574: \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \ud488\uc9c8 \ubcf4\uc7a5 - ETCN","description":"\uc758\ub8cc \uae30\uae30\uc758 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \uc774\ud574\ud558\uae30 \uc704\ud55c ETCN\uc758 \uad81\uadf9\uc801\uc778 \uac00\uc774\ub4dc\ub97c \ud1b5\ud574 ISO 13485\uc758 \ud798\uc744 \uc7a0\uae08 \ud574\uc81c\ud558\uc2ed\uc2dc\uc624.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/china-maching.com\/ko\/\uc774\ud574-iso-13485\/","og_locale":"ko_KR","og_type":"article","og_title":"Understanding ISO 13485: Ensuring Quality in the Medical Device Industry","og_description":"Unlock the power of ISO 13485 with ETCN's ultimate guide to understanding quality management systems for medical devices.","og_url":"https:\/\/china-maching.com\/ko\/\uc774\ud574-iso-13485\/","og_site_name":"ETCN","article_published_time":"2023-08-11T01:47:47+00:00","article_modified_time":"2023-08-29T01:56:50+00:00","og_image":[{"width":512,"height":512,"url":"https:\/\/china-maching.com\/wp-content\/uploads\/2023\/08\/ISO13485-1.png","type":"image\/png"}],"author":"Johnson","twitter_card":"summary_large_image","twitter_misc":{"\uae00\uc4f4\uc774":"Johnson","\uc608\uc0c1 \ub418\ub294 \ud310\ub3c5 \uc2dc\uac04":"11\ubd84"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/china-maching.com\/understanding-iso-13485\/#article","isPartOf":{"@id":"https:\/\/china-maching.com\/understanding-iso-13485\/"},"author":{"name":"Johnson","@id":"https:\/\/china-maching.com\/#\/schema\/person\/72d0a7fa5f1581f3e6f3dd4b93168a88"},"headline":"Understanding ISO 13485: Ensuring Quality in the Medical Device Industry","datePublished":"2023-08-11T01:47:47+00:00","dateModified":"2023-08-29T01:56:50+00:00","mainEntityOfPage":{"@id":"https:\/\/china-maching.com\/understanding-iso-13485\/"},"wordCount":2226,"commentCount":0,"publisher":{"@id":"https:\/\/china-maching.com\/#organization"},"image":{"@id":"https:\/\/china-maching.com\/understanding-iso-13485\/#primaryimage"},"thumbnailUrl":"https:\/\/china-maching.com\/wp-content\/uploads\/2023\/08\/ISO13485-1.png","articleSection":["CNC Machining Blog"],"inLanguage":"ko-KR","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/china-maching.com\/understanding-iso-13485\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/china-maching.com\/understanding-iso-13485\/","url":"https:\/\/china-maching.com\/understanding-iso-13485\/","name":"ISO 13485 \uc774\ud574: \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \ud488\uc9c8 \ubcf4\uc7a5 - ETCN","isPartOf":{"@id":"https:\/\/china-maching.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/china-maching.com\/understanding-iso-13485\/#primaryimage"},"image":{"@id":"https:\/\/china-maching.com\/understanding-iso-13485\/#primaryimage"},"thumbnailUrl":"https:\/\/china-maching.com\/wp-content\/uploads\/2023\/08\/ISO13485-1.png","datePublished":"2023-08-11T01:47:47+00:00","dateModified":"2023-08-29T01:56:50+00:00","description":"\uc758\ub8cc \uae30\uae30\uc758 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \uc774\ud574\ud558\uae30 \uc704\ud55c ETCN\uc758 \uad81\uadf9\uc801\uc778 \uac00\uc774\ub4dc\ub97c \ud1b5\ud574 ISO 13485\uc758 \ud798\uc744 \uc7a0\uae08 \ud574\uc81c\ud558\uc2ed\uc2dc\uc624.","breadcrumb":{"@id":"https:\/\/china-maching.com\/understanding-iso-13485\/#breadcrumb"},"inLanguage":"ko-KR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/china-maching.com\/understanding-iso-13485\/"]}]},{"@type":"ImageObject","inLanguage":"ko-KR","@id":"https:\/\/china-maching.com\/understanding-iso-13485\/#primaryimage","url":"https:\/\/china-maching.com\/wp-content\/uploads\/2023\/08\/ISO13485-1.png","contentUrl":"https:\/\/china-maching.com\/wp-content\/uploads\/2023\/08\/ISO13485-1.png","width":512,"height":512,"caption":"ISO13485"},{"@type":"BreadcrumbList","@id":"https:\/\/china-maching.com\/understanding-iso-13485\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/china-maching.com\/"},{"@type":"ListItem","position":2,"name":"Understanding ISO 13485: Ensuring Quality in the Medical Device Industry"}]},{"@type":"WebSite","@id":"https:\/\/china-maching.com\/#website","url":"https:\/\/china-maching.com\/","name":"ETCN","description":"\uc911\uad6d \ucd5c\uace0\uc758 CNC \uba38\uc2dc\ub2dd \uc11c\ube44\uc2a4 \uacf5\uae09\uc5c5\uccb4","publisher":{"@id":"https:\/\/china-maching.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/china-maching.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ko-KR"},{"@type":"Organization","@id":"https:\/\/china-maching.com\/#organization","name":"ETCN","url":"https:\/\/china-maching.com\/","logo":{"@type":"ImageObject","inLanguage":"ko-KR","@id":"https:\/\/china-maching.com\/#\/schema\/logo\/image\/","url":"https:\/\/china-maching.com\/wp-content\/uploads\/2024\/02\/cropped-ETCN.png","contentUrl":"https:\/\/china-maching.com\/wp-content\/uploads\/2024\/02\/cropped-ETCN.png","width":511,"height":171,"caption":"ETCN"},"image":{"@id":"https:\/\/china-maching.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/china-maching.com\/#\/schema\/person\/72d0a7fa5f1581f3e6f3dd4b93168a88","name":"\uc874\uc2a8","image":{"@type":"ImageObject","inLanguage":"ko-KR","@id":"https:\/\/secure.gravatar.com\/avatar\/c1c79a5cb5d1dcf3d18fc959f37059ad6971f7511b7ce557c60a7c40246890e5?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/c1c79a5cb5d1dcf3d18fc959f37059ad6971f7511b7ce557c60a7c40246890e5?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/c1c79a5cb5d1dcf3d18fc959f37059ad6971f7511b7ce557c60a7c40246890e5?s=96&d=mm&r=g","caption":"Johnson"},"url":"https:\/\/china-maching.com\/ko\/author\/johnson\/"}]}},"_links":{"self":[{"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/posts\/10221","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/comments?post=10221"}],"version-history":[{"count":2,"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/posts\/10221\/revisions"}],"predecessor-version":[{"id":10770,"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/posts\/10221\/revisions\/10770"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/media\/10226"}],"wp:attachment":[{"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/media?parent=10221"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/categories?post=10221"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/china-maching.com\/ko\/wp-json\/wp\/v2\/tags?post=10221"}],"curies":[{"name":"\uc6cc\ub4dc\ud504\ub808\uc2a4","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}