{"id":26100,"date":"2026-05-16T09:36:36","date_gmt":"2026-05-16T09:36:36","guid":{"rendered":"https:\/\/yicenprecision.com\/?p=26100"},"modified":"2026-05-17T11:10:12","modified_gmt":"2026-05-17T11:10:12","slug":"%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e5%90%91%e3%81%91cnc%e5%8a%a0%e5%b7%a5-%e3%82%b5%e3%83%97%e3%83%a9%e3%82%a4%e3%83%a4%e3%83%bc%e8%b3%87%e6%a0%bc%e3%82%ac%e3%82%a4%e3%83%89-2026","status":"publish","type":"post","link":"https:\/\/yicenprecision.com\/ja\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e5%90%91%e3%81%91cnc%e5%8a%a0%e5%b7%a5-%e3%82%b5%e3%83%97%e3%83%a9%e3%82%a4%e3%83%a4%e3%83%bc%e8%b3%87%e6%a0%bc%e3%82%ac%e3%82%a4%e3%83%89-2026\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u5411\u3051CNC\u52a0\u5de5\uff1a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8a8d\u5b9a\u30ac\u30a4\u30c92026"},"content":{"rendered":"<h1 class=\"wp-block-heading\"><strong>\u533b\u7642\u6a5f\u5668\u5411\u3051CNC\u52a0\u5de5\uff1a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8a8d\u5b9a\u30ac\u30a4\u30c92026<\/strong><\/h1>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u8457\u8005\u30a4\u30fc\u30bb\u30f3\u30fb\u30d7\u30ec\u30b7\u30b8\u30e7\u30f3\u3001\u30b7\u30cb\u30a2\u30fb\u30d7\u30ed\u30bb\u30b9\u30fb\u30a8\u30f3\u30b8\u30cb\u30a2\u3001\u30a8\u30ea\u30c3\u30af\u30fb\u30ea\u30f3<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a8\u30ea\u30c3\u30af\u30fb\u30ea\u30f3\u306f11\u5e74\u306b\u308f\u305f\u308bCNC\u30d7\u30ed\u30bb\u30b9\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u306e\u7d4c\u9a13\u3092\u6301\u3061\u3001\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u8a8d\u5b9a\u3001\u751f\u4f53\u9069\u5408\u6750\u6599\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3001ISO 13485\u306b\u6e96\u62e0\u3057\u305f\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u6587\u66f8\u4f5c\u6210\u306b\u76f4\u63a5\u643a\u308f\u3063\u3066\u304d\u305f\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2026\u5e74\u306b\u65b0\u3057\u3044CNC\u6a5f\u68b0\u52a0\u5de5\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u8a8d\u5b9a\u3059\u308b\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u30a8\u30f3\u30b8\u30cb\u30a2\u306b\u3068\u3063\u3066\u3001\u552f\u4e00\u6700\u3082\u5371\u967a\u306a\u8fd1\u9053\u306f\u3001ISO 13485\u8a3c\u660e\u66f8\u3060\u3051\u306b\u57fa\u3065\u3044\u3066\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u627f\u8a8d\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002ISO13485\u8a8d\u8a3c\u66f8\u306f\u3001\u8a2d\u8a08\u306e\u307f\u3001\u6700\u7d42\u7d44\u7acb\u306e\u307f\u3001\u307e\u305f\u306f\u6d41\u901a\u306e\u307f\u3092\u7bc4\u56f2\u3068\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u533b\u7642\u6a5f\u5668\u7d44\u7acb\u300d\u306eISO 13485\u8a8d\u8a3c\u66f8\u3092\u4fdd\u6709\u3059\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u3001\u30af\u30e9\u30b9\u2161\u306e\u30ab\u30c6\u30fc\u30c6\u30eb\u30fb\u30ac\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306e\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u6a5f\u68b0\u52a0\u5de5\u3059\u308b\u5834\u5408\u3001\u8a8d\u8a3c\u66f8\u306f\u6a5f\u68b0\u52a0\u5de5\u4f5c\u696d\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u305b\u3093\u3002\u3053\u306e\u9055\u3044\u304cFDA\u306e\u76e3\u67fb\u3067\u767a\u898b\u3055\u308c\u305f\u5834\u5408\u3001\u30ea\u30b3\u30fc\u30eb1\u30ed\u30c3\u30c8\u3042\u305f\u308a$3\u4e07\uff5e$2\u4e07\u5186\u306e\u8cbb\u7528\u304c\u304b\u304b\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e8c\u756a\u76ee\u306b\u5371\u967a\u306a\u8fd1\u9053\u306f\u3001ISO 13485\u3068IATF 16949\u3092\u533b\u7642\u6a5f\u5668\u8a8d\u5b9a\u306b\u304a\u3044\u3066\u540c\u7b49\u3068\u307f\u306a\u3059\u3053\u3068\u3067\u3042\u308b\u3002IATF 16949\u306f\u3001\u5de5\u7a0b\u7ba1\u7406\u306b\u304a\u3044\u3066\u306fISO 9001\u3088\u308a\u3082\u53b3\u683c\u3067\u3059\u304c\u3001\u533b\u7642\u6a5f\u5668\u898f\u5236\u304c\u8981\u6c42\u3059\u308b\u30ea\u30b9\u30af\u7ba1\u7406\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\uff08ISO 14971\uff09\u3001\u751f\u4f53\u9069\u5408\u6027\u6587\u66f8\u5316\u3001\u6a5f\u5668\u5c65\u6b74\u8a18\u9332\u8981\u4ef6\u3092\u6b20\u3044\u3066\u3044\u307e\u3059\u3002\u81ea\u52d5\u8eca\u90e8\u54c1\u7528\u306eIATF16949\u3092\u6301\u3061\u3001ISO13485\u3092\u6301\u305f\u306a\u3044CNC\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u5927\u5e45\u306b\u8ffd\u52a0\u3057\u306a\u3044\u9650\u308a\u3001\u30af\u30e9\u30b9II\u307e\u305f\u306fIII\u306e\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306b\u306f\u4e0d\u9069\u683c\u3067\u3042\u308b\u3002.