{"id":8699,"date":"2025-10-25T07:58:39","date_gmt":"2025-10-24T22:58:39","guid":{"rendered":"https:\/\/rakuten-med.com\/jp\/?page_id=8699"},"modified":"2026-02-24T10:10:55","modified_gmt":"2026-02-24T01:10:55","slug":"quality","status":"publish","type":"page","link":"https:\/\/rakuten-med.com\/jp\/social-responsibility\/quality\/","title":{"rendered":"\u300c\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u300d"},"content":{"rendered":"<div id=\"pl-8699\"  class=\"panel-layout\" ><div id=\"pg-8699-0\"  class=\"panel-grid panel-has-style\" ><div class=\"siteorigin-panels-stretch lazy rocket-lazyload panel-row-style panel-row-style-for-8699-0\" id=\"page-title-banner\" data-stretch-type=\"full\" data-bg=\"https:\/\/rakuten-med.com\/jp\/wp-content\/uploads\/sites\/8\/2025\/11\/Operation-GI-1473477211_opt.jpg\" ><div id=\"pgc-8699-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-8699-0-0-0\" class=\"so-panel widget widget_sow-headline panel-first-child panel-last-child\" data-index=\"0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-headline so-widget-sow-headline-default-717b776eaf13-8699\"\n\t\t\t\n\t\t><div class=\"sow-headline-container \">\n\t\t\t\t\t\t\t<h1 class=\"sow-headline\">\n\t\t\t\t\t\tQuality Management System\t\t\t\t\t\t<\/h1>\n\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"sow-sub-headline\">\n\t\t\t\t\t\t\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<\/div>\n<\/div><\/div><\/div><\/div><\/div><div id=\"pg-8699-1\"  class=\"panel-grid panel-has-style\" ><div class=\"panel-row-style panel-row-style-for-8699-1\" ><div id=\"pgc-8699-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-8699-1-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child\" data-index=\"1\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p><span style=\"font-weight: 400;\">\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u306f\u3001\u60a3\u8005\u3055\u3093\u30fb\u3054\u5bb6\u65cf\u30fb\u533b\u7642\u5f93\u4e8b\u8005\u306e\u7686\u3055\u3093\u306b\u5bfe\u3059\u308b\u8cac\u4efb\u3092\u679c\u305f\u3059\u305f\u3081\u3001\u79c1\u305f\u3061\u306e\u4fa1\u5024\u57fa\u6e96\u3067\u3042\u308bBrand Concept\u3001\u3068\u308a\u308f\u3051\u300c\u54c1\u6027\u9ad8\u6f54\u300d\u306b\u5247\u308a\u3001\u30a2\u30eb\u30df\u30ce\u30c3\u30af\u30b9\u00ae\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u3082\u3068\u306b\u3057\u305f\u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30fb\u5b9f\u7528\u5316\u30fb\u5b89\u5b9a\u4f9b\u7d66\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><b style=\"color: #bf0000;\">\u54c1\u8cea\u65b9\u91dd<\/b><\/p>\n<div style=\"border: 1px solid #bf0000; padding: 15px;\">\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u306f\u3001\u8cac\u4efb\u3092\u3082\u3063\u3066\u3001\u304c\u3093\u3084\u305d\u306e\u95a2\u9023\u75be\u60a3\u3092\u6cbb\u7642\u3059\u308b\u305f\u3081\u306e\u9ad8\u54c1\u8cea\u306e\u533b\u85ac\u54c1\u3068\u533b\u7642\u6a5f\u5668\u306e\u7d44\u307f\u5408\u308f\u305b\u88fd\u54c1\u306e\u958b\u767a\u3068\u5546\u54c1\u5316\u3001\u4e26\u3073\u306b\u5b89\u5b9a\u4f9b\u7d66\u306b\u53d6\u308a\u7d44\u307f\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u5f93\u696d\u54e1\u306f\u8cac\u4efb\u3092\u3082\u3063\u3066\u3001\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u9075\u5b88\u3057\u3001\u7dad\u6301\u3057\u3001\u4e14\u3064\u7d99\u7d9a\u7684\u306b\u6539\u5584\u3057\u3001\u60a3\u8005\u304a\u3088\u3073\u81e8\u5e8a\u533b\u3092\u652f\u63f4\u3059\u308b\u3068\u3044\u3046\u5f53\u793e\u306e\u7fa9\u52d9\u3092\u679c\u305f\u3059\u4e0a\u3067\u306e\u898f\u5236\u8981\u4ef6\u3092\u9075\u5b88\u3057\u307e\u3059\u3002<\/div>\n<p>&nbsp;<\/p>\n<p><b