{"id":37,"date":"2025-03-08T12:28:16","date_gmt":"2025-03-08T03:28:16","guid":{"rendered":"https:\/\/www.csoboston.com\/?page_id=37"},"modified":"2025-03-08T12:28:18","modified_gmt":"2025-03-08T03:28:18","slug":"%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e5%93%81%e8%b3%aa%e7%ae%a1%e7%90%86%ef%bc%9aiso13485%e5%af%be%e5%bf%9c%e3%81%ae%e3%83%9d%e3%82%a4%e3%83%b3%e3%83%88%e3%81%a8%e5%ae%9f%e8%b7%b5%e4%be%8b","status":"publish","type":"page","link":"https:\/\/www.csoboston.com\/?page_id=37","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\uff1aISO13485\u5bfe\u5fdc\u306e\u30dd\u30a4\u30f3\u30c8\u3068\u5b9f\u8df5\u4f8b"},"content":{"rendered":"\n<p>\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u306b\u304a\u3044\u3066\u3001ISO13485\u306f\u4e16\u754c\u5171\u901a\u306e\u4fe1\u983c\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306b\u6b20\u304b\u305b\u306a\u3044\u56fd\u969b\u898f\u683c\u3067\u3059\u3002<br>\u79c1\u81ea\u8eab\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306710\u5e74\u307b\u3069\u958b\u767a\u696d\u52d9\u306b\u643a\u308f\u308a\u3001\u305d\u306e\u3046\u30613\u5e74\u306f\u54c1\u8cea\u7ba1\u7406\u90e8\u9580\u3067\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u62c5\u5f53\u3057\u307e\u3057\u305f\u3002<br>\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u304c\u3082\u305f\u3089\u3059\u5f71\u97ff\u306f\u975e\u5e38\u306b\u5927\u304d\u304f\u3001\u60a3\u8005\u3055\u3093\u306e\u5b89\u5168\u6027\u3084\u533b\u7642\u5f93\u4e8b\u8005\u306e\u4fe1\u983c\u306b\u76f4\u7d50\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001ISO13485\u306e\u57fa\u672c\u7684\u306a\u6982\u8981\u304b\u3089\u3001\u5b9f\u969b\u306e\u73fe\u5834\u3067\u3069\u306e\u3088\u3046\u306b\u54c1\u8cea\u7ba1\u7406\u3092\u9032\u3081\u308b\u304b\u3092\u5177\u4f53\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u306b\u6cbf\u3063\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002<br>\u3055\u3089\u306b\u3001\u6210\u529f\u4e8b\u4f8b\u3068\u5931\u6557\u4e8b\u4f8b\u3092\u6bd4\u8f03\u3059\u308b\u3053\u3068\u3067\u3001\u4f55\u304c\u54c1\u8cea\u7ba1\u7406\u306e\u30ab\u30ae\u306b\u306a\u308b\u304b\u3092\u660e\u78ba\u306b\u3057\u3066\u3044\u304d\u305f\u3044\u3068\u601d\u3044\u307e\u3059\u3002<br>\u8aad\u3093\u3067\u3044\u305f\u3060\u304f\u3053\u3068\u3067\u3001ISO13485\u306b\u307e\u3060\u89e6\u308c\u305f\u3053\u3068\u306e\u306a\u3044\u65b9\u3067\u3082\u3001\u307e\u305f\u65e2\u306b\u904b\u7528\u3055\u308c\u3066\u3044\u308b\u65b9\u3067\u3082\u3001\u54c1\u8cea\u7ba1\u7406\u306e\u91cd\u8981\u30dd\u30a4\u30f3\u30c8\u3092\u518d\u78ba\u8a8d\u3067\u304d\u308b\u306f\u305a\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u6700\u7d42\u7684\u306b\u306f\u3001ISO13485\u3078\u306e\u5bfe\u5fdc\u3092\u4f01\u696d\u5185\u3067\u52b9\u679c\u7684\u306b\u9032\u3081\u308b\u305f\u3081\u306e\u30d2\u30f3\u30c8\u3084\u3001\u4eca\u5f8c\u306e\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u7ba1\u7406\u306e\u5c55\u671b\u306b\u3064\u3044\u3066\u3082\u89e6\u308c\u307e\u3059\u3002<br>\u672c\u8a18\u4e8b\u3092\u901a\u3058\u3066\u3001\u533b\u7642\u6a5f\u5668\u306b\u643a\u308f\u308b\u65b9\u3005\u304c\u3001\u54c1\u8cea\u7ba1\u7406\u306e\u8981\u70b9\u3092\u62bc\u3055\u3048\u306a\u304c\u3089\u81ea\u793e\u306e\u4ed5\u7d44\u307f\u3092\u898b\u76f4\u3057\u3001\u3088\u308a\u826f\u3044\u533b\u7642\u306e\u73fe\u5834\u306b\u8ca2\u732e\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308b\u3053\u3068\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<div id=\"toc_container\" class=\"no_bullets\"><p class=\"toc_title\">\u76ee\u6b21<\/p><ul class=\"toc_list\"><li><a href=\"#ISO13485\"><span class=\"toc_number toc_depth_1\">1<\/span> ISO13485\u306e\u57fa\u790e\u77e5\u8b58\u3068\u91cd\u8981\u6027<\/a><ul><li><a href=\"#ISO13485-2\"><span class=\"toc_number toc_depth_2\">1.1<\/span> ISO13485\u306e\u6982\u8981\u3068\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u7ba1\u7406\u3078\u306e\u5f71\u97ff<\/a><\/li><li><a href=\"#ISO13485-3\"><span class=\"toc_number toc_depth_2\">1.2<\/span> ISO13485\u304c\u6c42\u3081\u308b\u54c1\u8cea\u7ba1\u7406\u8981\u4ef6\uff1a\u5b9f\u52d9\u76ee\u7dda\u3067\u306e\u30dd\u30a4\u30f3\u30c8<\/a><\/li><\/ul><\/li><li><a href=\"#i\"><span class=\"toc_number toc_depth_1\">2<\/span> \u5b9f\u8df5\u4f8b\uff1a\u54c1\u8cea\u7ba1\u7406\u306e\u5177\u4f53\u7684\u30d7\u30ed\u30bb\u30b9<\/a><ul><li><a href=\"#i-2\"><span class=\"toc_number toc_depth_2\">2.1<\/span> \u8a2d\u8a08\u958b\u767a\u6bb5\u968e\u306b\u304a\u3051\u308b\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5b9f\u8df5<\/a><\/li><li><a href=\"#i-3\"><span