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>ISO13485\u3068IATF16949\u306e\u6bd4\u8f03\uff1aCNC\u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u305f\u3081\u306e\u305d\u308c\u305e\u308c\u306e\u30ab\u30d0\u30fc\u5185\u5bb9<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u5fc5\u8981\u6761\u4ef6<\/strong><\/th><th><strong>ISO 13485:2016\uff08\u533b\u7642\uff09<\/strong><\/th><th><strong>IATF 16949:2016 (\u81ea\u52d5\u8eca)<\/strong><\/th><th><strong>\u533b\u7642\u6a5f\u5668\u3068\u306e\u95a2\u9023\u6027<\/strong><\/th><\/tr><\/thead><tbody><tr><td>\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u67a0\u7d44\u307f<\/td><td>\u5fc5\u9808 - ISO 14971 PFMEA<\/td><td>\u5fc5\u9808 - AIAG PFMEA\uff08\u7570\u306a\u308b\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\uff09<\/td><td>ISO 14971\u306f\u533b\u7642\u7528\u306e\u6b63\u3057\u3044\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3067\u3042\u308a\u3001AIAG PFMEA\u306f\u76f4\u63a5\u30de\u30c3\u30d4\u30f3\u30b0\u3067\u304d\u306a\u3044\u3002<\/td><\/tr><tr><td>\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u30ec\u30b3\u30fc\u30c9\uff08DHR\uff09<\/td><td>\u5fc5\u9808 - \u5b8c\u5168\u306a\u30ed\u30c3\u30c8\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/td><td>\u4e0d\u8981\uff08\u88fd\u9020\u90e8\u54c1\u306e\u8a18\u9332\uff09<\/td><td>DHR\u306fFDA\u306e\u76e3\u67fb\u6587\u66f8\u3067\u3042\u308b\u3002<\/td><\/tr><tr><td>\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08IQ\/OQ\/PQ\uff09<\/td><td>\u51fa\u529b\u304c\u691c\u8a3c\u3067\u304d\u306a\u3044\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u5fc5\u9808<\/td><td>\u5fc5\u9808 - \u751f\u7523\u5b9f\u884c\u80fd\u529b\u8abf\u67fb\uff08PPAP\uff09<\/td><td>\u3069\u3061\u3089\u3082\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3092\u5fc5\u8981\u3068\u3059\u308b\u304c\u3001ISO 13485 IQ\/OQ\/PQ\u306fFDA QMSR\u306b\u76f4\u63a5\u30de\u30c3\u30d4\u30f3\u30b0\u3055\u308c\u308b\u3002<\/td><\/tr><tr><td>\u751f\u4f53\u9069\u5408\u6027\u306b\u95a2\u3059\u308b\u6587\u66f8<\/td><td>\u5fc5\u9808 - \u60a3\u8005\u306b\u63a5\u89e6\u3059\u308b\u6750\u6599\u306b\u95a2\u3059\u308b ISO 10993<\/td><td>\u4e0d\u8981<\/td><td>IATF 16949\u306b\u76f8\u5f53\u3059\u308b\u751f\u4f53\u9069\u5408\u6027\u6587\u66f8\u304c\u306a\u3044<\/td><\/tr><tr><td><a href=\"https:\/\/www.fda.gov\" data-type=\"link\" data-id=\"https:\/\/www.fda.gov\">FDA QMSR<\/a> \u30a2\u30e9\u30a4\u30e1\u30f3\u30c8<\/td><td>\u76f4\u63a5 - ISO 13485\u304cFDA QMSR\u306b\u7d44\u307f\u8fbc\u307e\u308c\u308b\uff082026\u5e742\u6708\uff09<\/td><td>\u9593\u63a5\u7684 - IATF 16949\u306fFDA QMSR\u3068\u6574\u5408\u3057\u3066\u3044\u306a\u3044<\/td><td>ISO13485\u306f\u30012026\u5e742\u6708\u4ee5\u964d\u306bFDA\u304c\u627f\u8a8d\u3059\u308bQMS\u898f\u683c\u3067\u3042\u308b\u3002<\/td><\/tr><tr><td>\u9867\u5ba2\u56fa\u6709\u306e\u8981\u4ef6\uff08CSR\uff09<\/td><td>\u3042\u307e\u308a\u6b63\u5f0f\u3067\u306f\u306a\u3044 - \u7279\u5b9a\u306eOEM CSR\u306f\u3042\u307e\u308a\u4e00\u822c\u7684\u3067\u306f\u306a\u3044<\/td><td>\u5fc5\u9808 - OEM\u306eCSR\uff08VW\u3001\u30d5\u30a9\u30fc\u30c9\u3001BMW\uff09<\/td><td>\u533b\u7642\u7528OEM\u306eCSR\u306f\u3001\u6a19\u6e96\u5316\u3055\u308c\u305f\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u5951\u7d04\u306b\u57fa\u3065\u3044\u3066\u4ea4\u6e09\u3055\u308c\u308b<\/td><\/tr><tr><td>\u91cd\u8981\u306a\u6a5f\u80fd\u306b\u95a2\u3059\u308bCpk\u8981\u4ef6<\/td><td>CTQ\u306e\u7279\u5fb4\u306b\u95a2\u3059\u308bCpk\u22651.67<\/td><td>Cpk\u22671.67\uff08\u7279\u6b8a\u7279\u6027\u306b\u3064\u3044\u3066<\/td><td>\u3069\u3061\u3089\u3082Cpk\u22651.67\u3092\u8981\u6c42\u3057\u3066\u3044\u308b\u3002<\/td><\/tr><tr><td>\u662f\u6b63\u63aa\u7f6e\uff08CAPA\uff09<\/td><td>\u5177\u4f53\u7684\u306a\u671f\u9650\u3092\u5b9a\u3081\u305f\u7fa9\u52d9<\/td><td>\u5fc5\u9808<\/td><td>\u3069\u3061\u3089\u3082CAPA\u304c\u5fc5\u8981\u3067\u3042\u308b\u304c\u3001\u533b\u7642\u306f\u898f\u5236\u5f53\u5c40\u3078\u306e\u5831\u544a\u7fa9\u52d9\u304c\u3042\u308b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u6613\u5c91\u7cbe\u5bc6\u306e <a href=\"https:\/\/yicenprecision.com\/ja\/%e3%82%b5%e3%83%bc%e3%83%93%e3%82%b9\/cnc%e5%8a%a0%e5%b7%a5%e3%82%b5%e3%83%bc%e3%83%93%e3%82%b9\/\">CNC\u52a0\u5de5\u30b5\u30fc\u30d3\u30b9<\/a> \u306f\u3001ISO 13485\u306b\u6e96\u62e0\u3057\u305f\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u3082\u3068\u3001\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6587\u66f8\u3001\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u8a18\u9332\u6a5f\u80fd\u3001\u304a\u3088\u3073\u30af\u30e9\u30b9I\u304a\u3088\u3073\u30af\u30e9\u30b9II\u306e\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u751f\u4f53\u9069\u5408\u6750\u6599\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u7ba1\u7406\u6a5f\u80fd\u3092\u5099\u3048\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>CNC\u52a0\u5de5\u533b\u7642\u90e8\u54c1\u7528\u751f\u4f53\u9069\u5408\u6750\u6599<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u7d20\u6750<\/strong><\/th><th><strong>\u30b0\u30ec\u30fc\u30c9\uff0f\u30b9\u30da\u30c3\u30af<\/strong><\/th><th><strong>\u30af\u30e9\u30b9\uff08ISO 10993\u30c6\u30b9\u30c8\u6e08\u307f\uff09<\/strong><\/th><th><strong>\u30d7\u30e9\u30a4\u30de\u30ea\u30fcCNC\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3<\/strong><\/th><th><strong>\u30de\u30b7\u30cb\u30f3\u30b0\u30fb\u30ce\u30fc\u30c8<\/strong><\/th><\/tr><\/thead><tbody><tr><td>\u30c1\u30bf\u30f3\u30fb\u30b0\u30ec\u30fc\u30c95<\/td><td>Ti-6Al-4V ELI - AMS 4928<\/td><td>\u9577\u671f\u690d\u8fbc\u307f\u578b<\/td><td>\u6574\u5f62\u5916\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u810a\u690e\u56fa\u5b9a\u3001\u6b6f\u79d1\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8<\/td><td>\u56f0\u96e3 - \u9ad8\u5727\u30af\u30fc\u30e9\u30f3\u30c8\u304c\u5fc5\u9808<\/td><\/tr><tr><td>\u30c1\u30bf\u30f3\u30fb\u30b0\u30ec\u30fc\u30c923<\/td><td>Ti-6Al-4V ELI \u8d85\u4f4e\u9593\u5145\u3066\u3093\u6750<\/td><td>\u79fb\u690d\u53ef\u80fd\u306a\u9577\u671f\uff08\u3088\u308a\u9ad8\u3044\u75b2\u52b4\uff09<\/td><td>\u8010\u8377\u91cd\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u5fc3\u8840\u7ba1<\/td><td>\u30b0\u30ec\u30fc\u30c95\u3068\u540c\u3058\u3060\u304c\u3001\u5316\u5b66\u7684\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u304c\u53b3\u3057\u3044<\/td><\/tr><tr><td>316LVM\u30b9\u30c6\u30f3\u30ec\u30b9<\/td><td>ASTM F138<\/td><td>\u30c6\u30f3\u30dd\u30e9\u30ea\u30fc\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8<\/td><td>\u9aa8\u30d7\u30ec\u30fc\u30c8\u3001\u9aa8\u30cd\u30b8\u3001\u624b\u8853\u5668\u5177<\/td><td>\u52a0\u5de5\u786c\u5316 - \u6d78\u6c34\u30af\u30fc\u30e9\u30f3\u30c8\u3001\u92ed\u5229\u306a\u30ab\u30fc\u30d0\u30a4\u30c9<\/td><\/tr><tr><td>PEEK\uff08\u672a\u5145\u586b\uff09<\/td><td>ISO 10993\u30c6\u30b9\u30c8\u6e08\u307f<\/td><td>\u79fb\u690d\u53ef\u80fd<\/td><td>\u810a\u690e\u30b1\u30fc\u30b8\u3001\u8a66\u9a13\u5668\u5177\u3001\u6b6f\u79d1\u7528\u30a2\u30d0\u30c3\u30c8\u30e1\u30f3\u30c8<\/td><td>\u8981\u713c\u920d\uff1b\u4e7e\u5f0f\u30a8\u30a2\u30d6\u30e9\u30b9\u30c8\u51b7\u5374<\/td><\/tr><tr><td>PEEK-OPTIMA<\/td><td>\u30a4\u30f3\u30d3\u30d3\u30aa\u30fb\u30b0\u30ec\u30fc\u30c9<\/td><td>\u9577\u671f\u690d\u8fbc\u307f\u578b<\/td><td>\u898f\u5236\u5c65\u6b74\u306e\u3042\u308b\u9577\u671f\u690d\u8fbc\u307f\u578b\u6a5f\u5668<\/td><td>\u9ad8\u3044\u30b3\u30b9\u30c8 - \u30a4\u30f3\u30d3\u30d3\u30aa\u8a8d\u8a3c\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u304c\u5fc5\u8981<\/td><\/tr><tr><td>\u30b3\u30d0\u30eb\u30c8\u30fb\u30af\u30ed\u30e0<\/td><td>\u30a2\u30b9\u30c8\u30de F75 \/ F799<\/td><td>\u9577\u671f\u690d\u8fbc\u307f\u578b<\/td><td>\u819d\uff0f\u8170\u306e\u652f\u6301\u9762\u3001\u6b6f\u79d1\u88dc\u7db4\u7269<\/td><td>\u975e\u5e38\u306b\u96e3\u3057\u3044 - CBN\u5de5\u5177\u3092\u63a8\u5968<\/td><\/tr><tr><td>\u30a2\u30eb\u30df\u30cb\u30a6\u30e0 