{"id":3329,"date":"2026-05-24T20:28:28","date_gmt":"2026-05-24T12:28:28","guid":{"rendered":"https:\/\/zscncparts.com\/?p=3329"},"modified":"2026-05-24T20:58:31","modified_gmt":"2026-05-24T12:58:31","slug":"key-requirements-for-cnc-machining-medical-device-components-2","status":"publish","type":"post","link":"https:\/\/zscncparts.com\/ko\/key-requirements-for-cnc-machining-medical-device-components-2\/","title":{"rendered":"\uc758\ub8cc\uae30\uae30 \ubd80\ud488 CNC \uac00\uacf5\uc758 \ud575\uc2ec \uc694\uad6c\uc0ac\ud56d"},"content":{"rendered":"<h2 class=\"wp-block-heading\">CNC \uac00\uacf5 \uc758\ub8cc\uae30\uae30 \ubd80\ud488\uc5d0 \ub300\ud55c \uaddc\uc81c \uc694\uad6c\uc0ac\ud56d<\/h2>\n\n\n\n<p>\uc758\ub8cc\uae30\uae30 \ubd80\ud488\uc744 \uac00\uacf5\ud560 \ub54c, \uadc0\ud558\ub294 \ub2e4\uc74c \ud658\uacbd\uc5d0\uc11c \uc791\uc5c5\ud558\uac8c \ub429\ub2c8\ub2e4. <strong>\uaddc\uc81c\ub41c \uc758\ub8cc \ud658\uacbd<\/strong>, \ub2e8\uc21c\ud788 \uc815\ubc00 \uae30\uacc4 \uac00\uacf5 \uacf5\uc7a5\uc774 \uc544\ub2d9\ub2c8\ub2e4. \uadc0\ud558\uac00 \uac00\uacf5\ud558\ub294 \ubaa8\ub4e0 \ubd80\ud488\uc740 \uad81\uadf9\uc801\uc73c\ub85c \ub2e4\uc74c \uc0ac\ud56d\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4. <strong>\ud658\uc790 \uc548\uc804<\/strong>, \uc774\uac83\uc774 \ubc14\ub85c <strong>\uc758\ub8cc\uc6a9 CNC \uac00\uacf5 \ud45c\uc900<\/strong> \uc774 \uc5c4\uaca9\ud558\uace0 \ucca0\uc800\ud558\uac8c \ubb38\uc11c\ud654\ub418\ub294 \uc774\uc720\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\uc8fc\uc694 \uaddc\uc815: FDA 21 CFR Part 820 \ubc0f ISO 13485<\/h3>\n\n\n\n<p>CNC \uac00\uacf5 \uc758\ub8cc\uae30\uae30 \ubd80\ud488\uc758 \uacbd\uc6b0, \ub450 \uac00\uc9c0 \ud504\ub808\uc784\uc6cc\ud06c\uac00 \ub300\ubd80\ubd84\uc758 \uc694\uad6c\uc0ac\ud56d\uc744 \ub2e4\ub8f9\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>FDA 21 CFR Part 820 (\ud488\uc9c8 \uc2dc\uc2a4\ud15c \uaddc\uc815)<\/strong> \u2014 \ub300\ud55c\ubbfc\uad6d\uc5d0\uc11c \ud310\ub9e4\ub418\ub294 \uae30\uae30\uc5d0 \ud544\uc218\n<ul>\n<li>\uc694\uad6c\uc0ac\ud56d: <strong>\ud1b5\uc81c\ub41c \uacf5\uc815<\/strong>, \ubb38\uc11c\ud654\ub41c \uc808\ucc28, \uadf8\ub9ac\uace0 \ubaa8\ub4e0 \uc911\uc694 \ub2e8\uacc4\uc5d0 \ub300\ud55c \uae30\ub85d<\/li>\n<li>CNC \uac00\uacf5\uc740 \ub2e4\uc74c\uc73c\ub85c \uac04\uc8fc\ub429\ub2c8\ub2e4. <strong>\ud2b9\uc218 \uacf5\uc815<\/strong> \uadf8 \uacb0\uacfc\ubb3c\uc774 \uac80\uc0ac\ub9cc\uc73c\ub85c\ub294 \uc644\uc804\ud788 \uac80\uc99d\ub420 \uc218 \uc5c6\uc744 \ub54c<\/li>\n<\/ul>\n<\/li>\n<li><strong>ISO 13485 (\uc758\ub8cc\uae30\uae30 \u2013 QMS \uc694\uad6c\uc0ac\ud56d)<\/strong> \u2014 \uae00\ub85c\ubc8c \ubca4\uce58\ub9c8\ud06c for <strong>\uc758\ub8cc CNC \uac00\uacf5 \uc694\uad6c\uc0ac\ud56d<\/strong>\n<ul>\n<li>\uc815\uc758\ud558\ub294 \ubc29\ubc95 <strong>\ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c (QMS)<\/strong> \uc758\ub8cc \uc81c\uc870\ub97c \uc704\ud574 \uad6c\uc870\ud654\ub418\uc5b4\uc57c \ud558\ub294<\/li>\n<li>\uc758\ub8cc OEM\uc744 \uc9c0\uc6d0\ud558\ub294 CNC \uc5c5\uccb4\ub294 ISO 13485\ub97c \uc0ac\uc6a9\ud558\uc5ec \ucda9\uc871 <strong>\uc7a5\uce58 \uc81c\uc870\uc0ac \uc900\uc218<\/strong> \ubc0f \uac10\uc0ac \uae30\ub300\uce58<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>CNC \uacf5\uae09\uc5c5\uccb4\uac00 \uc790\uc2e0\uc758 \uc5c5\uccb4\uac00 <strong>FDA 21 CFR Part 820 CNC \uac00\uacf5\uacfc \uc5b4\ub5bb\uac8c \uc77c\uce58\ud558\ub294\uc9c0 \uc124\uba85\ud560 \uc218 \uc5c6\ub2e4\uba74<\/strong> \ubc0f <strong>ISO 13485<\/strong>\uadf8\ub4e4\uc740 \uc544\uc9c1 \uc9c4\uc815\ud55c \uc758\ub8cc \uc791\uc5c5\uc744 \uc218\ud589\ud560 \uc900\ube44\uac00 \ub418\uc9c0 \uc54a\uc740 \uac83<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">QMS\uac00 CNC \uae30\uacc4 \uacf5\uc7a5\uc5d0 \uc801\uc6a9\ub418\ub294 \ubc29\ubc95<\/h3>\n\n\n\n<p>\uc758\ub8cc \uc9c0\uc6d0 CNC \uacf5\uc7a5\uc740 <strong>\uacf5\uc2dd \ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c<\/strong>\ud558\uc5d0 \uc6b4\uc601\ub418\uba70<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\ube44\uacf5\uc2dd\uc801\uc778 \ubd80\uc871 \uc9c0\uc2dd\uc774 \uc544\ub2d8. \uc2e4\uc81c\ub85c \uc774\ub294:<\/strong> \uacac\uc801, \ud504\ub85c\uadf8\ub798\ubc0d, \uc14b\uc5c5, \uac00\uacf5, \uac80\uc0ac, \uc2b9\uc778\uc5d0 \ub300\ud55c<\/li>\n<li><strong>\ubb38\uc11c\ud654\ub41c \uc808\ucc28<\/strong> \uc791\uc5c5\uc790, \ud504\ub85c\uadf8\ub798\uba38, \uac80\uc0ac\uad00\uc758<\/li>\n<li><strong>\ubcc0\uacbd \uad00\ub9ac<\/strong> CNC \ud504\ub85c\uadf8\ub7a8, \ub3c4\uba74 \ubc0f \uacf5\uc815 \ub9e4\uac1c\ubcc0\uc218\uc6a9<\/li>\n<li><strong>\ubd80\uc801\ud569 \uad00\ub9ac \ubc0f CAPA (\uc2dc\uc815 \ubc0f \uc608\ubc29 \uc870\uce58)<\/strong> \ubb38\uc81c\uac00 \ubc1c\uc0dd\ud560 \ub54c<\/li>\n<\/ul>\n\n\n\n<p>\uc6b0\ub9ac\ub294 \ubaa8\ub4e0 CNC \uacf5\uc815\uc744 <strong>\uc815\uc758\ub418\uace0, \ud1b5\uc81c\ub418\uba70, \ubc18\ubcf5 \uac00\ub2a5\ud558\uac8c<\/strong>\uba85\ud655\ud55c \uc99d\uac70\ub85c \uc785\uc99d\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\uc704\ud5d8 \uad00\ub9ac, \uac80\uc99d \ubc0f \ubb38\uc11c\ud654<\/h3>\n\n\n\n<p>\uaddc\uc81c \uae30\uad00\uc740 \uae30\ub300\ud569\ub2c8\ub2e4 <strong>\uc704\ud5d8 \uae30\ubc18 \ud1b5\uc81c<\/strong> \uc7a5\uce58 \uc548\uc804 \ub610\ub294 \uc131\ub2a5\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \uac00\uacf5 \uacf5\uc815\uc5d0 \ub300\ud55c:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\uc704\ud5d8 \uad00\ub9ac<\/strong> (ISO 14971 \uc6d0\uce59\uc5d0 \ub530\ub77c)\n<ul>\n<li>\uac00\uacf5 \uad00\ub828 \uc704\ud5d8 \uc2dd\ubcc4: \uc798\ubabb\ub41c \uce58\uc218, \ubd80\uc801\uc808\ud55c \uc7ac\ub8cc, \ud45c\uba74 \uacb0\ud568, \uc624\uc5fc \ub4f1<\/li>\n<li>\ud1b5\uc81c \uc801\uc6a9: \ub354 \uc5c4\uaca9\ud55c \uac80\uc0ac, \uac80\uc99d\ub41c \ud504\ub85c\uadf8\ub7a8, \uacf5\uad6c \uc218\uba85 \uad00\ub9ac, \uccad\uacb0\ud55c \ucde8\uae09<\/li>\n<\/ul>\n<\/li>\n<li><strong>\uacf5\uc815 \uac80\uc99d (IQ\/OQ\/PQ)<\/strong> for critical or &#8220;special&#8221; CNC processes:\n<ul>\n<li><strong>IQ (\uc124\uce58 \uc801\uaca9\uc131)<\/strong>: \uae30\uacc4, \uc18c\ud504\ud2b8\uc6e8\uc5b4, \uac8c\uc774\uc9c0\uac00 \uc801\uc808\ud788 \uc124\uce58\ub418\uace0 \uad50\uc815\ub428<\/li>\n<li><strong>OQ (\uc6b4\uc601 \uc801\uaca9\uc131 \ud3c9\uac00)<\/strong>: \ud574\ub2f9 \uacf5\uc815\uc740 \uc608\uc0c1 \uc791\ub3d9 \ubc94\uc704 \ub0b4\uc5d0\uc11c \uc0ac\uc591\uc744 \ucda9\uc871\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>PQ (\uc131\ub2a5 \uc801\uaca9\uc131 \ud3c9\uac00)<\/strong>: \ud574\ub2f9 \uacf5\uc815\uc740 \uc2e4\uc81c \uc0dd\uc0b0 \ubc30\uce58\uc5d0\uc11c \ubaa8\ub4e0 \uc0ac\uc591\uc744 \uc77c\uad00\ub418\uac8c \ucda9\uc871\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n<li><strong>\uad00\ub9ac \ubb38\uc11c<\/strong>\n<ul>\n<li>\ub2e8 <strong>\uc2b9\uc778\ub41c \ub3c4\uba74, CNC \ud504\ub85c\uadf8\ub7a8 \ubc0f \uc791\uc5c5 \uc9c0\uc2dc\uc11c<\/strong> \ud604\uc7a5\uc5d0\uc11c \uc0ac\uc6a9\ub429\ub2c8\ub2e4.