{"id":4647,"date":"2024-03-14T11:20:56","date_gmt":"2024-03-14T03:20:56","guid":{"rendered":"https:\/\/www.thy-precision.com\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e7%94%a3%e6%a5%ad%e3%81%aeiso%e5%9f%ba%e6%ba%96%ef%bc%9aiso-13485%e3%81%a8%e3%81%af\/"},"modified":"2025-06-18T23:46:15","modified_gmt":"2025-06-18T15:46:15","slug":"iso-standards-for-medical-devices-the-meaning-of-iso-13485","status":"publish","type":"post","link":"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/","title":{"rendered":"ISO 13485\uff1a\u533b\u7642\u6a5f\u5668\u7523\u696d\u306eISO\u57fa\u6e96"},"content":{"rendered":"\n<p>\u533b\u7642\u5206\u91ce\u3067\u306f\u3001\u9ad8\u54c1\u8cea\u306a\u6a5f\u5668\u3092\u7dad\u6301\u3059\u308b\u306f\u3001\u4eba\u547d\u306b\u95a2\u3059\u308b\u3068\u3066\u3082\u91cd\u8981\u306a\u8ab2\u984c\u3067\u3059\u3002 \u5c11\u3057\u306e\u30df\u30b9\u3084\u898b\u843d\u3068\u3057\u304c\u3001\u91cd\u5927\u306a\u640d\u5bb3\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002 \u305d\u306e\u305f\u3081\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u304a\u3051\u308bISO\u57fa\u6e96\u3078\u306e\u9075\u5b88\u306f\u3001\u898f\u5236\u8981\u4ef6\u3060\u3051\u3067\u306a\u304f\u3001\u5b89\u5168\u6027\u3068\u54c1\u8cea\u3078\u306e\u8cac\u4efb\u3067\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306e\u5c04\u51fa\u6210\u5f62\u3092\u627f\u3063\u3066\u3044\u308b<a href=\"https:\/\/www.thy-precision.com\/ja\/medical\/\" target=\"_blank\" rel=\"noreferrer noopener\">THY\u7cbe\u5bc6\u5de5\u696d<\/a>\u306f\u3001ISO 13485\u8a8d\u8a3c\u306b\u3064\u3044\u3066\u8aa0\u5b9f\u306b\u5411\u304d\u5408\u3063\u3066\u304a\u308a\u307e\u3059\u3002vice injection molding company, stands out with their ISO 13485 certification. \u7cbe\u5bc6\u5c04\u51fa\u6210\u5f62\u3092\u901a\u3058\u3066\u6700\u9ad8\u6c34\u6e96\u306e\u533b\u7642\u6a5f\u5668\u3092\u751f\u7523\u3059\u308b\u3053\u3068\u306b\u5c02\u5ff5\u3059\u308b\u3068\u540c\u6642\u306b\u3001\u6700\u3082\u53b3\u3057\u3044\u4e16\u754c\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306eISO\u57fa\u6e96\u3001\u8a8d\u8a3c\u53d6\u5f97\u306e\u5229\u70b9\u3001\u304a\u3088\u3073THY\u7cbe\u5bc6\u5de5\u696d\u306e\u54c1\u8cea\u30ce\u30a6\u30cf\u30a6\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AEISO%E5%9F%BA%E6%BA%96%E3%81%A8%E3%81%AF%EF%BC%9F\" >\u533b\u7642\u6a5f\u5668\u306eISO\u57fa\u6e96\u3068\u306f\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E3%81%9F%E3%82%81%E3%81%AEISO_13485%E8%AA%8D%E8%A8%BC\" >\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306eISO 13485\u8a8d\u8a3c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/#ISO_13485%E3%82%92%E5%8F%96%E5%BE%97%E3%81%99%E3%82%8B%E3%83%A1%E3%83%AA%E3%83%83%E3%83%88\" >ISO 13485\u3092\u53d6\u5f97\u3059\u308b\u30e1\u30ea\u30c3\u30c8<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/#THY%E7%B2%BE%E5%AF%86%E5%B7%A5%E6%A5%AD%E3%81%8B%E3%82%89%E3%81%AE%E5%8C%BB%E7%99%82%E6%A5%AD%E7%95%8C%E5%90%91%E3%81%91%E3%81%AE%E8%A3%BD%E9%80%A0%E3%83%8E%E3%82%A6%E3%83%8F%E3%82%A6\" >THY\u7cbe\u5bc6\u5de5\u696d\u304b\u3089\u306e\u533b\u7642\u696d\u754c\u5411\u3051\u306e\u88fd\u9020\u30ce\u30a6\u30cf\u30a6<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AEISO%E5%9F%BA%E6%BA%96%E3%81%A8%E3%81%AF%EF%BC%9F\"><\/span><strong>\u533b\u7642\u6a5f\u5668<\/strong>\u306e<strong>ISO\u57fa\u6e96\u3068\u306f\uff1f<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-07-jpg.webp\" alt=\"&#x533B;&#x7642;&#x6A5F;&#x5668;&#x306E;ISO&#x57FA;&#x6E96;&#x3068;&#x306F;&#xFF1F;\" class=\"wp-image-4485\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-07-jpg.