6061-T6<\/td><td>ASTM<\/td><td>\u88c5\u7f6e\u672c\u4f53\u3001\u975e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8<\/td><td>\u624b\u8853\u5668\u5177\u306e\u30cf\u30f3\u30c9\u30eb\u3001\u30cf\u30a6\u30b8\u30f3\u30b0\u3001\u6cbb\u5177<\/td><td>\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u79fb\u690d\u4e0d\u53ef\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3068\u63a5\u89e6\u3059\u308b\u3068\u751f\u4f53\u9069\u5408\u6027\u306a\u3057<\/td><\/tr><tr><td>\u30a6\u30eb\u30c6\u30e0\uff08PEI\uff09<\/td><td>ISO 10993\u30c6\u30b9\u30c8\u6e08\u307f<\/td><td>\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u5bfe\u5fdc\u5668\u5177<\/td><td>\u6ec5\u83cc\u304c\u5fc5\u8981\u306a\u518d\u5229\u7528\u53ef\u80fd\u306a\u5668\u5177\u672c\u4f53<\/td><td>ISO10993\u306e\u30ed\u30c3\u30c8\u8a3c\u660e\u66f8\u3092\u6307\u5b9a\u3059\u308b\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>8\u3064\u306e\u30dd\u30a4\u30f3\u30c8\u306b\u3088\u308b\u533b\u7642\u7528CNC\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u9069\u683c\u6027\u76e3\u67fb<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1.\u8a3c\u660e\u66f8\u306e\u30b9\u30b3\u30fc\u30d7\u691c\u8a3c<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">(a)\u8a8d\u5b9a\u6a5f\u95a2\u304cANAB\u307e\u305f\u306f\u540c\u7b49\u306e\u6a5f\u95a2\u3067\u3042\u308b\u3053\u3068\u3001(b)\u9069\u7528\u7bc4\u56f2\u306bCNC\u6a5f\u68b0\u52a0\u5de5\u307e\u305f\u306f\u7cbe\u5bc6\u6a5f\u68b0\u52a0\u5de5\u304c\u660e\u793a\u7684\u306b\u542b\u307e\u308c\u3066\u3044\u308b\u3053\u3068\uff08\u5358\u306a\u308b\u300c\u7d44\u7acb\u300d\u3084\u300c\u8ca9\u58f2\u300d\u3067\u306f\u306a\u3044\u3053\u3068\uff09\u3001(c)\u8a8d\u5b9a\u66f8\u304c\u6700\u65b0\u306e\u3082\u306e\u3067\u3042\u308b\u3053\u3068\uff08\u6709\u52b9\u671f\u9650\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\uff09\u3002(c)\u8a3c\u660e\u66f8\u304c\u6700\u65b0\u306e\u3082\u306e\u3067\u3042\u308b\u3053\u3068\uff08\u6709\u52b9\u671f\u9650\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\uff09\u3002\u300c\u624b\u8853\u5668\u5177\u306e\u8a2d\u8a08\u304a\u3088\u3073\u7d44\u7acb\u300d\u3092\u7bc4\u56f2\u3068\u3059\u308b\u8a3c\u660e\u66f8\u306b\u306f\u3001\u6a5f\u68b0\u52a0\u5de5\u306f\u542b\u307e\u308c\u306a\u3044\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2.\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6587\u66f8\uff08IQ\/OQ\/PQ\uff09<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u540c\u7b49\u306e\u6a5f\u68b0\u52a0\u5de5\u4f5c\u696d\u306e\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c\u30b5\u30de\u30ea\u30fc\uff08\u5b8c\u5168\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u6a5f\u5bc6\u3067\u3042\u308b\u305f\u3081\u4e0d\u53ef\uff09\u3092\u8981\u6c42\u3059\u308b\u3002\u636e\u4ed8\u6642\u9069\u683c\u6027\u78ba\u8a8d\uff08IQ\uff09\u3001\u904b\u8ee2\u6642\u9069\u683c\u6027\u78ba\u8a8d\uff08OQ\uff09\u3001\u6027\u80fd\u9069\u683c\u6027\u78ba\u8a8d\uff08PQ\uff09\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u5b58\u5728\u3057\u3001\u6700\u65b0\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3002\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6587\u66f8\u3092\u4f5c\u6210\u3067\u304d\u306a\u3044\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u305d\u306e\u8a8d\u8a3c\u306b\u95a2\u4fc2\u306a\u304f\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3055\u308c\u305f\u30d7\u30ed\u30bb\u30b9\u3092\u904b\u7528\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u306b\u306a\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3.\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u8a18\u9332\uff08DHR\uff09\u30b5\u30f3\u30d7\u30eb<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b8c\u6210\u3057\u305f\u533b\u7642\u7528\u30ed\u30c3\u30c8\u306eDHR\uff08redacted example\uff09\u3092\u8981\u6c42\u3059\u308b\u3002\u539f\u6750\u6599\u8a3c\u660e\u66f8(\u30d2\u30fc\u30c8\u30ed\u30c3\u30c8\u306b\u30c8\u30ec\u30fc\u30b5\u30d6\u30eb)\u3001\u30a4\u30f3\u30d7\u30ed\u30bb\u30b9\u691c\u67fb\u8a18\u9332\u3001\u56f3\u9762\u306e\u30b3\u30fc\u30eb\u30a2\u30a6\u30c8\u306b\u30de\u30c3\u30d4\u30f3\u30b0\u3055\u308c\u305f\u6700\u7d42CMM\u5bf8\u6cd5\u30ec\u30dd\u30fc\u30c8\u3001\u30ed\u30c3\u30c8\u30ea\u30ea\u30fc\u30b9\u627f\u8a8d\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u3053\u308c\u306f\u3001FDA\u304c\u67fb\u5bdf\u306e\u969b\u306b\u78ba\u8a8d\u3059\u308b\u6587\u66f8\u3067\u3042\u308a\u3001\u3082\u3057\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u5b8c\u5168\u306a\u4f8b\u3092\u4f5c\u6210\u3067\u304d\u306a\u3051\u308c\u3070\u3001FDA\u306e\u76e3\u67fb\u306b\u5408\u683c\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u306a\u3044\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>4.