class=\"toc_number toc_depth_2\">2.2<\/span> \u88fd\u9020\u6bb5\u968e\u3068\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406<\/a><\/li><li><a href=\"#CAPA\"><span class=\"toc_number toc_depth_2\">2.3<\/span> \u82e6\u60c5\u5bfe\u5fdc\u3068CAPA\uff08\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff09\u306e\u91cd\u8981\u6027<\/a><\/li><\/ul><\/li><li><a href=\"#i-4\"><span class=\"toc_number toc_depth_1\">3<\/span> \u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u306e\u6210\u529f\u4e8b\u4f8b\u3068\u5931\u6557\u4e8b\u4f8b<\/a><ul><li><a href=\"#i-5\"><span class=\"toc_number toc_depth_2\">3.1<\/span> \u6210\u529f\u4e8b\u4f8b\uff1a\u554f\u984c\u767a\u751f\u7387\u3092\u4e0b\u3052\u305f\u54c1\u8cea\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9<\/a><\/li><li><a href=\"#i-6\"><span class=\"toc_number toc_depth_2\">3.2<\/span> \u5931\u6557\u4e8b\u4f8b\uff1a\u4e0d\u5341\u5206\u306a\u7ba1\u7406\u304c\u62db\u3044\u305f\u30ea\u30b3\u30fc\u30eb\u3068\u305d\u306e\u5bfe\u7b56<\/a><\/li><\/ul><\/li><li><a href=\"#ISO13485-4\"><span class=\"toc_number toc_depth_1\">4<\/span> ISO13485\u5bfe\u5fdc\u3092\u52b9\u679c\u7684\u306b\u9032\u3081\u308b\u305f\u3081\u306e\u30dd\u30a4\u30f3\u30c8<\/a><ul><li><a href=\"#i-7\"><span class=\"toc_number toc_depth_2\">4.1<\/span> \u793e\u54e1\u6559\u80b2\u3068\u30c1\u30fc\u30e0\u4f53\u5236\u3065\u304f\u308a<\/a><\/li><li><a href=\"#i-8\"><span class=\"toc_number toc_depth_2\">4.2<\/span> \u6587\u66f8\u7ba1\u7406\u3068\u8a18\u9332\u306e\u6b63\u78ba\u6027<\/a><\/li><li><a href=\"#i-9\"><span class=\"toc_number toc_depth_2\">4.3<\/span> \u898f\u5236\u5f53\u5c40\u3068\u306e\u9023\u643a\u3068\u6700\u65b0\u60c5\u5831\u306e\u30ad\u30e3\u30c3\u30c1\u30a2\u30c3\u30d7<\/a><\/li><\/ul><\/li><li><a href=\"#i-10\"><span class=\"toc_number toc_depth_1\">5<\/span> \u4eca\u5f8c\u306e\u5c55\u671b\uff1a\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u7ba1\u7406\u306e\u52d5\u5411<\/a><ul><li><a href=\"#i-11\"><span class=\"toc_number toc_depth_2\">5.1<\/span> \u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u6642\u4ee3\u306b\u304a\u3051\u308b\u54c1\u8cea\u7ba1\u7406\u306e\u9769\u65b0<\/a><\/li><li><a href=\"#AIIoT\"><span class=\"toc_number toc_depth_2\">5.2<\/span> AI\u30fbIoT\u6280\u8853\u306e\u6d3b\u7528\u304c\u3082\u305f\u3089\u3059\u65b0\u305f\u306a\u8ab2\u984c\u3068\u5bfe\u5fdc\u7b56<\/a><\/li><li><a href=\"#i-12\"><span class=\"toc_number toc_depth_2\">5.3<\/span> \u56fd\u969b\u898f\u683c\u30fb\u5404\u56fd\u898f\u5236\u306e\u52d5\u5411\u3068\u5c06\u6765\u4e88\u6e2c<\/a><\/li><\/ul><\/li><li><a href=\"#i-13\"><span class=\"toc_number toc_depth_1\">6<\/span> \u307e\u3068\u3081<\/a><\/li><\/ul><\/div>\n<h2 class=\"wp-block-heading\"><span id=\"ISO13485\">ISO13485\u306e\u57fa\u790e\u77e5\u8b58\u3068\u91cd\u8981\u6027<\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"ISO13485-2\">ISO13485\u306e\u6982\u8981\u3068\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u7ba1\u7406\u3078\u306e\u5f71\u97ff<\/span><\/h3>\n\n\n\n<p>ISO13485\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u7279\u5316\u3057\u305f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u56fd\u969b\u898f\u683c\u3067\u3059\u3002<br>\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u5b89\u5168\u6027\u3068\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3001\u8a2d\u8a08\u6bb5\u968e\u304b\u3089\u8ca9\u58f2\u5f8c\u306e\u30a2\u30d5\u30bf\u30fc\u30b5\u30fc\u30d3\u30b9\u306b\u81f3\u308b\u307e\u3067\u3001\u3042\u3089\u3086\u308b\u30d7\u30ed\u30bb\u30b9\u304c\u898f\u683c\u8981\u4ef6\u306b\u5408\u81f4\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>ISO13485\u304c\u91cd\u8996\u3059\u308b\u306e\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8981\u7d20\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/strong><br>\u88fd\u54c1\u304c\u3082\u305f\u3089\u3059\u30ea\u30b9\u30af\u3092\u65e9\u671f\u306b\u628a\u63e1\u3057\u3001\u305d\u308c\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306e\u5bfe\u7b56\u3092\u691c\u8a0e\u30fb\u5b9f\u65bd\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/strong><br>\u8a2d\u8a08\u5909\u66f4\u3084\u4e0d\u5177\u5408\u5bfe\u5fdc\u306a\u3069\u306e\u5c65\u6b74\u3092\u660e\u78ba\u306b\u8a18\u9332\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u7d20\u65e9\u304f\u53c2\u7167\u3067\u304d\u308b\u72b6\u614b\u3092\u7dad\u6301\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u7d99\u7d9a\u7684\u6539\u5584<\/strong><br>\u4e0d\u9069\u5408\u3084\u82e6\u60c5\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u3001\u305d\u306e\u539f\u56e0\u3092\u5206