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-07-300x165.webp 300w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-07-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p><a href=\"https:\/\/www.iso.org\/home.html\" target=\"_blank\" rel=\"noreferrer noopener\">\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb\uff08ISO\uff09<\/a>\u306b\u3088\u3063\u3066\u78ba\u7acb\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u306eISO\u57fa\u6e96\u306f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u754c\u306b\u304a\u3051\u308b\u5b89\u5168\u6027\u3068\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u5236\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u3089\u306e\u57fa\u6e96\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u88fd\u54c1\u304c\u9867\u5ba2\u306b\u5b89\u5168\u304b\u3064\u52b9\u679c\u7684\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u898f\u5236\u8981\u4ef6\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4ee5\u4e0b\u306f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u754c\u306b\u95a2\u9023\u3059\u308b\u4e3b\u8981\u306aISO\u57fa\u6e96\u306e\u6982\u8981\u3067\u3059\uff1a<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th class=\"has-text-align-center\" data-align=\"center\"><strong>ISO\u57fa\u6e96<\/strong><\/th><th><strong>\u8aac\u660e<\/strong><\/th><\/tr><\/thead><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\">ISO 13485<\/td><td>\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">ISO 14971<\/td><td>\u533b\u7642\u6a5f\u5668\u3078\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u9069\u7528<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">ISO 10993<\/td><td>\u533b\u7642\u6a5f\u5668\u306e\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u306b\u3088\u308b\u751f\u4f53\u9069\u5408\u6027\u306e\u8a55\u4fa1<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">ISO 10991<\/td><td>\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u4ed5\u69d8\u306e\u56fd\u969b\u6a19\u6e96<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">ISO 15223<\/td><td>\u533b\u7642\u6a5f\u5668\u5305\u88c5\u306e\u305f\u3081\u306e\u30b7\u30f3\u30dc\u30eb\u3068\u30e9\u30d9\u30eb\u3001\u4e16\u754c\u7684\u306a\u8a18\u53f7\u306b\u3064\u3044\u3066\u306e\u898f\u5b9a<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">ISO 14155<\/td><td>\u4eba\u9593\u7528\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13 <\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E3%81%9F%E3%82%81%E3%81%AEISO_13485%E8%AA%8D%E8%A8%BC\"><\/span><strong>\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306eISO 13485<\/strong>\u8a8d\u8a3c<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-08-jpg.webp\" alt=\"&#x533B;&#x7642;&#x6A5F;&#x5668;&#x306E;ISO 13485\" class=\"wp-image-4487\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-08-jpg.