{"id":10,"date":"2025-04-09T19:08:45","date_gmt":"2025-04-09T10:08:45","guid":{"rendered":"https:\/\/www.mjb.jp\/ISO17025n\/?page_id=2"},"modified":"2025-04-11T19:13:45","modified_gmt":"2025-04-11T10:13:45","slug":"sample-page-2","status":"publish","type":"page","link":"https:\/\/www.mjb.jp\/iso13485n\/","title":{"rendered":"\u30db\u30fc\u30e0"},"content":{"rendered":"<h3 data-start=\"59\" data-end=\"94\" class=\"\">ISO 13485\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u30e1\u30ea\u30c3\u30c8<\/h3>\n<ol data-start=\"96\" data-end=\"567\">\n<li data-start=\"96\" data-end=\"165\" class=\"\">\n<p data-start=\"99\" data-end=\"165\" class=\"\">\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u4f7f\u3046\u3053\u3068\u3067\u3001\u3069\u306e\u76e3\u67fb\u54e1\u304c\u62c5\u5f53\u3057\u3066\u3082\u540c\u3058\u57fa\u6e96\u3067\u78ba\u8a8d\u30fb\u8a55\u4fa1\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"167\" data-end=\"230\" class=\"\">\n<p data-start=\"170\" data-end=\"230\" class=\"\">\u6587\u66f8\u7ba1\u7406\u3001\u88fd\u9020\u7ba1\u7406\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306a\u3069\u3001\u8907\u96d1\u306a\u8981\u6c42\u4e8b\u9805\u306e\u898b\u843d\u3068\u3057\u3092\u9632\u304e\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"232\" data-end=\"301\" class=\"\">\n<p data-start=\"235\" data-end=\"301\" class=\"\">\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u4f7f\u3048\u3070\u3001\u4e8b\u524d\u306b\u3069\u3053\u3092\u91cd\u70b9\u7684\u306b\u898b\u308b\u304b\u660e\u78ba\u306b\u3067\u304d\u3001\u52b9\u7387\u7684\u306b\u6e96\u5099\u304c\u9032\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"303\" data-end=\"371\" class=\"\">\n<p data-start=\"306\" data-end=\"371\" class=\"\">\u30c1\u30a7\u30c3\u30af\u9805\u76ee\u3054\u3068\u306b\u3001\u95a2\u9023\u6587\u66f8\u30fb\u8a18\u9332\u3092\u628a\u63e1\u3057\u3066\u304a\u304f\u3053\u3068\u3067\u3001\u73fe\u5834\u3067\u306e\u78ba\u8a8d\u304c\u5186\u6ed1\u306b\u3002<\/p>\n<\/li>\n<li data-start=\"373\" data-end=\"442\" class=\"\">\n<p data-start=\"376\" data-end=\"442\" class=\"\">\u767a\u898b\u3055\u308c\u305f\u4e0d\u9069\u5408\u3084\u6539\u5584\u70b9\u3092\u3001\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u9805\u76ee\u3068\u7167\u3089\u3057\u3066\u5206\u6790\u30fb\u5bfe\u7b56\u304c\u7acb\u3066\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"444\" data-end=\"506\" class=\"\">\n<p data-start=\"447\" data-end=\"506\" class=\"\">\u65b0\u3057\u3044\u76e3\u67fb\u54e1\u306e\u80b2\u6210\u3084\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u7406\u89e3\u3092\u6df1\u3081\u308b\u6559\u6750\u3068\u3057\u3066\u4f7f\u3048\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"508\" data-end=\"567\" class=\"\">\n<p data-start=\"511\" data-end=\"567\" class=\"\">\u5185\u90e8\u76e3\u67fb\u304c\u3057\u3063\u304b\u308a\u3068\u884c\u308f\u308c\u3066\u3044\u308b\u8a3c\u62e0\u3068\u306a\u308a\u3001\u5916\u90e8\u5be9\u67fb\u6a5f\u95a2\u3078\u306e\u4fe1\u983c\u6027\u30a2\u30c3\u30d7\u306b\u3002<\/p>\n<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: center;\">\u5185\u90e8\u76e3\u67fb\u898f\u5b9a<\/h2>\n<p><a name=\"_Toc518727618\"><\/a><strong>\u7b2c\uff12\uff17\u7ae0\u3000\u5185\u90e8\u76e3\u67fb\uff08\uff18.\uff12.