\u6790\u3057\u3001\u518d\u767a\u9632\u6b62\u7b56\u3092\u8b1b\u3058\u3066QMS\u3092\u9032\u5316\u3055\u305b\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u3046\u3057\u305f\u8003\u3048\u65b9\u306f\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u7ba1\u7406\u306e\u6839\u5e79\u3092\u652f\u3048\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u56fd\u5185\u5916\u306e\u898f\u5236\u5f53\u5c40\u3082\u3053\u306e\u898f\u683c\u3092\u53c2\u8003\u306b\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u591a\u3044\u3067\u3059\u3002<br>\u79c1\u304c\u52e4\u52d9\u3057\u3066\u3044\u305f\u4f01\u696d\u3067\u3082\u3001ISO13485\u6e96\u62e0\u306e\u4f53\u5236\u3092\u6574\u3048\u308b\u3053\u3068\u3067\u3001\u6d77\u5916\u5e02\u5834\u3078\u306e\u53c2\u5165\u3084\u533b\u7642\u6a5f\u95a2\u304b\u3089\u306e\u4fe1\u983c\u5ea6\u5411\u4e0a\u306b\u3064\u306a\u304c\u308a\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"ISO13485-3\">ISO13485\u304c\u6c42\u3081\u308b\u54c1\u8cea\u7ba1\u7406\u8981\u4ef6\uff1a\u5b9f\u52d9\u76ee\u7dda\u3067\u306e\u30dd\u30a4\u30f3\u30c8<\/span><\/h3>\n\n\n\n<p>ISO13485\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u306f\u3001\u5358\u306b\u6587\u66f8\u3092\u6574\u5099\u3059\u308b\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002<br>\u5b9f\u52d9\u306e\u73fe\u5834\u3067\u7279\u306b\u610f\u8b58\u3057\u305f\u3044\u30dd\u30a4\u30f3\u30c8\u3068\u3057\u3066\u3001\u6b21\u306e3\u3064\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u8a2d\u8a08\u30fb\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306e\u6587\u66f8\u5316<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u4ed5\u69d8\u66f8\u3084\u30ea\u30b9\u30af\u5206\u6790\u8868\u306f\u3082\u3061\u308d\u3093\u3001\u5404\u30d5\u30a7\u30fc\u30ba\u3067\u306e\u30ec\u30d3\u30e5\u30fc\u8a18\u9332\u3092\u8a73\u7d30\u306b\u6b8b\u3059\u3002<\/li>\n\n\n\n<li>\u8a2d\u8a08\u5909\u66f4\u306e\u610f\u56f3\u3084\u7406\u7531\u3092\u660e\u78ba\u5316\u3057\u3001\u90e8\u9580\u9593\u3067\u60c5\u5831\u5171\u6709\u3059\u308b\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3084\u5916\u90e8\u59d4\u8a17\u5148\u306e\u7ba1\u7406<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u53d6\u5f15\u5148\u304cISO13485\u306e\u8981\u6c42\u3092\u7406\u89e3\u3057\u3066\u3044\u308b\u304b\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u76e3\u67fb\u3092\u884c\u3046\u3002<\/li>\n\n\n\n<li>\u8cc7\u6750\u3084\u90e8\u54c1\u306e\u54c1\u8cea\u304c\u6700\u7d42\u88fd\u54c1\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u3092\u7406\u89e3\u3057\u3001\u7d99\u7d9a\u7684\u306a\u8a55\u4fa1\u4f53\u5236\u3092\u69cb\u7bc9\u3059\u308b\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u82e6\u60c5\u51e6\u7406\u3068CAPA\u306e\u8fc5\u901f\u5316<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u82e6\u60c5\u60c5\u5831\u3092\u4e00\u5143\u7ba1\u7406\u3057\u3001\u95a2\u4fc2\u90e8\u7f72\u3068\u5373\u5ea7\u306b\u9023\u643a\u3067\u304d\u308b\u30d5\u30ed\u30fc\u3092\u4f5c\u308b\u3002<\/li>\n\n\n\n<li>\u4e0d\u5177\u5408\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306f\u6839\u672c\u539f\u56e0\u3092\u8ffd\u7a76\u3057\u3001\u6052\u4e45\u7684\u306a\u5bfe\u7b56\u3092\u8b1b\u3058\u308b\u3053\u3068\u3067\u518d\u767a\u3092\u9632\u3050\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<p>\u79c1\u304c\u54c1\u8cea\u7ba1\u7406\u90e8\u9580\u3092\u62c5\u5f53\u3057\u3066\u3044\u305f\u3068\u304d\u3001\u6700\u3082\u82e6\u52b4\u3057\u305f\u306e\u306f\u90e8\u9580\u9593\u306e\u9023\u643a\u3067\u3059\u3002<br>\u4f8b\u3048\u3070\u3001\u958b\u767a\u30c1\u30fc\u30e0\u304c\u88fd\u54c1\u6539\u826f\u3092\u63d0\u6848\u3059\u308b\u969b\u306b\u3001\u55b6\u696d\u3084\u88fd\u9020\u90e8\u9580\u306b\u3082\u5fc5\u305a\u5f71\u97ff\u304c\u53ca\u3073\u307e\u3059\u3002<br>\u305d\u3053\u3067\u3001\u62c5\u5f53\u8005\u3060\u3051\u306e\u8996\u70b9\u3067\u306f\u306a\u304f\u3001\u5404\u90e8\u9580\u306e\u5229\u5bb3\u3092\u8e0f\u307e\u3048\u305f\u3046\u3048\u3067\u6c7a\u5b9a\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3092\u6574\u5099\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3057\u305f\u3002<br>ISO13485\u3092\u5c0e\u5165\u3059\u308b\u3068\u3001\u3053\u3046\u3057\u305f\u9023\u643a\u4f53\u5236\u306e\u554f\u984c\u70b9\u304c\u81ea\u7136\u3068\u6d6e\u304d\u5f6b\u308a\u306b\u306a\u308b\u306e\u3067\u3001\u8ab2\u984c\u62bd\u51fa\u3068\u89e3\u6c7a\u304c\u30b9\u30e0\u30fc\u30ba\u306b\u306a\u308b\u3068\u611f\u3058\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span