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-08-300x165.webp 300w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-08-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p>ISO\u57fa\u6e96\u306e\u4e2d\u3067\u3001<a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 13485<\/a>\u306f\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u754c\u306b\u304a\u3051\u308b\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u57fa\u6e96\u3067\u3059\u3002 \u3053\u308c\u306f\u3001\u4f01\u696d\u304c\u533b\u7642\u6a5f\u5668\u304c\u9867\u5ba2\u3068\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u67a0\u7d44\u307f\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>ISO 13485\u306f\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u52b9\u679c\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u5236\u5fa1\u3001\u88fd\u54c1\u306e\u6e05\u6f54\u3055\u3001\u304a\u3088\u3073\u5341\u5206\u306b\u6587\u66f8\u5316\u3055\u308c\u305f\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002 \u3053\u306e\u57fa\u6e96\u306f\u3001\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u4fdd\u7ba1\u3001\u6d41\u901a\u3001\u8a2d\u7f6e\u3001\u304a\u3088\u3073\u30b5\u30fc\u30d3\u30b9\u306b\u81f3\u308b\u307e\u3067\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u3059\u3079\u3066\u306e\u6bb5\u968e\u306b\u9069\u7528\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>ISO 13485\u306f\u3001\u4ee5\u4e0b\u306e8\u3064\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u5206\u304b\u308c\u3066\u3044\u307e\u3059\uff1a <\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u7bc4\u56f2\uff1a<\/strong>\u6a19\u6e96\u304c\u9069\u7528\u3055\u308c\u308b\u5bfe\u8c61\u8005\u3092\u8aac\u660e\u3057\u3001\u8a2d\u8a08\u3001\u88fd\u9020\u3001\u8a2d\u7f6e\u3001\u304a\u3088\u3073\u30b5\u30fc\u30d3\u30b9\u3092\u542b\u307f\u307e\u3059\u3002 <\/li>\n<\/ol>\n\n\n\n<ol start=\"2\" class=\"wp-block-list\">\n<li><strong>\u898f\u7bc4\u7684\u53c2\u7167\uff1a<\/strong>\u6a19\u6e96\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u95a2\u9023\u6587\u66f8\u3092\u30ea\u30b9\u30c8\u3057\u307e\u3059\u3002<\/li>\n<\/ol>\n\n\n\n<ol start=\"3\" class=\"wp-block-list\">\n<li><strong>\u7528\u8a9e\u3068\u5b9a\u7fa9\uff1a<\/strong>\u6a19\u6e96\u5185\u3067\u4f7f\u7528\u3055\u308c\u308b\u4e3b\u8981\u306a\u7528\u8a9e\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002<\/li>\n<\/ol>\n\n\n\n<ol start=\"4\" class=\"wp-block-list\">\n<li><strong>\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff1a<\/strong>\u4e00\u8cab\u3057\u305f\u54c1\u8cea\u57fa\u6e96\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u78ba\u7acb\u3001\u6587\u66f8\u5316\u3001\u5b9f\u88c5\u3001\u7dad\u6301\u3001\u304a\u3088\u3073\u6539\u5584\u3059\u308b\u65b9\u6cd5\u3092\u6982\u8aac\u3057\u307e\u3059\u3002<\/li>\n<\/ol>\n\n\n\n<ol start=\"5\" class=\"wp-block-list\">\n<li><strong>\u7ba1\u7406\u8cac\u4efb\uff1a<\/strong>QMS\u306e\u7ba1\u7406\u306e\u5f79\u5272\u3068\u8cac\u4efb\u3092\u6307\u5b9a\u3057\u3001\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u3001\u9867\u5ba2\u4e2d\u5fc3\u6027\u3001\u65b9\u91dd\u3001\u8a08\u753b\u3001\u8cac\u4efb\u3001\u304a\u3088\u3073\u30ec\u30d3\u30e5\u30fc\u3092\u542b\u307f\u307e\u3059\u3002<\/li>\n<\/ol>\n\n\n\n<ol start=\"6\" class=\"wp-block-list\">\n<li><strong>\u30ea\u30bd\u30fc\u30b9\u7ba1\u7406\uff1a<\/strong>QMS\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u4eba\u54e1\u3001\u30a4\u30f3\u30d5\u30e9\u30b9\u30c8\u30e9\u30af\u30c1\u30e3\u3001\u304a\u3088\u3073\u4f5c\u696d\u74b0\u5883\u306e\u7ba1\u7406\u3092\u8a73\u8ff0\u3057\u307e\u3059\u3002 <\/li>\n<\/ol>\n\n\n\n<ol