\u751f\u4f53\u9069\u5408\u6750\u6599\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u6750\u6599\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u5834\u5408\uff1a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u3042\u306a\u305f\u306e\u30d7\u30ed\u30b0\u30e9 \u30e0\u3067\u4f7f\u7528\u3059\u308b\u7279\u5b9a\u306e\u6750\u6599\u30ed\u30c3\u30c8\u306e\u9069\u5408\u8a3c\u660e\u66f8\u3092\u8981\u6c42\u3059\u308b\u3053\u3068\u3002\u3053\u308c\u306b\u306f\u3001\u6750\u6599 \u4ed5\u69d8\u3078\u306e\u6e96\u62e0\uff08AMS 4928\u3001ASTM F138\u306a\u3069\uff09\u3001\u30d2\u30fc\u30c8\u30ed\u30c3\u30c8\u756a\u53f7\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u7b2c\u4e09\u8005\u6a5f \u68b0\u8a66\u9a13\u30c7\u30fc\u30bf\u3001\u6750\u6599\u30b0\u30ec\u30fc\u30c9\u306b\u9069\u7528\u3055\u308c\u308bISO 10993\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u306e\u78ba\u8a8d\u304c\u542b\u307e\u308c\u308b\u3002\u4e00\u822c\u7684\u306a\u6750\u6599\u4ed5\u69d8\u3067\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>5.Cpk\u80fd\u529b\u30c7\u30fc\u30bf<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u65cb\u524a\u76f4\u5f84\u3001\u306d\u3058\u5f62\u72b6\u3001\u5185\u5f84\u3001\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306a\u3069\u3001\u304a\u5ba2\u69d8\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u9069\u5408\u3059\u308b\u7279\u5b9a\u306e\u30d5\u30a3\u30fc\u30c1\u30e3\u30fc\u30bf\u30a4\u30d7\u306eCpk\u30c7\u30fc\u30bf\u3092\u3054\u8acb\u6c42\u304f\u3060\u3055\u3044\u3002\u533b\u7642\u751f\u7523\u3067\u306f\u3001Critical-to-Quality\uff08CTQ\uff09\u30d5\u30a3\u30fc\u30c1\u30e3\u30fc\u306eCpk\u22651.67\u304c\u5fc5\u8981\u3067\u3059\u3002Cpk\u22651.33\u3092\u63d0\u793a\u3059\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u533b\u7642\u7528\u3067\u306f\u306a\u304f\u81ea\u52d5\u8eca\u7528\u306e\u54c1\u8cea\u30ec\u30d9\u30eb\u3067\u3059\u3002Cpk \u30c7\u30fc\u30bf\u306f\u3001\u7279\u5225\u306b\u9078\u629e\u3055\u308c\u305f\u30e9\u30f3\u306e\u80fd\u529b\u8abf\u67fb\u3067\u306f\u306a\u304f\u3001\u751f\u7523\u30e9\u30f3\u304b\u3089\u5f97 \u3089\u308c\u305f\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>6.\u7b2c\u4e00\u6761\u691c\u67fb\uff08FAI\uff09\u306e\u4f8b<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u540c\u7b49\u306e\u533b\u7642\u7528\u90e8\u54c1\u306b\u3064\u3044\u3066\u3001\u5197\u9577\u5316\u3055\u308c\u305fFAI\u30d1\u30c3\u30b1\u30fc\u30b8\u3092\u8981\u6c42\u3059\u308b\u3002FAI\u306b\u306f\u3001\u3059\u3079\u3066\u306e\u56f3\u9762\u306e\u5439\u304d\u51fa\u3057\u3001NIST\u306b\u30c8\u30ec\u30fc\u30b5\u30d6\u30eb\u306a\u6821\u6b63\u6e08\u307fCMM\u306b\u3088\u308b\u6e2c\u5b9a\u7d50\u679c\u3001\u6750\u6599\u8a3c\u660e\u66f8\u3001\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u8a18\u9332\u304c\u542b\u307e\u308c\u308b\u3053\u3068\u3002\u822a\u7a7a\u5b87\u5b99FAI\uff08AS9102\u30d5\u30a9\u30fc\u30e01\/2\/3\uff09\u306f\u540c\u7b49\u30ec\u30d9\u30eb\u306e\u53b3\u5bc6\u3055\u3067\u3042\u308a\u3001\u53c2\u8003\u3068\u3057\u3066\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>7.\u6821\u6b63\u8a18\u9332<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u4f7f\u7528\u3059\u308bCMM\u3068\u6e2c\u5b9a\u6a5f\u5668\u306e\u6821\u6b63\u8a18\u9332\u3092\u63d0\u51fa\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6821\u6b63\u306f\u3001\u5fc5\u8981\u3068\u3055\u308c\u308b\u6e2c\u5b9a\u306e\u4e0d\u78ba\u304b\u3055\u306b\u9069\u3057\u305f\u6821\u6b63\u983b\u5ea6\u3067\u3001\u56fd\u5bb6\u6a19\u6e96\uff08NIST\u307e\u305f\u306f\u540c\u7b49\u306e\u3082\u306e\uff09\u306b\u30c8\u30ec\u30fc\u30b5\u30d6\u30eb\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u6bce\u5e74\u00b10.005 