id=\"i\">\u5b9f\u8df5\u4f8b\uff1a\u54c1\u8cea\u7ba1\u7406\u306e\u5177\u4f53\u7684\u30d7\u30ed\u30bb\u30b9<\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"i-2\">\u8a2d\u8a08\u958b\u767a\u6bb5\u968e\u306b\u304a\u3051\u308b\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5b9f\u8df5<\/span><\/h3>\n\n\n\n<p>\u8a2d\u8a08\u958b\u767a\u306e\u6bb5\u968e\u3067\u306f\u3001\u300c\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u672c\u5f53\u306b\u5b89\u5168\u306a\u306e\u304b\u300d\u300c\u30e6\u30fc\u30b6\u30fc\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306f\u9069\u5207\u304b\u300d\u3068\u3044\u3063\u305f\u89b3\u70b9\u3067\u614e\u91cd\u306b\u30ea\u30b9\u30af\u8a55\u4fa1\u3092\u884c\u3044\u307e\u3059\u3002<br>\u79c1\u304c\u533b\u7642\u753b\u50cf\u8a3a\u65ad\u6a5f\u5668\u306e\u958b\u767a\u3092\u3057\u3066\u3044\u305f\u9803\u306f\u3001\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u306e\u624b\u6cd5\u3082\u53d6\u308a\u5165\u308c\u3001\u5b9f\u969b\u306b\u533b\u5e2b\u3084\u691c\u67fb\u6280\u5e2b\u306e\u65b9\u3005\u306b\u64cd\u4f5c\u6027\u3092\u30c6\u30b9\u30c8\u3057\u3066\u3082\u3089\u3046\u6a5f\u4f1a\u3092\u591a\u304f\u8a2d\u3051\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u305d\u306e\u969b\u306b\u6ce8\u610f\u3057\u3066\u3044\u305f\u306e\u306f\u3001\u4e0b\u8a18\u306e\u3088\u3046\u306a\u30dd\u30a4\u30f3\u30c8\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u304c\u767a\u751f\u3057\u3084\u3059\u3044\u7b87\u6240\u306e\u7279\u5b9a\u3068\u5bfe\u7b56<\/strong><br>\u30bf\u30c3\u30c1\u30d1\u30cd\u30eb\u306e\u914d\u7f6e\u3084\u30dc\u30bf\u30f3\u306e\u30e9\u30d9\u30ea\u30f3\u30b0\u306a\u3069\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u64cd\u4f5c\u30df\u30b9\u304c\u91cd\u5927\u306a\u4e8b\u6545\u306b\u3064\u306a\u304c\u3089\u306a\u3044\u3088\u3046\u5de5\u592b\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406\u3068\u8a18\u9332<\/strong><br>\u8a66\u4f5c\u6bb5\u968e\u3067\u306e\u5b9f\u9a13\u7d50\u679c\u3084\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u8a73\u7d30\u306b\u6b8b\u3057\u3001\u5f8c\u3005\u307e\u3067\u8ffd\u3048\u308b\u3088\u3046\u306b\u30b7\u30b9\u30c6\u30e0\u5316\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30c9\u30a2\u30d7\u30ed\u30fc\u30c1<\/strong><br>\u91cd\u5927\u306a\u30ea\u30b9\u30af\u306b\u512a\u5148\u7684\u306b\u53d6\u308a\u7d44\u3080\u4e00\u65b9\u3067\u3001\u5c0f\u3055\u306a\u8ab2\u984c\u3082\u898b\u843d\u3068\u3055\u306a\u3044\u30d0\u30e9\u30f3\u30b9\u304c\u91cd\u8981\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u8a2d\u8a08\u30ec\u30d3\u30e5\u30fc\u306e\u6bb5\u968e\u3067\u30ea\u30b9\u30af\u3092\u7a4d\u307f\u4e0a\u3052\u5f0f\u306b\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3067\u3001\u88fd\u54c1\u30ea\u30ea\u30fc\u30b9\u5f8c\u306e\u30c8\u30e9\u30d6\u30eb\u3092\u5927\u5e45\u306b\u4f4e\u6e1b\u3067\u304d\u307e\u3057\u305f\u3002<br>\u533b\u7642\u6a5f\u95a2\u306b\u5c0e\u5165\u3055\u308c\u308b\u524d\u306b\u3001\u3067\u304d\u308b\u3060\u3051\u591a\u304f\u306e\u30b7\u30df\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u3084\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30c6\u30b9\u30c8\u3092\u5b9f\u65bd\u3057\u3001\u4e0d\u5177\u5408\u30ea\u30b9\u30af\u3092\u6d17\u3044\u51fa\u3059\u3053\u3068\u304c\u30dd\u30a4\u30f3\u30c8\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"i-3\">\u88fd\u9020\u6bb5\u968e\u3068\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406<\/span><\/h3>\n\n\n\n<p>\u8a2d\u8a08\u304c\u56fa\u307e\u3063\u305f\u5f8c\u306f\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3067\u306e\u54c1\u8cea\u7ba1\u7406\u304c\u8ab2\u984c\u3068\u306a\u308a\u307e\u3059\u3002<br>ISO13485\u3067\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u9078\u5b9a\u3084\u5916\u90e8\u59d4\u8a17\u5148\u3078\u306e\u76e3\u67fb\u3082\u91cd\u8981\u306a\u8981\u4ef6\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4f8b\u3048\u3070\u3001\u79c1\u304c\u5728\u7c4d\u3057\u3066\u3044\u305f\u4f01\u696d\u3067\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u76e3\u67fb\u9805\u76ee\u3092\u8a2d\u3051\u3066\u3044\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th>\u9805\u76ee<\/th><th>\u5177\u4f53\u4f8b<\/th><\/tr><\/thead><tbody><tr><td>\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u6574\u5099\u72b6\u6cc1<\/td><td>\u624b\u9806\u66f8\u3084\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u6709\u7121\u3001ISO13485\u8a8d\u8a3c\u306e\u6709\u7121\u306a\u3069<\/td><\/tr><tr><td>\u751f\u7523\u30e9\u30a4\u30f3\u306e\u8a2d\u5099<\/td><td>\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u5c65\u6b74\u3001\u4e88\u5099\u8a2d\u5099\u306e\u78ba\u4fdd\u72b6\u6cc1<\/td><\/tr><tr><td>\u4e0d\u5177\u5408\u5bfe\u5fdc\u306e\u5b9f\u7e3e<\/td><td>\u904e\u53