start=\"7\" class=\"wp-block-list\">\n<li><strong>\u88fd\u54c1\u306e\u5b9f\u73fe\uff1a<\/strong>\u88fd\u54c1\u306e\u8a2d\u8a08\u304b\u3089\u958b\u767a\u304a\u3088\u3073\u63d0\u4f9b\u307e\u3067\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u30ab\u30d0\u30fc\u3057\u3001\u9867\u5ba2\u8981\u4ef6\u3068\u30b5\u30fc\u30d3\u30b9\u63d0\u4f9b\u306b\u7279\u306b\u7126\u70b9\u3092\u5f53\u3066\u307e\u3059\u3002 <\/li>\n<\/ol>\n\n\n\n<ol start=\"8\" class=\"wp-block-list\">\n<li><strong>\u6e2c\u5b9a\u3001\u5206\u6790\u3001\u304a\u3088\u3073\u6539\u5584\uff1a<\/strong>\u88fd\u54c1\u3068\u30b7\u30b9\u30c6\u30e0\u306e\u54c1\u8cea\u3092\u7d99\u7d9a\u7684\u306b\u30c1\u30a7\u30c3\u30af\u304a\u3088\u3073\u6539\u5584\u3059\u308b\u3053\u3068\u306b\u7126\u70b9\u3092\u5f53\u3066\u307e\u3059\u3002<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"ISO_13485%E3%82%92%E5%8F%96%E5%BE%97%E3%81%99%E3%82%8B%E3%83%A1%E3%83%AA%E3%83%83%E3%83%88\"><\/span><strong>ISO 13485\u3092\u53d6\u5f97\u3059\u308b\u30e1\u30ea\u30c3\u30c8<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-09-jpg.webp\" alt=\"ISO 13485&#x306E;&#x53D6;&#x5F97;&#x306E;&#x5229;&#x70B9;\" class=\"wp-image-4489\" style=\"width:840px;height:auto\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-09-jpg.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-09-300x165.webp 300w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-09-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p>\u30a2\u30e1\u30ea\u30ab\u3067\u306f2018\u5e74\u304b\u30892022\u5e74\u306e\u9593\u306b\u3001\u306a\u3093\u3068<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC10204764\/\" target=\"_blank\" rel=\"noreferrer noopener\">13,623<\/a>\u500b\u306e\u533b\u7642\u6a5f\u5668\u304c\u30ea\u30b3\u30fc\u30eb\u3055\u308c\u3066\u3044\u307e\u3059\u3002 ISO\u57fa\u6e96\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u54c1\u8cea\u306e\u554f\u984c\u3092\u9632\u3050\u305f\u3081\u306b\u5b58\u5728\u3057\u3066\u3044\u307e\u3059\u3002 ISO 13485\u306e\u8a8d\u8a3c\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u9ad8\u54c1\u8cea\u306e\u88fd\u54c1\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5229\u70b9\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<p><strong>\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u5b89\u5168\u6027\u3092\u4fdd\u8a3c\u3059\u308b<\/strong><br>ISO 13485\u306f\u3001\u4f01\u696d\u304c\u88fd\u9020\u3059\u308b\u533b\u7642\u6a5f\u5668\u304c\u6700\u9ad8\u54c1\u8cea\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002 \u3053\u308c\u306f\u3001\u4e16\u754c\u7684\u306b\u8a8d\u77e5\u3055\u308c\u305fQMS\u304b\u3089\u306e\u627f\u8a8d\u3067\u3042\u308a\u3001\u88fd\u54c1\u306e\u56de\u53ce\u3084\u5b89\u5168\u4e0a\u306e\u61f8\u5ff5\u306e\u53ef\u80fd\u6027\u3092\u6e1b\u3089\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u6539\u5584\u3059\u308b <\/strong><br>ISO 13485\u306f\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u91cd\u8996\u3057\u3066\u3044\u307e\u3059\u3002 \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u3046\u3053\u3068\u3067\u3001\u4e8b\u696d\u8005\u306f\u30ea\u30b9\u30af\u3092\u3088\u308a\u3088\u304f\u7279\u5b9a\u3057\u3001\u7ba1\u7406\u3057\u3001\u7de9\u548c\u3067\u304d\u307e\u3059\u3002 \u3053\u308c\u306b\u3088\u308a\u3001\u533b\u7642\u6a5f\u5668\u3078\u306e\u9867\u5ba2\u306e\u4fe1\u983c\u304c\u5927\u5e45\u306b\u9ad8\u307e\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<p><strong>\u898f\u5236\u306e\u9075\u5b88\u3092\u5408\u7406\u5316\u3059\u308b<\/strong><br>ISO 