style=\"color: #bf0000;\">\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u3067\u306f\u3001\u533b\u85ac\u54c1\u3068\u533b\u7642\u6a5f\u5668\u3092\u7d44\u307f\u5408\u308f\u305b\u305f\u3053\u308c\u307e\u3067\u306b\u306a\u3044\u6280\u8853\u306b\u3088\u308b\u9769\u65b0\u7684\u306a\u6cbb\u7642\u3092\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u306b\u5b89\u5b9a\u7684\u304b\u3064\u8fc5\u901f\u306b\u63d0\u4f9b\u3059\u308b\u305f\u3081\u3001\u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u306b\u95a2\u4fc2\u3059\u308b\u90e8\u9580\u304c\u7dca\u5bc6\u306b\u9023\u643a\u3057\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236\u3092\u69cb\u7bc9\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u7279\u306b\u3001\u4e16\u754c\u306b\u5148\u99c6\u3051\u3066\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u3092\u53d6\u5f97\u3057\u305f\u65e5\u672c\u306b\u304a\u3044\u3066\u306f\u3001\u6975\u3081\u3066\u9ad8\u5ea6\u306a\u54c1\u8cea\u3068\u5b89\u5168\u6027\u3092\u5099\u3048\u305f\u88fd\u54c1\u3092\u5b89\u5b9a\u7684\u306b\u4f9b\u7d66\u3067\u304d\u308b\u3088\u3046\u3001\u56fd\u5185\u57fa\u6e96\u306e\u307f\u306a\u3089\u305a\u56fd\u969b\u6c34\u6e96\u306b\u3082\u5247\u3063\u305f\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236\u3092\u6574\u5099\u30fb\u904b\u7528\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><b>\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u682a\u5f0f\u4f1a\u793e\uff08\u65e5\u672c\u6cd5\u4eba\uff09\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236<\/b><\/p>\n<\/div>\n<\/div><\/div><div id=\"panel-8699-1-0-1\" class=\"so-panel widget widget_sow-image\" data-index=\"2\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-image so-widget-sow-image-default-c67d20f9f743-8699\"\n\t\t\t\n\t\t>\n<div class=\"sow-image-container\">\n\t\t<img \n\tsrc=\"https:\/\/rakuten-med.com\/jp\/wp-content\/uploads\/sites\/8\/2025\/10\/\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u682a\u5f0f\u4f1a\u793e\uff08\u65e5\u672c\u6cd5\u4eba\uff09\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236.png\" width=\"960\" height=\"720\" srcset=\"https:\/\/rakuten-med.com\/jp\/wp-content\/uploads\/sites\/8\/2025\/10\/\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u682a\u5f0f\u4f1a\u793e\uff08\u65e5\u672c\u6cd5\u4eba\uff09\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236.png 960w, https:\/\/rakuten-med.com\/jp\/wp-content\/uploads\/sites\/8\/2025\/10\/\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u682a\u5f0f\u4f1a\u793e\uff08\u65e5\u672c\u6cd5\u4eba\uff09\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236-300x225.png 300w, https:\/\/rakuten-med.com\/jp\/wp-content\/uploads\/sites\/8\/2025\/10\/\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u682a\u5f0f\u4f1a\u793e\uff08\u65e5\u672c\u6cd5\u4eba\uff09\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236-768x576.png 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" alt=\"\" \t\tclass=\"so-widget-image\"\/>\n\t<\/div>\n\n<\/div><\/div><div