bb\u306e\u4e0d\u5177\u5408\u4ef6\u6570\u3068\u539f\u56e0\u7a76\u660e\u3001\u662f\u6b63\u63aa\u7f6e\u306e\u5b9f\u65bd\u30ec\u30dd\u30fc\u30c8<\/td><\/tr><tr><td>\u30b5\u30fc\u30d3\u30b9\u30fb\u30b5\u30dd\u30fc\u30c8\u4f53\u5236<\/td><td>\u7d0d\u671f\u9045\u5ef6\u6642\u306e\u5bfe\u5fdc\u65b9\u91dd\u3001\u7dca\u6025\u6642\u306e\u9023\u7d61\u7d4c\u8def<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u3053\u306e\u3088\u3046\u306b\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3084\u5916\u90e8\u59d4\u8a17\u5148\u304c\u81ea\u793e\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u3069\u306e\u3088\u3046\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u304b\u3092\u201c\u898b\u3048\u308b\u5316\u201d\u3057\u3001\u5b9a\u671f\u7684\u306a\u76e3\u67fb\u3084\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u7d99\u7d9a\u3059\u308b\u3053\u3068\u304c\u5927\u5207\u3067\u3059\u3002<br>\u307e\u305f\u3001\u533b\u7642\u6a5f\u5668\u306f\u6cd5\u898f\u5236\u3082\u7d61\u3093\u3067\u304f\u308b\u305f\u3081\u3001\u5404\u56fd\u306e\u898f\u5236\u8981\u4ef6\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u304b\u3092\u4e8b\u524d\u306b\u78ba\u8a8d\u3057\u3001\u4e0d\u5099\u304c\u3042\u308c\u3070\u65e9\u3081\u306b\u5bfe\u7b56\u3092\u8b1b\u3058\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"CAPA\">\u82e6\u60c5\u5bfe\u5fdc\u3068CAPA\uff08\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff09\u306e\u91cd\u8981\u6027<\/span><\/h3>\n\n\n\n<p>ISO13485\u3067\u7279\u306b\u91cd\u8996\u3055\u308c\u308b\u306e\u304c\u3001\u82e6\u60c5\u5bfe\u5fdc\u3068CAPA\uff08Corrective and Preventive Action\uff09\u3067\u3059\u3002<br>\u88fd\u54c1\u3092\u51fa\u8377\u3057\u305f\u5f8c\u306b\u4e0d\u5177\u5408\u304c\u898b\u3064\u304b\u3063\u305f\u308a\u3001\u533b\u7642\u6a5f\u95a2\u304b\u3089\u82e6\u60c5\u304c\u5bc4\u305b\u3089\u308c\u305f\u308a\u3057\u305f\u5834\u5408\u306f\u3001\u8fc5\u901f\u306b\u539f\u56e0\u3092\u7a76\u660e\u3057\u3001\u518d\u767a\u9632\u6b62\u7b56\u3092\u6253\u3061\u7acb\u3066\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u79c1\u304c\u5370\u8c61\u7684\u3060\u3063\u305f\u306e\u306f\u3001\u82e6\u60c5\u304b\u3089\u5f97\u3089\u308c\u308b\u60c5\u5831\u304c\u300c\u6b21\u306e\u88fd\u54c1\u6539\u826f\u306b\u3064\u306a\u304c\u308b\u5927\u304d\u306a\u30d2\u30f3\u30c8\u300d\u306b\u306a\u308b\u30b1\u30fc\u30b9\u304c\u591a\u3044\u70b9\u3067\u3059\u3002<br>\u4f8b\u3048\u3070\u3001\u533b\u5e2b\u304b\u3089\u300c\u64cd\u4f5c\u753b\u9762\u304c\u8996\u8a8d\u3057\u3065\u3089\u3044\u300d\u3068\u3044\u3046\u58f0\u304c\u4e0a\u304c\u3063\u305f\u5834\u5408\u3001\u5358\u306b\u753b\u9762\u306e\u660e\u308b\u3055\u3092\u8abf\u6574\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u5168\u4f53\u306eUI\u8a2d\u8a08\u3092\u898b\u76f4\u3059\u304d\u3063\u304b\u3051\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u300c\u54c1\u8cea\u7ba1\u7406\u306f\u5e38\u306b\u9032\u5316\u3057\u7d9a\u3051\u308b\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308a\u3001\u4e00\u5ea6\u306e\u5bfe\u5fdc\u3067\u5b8c\u4e86\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3002<br>\u3080\u3057\u308d\u3001\u82e6\u60c5\u3084\u4e0d\u5177\u5408\u3092\u901a\u3058\u3066\u5b66\u3073\u3001\u7d44\u7e54\u5168\u4f53\u3067\u6210\u9577\u3059\u308b\u30c1\u30e3\u30f3\u30b9\u3060\u3002\u300d<\/p>\n<\/blockquote>\n\n\n\n<p>\u3053\u306e\u8a00\u8449\u306f\u79c1\u304c\u54c1\u8cea\u7ba1\u7406\u90e8\u9580\u3067\u5b66\u3093\u3060\u6700\u5927\u306e\u6559\u8a13\u306e\u4e00\u3064\u3067\u3059\u3002<br>CAPA\u3092\u5fb9\u5e95\u3059\u308b\u3053\u3068\u3067\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u4fe1\u983c\u6027\u3092\u7740\u5b9f\u306b\u9ad8\u3081\u308b\u3068\u540c\u6642\u306b\u3001\u4f01\u696d\u3068\u3057\u3066\u3082\u5927\u304d\u304f\u6210\u9577\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span id=\"i-4\">\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u306e\u6210\u529f\u4e8b\u4f8b\u3068\u5931\u6557\u4e8b\u4f8b<\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"i-5\">\u6210\u529f\u4e8b\u4f8b\uff1a\u554f\u984c\u767a\u751f\u7387\u3092\u4e0b\u3052\u305f\u54c1\u8cea\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9<\/span><\/h3>\n\n\n\n<p>\u3042\u308b\u4f01\u696d\u3067\u306f\u3001\u8a2d\u8a08\u6bb5\u968e\u304b\u3089\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30c6\u30b9\u30c8\u3092\u91cd\u8996\u3057\u3001\u533b\u7642\u73fe\u5834\u3067\u306e\u30ea\u30b9\u30af\u3092\u5fb9\u5e95\u7684\u306b\u6d17\u3044\u51fa\u3059\u4f53\u5236\u3092\u6574\u5099\u3057\u307e\u3057\u305f\u3002<br>\u5177\u4f53\u7684\u306b\u306f\u3001\u6bce\u67081\u56de\u306e\u