mm\u306e\u6821\u6b63\u3092\u884c\u3046\u4e09\u6b21\u5143\u6e2c\u5b9a\u6a5f\u306f\u3001\u9069\u5207\u3067\u306a\u3044\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>8.FDA QMSR \/ FDA\u767b\u9332<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u7c73\u56fd\u5e02\u5834\u3067\u8ca9\u58f2\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u5411\u3051\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u5834\u5408\uff1a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306eFDA\u767b\u9332\uff08DUNS\u307e\u305f\u306fFDA\u767b\u9332\u756a\u53f7\uff09\u304c\u6700\u65b0\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u30022026\u5e742\u6708\u73fe\u5728\u3001FDA QMSR\u306f21 CFR Part 820\u3068ISO 13485\u3092\u6574\u5408\u3055\u305b\u3066\u3044\u307e\u3059\u3002QMSR\u30ae\u30e3\u30c3\u30d7\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u307e\u305f\u306f\u79fb\u884c\u6587\u66f8\u3092\u8981\u6c42\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u306a\u305cIATF16949\u306e\u307f\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u76f4\u63a5\u533b\u7642\u8cc7\u683c\u3092\u5f97\u3089\u308c\u306a\u3044\u306e\u304b\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Yicen Precision\u3092\u542b\u3080\u3044\u304f\u3064\u304b\u306eCNC\u6a5f\u68b0\u52a0\u5de5\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001IATF 16949\u3068ISO 13485\u306e\u4e21\u65b9\u306b\u6e96\u62e0\u3057\u305f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u4fdd\u6301\u3057\u3066\u3044\u307e\u3059\u3002IATF16949\u3060\u3051\u3067\u306f\u533b\u7642\u6a5f\u5668\u306e\u8a8d\u5b9a\u306b\u306f\u4e0d\u5341\u5206\u3067\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>IATF16949\u306f\u3001FDA\u306e\u4e3b\u8981\u306a\u76e3\u67fb\u6587\u66f8\u3067\u3042\u308b\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u8a18\u9332\u3092\u8981\u6c42\u3057\u3066\u3044\u306a\u3044\u3002<\/li>\n\n\n\n<li>IATF16949\u306f\u3001AIAG PFMEA\uff08\u81ea\u52d5\u8eca\u30ea\u30b9\u30af\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\uff09\u3068ISO14971\uff08\u533b\u7642\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff09\u3092\u4f7f\u7528\u3057\u3066\u3044\u308b\u3002<\/li>\n\n\n\n<li>IATF16949\u306fISO10993\u306e\u751f\u4f53\u9069\u5408\u6027\u6587\u66f8\u5316\u306b\u306f\u5bfe\u5fdc\u3057\u3066\u3044\u306a\u3044 - \u60a3\u8005\u306b\u63a5\u89e6\u3059\u308b\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u6750\u6599\u306b\u306f\u5fc5\u9808<\/li>\n\n\n\n<li>IATF16949\u306fFDA QMSR\uff082026\u5e742\u6708\u4ee5\u964d\uff09\u3068\u6574\u5408\u3057\u306a\u3044 - FDA\u306e\u65b0\u3057\u3044\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u898f\u5236\u306f\u3001IATF16949\u3067\u306f\u306a\u304fISO 13485:2016\u3092\u53c2\u7167\u3057\u3066\u3044\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u5834\u5408\u3001\u5fc5\u8981\u306a\u7d4c\u8def\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3042\u308b\uff1aISO13485\u8a8d\u8a3c\uff08\u52a0\u5de5\u7bc4\u56f2\u4ed8\u304d\uff09\uff0bFDA QMSR\u30a2\u30e9\u30a4\u30e1\u30f3\u30c8\uff0b\u751f\u4f53\u9069\u5408\u6750\u6599\u6587\u66f8\u5316\uff0bIQ\/OQ\/PQ\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff0bDHR\u80fd\u529b\u3002IATF16949\u306f\u3053\u306e\u30b9\u30bf\u30c3\u30af\u3092\u88dc\u5b8c\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u4ee3\u66ff\u3067\u306f\u306a\u3044\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u3088\u304f\u3042\u308b\u8cea\u554f<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306eCNC\u52a0\u5de5\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u8a8d\u8a3c\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.iso.org\">ISO 13485:2016<\/a> CNC\u6a5f\u68b0\u52a0\u5de5\u4f5c\u696d\u3092\u660e\u78ba\u306b\u30ab\u30d0\u30fc\u3059\u308b\u7bc4\u56f2\u3092\u6301\u3064\u8a8d\u8a3c\u304c\u57fa\u672c\u8981\u4ef6\u3067\u3059\u3002\u8a8d\u8a3c\u66f8\u304cANAB\u516c\u8a8d\u306e\u767b\u9332\u6a5f\u95a2\u306e\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3001\u304a\u3088\u3073\u8a8d\u8a3c\u7bc4\u56f2\u306b\u8a2d\u8a08\u3084\u7d44\u307f\u7acb\u3066\u3060\u3051\u3067\u306a\u304f\u3001\u6a5f\u68b0\u52a0\u5de5\u3084\u7cbe\u5bc6\u88fd\u9020\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3055\u3089\u306b\u7c73\u56fd\u3067\u8ca9\u58f2\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u88fd\u9020\u3059\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306eFDA\u767b\u9332\uff0821 