13485\u306f\u591a\u304f\u306e\u56fd\u969b\u7684\u306a\u898f\u5236\u8981\u4ef6\u3068\u4e00\u81f4\u3059\u308b\u67a0\u7d44\u307f\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002 \u3053\u308c\u306b\u3088\u308a\u3001\u9069\u5408\u30d7\u30ed\u30bb\u30b9\u304c\u7c21\u7d20\u5316\u3055\u308c\u3001\u4e8b\u696d\u8005\u306f\u6f5c\u5728\u7684\u306a\u6cd5\u7684\u304a\u3088\u3073\u8ca1\u52d9\u7684\u30da\u30ca\u30eb\u30c6\u30a3\u304b\u3089\u4fdd\u8b77\u3055\u308c\u307e\u3059\u3002 <\/p>\n\n\n\n<p><strong>\u3088\u308a\u826f\u3044\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u95a2\u4fc2\u306e\u69cb\u7bc9<\/strong><br>\u3059\u3079\u3066\u306e\u90e8\u54c1\u3068\u6750\u6599\u306f\u8a8d\u8a3c\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 \u3059\u3079\u3066\u306e\u6bb5\u968e\u3067\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u54c1\u8cea\u3078\u306e\u6ce8\u610f\u306f\u88fd\u54c1\u306e\u4fe1\u983c\u6027\u3092\u9ad8\u3081\u307e\u3059\u3002 \u307e\u305f\u3001\u4e00\u8cab\u3057\u305f\u54c1\u8cea\u306f\u30b9\u30e0\u30fc\u30ba\u306a\u751f\u7523\u30d7\u30ed\u30bb\u30b9\u3068\u5c11\u306a\u3044\u4e2d\u65ad\u306b\u3064\u306a\u304c\u308a\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3092\u5f37\u5316\u3057\u307e\u3059\u3002 <\/p>\n\n\n\n<p><strong>\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u62e1\u5927 <\/strong><br>ISO 13485\u8a8d\u8a3c\u306f\u56fd\u969b\u7684\u306b\u8a8d\u8b58\u3055\u308c\u3001\u3057\u3070\u3057\u3070\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u3078\u306e\u53c2\u5165\u306e\u524d\u63d0\u6761\u4ef6\u3068\u306a\u308a\u307e\u3059\u3002 \u3053\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u3067\u3001\u65b0\u305f\u306a\u30d3\u30b8\u30cd\u30b9\u6a5f\u4f1a\u304c\u958b\u304b\u308c\u3001\u56fd\u969b\u7684\u306a\u898f\u5236\u8981\u4ef6\u3078\u306e\u9069\u5408\u304c\u5bb9\u6613\u306b\u306a\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"THY%E7%B2%BE%E5%AF%86%E5%B7%A5%E6%A5%AD%E3%81%8B%E3%82%89%E3%81%AE%E5%8C%BB%E7%99%82%E6%A5%AD%E7%95%8C%E5%90%91%E3%81%91%E3%81%AE%E8%A3%BD%E9%80%A0%E3%83%8E%E3%82%A6%E3%83%8F%E3%82%A6\"><\/span><strong>THY\u7cbe\u5bc6\u5de5\u696d\u304b\u3089\u306e\u533b\u7642\u696d\u754c\u5411\u3051\u306e\u88fd\u9020\u30ce\u30a6\u30cf\u30a6<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-10-jpg.webp\" alt=\"THY&#x7CBE;&#x5BC6;&#x5DE5;&#x696D;&#x304B;&#x3089;&#x306E;&#x533B;&#x7642;&#x696D;&#x754C;&#x5411;&#x3051;&#x30CE;&#x30A6;&#x30CF;&#x30A6;\" class=\"wp-image-4491\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-10-jpg.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-10-300x165.webp 300w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/04\/\u6587\u7ae04_ISO13485-10-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p>THY\u7cbe\u5bc6\u5de5\u696d\u306f<a href=\"https:\/\/www.thy-precision.com\/ja\/quality\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u305f<\/a>\u533b\u7642\u30ce\u30a6\u30cf\u30a6\u306e\u63d0\u4f9b\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\u3002 ISO 13485\u3068ISO 