30da\u30fc\u30b9\u3067\u533b\u5e2b\u3084\u770b\u8b77\u5e2b\u3092\u62db\u3044\u3066\u3001\u8a66\u4f5c\u54c1\u306e\u4f7f\u3044\u52dd\u624b\u3092\u8a55\u4fa1\u3057\u3066\u3082\u3089\u3046\u4ed5\u7d44\u307f\u3092\u5c0e\u5165\u3002<br>\u305d\u308c\u3089\u306e\u610f\u898b\u3092\u8a2d\u8a08\u306b\u5373\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3059\u308b\u3053\u3068\u3067\u3001\u91cf\u7523\u6bb5\u968e\u306b\u304a\u3051\u308b\u4e0d\u5177\u5408\u5831\u544a\u7387\u304c\u5927\u5e45\u306b\u6e1b\u5c11\u3057\u305f\u305d\u3046\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u3055\u3089\u306b\u3001\u88fd\u54c1\u30ea\u30ea\u30fc\u30b9\u5f8c\u3082\u5b9a\u671f\u7684\u306b\u30e6\u30fc\u30b6\u30fc\u30a4\u30f3\u30bf\u30d3\u30e5\u30fc\u3092\u5b9f\u65bd\u3057\u3001\u65b0\u305f\u306a\u8ab2\u984c\u3092\u30ad\u30e3\u30c3\u30c1\u3059\u308b\u3068\u540c\u6642\u306bCAPA\u3092\u8fc5\u901f\u5316\u3002<br>\u7d50\u679c\u3068\u3057\u3066\u3001\u540c\u793e\u306e\u533b\u7642\u6a5f\u5668\u306f\u81e8\u5e8a\u73fe\u5834\u304b\u3089\u9ad8\u3044\u8a55\u4fa1\u3092\u5f97\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u30ea\u30b3\u30fc\u30eb\u3084\u30af\u30ec\u30fc\u30e0\u5bfe\u5fdc\u306b\u304b\u304b\u308b\u30b3\u30b9\u30c8\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u306b\u3082\u6210\u529f\u3057\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"i-6\">\u5931\u6557\u4e8b\u4f8b\uff1a\u4e0d\u5341\u5206\u306a\u7ba1\u7406\u304c\u62db\u3044\u305f\u30ea\u30b3\u30fc\u30eb\u3068\u305d\u306e\u5bfe\u7b56<\/span><\/h3>\n\n\n\n<p>\u4e00\u65b9\u3067\u3001\u5931\u6557\u4e8b\u4f8b\u3068\u3057\u3066\u3088\u304f\u8033\u306b\u3059\u308b\u306e\u304c\u3001\u958b\u767a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u304c\u30bf\u30a4\u30c8\u306a\u3042\u307e\u308a\u3001\u5341\u5206\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\u3084\u30e6\u30fc\u30b6\u30fc\u691c\u8a3c\u3092\u884c\u308f\u305a\u306b\u88fd\u54c1\u5316\u3057\u3066\u3057\u307e\u3046\u30b1\u30fc\u30b9\u3067\u3059\u3002<br>\u5b9f\u969b\u3001\u3042\u308b\u4f01\u696d\u3067\u306f\u64cd\u4f5c\u753b\u9762\u306e\u8aa4\u8868\u793a\u3092\u653e\u7f6e\u3057\u305f\u307e\u307e\u8ca9\u58f2\u3092\u958b\u59cb\u3057\u3001\u533b\u7642\u73fe\u5834\u3067\u6df1\u523b\u306a\u30c8\u30e9\u30d6\u30eb\u304c\u7d9a\u51fa\u3002<br>\u6700\u7d42\u7684\u306b\u306f\u30ea\u30b3\u30fc\u30eb\u306b\u8e0f\u307f\u5207\u3089\u3056\u308b\u3092\u5f97\u305a\u3001\u5927\u304d\u306a\u7d4c\u6e08\u7684\u640d\u5931\u3068\u30d6\u30e9\u30f3\u30c9\u30a4\u30e1\u30fc\u30b8\u306e\u4f4e\u4e0b\u3092\u62db\u3044\u3066\u3057\u307e\u3044\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u305d\u306e\u4f01\u696d\u3067\u306f\u3001\u305d\u306e\u5f8cISO13485\u306b\u57fa\u3065\u304fQMS\u306e\u518d\u69cb\u7bc9\u3092\u56f3\u308a\u3001CAPA\u306e\u8fc5\u901f\u5316\u3068\u5fb9\u5e95\u3057\u305f\u8a18\u9332\u7ba1\u7406\u3092\u5c0e\u5165\u3002<br>\u533b\u7642\u73fe\u5834\u306e\u58f0\u3092\u65e5\u3005\u53d6\u308a\u5165\u308c\u308b\u4f53\u5236\u3092\u6574\u3048\u305f\u7d50\u679c\u3001\u518d\u3073\u5e02\u5834\u3067\u306e\u4fe1\u983c\u3092\u53d6\u308a\u623b\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3057\u305f\u3002<br>\u3053\u306e\u3088\u3046\u306b\u3001\u5931\u6557\u304b\u3089\u5f97\u3089\u308c\u308b\u6559\u8a13\u306f\u5927\u304d\u304f\u3001\u9069\u5207\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u6839\u4ed8\u304b\u305b\u308b\u5951\u6a5f\u306b\u3082\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span id=\"ISO13485-4\">ISO13485\u5bfe\u5fdc\u3092\u52b9\u679c\u7684\u306b\u9032\u3081\u308b\u305f\u3081\u306e\u30dd\u30a4\u30f3\u30c8<\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"i-7\">\u793e\u54e1\u6559\u80b2\u3068\u30c1\u30fc\u30e0\u4f53\u5236\u3065\u304f\u308a<\/span><\/h3>\n\n\n\n<p>ISO13485\u3092\u5c0e\u5165\u30fb\u904b\u7528\u3059\u308b\u3046\u3048\u3067\u3001\u73fe\u5834\u306e\u62c5\u5f53\u8005\u3084\u7ba1\u7406\u8077\u304c\u305d\u306e\u610f\u7fa9\u3092\u3057\u3063\u304b\u308a\u7406\u89e3\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u5f62\u9ab8\u5316\u3057\u3066\u3057\u307e\u3044\u307e\u3059\u3002<br>\u79c1\u304c\u54c1\u8cea\u7ba1\u7406\u90e8\u9580\u3092\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3057\u3066\u3044\u305f\u9803\u3001\u3082\u3063\u3068\u3082\u529b\u3092\u6ce8\u3044\u3060\u306e\u304c\u300c\u793e\u54e1\u6559\u80b2\u300d\u3067\u3057\u305f\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u5b9a\u671f\u7814\u4fee\u306e\u5b9f\u65bd<\/strong><br>ISO13485\u306e\u57fa\u790e\u3084\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u624b\u6cd5\u3092\u5b66\u3076\u6a5f\u4f1a\u3092\