id=\"panel-8699-1-0-2\" class=\"so-panel widget widget_sow-editor panel-last-child\" data-index=\"3\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p><b style=\"color: #bf0000;\">\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u8a8d\u8a3c\u53d6\u5f97<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u56fd\u969b\u898f\u683c\u3067\u3042\u308bISO 13485\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3001\u4e16\u754c\u7684\u306b\u3082\u9ad8\u6c34\u6e96\u306e\u54c1\u8cea\u3068\u5b89\u5168\u6027\u306e\u7dad\u6301\u306b\u52aa\u3081\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u7b2c\u4e09\u8005\u8a8d\u8a3c\u6a5f\u95a2\u306b\u3088\u308b\u5b9a\u671f\u7684\u306a\u5be9\u67fb\u3092\u901a\u3058\u3066\u3001\u9ad8\u3044\u6c34\u6e96\u306e\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236\u306e\u7dad\u6301\u3068\u3055\u3089\u306a\u308b\u5411\u4e0a\u306b\u52aa\u3081\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><div id=\"pg-8699-2\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-8699-2-0\"  class=\"panel-grid-cell\" ><div id=\"panel-8699-2-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child\" data-index=\"4\" ><div class=\"pink-heading-box panel-widget-style panel-widget-style-for-8699-2-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p><b>ISO\u8a8d\u8a3c\u53d6\u5f97\u72b6\u6cc1<\/b><\/p>\n<p>&nbsp;<\/p>\n<table style=\"width: 100%;\">\n<tbody>\n<tr>\n<th style=\"width: 26.085%;\"><b>\u62e0\u70b9\u540d<\/b><\/th>\n<th style=\"width: 18.2593%;\"><b>ISO 13485<\/b><\/p>\n<p><b>\u521d\u56de\u8a8d\u8a3c\u53d6\u5f97\u5e74<\/b><\/p>\n<\/th>\n<th style=\"width: 65.1891%;\"><b>\u8a8d\u8a3c\u7bc4\u56f2<\/b><\/p>\n<p><b>\uff08\u30ab\u30c3\u30b3\u5185\u306f\u8a8d\u8a3c\u66f8\u539f\u6587\uff09<\/b><\/p>\n<\/th>\n<\/tr>\n<tr>\n<td style=\"width: 26.085%;\"><span style=\"font-weight: 400;\">\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u682a\u5f0f\u4f1a\u793e<br \/>\n\uff08\u65e5\u672c\u6cd5\u4eba\uff09<\/span><span style=\"font-weight: 400;\">\u672c\u793e<\/span><\/td>\n<td style=\"width: 18.2593%;\"><span style=\"font-weight: 400;\">2024\u5e741\u6708<\/span><\/td>\n<td style=\"width: 65.1891%;\">\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u304c\u3093\u9818\u57df\u306b\u304a\u3051\u308b\u5149\u514d\u75ab\u7642\u6cd5\u306b\u7528\u3044\u308b\u30ac\u30a4\u30c9\u7ba1\u304a\u3088\u3073\u30cb\u30fc\u30c9\u30eb\u30ab\u30c6\u30fc\u30c6\u30eb\u306e\u8a2d\u8a08\u30fb\u958b\u767a\uff08Design and development of Guide tubes and Needle catheters intended for use in photoimmunotherapy (PIT) for oncologic applications\uff09<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u304c\u3093\u9818\u57df\u306b\u304a\u3051\u308b\u5149\u514d\u75ab\u7642\u6cd5\u306b\u7528\u3044\u308b\u30ec\u30fc\u30b6\u30b7\u30b9\u30c6\u30e0\uff08\u30ec\u30fc\u30b6\u88c5\u7f6e\u3001\u30c7\u30a3\u30d5\u30e5\u30fc\u30b6\u30fc\u3001\u30cb\u30fc\u30c9\u30eb\u30ab\u30c6\u30fc\u30c6\u30eb\u3001\u8f03\u6b63\u7528\u4ed8\u5c5e\u54c1\u7b49\uff09\u304a\u3088\u3073\u30ac\u30a4\u30c9\u7ba1\u306e\u6d41\u901a\u30fb\u8ca9\u58f2\uff08Distribution and sales of Laser systems (including Laser device, Diffusers, Needle catheters and Calibration port insert) and Guide tubes intended for use in photoimmunotherapy (PIT) for oncologic applications\uff09<\/span><\/li>\n<\/ol>\n<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 