9001\u306e\u4e21\u65b9\u306e\u8a8d\u8a3c\u3092\u4fdd\u6709\u3057\u3001\u533b\u7642\u6a5f\u5668\u7528\u306e\u7cbe\u5bc6\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u5c04\u51fa\u6210\u5f62\u306b\u7279\u5316\u3057\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n<p>\u5f53\u793e\u306e\u30ab\u30b9\u30bf\u30e0\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u5c04\u51fa\u6210\u5f62\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u6700\u9ad8\u306e\u696d\u754c\u30af\u30ea\u30fc\u30f3\u30ea\u30cd\u30b9\u3068\u5b89\u5168\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002 \u6210\u5f62\u7528\u306eISO 8\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3092\u904b\u7528\u3057\u3066\u304a\u308a\u3001\u5236\u5fa1\u3055\u308c\u305f\u74b0\u5883\u3092\u901a\u3058\u3066\u6c5a\u67d3\u306e\u30ea\u30b9\u30af\u3092\u52b9\u679c\u7684\u306b\u6700\u5c0f\u9650\u306b\u6291\u3048\u3066\u3044\u307e\u3059\u3002 \u307e\u305f\u3001\u7d44\u7acb\u3068\u68b1\u5305\u30d7\u30ed\u30bb\u30b9\u4e2d\u306e\u7a7a\u6c17\u54c1\u8cea\u3068\u7c92\u5b50\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306eISO 7\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3082\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n<p>THY\u7cbe\u5bc6\u5de5\u696d\u306f\u3001\u8a2d\u8a08\u304b\u3089\u751f\u7523\u307e\u3067\u306e\u5e45\u5e83\u3044\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u304a\u308a\u3001<a href=\"https:\/\/www.thy-precision.com\/ja\/in-house-tooling\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u793e\u5185\u3067\u306e\u91d1\u578b\u88fd\u4f5c<\/a>\u3001<a href=\"https:\/\/www.thy-precision.com\/ja\/medical-device-contractmanufacturing\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020<\/a>\u3001\u304a\u3088\u3073<a href=\"https:\/\/www.thy-precision.com\/ja\/automated-manufacturing\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u81ea\u52d5\u5316\u3055\u308c\u305f\u88fd\u9020<\/a>\u3092\u542b\u307f\u307e\u3059\u3002 \u5f53\u793e\u306e\u5305\u62ec\u7684\u306a\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u306f\u3001\u5c06\u6765\u306e\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306b\u5bfe\u3057\u3066\u8cbb\u7528\u5bfe\u52b9\u679c\u306e\u9ad8\u3044\u30b9\u30e0\u30fc\u30ba\u306a\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002 <\/p>\n\n\n\n<p>\u8a73\u7d30\u307e\u305f\u306f\u304a\u554f\u3044\u5408\u308f\u305b\u306f\u3001THY\u7cbe\u5bc6\u5de5\u696d\u306b<a href=\"https:\/\/www.thy-precision.com\/ja\/contact\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u3054\u9023\u7d61<\/a>\u304f\u3060\u3055\u3044\u3002 <\/p>\n\n\n\n<p>\u95a2\u9023\u8a18\u4e8b\uff1a <a href=\"https:\/\/www.thy-precision.com\/ja\/injection-moulding-a-step-by-step-process-breakdown-jp\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u5c04\u51fa\u6210\u5f62\u3092\u624b\u9806\u5225\u306b\u5fb9\u5e95\u89e3\u8aac<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u533b\u7642\u5206\u91ce\u3067\u306f\u3001\u9ad8\u54c1\u8cea\u306a\u6a5f\u5668\u3092\u7dad\u6301\u3059\u308b\u306f\u3001\u4eba\u547d\u306b\u95a2\u3059\u308b\u3068\u3066\u3082\u91cd\u8981\u306a\u8ab2\u984c\u3067\u3059\u3002 \u5c11\u3057\u306e\u30df\u30b9\u3084\u898b\u843d\u3068\u3057\u304c\u3001\u91cd\u5927\u306a\u640d\u5bb3\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002 \u305d\u306e\u305f\u3081\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u304a\u3051\u308bISO\u57fa\u6e96\u3078\u306e\u9075\u5b88\u306f\u3001\u898f\u5236\u8981\u4ef6\u3060\u3051\u3067\u306a\u304f\u3001\u5b89\u5168\u6027\u3068 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