<\/li>\n<li>\ubaa8\ub4e0 \uac1c\uc815 \uc0ac\ud56d\uc740 \ucd94\uc801\ub418\uba70, \uacf5\uc2dd\uc801\uc778 \uac80\ud1a0 \ubc0f \uc2b9\uc778 \uc5c6\uc774\ub294 \uc544\ubb34\uac83\ub3c4 \ubcc0\uacbd\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>\uc774\ub294 \uaddc\uc81c \uac10\uc0ac\uad00\ub4e4\uc774 \uac80\ud1a0 \uc2dc \ud655\uc778\ud558\ub294 \uc0ac\ud56d\uc785\ub2c8\ub2e4. <strong>\uc720\ud6a8\uc131 \uac80\uc99d\ub41c \uc784\ud50c\ub780\ud2b8 \ubc0f \uae30\uad6c \uac00\uacf5 \uacf5\uc815<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\ucd94\uc801\uc131, \ubc30\uce58 \uad00\ub9ac, DHR \ubc0f DMR<\/h3>\n\n\n\n<p>\uc758\ub8cc\uae30\uae30 \uac00\uacf5\uc758 \uacbd\uc6b0, <strong>\ucd94\uc801\uc131 \ubc0f \ubc30\uce58 \uad00\ub9ac<\/strong> \ud544\uc218\uc801\uc785\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\ubc30\uce58 \uad00\ub9ac<\/strong>\n<ul>\n<li>\ubaa8\ub4e0 \uc791\uc5c5 \uc9c0\uc2dc \ub610\ub294 \ub85c\ud2b8\uc5d0\ub294 <strong>\uace0\uc720\ud55c \ub85c\ud2b8 \ubc88\ud638\uac00 \uc788\uc2b5\ub2c8\ub2e4.<\/strong><\/li>\n<li>\ub2f9\uc0ac\ub294 \ub2e4\uc74c\uc744 \ucd94\uc801\ud569\ub2c8\ub2e4: <strong>\uc7ac\ub8cc \uc5f4\ucc98\ub9ac, \ud504\ub85c\uadf8\ub7a8, \ud234\ub9c1, \uc791\uc5c5\uc790, \uae30\uacc4 \ubc0f \uac80\uc0ac \uacb0\uacfc<\/strong> \uadf8 \ud574\ub2f9 \uad6c\uc5ed<\/li>\n<\/ul>\n<\/li>\n<li><strong>DHR (\uc7a5\uce58 \uc774\ub825 \uae30\ub85d)<\/strong>\n<ul>\n<li>\uc0dd\uc0b0 \uacfc\uc815\uc5d0\uc11c \uc77c\uc5b4\ub09c \ubaa8\ub4e0 \uac83\uc744 \uae30\ub85d\ud569\ub2c8\ub2e4: \uc5b4\ub5a4 \uae30\uacc4, \uc5b4\ub5a4 \ud504\ub85c\uadf8\ub7a8, \ub204\uac00 \uc791\ub3d9\ud588\ub294\uc9c0, \uac80\uc0ac \uacb0\uacfc<\/li>\n<li>\uc81c\uacf5\ud569\ub2c8\ub2e4 <strong>\uc885\ub2e8 \uac04 \ucd94\uc801 \uac00\ub2a5\uc131<\/strong> \uac01 \uc0dd\uc0b0 \ubc30\uce58\ub9c8\ub2e4<\/li>\n<\/ul>\n<\/li>\n<li><strong>DMR (\uc7a5\uce58 \ub9c8\uc2a4\ud130 \uae30\ub85d)<\/strong>\n<ul>\n<li>\uc644\uc804\ud55c \uc0ac\uc591 \uc138\ud2b8: \uc2b9\uc778\ub41c \ub3c4\uba74, \uc7ac\ub8cc \uc0ac\uc591, CNC \ud504\ub85c\uadf8\ub7a8, \uac80\uc0ac \uacc4\ud68d<\/li>\n<li>\uc7a5\uce58\uac00 \uc815\ud655\ud788 \uc5b4\ub5bb\uac8c <strong>\ubc18\ub4dc\uc2dc<\/strong> \uc81c\uc870\ub418\uc5b4\uc57c \ud558\ub294\uc9c0 \uc815\uc758<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>If an auditor asks &#8220;prove that lot XYZ was machined correctly,&#8221; the <strong>DHR\uacfc DMR<\/strong> \uc774 \ub2f5\ubcc0\uc785\ub2c8\ub2e4. \ubaa8\ub4e0 \uac83\uc774 \uae30\ub85d\ub418\uace0 \uac80\uc0c9 \uac00\ub2a5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\uc758\ub8cc CNC \ubd80\ud488 \uc7ac\ub8cc \uc694\uad6c\uc0ac\ud56d<\/h3>\n\n\n\n<p>\uc758\ub8cc \uae30\uae30 \uc7ac\ub8cc\ub294 \uc5c4\uaca9\ud558\uac8c \ud1b5\uc81c\ub429\ub2c8\ub2e4. \uc6b0\ub9ac\uac00 \uac00\uacf5\ud558\ub294 \uc77c\ubc18 \uc7ac\ub8cc\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th>\uc7ac\ub8cc<\/th><th>\ud45c\uc900<\/th><th>\uc77c\ubc18\uc801\uc778 \uc801\uc6a9 \ubd84\uc57c<\/th><\/tr><\/thead><tbody><tr><td><strong>\uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8 316L<\/strong><\/td><td>ASTM F138, ISO 5832-1<\/td><td>\uc218\uc220 \uae30\uad6c, \uc784\ud50c\ub780\ud2b8, \uc815\ud615\uc678\uacfc \ub3c4\uad6c<\/td><\/tr><tr><td><strong>\ud2f0\ud0c0\ub284 \ub4f1\uae09 5 (Ti-6Al-4V)<\/strong><\/td><td>ASTM F136, ISO 5832-3<\/td><td>\uc784\ud50c\ub780\ud2b8, \ubcf4\ucca0\ubb3c, \uc218\uc220 \uae30\uad6c<\/td><\/tr><tr><td><strong>PEEK<\/strong><\/td><td>ASTM F2026, USP Class VI<\/td><td>\ucc99\ucd94 \uc784\ud50c\ub780\ud2b8, \ubf08 \uace0\uc815, \uc218\uc220 \uc190\uc7a1\uc774<\/td><\/tr><tr><td><strong>Delrin \/ \uc544\uc138\ud0c8<\/strong><\/td><td>USP Class VI<\/td><td>\uc218\uc220\uc6a9 \uc9c0\uadf8, \uace0\uc815\uc7a5\uce58, \uae30\uad6c\ub958<\/td><\/tr><tr><td><strong>\uc774 \uae00\uc5d0\uc11c\ub294 Aluminum 6061<\/strong><\/td><td>ASTM B211, AMS 4117<\/td><td>\uc218\uc220\uc6a9 \ud2b8\ub808\uc774, \uae30\uad6c \ud558\uc6b0\uc9d5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\ubaa8\ub4e0 \uc7ac\ub8cc\ub294 <strong>\uc758\ub8cc\uc6a9 \ub4f1\uae09\uc774\uba70 \uc644\uc804\ud55c \ucd94\uc801 \uac00\ub2a5\uc131\uc744 \uac16\ucd94\uc5b4\uc57c \ud568<\/strong> \u2014 \uc2b9\uc778\ub41c \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \ubcc0\uacbd \uc5c6\uc774\ub294 \ub300\uccb4\ud488 \uc0ac\uc6a9 \uae08\uc9c0.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\uc138\ucc99 \ubc0f \ud45c\uba74 \ub9c8\uac10 \uc694\uad6c\uc0ac\ud56d<\/h3>\n\n\n\n<p>\uc758\ub8cc \ubd80\ud488\uc740 \uc5c4\uaca9\ud55c \uccad\uacb0\ub3c4 \ubc0f \ud45c\uba74 \ub9c8\uac10 \uae30\uc900\uc744 \ucda9\uc871\ud574\uc57c \ud568:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\ud45c\uba74 \ub9c8\uac10<\/strong>: \uc218\uc220 \uae30\uad6c\uc758 \uacbd\uc6b0 Ra 0.2\u20130.8 \u00b5m\uc758 \ud45c\uc900; \uc784\ud50c\ub780\ud2b8 \ubca0\uc5b4\ub9c1 \ud45c\uba74\uc740 \ubbf8\ub7ec \ub9c8\uac10<\/li>\n<li><strong>\ubc84\ub9c1 \uc81c\uac70<\/strong>: \ubaa8\ub4e0 \uac00\uc7a5\uc790\ub9ac\uc640 \uad6c\uba4d\uc740 \ub9e4\ub044\ub7ec\uc6cc\uc57c \ud568 \u2014 \ubc84, \ub0a0\uce74\ub85c\uc6b4 \uac00\uc7a5\uc790\ub9ac, \uc624\uc5fc \uc704\ud5d8 \uc5c6\uc74c<\/li>\n<li><strong>\uc138\ucc99<\/strong>: \ubd80\ud488\uc740 \uac00\uacf5 \uc624\uc77c, \uce69, \uc794\uc5ec\ubb3c\uc774 \uc5c6\uc5b4\uc57c \ud568. \ud1b5\uc81c\ub41c \uc138\ucc99 \uacfc\uc815\uc774 \ubb38\uc11c\ud654\ub428<\/li>\n<li><strong>\ud328\uc2dc\ubca0\uc774\uc158<\/strong>: \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8 \ubd80\ud488\uc740 \ubd80\uc2dd \ubc29\uc9c0 \ubcf5\uc6d0\uc744 \uc704\ud574 \uc885\uc885 \ud328\uc2dc\ubca0\uc774\uc158(ASTM A967)\uc774 \ud544\uc694\ud568<\/li>\n<li><strong>\ud3ec\uc7a5<\/strong>: \uc870\ub9bd \ub610\ub294 \uba78\uade0 \uc804\uae4c\uc9c0 \ubd80\ud488\uc758 \uccad\uacb0\ub3c4\ub97c \uc720\uc9c0\ud558\uae30 \uc704\ud55c \ud074\ub9b0\ub8f8 \ud638\ud658 \ud3ec\uc7a5<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">\uacf5\uae09\uc5c5\uccb4 \uc790\uaca9 \uac80\uc99d \u2014 \ud655\uc778\ud560 \uc0ac\ud56d<\/h3>\n\n\n\n<p>\uc758\ub8cc \ubd80\ud488\uc6a9 CNC \uac00\uacf5 \ud30c\ud2b8\ub108\ub97c \uc120\ud0dd\ud560 \ub54c \ub2e4\uc74c \ub2a5\ub825\uc744 \uac80\uc99d\ud558\uc138\uc694:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>ISO 13485 \uc778\uc99d<\/strong> \u2014 \uadf8\ub4e4\uc758 \ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c(QMS)\uc774 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5d0 \uc801\ud569\ud558\uac8c \uc778\uc99d\ub418\uc5b4 \uc788\ub098\uc694?<\/li>\n<li><strong>\uc7ac\ub8cc \ucd94\uc801\uc131<\/strong> \u2014 \uadf8\ub4e4\uc740 \uc5f4 \ubc88\ud638\ub97c \ucd94\uc801\ud558\uace0 \uc7ac\ub8cc \uacf5\uae09\uc744 \uc778\uc99d\ud569\ub2c8\uae4c?<\/li>\n<li><strong>\uac80\uc0ac \ub2a5\ub825<\/strong> \u2014 CMM, \uad11\ud559 \ube44\uad50\uae30, \ud45c\uba74 \ud504\ub85c\ud544\ub7ec, \uad50\uc815\ub41c \uac8c\uc774\uc9c0<\/li>\n<li><strong>\ud074\ub9b0\ub8f8 \ub610\ub294 \ud1b5\uc81c\ub41c \ud658\uacbd<\/strong> \u2014 \uadf8\ub4e4\uc740 \uae68\ub057\ud55c \ud658\uacbd\uc5d0\uc11c \ubd80\ud488\uc744 \uac00\uacf5\ud558\uace0 \ucc98\ub9ac\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<\/li>\n<li><strong>\uacf5\uc815 \uac80\uc99d<\/strong> \u2014 \uadf8\ub4e4\uc740 \uc911\uc694\ud55c \uacf5\uc815(\uc138\ucc99, \ud53c\ub9c9\ucc98\ub9ac, \ud2b9\uc218 \uacf5\uc815)\uc744 \uac80\uc99d\ud569\ub2c8\uae4c?