CFR Part 807\uff09\u3001\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6587\u66f8\uff08IQ\/OQ\/PQ\uff09\u3001\u304a\u3088\u3073Device History Record\u6a5f\u80fd\u3002ISO13485\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3042\u308a\u30013\u3064\u306e\u8ffd\u52a0\u8981\u7d20\u3059\u3079\u3066\u3092\u691c\u8a3c\u3059\u308b\u3053\u3068\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u533b\u7642\u7528CNC\u6a5f\u68b0\u52a0\u5de5\u3067\u306f\u3001ISO 13485\u306e\u4ee3\u308f\u308a\u306bIATF 16949\u3092\u4f7f\u7528\u3067\u304d\u307e\u3059\u304b\uff1f<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">IATF 16949\u306f\u81ea\u52d5\u8eca\u306e\u54c1\u8cea\u898f\u683c\u3067\u3042\u308a\u3001FDA\u306eQMSR\u3092\u6e80\u305f\u3059\u3082\u306e\u3067\u306f\u306a\u3044\u3001, <a href=\"https:\/\/www.iso.org\" data-type=\"link\" data-id=\"https:\/\/www.iso.org\">ISO 14971 \u533b\u7642\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8,<\/a> ISO 10993\u306e\u751f\u4f53\u9069\u5408\u6027\u3001\u307e\u305f\u306fDevice History Record\u306e\u8981\u6c42\u4e8b\u9805\u3002IATF16949\u306f\u6301\u3063\u3066\u3044\u308b\u304cISO13485\u306f\u6301\u3063\u3066\u3044\u306a\u3044\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u898f\u5236\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306b\u5fc5\u8981\u306a\u533b\u7642\u7279\u6709\u306e\u54c1\u8cea\u30a4\u30f3\u30d5\u30e9\u3092\u6b20\u3044\u3066\u3044\u308b\u3002IATF16949\u306f\u5f37\u529b\u306a\u5de5\u7a0b\u7ba1\u7406\u306e\u898f\u5f8b\u3092\u793a\u3059\u304c\uff08\u3053\u308c\u306f\u57fa\u790e\u3068\u3057\u3066\u4fa1\u5024\u304c\u3042\u308b\uff09\u3001\u533b\u7642\u7279\u6709\u306e\u8981\u7d20\u306fISO13485\u306b\u6574\u5408\u3057\u305f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u305d\u306e\u4e0a\u306b\u69cb\u7bc9\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u533b\u7642\u7528CNC\u52a0\u5de5\u306b\u5fc5\u8981\u306aCpk\u306f\uff1f<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u7528CNC\u52a0\u5de5\u3067\u306f\u3001CTQ\uff08Critical-to-Quality\uff09\u30d5\u30a3\u30fc\u30c1\u30e3\u30fc\uff08\u88c5\u7f6e\u306e\u5b89\u5168\u6027\u3084\u6a5f\u80fd\u6027\u80fd\u306b\u76f4\u63a5\u5f71\u97ff\u3059\u308b\u30d5\u30a3\u30fc\u30c1\u30e3\u30fc\uff09\u306b\u5bfe\u3057\u3066\u3001Cpk\u22651.67\u304c\u8981\u6c42\u3055\u308c\u308b\u3002\u3053\u308c\u306f\u30d7\u30ed\u30bb\u30b9\u306e\u5b9a\u5e38\u72b6\u614b\u306b\u304a\u3044\u3066\u3001100\u4e07\u500b\u3042\u305f\u308a\u7d041\u500b\u306e\u4e0d\u826f\u54c1\uff081ppm\uff09\u306b\u76f8\u5f53\u3059\u308b\u3002Cpk\u22651.33\uff08\u81ea\u52d5\u8eca\u898f\u683c\u306e\u6700\u5c0f\u5024\uff09\u3067\u306f\u7d0464ppm\u3068\u306a\u308a\u3001\u30d5\u30a3\u30fc\u30eb\u30c9\u4e0d\u826f\u304c\u60a3\u8005\u306e\u5b89\u5168\u306b\u5f71\u97ff\u3059\u308b\u533b\u7642\u6a5f\u5668\u3067\u306f\u53d7\u3051\u5165\u308c\u3089\u308c\u307e\u305b\u3093\u3002\u4e00\u822c\u7684\u306a\u30ce\u30f3\u30af\u30ea\u30c6\u30a3\u30ab\u30eb\u30d5\u30a3\u30fc\u30c1\u30e3\u30fc\u306fCpk\u22651.33\u306b\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304c\u3001\u8a2d\u8a08\u30a8\u30f3\u30b8\u30cb\u30a2\u307e\u305f\u306f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306b\u3088\u3063\u3066CTQ\u306b\u6307\u5b9a\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u56f3\u9762\u30b3\u30fc\u30eb\u30a2\u30a6\u30c8\u306f\u3001\u751f\u7523\u30c7\u30fc\u30bf\u304b\u3089\u5b9f\u8a3c\u3055\u308c\u305fCpk\u22651.67\u3092\u5fc5\u8981\u3068\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u7d50\u8ad6\u627f\u8a8d\u524d\u306b\u30b9\u30b3\u30fc\u30d7\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001DHR\u80fd\u529b\u3092\u691c\u8a3c\u3059\u308b<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CNC\u52a0\u5de5\u7bc4\u56f2\uff0b\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08IQ\/OQ\/PQ\uff09\uff0b\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u8a18\u9332\u6a5f\u80fd\u3092\u5099\u3048\u305fISO 