26.085%;\"><span style=\"font-weight: 400;\">\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u682a\u5f0f\u4f1a\u793e<br \/>\n\uff08\u65e5\u672c\u6cd5\u4eba\uff09Device Analysis Lab<\/span><\/td>\n<td style=\"width: 18.2593%;\"><span style=\"font-weight: 400;\">2024\u5e741\u6708<\/span><\/td>\n<td style=\"width: 65.1891%;\">\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u304c\u3093\u9818\u57df\u306b\u304a\u3051\u308b\u5149\u514d\u75ab\u7642\u6cd5\u306b\u7528\u3044\u308b\u30ac\u30a4\u30c9\u7ba1\u304a\u3088\u3073\u30cb\u30fc\u30c9\u30eb\u30ab\u30c6\u30fc\u30c6\u30eb\u306e\u8a2d\u8a08\u30fb\u958b\u767a\uff08Design and development of Guide tubes and Needle catheters intended for use in photoimmunotherapy (PIT) for oncologic applications\uff09<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u304c\u3093\u9818\u57df\u306b\u304a\u3051\u308b\u5149\u514d\u75ab\u7642\u6cd5\u306b\u7528\u3044\u308b\u30ec\u30fc\u30b6\u30b7\u30b9\u30c6\u30e0\uff08\u30ec\u30fc\u30b6\u88c5\u7f6e\u3001\u30c7\u30a3\u30d5\u30e5\u30fc\u30b6\u30fc\u3001\u30cb\u30fc\u30c9\u30eb\u30ab\u30c6\u30fc\u30c6\u30eb\u3001\u8f03\u6b63\u7528\u4ed8\u5c5e\u54c1\u7b49\uff09\u304a\u3088\u3073\u30ac\u30a4\u30c9\u7ba1\u306e\u6d41\u901a\u30fb\u4fdd\u7ba1 \uff08Distribution and storage of Laser systems (including Laser device, Diffusers, Needle catheters and Calibration port insert) and Guide tubes intended for use in photoimmunotherapy (PIT) for oncologic applications\uff09<\/span><\/li>\n<\/ol>\n<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 26.085%;\"><span style=\"font-weight: 400;\">\u697d\u5929\u30e1\u30c7\u30a3\u30ab\u30eb\u682a\u5f0f\u4f1a\u793e<br \/>\n\uff08\u65e5\u672c\u6cd5\u4eba\uff09\u95a2\u897f\u30aa\u30d5\u30a3\u30b9<\/span><\/td>\n<td style=\"width: 18.2593%;\"><span style=\"font-weight: 400;\">2025\u5e748\u6708<\/span><\/td>\n<td style=\"width: 65.1891%;\"><span style=\"font-weight: 400;\">\u304c\u3093\u9818\u57df\u306b\u304a\u3051\u308b\u5149\u514d\u75ab\u7642\u6cd5\u306b\u7528\u3044\u308b\u30ec\u30fc\u30b6\u30b7\u30b9\u30c6\u30e0\uff08\u30ec\u30fc\u30b6\u88c5\u7f6e\u3001\u30c7\u30a3\u30d5\u30e5\u30fc\u30b6\u30fc\u3001\u30cb\u30fc\u30c9\u30eb\u30ab\u30c6\u30fc\u30c6\u30eb\u3001\u8f03\u6b63\u7528\u4ed8\u5c5e\u54c1\u7b49\uff09\u304a\u3088\u3073\u30ac\u30a4\u30c9\u7ba1\u306e\u8ca9\u58f2\uff08Sales of Laser systems<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(including Laser device, Diffusers, Needle catheters and<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Calibration port insert) and Guide tubes intended for use in<\/span><\/p>\n<p><span style=\"font-weight: 400;\">photoimmunotherapy (PIT) for oncologic Applications\uff09<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div><\/div><\/div><div id=\"panel-8699-2-0-1\" class=\"widget_text 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Concept\u3001\u3068\u308a\u308f\u3051\u300c\u54c1\u6027\u9ad8\u6f54\u300d\u306b\u5247\u308a\u3001\u30a2\u30eb\u30df\u30ce\u30c3\u30af\u30b9\u00ae\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u3082\u3068\u306b\u3057\u305f\u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30fb\u5b9f\u7528\u5316\u30fb\u5b89\u5b9a\u4f9b\u7d66\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\u3002 \u54c1\u8cea\u65b9\u91dd 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