u8a2d\u3051\u3001\u65b0\u5165\u793e\u54e1\u304b\u3089\u30d9\u30c6\u30e9\u30f3\u307e\u3067\u540c\u3058\u30ec\u30d9\u30eb\u306e\u77e5\u8b58\u3092\u5171\u6709\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30ea\u30fc\u30c0\u30fc\u306e\u80b2\u6210<\/strong><br>\u90e8\u9580\u6a2a\u65ad\u3067\u54c1\u8cea\u7ba1\u7406\u3092\u30ea\u30fc\u30c9\u3067\u304d\u308b\u4eba\u6750\u3092\u80b2\u3066\u3001\u5168\u793e\u7684\u306aQMS\u63a8\u9032\u30c1\u30fc\u30e0\u3092\u5f62\u6210\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30e2\u30c1\u30d9\u30fc\u30b7\u30e7\u30f3\u5411\u4e0a\u7b56<\/strong><br>\u6210\u679c\u304c\u51fa\u305f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u793e\u5185\u3067\u767a\u8868\u3057\u3001\u54c1\u8cea\u6539\u5584\u306b\u3088\u308b\u30d3\u30b8\u30cd\u30b9\u6210\u679c\u3092\u5b9f\u611f\u3067\u304d\u308b\u5834\u3092\u3064\u304f\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u793e\u54e1\u304cISO13485\u306e\u76ee\u7684\u3092\u7406\u89e3\u3057\u3001\u81ea\u5206\u3054\u3068\u5316\u3067\u304d\u308c\u3070\u3001\u81ea\u7136\u3068\u30d7\u30ed\u30bb\u30b9\u306e\u9075\u5b88\u3084\u6539\u5584\u304c\u9032\u307f\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"i-8\">\u6587\u66f8\u7ba1\u7406\u3068\u8a18\u9332\u306e\u6b63\u78ba\u6027<\/span><\/h3>\n\n\n\n<p>ISO13485\u3067\u306f\u3001\u300c\u6587\u66f8\u7ba1\u7406\u300d\u304c\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002<br>\u3069\u306e\u3088\u3046\u306a\u5909\u66f4\u304c\u3001\u3044\u3064\u3001\u8ab0\u306e\u5224\u65ad\u3067\u884c\u308f\u308c\u305f\u304b\u3092\u6b63\u78ba\u306b\u8a18\u9332\u3059\u308b\u3053\u3068\u3067\u3001\u4e07\u304c\u4e00\u306e\u30c8\u30e9\u30d6\u30eb\u6642\u306b\u8fc5\u901f\u306a\u5bfe\u5fdc\u304c\u53ef\u80fd\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u79c1\u81ea\u8eab\u3001\u958b\u767a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3084\u8a66\u9a13\u8a18\u9332\u306a\u3069\u3001\u81a8\u5927\u306a\u91cf\u306e\u60c5\u5831\u3092\u6271\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3057\u305f\u3002<br>\u305d\u306e\u969b\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5de5\u592b\u3092\u884c\u3044\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u96fb\u5b50\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165<\/strong><br>\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406\u3092\u81ea\u52d5\u5316\u3057\u3001\u30a2\u30af\u30bb\u30b9\u6a29\u9650\u306e\u8a2d\u5b9a\u3084\u691c\u7d22\u6a5f\u80fd\u3092\u5145\u5b9f\u3055\u305b\u308b\u3002<\/li>\n\n\n\n<li><strong>\u8a18\u9332\u5f62\u5f0f\u306e\u6a19\u6e96\u5316<\/strong><br>\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3084\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3092\u7d71\u4e00\u3057\u3001\u8ab0\u304c\u898b\u3066\u3082\u5185\u5bb9\u304c\u4e00\u76ee\u77ad\u7136\u306b\u306a\u308b\u3088\u3046\u306b\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u5b9a\u671f\u7684\u306a\u30ec\u30d3\u30e5\u30fc\u3068\u66f4\u65b0<\/strong><br>\u53e4\u3044\u6587\u66f8\u3084\u4e0d\u8981\u306a\u8a18\u9332\u3092\u6574\u7406\u3057\u3001\u6700\u65b0\u60c5\u5831\u304c\u3059\u3050\u306b\u53c2\u7167\u3067\u304d\u308b\u72b6\u614b\u3092\u7dad\u6301\u3059\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u6587\u66f8\u7ba1\u7406\u306e\u30df\u30b9\u306f\u30ea\u30b3\u30fc\u30eb\u5bfe\u5fdc\u3084\u76e3\u67fb\u6642\u306b\u5927\u304d\u306a\u30ea\u30b9\u30af\u3068\u306a\u308b\u305f\u3081\u3001\u65e9\u3081\u306e\u5bfe\u7b56\u3068\u7d99\u7d9a\u7684\u306a\u6539\u5584\u304c\u6b20\u304b\u305b\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"i-9\">\u898f\u5236\u5f53\u5c40\u3068\u306e\u9023\u643a\u3068\u6700\u65b0\u60c5\u5831\u306e\u30ad\u30e3\u30c3\u30c1\u30a2\u30c3\u30d7<\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306f\u898f\u5236\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u304c\u983b\u7e41\u306b\u884c\u308f\u308c\u308b\u9818\u57df\u3067\u3059\u3002<br>EU\u306eMDR\uff08Medical Device