13485\u8a8d\u8a3c\uff1d\u30af\u30e9\u30b9II\u304a\u3088\u3073III\u306e\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u6700\u4f4e\u8cc7\u683c\u57fa\u6e96<\/li>\n\n\n\n<li>IATF16949\u3060\u3051\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u8a8d\u5b9a\u306b\u304a\u3051\u308bISO13485\u306e\u4ee3\u66ff\u3068\u306f\u306a\u3089\u306a\u3044<\/li>\n\n\n\n<li>Cpk\u22671.33\u3067\u306f\u306a\u304f\u3001CTQ\u30d5\u30a3\u30fc\u30c1\u30e3\u30fc\u306eCpk\u22671.67\u304c\u533b\u7642\u751f\u7523\u57fa\u6e96\u3067\u3042\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Yicen Precision\u306fISO 13485\u306b\u6e96\u62e0\u3057\u305f\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306eCNC\u52a0\u5de5\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u304a\u5ba2\u69d8\u306e\u56f3\u9762\u3092\u63d0\u51fa\u3057\u3001\u4ee5\u4e0b\u306e\u30b5\u30a4\u30c8\u3067\u8cc7\u683c\u306b\u3064\u3044\u3066\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/yicenprecision.com\/ja\/\">yicenprecision.com<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>CNC Machining for Medical Devices: Supplier Qualification Guide 2026 Author: Eric Lin, Senior Process Engineer, Yicen Precision Eric Lin has 11 years of CNC process engineering experience with direct work on medical device component qualification, biocompatible material supply chains, and ISO 13485-aligned manufacturing process documentation. For medical device quality engineers qualifying a new CNC machining supplier in 2026, the single most dangerous shortcut is approving a supplier based on their ISO 13485 certificate alone without verifying that the certificate scope actually covers CNC machining operations. ISO 13485 certificates can be scoped to design only, final assembly only, or distribution only \u2014 none of which requires validated machining processes. A supplier [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":26101,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_titles_title":"CNC Machining Medical Devices 2026: Supplier Qualification Guide","_seopress_titles_desc":"How to qualify a CNC machining supplier for medical device components. ISO 13485 vs IATF 16949 comparison, biocompatible materials, and 8-point audit checklist.","_seopress_robots_index":"","_seopress_robots_follow":"","_seopress_robots_imageindex":"","_seopress_robots_snippet":"","_seopress_robots_primary_cat":"","_seopress_robots_breadcrumbs":"","_seopress_robots_freeze_modified_date":"","_seopress_robots_custom_modified_date":"","_seopress_robots_canonical":"","_seopress_social_fb_title":"","_seopress_social_fb_desc":"","_seopress_social_fb_img":"","_seopress_social_fb_img_attachment_id":0,"_seopress_social_fb_img_width":0,"_seopress_social_fb_img_height":0,"_seopress_social_twitter_title":"","_seopress_social_twitter_desc":"","_seopress_social_twitter_img":"","_seopress_social_twitter_img_attachment_id":0,"_seopress_social_twitter_img_width":0,"_seopress_social_twitter_img_height":0,"_seopress_redirections_value":"","_seopress_redirections_enabled":"","_seopress_redirections_enabled_regex":"","_seopress_redirections_logged_status":"","_seopress_redirections_param":"","_seopress_redirections_type":0,"_seopress_analysis_target_kw":"CNC machining medical devices,ISO 13485 CNC supplier,medical device CNC machining supplier,qualify CNC shop medical devices,biocompatible CNC machining,medical CNC supplier audit","footnotes":""},"categories":[22],"tags":[],"class_list":["post-26100","post","type-post","status-publish","format-standard","has-post-thumbnail","category-blog"],"acf":[],"_links":{"self":[{"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/posts\/26100","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/comments?post=26100"}],"version-history":[{"count":0,"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/posts\/26100\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/media\/26101"}],"wp:attachment":[{"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/media?parent=26100"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/categories?post=26100"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/yicenprecision.com\/ja\/wp-json\/wp\/v2\/tags?post=26100"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}