<\/li>\n<li><strong>\ubb38\uc11c\ud654<\/strong> \u2014 \uadf8\ub4e4\uc740 DHR, DMR, \uac80\uc0ac \ubcf4\uace0\uc11c \ubc0f \uc7ac\ub8cc \uc778\uc99d\uc11c\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">CNC \uc758\ub8cc \uac00\uacf5 \uacf5\uae09\uc5c5\uccb4\uc640\uc758 \ud30c\ud2b8\ub108\uc2ed<\/h2>\n\n\n\n<p>ZSCNC\uc5d0\uc11c\ub294 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc758 \uc5c4\uaca9\ud55c \uc694\uad6c\uc0ac\ud56d\uc744 \uc774\ud574\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc6b0\ub9ac\uc758 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc740 ISO 13485 \ubc0f FDA \uaddc\uc81c \ud658\uacbd\uc758 \uae30\ub300\uc5d0 \ubd80\uc751\ud558\ub3c4\ub85d \uc124\uacc4\ub418\uc5c8\uc73c\uba70, \ubaa8\ub4e0 \uc758\ub8cc \ubd80\ud488\uc5d0 \ub300\ud574 \uc644\uc804\ud55c \uc7ac\ub8cc \ucd94\uc801\uc131, \ud1b5\uc81c\ub41c \uacf5\uc815, \ud3ec\uad04\uc801\uc778 \uac80\uc0ac \ubb38\uc11c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>\uc758\ub8cc\uae30\uae30 \ubd80\ud488\uc744 \uc704\ud55c CNC \uac00\uacf5 \ud30c\ud2b8\ub108\ub97c \ucc3e\uace0 \uacc4\uc2ed\ub2c8\uae4c?<\/strong> <a href=\"https:\/\/zscncparts.com\/ko\/request-quote\/\">ZSCNC\uc5d0 \ubb38\uc758\ud558\uae30<\/a> \uc900\uc218 \uac80\ud1a0 \ubc0f \ud504\ub85c\uc81d\ud2b8 \ud3c9\uac00\ub97c \uc704\ud574 CAD \ud30c\uc77c\uacfc \uc0ac\uc591\uc744 \uc5c5\ub85c\ub4dc\ud558\uc138\uc694. \ubb34\ub8cc DFM \ud3c9\uac00\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 13485 \uc900\uc218 \uc7ac\ub8cc, \uacf5\ucc28, \ud45c\uba74 \ub9c8\uac10 \ub4f1 \uc758\ub8cc\uae30\uae30 \ubd80\ud488 CNC \uac00\uacf5\uc758 \ud575\uc2ec \uc694\uad6c\uc0ac\ud56d\uc744 \ud655\uc778\ud558\uc138\uc694<\/p>","protected":false},"author":1,"featured_media":3332,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"default","site-content-layout":"","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":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","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":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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