Regulation\uff09\u3084\u7c73\u56fd\u306eFDA\u8981\u4ef6\u3001\u3055\u3089\u306b\u306f\u56fd\u5185\u306ePMDA\uff08\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff09\u306e\u6307\u91dd\u306a\u3069\u3001\u591a\u5c90\u306b\u308f\u305f\u308b\u898f\u5236\u52d5\u5411\u3092\u30a6\u30a9\u30c3\u30c1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u898f\u5236\u5f53\u5c40\u3084\u696d\u754c\u56e3\u4f53\u306e\u30bb\u30df\u30ca\u30fc\u30fbWebinar\u3092\u5b9a\u671f\u7684\u306b\u30c1\u30a7\u30c3\u30af<\/li>\n\n\n\n<li>\u4e3b\u8981\u56fd\u306e\u898f\u5236\u60c5\u5831\u3092\u62c5\u5f53\u30e1\u30f3\u30d0\u30fc\u304c\u5206\u62c5\u3057\u3066\u53ce\u96c6\u3057\u3001\u793e\u5185\u306b\u5171\u6709<\/li>\n\n\n\n<li>\u65b0\u305f\u306a\u898f\u5236\u8981\u4ef6\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u30ea\u30b9\u30af\u8a55\u4fa1\u3068\u624b\u9806\u66f8\u6539\u8a02<\/li>\n<\/ul>\n\n\n\n<p>\u79c1\u306e\u7d4c\u9a13\u4e0a\u3001\u898f\u5236\u306b\u5148\u56de\u308a\u3057\u3066\u5bfe\u5fdc\u3067\u304d\u308b\u4f01\u696d\u306f\u4fe1\u983c\u5ea6\u304c\u9ad8\u304f\u3001\u533b\u7642\u6a5f\u95a2\u3084\u53d6\u5f15\u5148\u304b\u3089\u3082\u9ad8\u8a55\u4fa1\u3092\u5f97\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002<br>\u6700\u65b0\u60c5\u5831\u3092\u30ad\u30e3\u30c3\u30c1\u30a2\u30c3\u30d7\u3057\u3001QMS\u306b\u9069\u5207\u306b\u53cd\u6620\u3055\u305b\u308b\u30b5\u30a4\u30af\u30eb\u3092\u78ba\u7acb\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u3001ISO13485\u3092\u6d3b\u304b\u3059\u3046\u3048\u3067\u306e\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u3067\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span id=\"i-10\">\u4eca\u5f8c\u306e\u5c55\u671b\uff1a\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u7ba1\u7406\u306e\u52d5\u5411<\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"i-11\">\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u6642\u4ee3\u306b\u304a\u3051\u308b\u54c1\u8cea\u7ba1\u7406\u306e\u9769\u65b0<\/span><\/h3>\n\n\n\n<p>\u8fd1\u5e74\u3001\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u3084\u9060\u9694\u533b\u7642\u304c\u6025\u901f\u306b\u666e\u53ca\u3057\u3001\u533b\u7642\u6a5f\u5668\u306e\u6982\u5ff5\u81ea\u4f53\u304c\u5e83\u304c\u308a\u3064\u3064\u3042\u308a\u307e\u3059\u3002<br>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u5358\u4f53\u3067\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u8a8d\u5b9a\u3055\u308c\u308b\u30b1\u30fc\u30b9\u3082\u5897\u3048\u3001\u30af\u30e9\u30a6\u30c9\u3084\u30e2\u30d0\u30a4\u30eb\u30a2\u30d7\u30ea\u304cQMS\u306e\u5bfe\u8c61\u3068\u306a\u308b\u3053\u3068\u3082\u73cd\u3057\u304f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u3088\u3046\u306a\u72b6\u6cc1\u3067\u306f\u3001\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u3084\u30c7\u30fc\u30bf\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u3068\u3044\u3063\u305f\u65b0\u3057\u3044\u30ea\u30b9\u30af\u8981\u56e0\u304c\u30af\u30ed\u30fc\u30ba\u30a2\u30c3\u30d7\u3055\u308c\u3066\u304d\u307e\u3059\u3002<br>ISO13485\u306e\u67a0\u7d44\u307f\u3092\u30d9\u30fc\u30b9\u306b\u3057\u306a\u304c\u3089\u3082\u3001\u3088\u308a\u8907\u5408\u7684\u306a\u54c1\u8cea\u7ba1\u7406\u6226\u7565\u304c\u6c42\u3081\u3089\u308c\u308b\u6642\u4ee3\u306b\u5165\u3063\u3066\u3044\u308b\u3068\u3044\u3048\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span id=\"AIIoT\">AI\u30fbIoT\u6280\u8853\u306e\u6d3b\u7528\u304c\u3082\u305f\u3089\u3059\u65b0\u305f\u306a\u8ab2\u984c\u3068\u5bfe\u5fdc\u7b56<\/span><\/h3>\n\n\n\n<p>AI\u3092\u4f7f\u3063\u305f\u753b\u50cf\u8a3a\u65ad\u30b7\u30b9\u30c6\u30e0\u3084IoT\u6a5f\u5668\u3092\u6d3b\u7528\u3057\u305f\u60a3\u8005\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306a\u3069\u3001\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u306e\u9032\u6b69\u306f\u533b\u7642\u3092\u5927\u304d\u304f\u5909\u3048\u3066\u3044\u307e\u3059\u3002<br>\u3057\u304b\u3057\u3001AI\u3084IoT\u306b\u306f\u65e2\u5b58\u306e\u533b\u7642\u6a5f\u5668\u4ee5\u4e0a\u306b\u4e0d\u78ba\u5b9a\u8981\u7d20\u304c\u591a\u304f\u3001\u5b66\u7fd2\u30c7\u30fc\u30bf\u306e\u504f\u308a\u3084\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u66f4\u65b0\u306e\u7ba1\u7406\u306a\u3069\u3001\u54c1\u8cea\u7ba1\u7406\u304c\u8907\u96d1\u5316\u3059\u308b\u9762\u3082\u5426\u3081\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u65b9\u6cd5<\/strong><\/li>\n\n\n\n<li><strong>\u30c7\u30fc\u30bf\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u983b\u5ea6\u3068\u691c\u8a3c\u30d7\u30ed\u30bb\u30b9<\/strong><\/li>\n\n\n\n<li><strong>\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u76e3\u8996\u4f53\u5236\u3068\u7dca\u6025\u505c\u6b62\u6a5f\u80fd<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u3053\u3046\u3057\u305f\u8ab2\u984c\u306b\u5bfe\u3057\u3066\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306b\u7279\u5316\u3057\u305f\u898f\u683c\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u53c2\u7167\u3057\u306a\u304c\u3089\u3001\u65e2\u5b58\u306eISO13485\u3068\u4f75\u305b\u3066\u904b\u7528\u3059\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u304c\u4e00\u822c\u7684\u3068\u306a\u308a\u3064\u3064\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span 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