\uff14\uff09<\/strong><\/p>\n<p>\uff11\uff0e\u76ee\u7684<\/p>\n<p>\u76ee\u7684\u306f\u3001\u6821\u6b63\u30bb\u30f3\u30bf\u30fc\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3057\u3066\u4ee5\u4e0b\u306e\u4e8b\u9805\u304c\u6e80\u8db3\u3055\u308c\u3066\u3044\u308b\u304b\u5426\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306b\u5185\u90e8\u76e3\u67fb\u306b\u95a2\u3059\u308b\u624b\u9806\u3092\u660e\u78ba\u306b\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002<\/p>\n<p>\u2460\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u304c\u3001<span>ISO 17025:2017<\/span>\uff08<span>JIS Q 17025:2017<\/span>\uff09\u306e\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u8981\u6c42\u4e8b\u9805\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u304b\u3002<\/p>\n<p>\u2461\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u304c\u52b9\u679c\u7684\u306b\u5b9f\u65bd\u3055\u308c\u3001\u7dad\u6301\u3055\u308c\u3066\u3044\u308b\u304b\u3002<\/p>\n<p>\u2462\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u304c\u3053\u306e\u898f\u683c\u306e\u8981\u6c42\u4e8b\u9805\u3092\u542b\u3081\u3066\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u305f\u3081\u306b\u8a08\u753b\u3055\u308c\u305f\u53d6\u6c7a\u3081\u306b\u5408\u81f4\u3057\u3066\u3044\u308b\u304b\u3002<\/p>\n<p>\u2463\u76e3\u67fb\u306e\u7d50\u679c\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u793e\u9577\u306b\u63d0\u4f9b\u3059\u308b\u3002<\/p>\n<p>\uff12\uff0e\u9069\u7528\u7bc4\u56f2<\/p>\n<p>\u6821\u6b63\u30bb\u30f3\u30bf\u30fc\u304c\u5b9f\u65bd\u3059\u308b\u5e74\uff11\u56de\uff08\uff11\u6708\uff09\u306e\u5185\u90e8\u76e3\u67fb\u306b\u9069\u7528\u3059\u308b\u3002\u306a\u304a\u3001\u793e\u9577\u307e\u305f\u306f\u54c1\u8cea\u7ba1\u7406\u8005\u304c\u5fc5\u8981\u3068\u5224\u65ad\u3057\u305f\u969b\u306b\u306f\u81e8\u6642\u306b\u5185\u90e8\u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u3002<\/p>\n<p>\uff13\uff0e\u8cac\u4efb\u53ca\u3073\u6a29\u9650<\/p>\n<p>\u5185\u90e8\u76e3\u67fb\u3092\u7d71\u62ec\u3059\u308b\u8cac\u4efb\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u8005\u306b\u3042\u308b\u3002\u5185\u90e8\u76e3\u67fb\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u8005\uff08\u5185\u90e8\u76e3\u67fb\u54e1\u3068\u3057\u3066\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\uff09\u304c\u5b9f\u65bd\u3057\u3001\uff08\u54c1\u8cea\u7ba1\u7406\u8005\u306b\u5bfe\u3057\u3066\u306f\u4ed6\u306e\u76e3\u67fb\u54e1\u304c\u884c\u3046\uff09\u793e\u9577\u306b\u5831\u544a\u3059\u308b\u3002<\/p>\n<p>\uff14\uff0e\u53c2\u7167\u6587\u66f8\u53ca\u3073\u95a2\u9023\u5e33\u8868<\/p>\n<p>\u5185\u90e8\u76e3\u67fb\u5b9f\u65bd\u8a08\u753b\u66f8\u3000\u3000\u3000\u3000\u3000\u3000\u00a0\u00a0\u00a0\u00a0\u00a0 8.8-01<\/p>\n<p>\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3000\u3000\u3000\u3000<span>\u00a0\u00a0\u00a0\u00a0\u00a0 8.8-02<\/span><\/p>\n<p>\u5185\u90e8\u76e3\u67fb\u5831\u544a\u66f8\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u00a0\u00a0\u00a0\u00a0\u00a0 8.8-03<\/p>\n<p>\u662f\u6b63\u51e6\u7f6e\u5831\u544a\u66f8\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u30008.7-01<\/p>\n<p>\u4e88\u9632\u51e6\u7f6e\u5831\u544a\u66f8\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u3000\u3000\u3000\u30008.7-02<\/p>\n<p>\u6709\u8cc7\u683c\u8005\u4e00\u89a7\u8868\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u00a0\u00a0\u00a0\u00a0\u00a0 6.2-04<\/p>\n<p>\uff15\uff0e\u5b9f\u65bd\u4e8b\u9805<\/p>\n<p>\uff08\uff11\uff09\u5185\u90e8\u76e3\u67fb\u306e\u8a08\u753b<\/p>\n<p>\uff11\uff09\u5185\u90e8\u76e3\u67fb\u54e1\u306e\u8cc7\u683c\u8a8d\u5b9a<\/p>\n<p>\u793e\u5185\u5916\u306e<span>ISO 17025<\/span>\u306e\u5185\u90e8\u76e3\u67fb\u54e1\u990a\u6210\u30b3\u30fc\u30b9\u3092\u53d7\u8b1b\u3057\u7d42\u4e86\u3057\u305f\u8005\u3092\u54c1\u8cea\u7ba1\u7406\u8005\u304c\u5185\u90e8\u76e3\u67fb\u54e1\u3068\u3057\u3066\u8a8d\u5b9a\u3057\u3001\u793e\u9577\u304c\u627f\u8a8d\u3059\u308b\u3002\u54c1\u8cea\u7ba1\u7406\u8005\u306f\u3001\u300c\u6709\u8cc7\u683c\u8005\u4e00\u89a7\u8868\u300d\u306b\u767b\u9332\u3057\u300c\u8077\u52d9\u4efb\u547d\u66f8\u300d\u3092\u767a\u884c\u3059\u308b\u3002<\/p>\n<p>\uff12\uff09\u300c\u5185\u90e8\u76e3\u67fb\u5b9f\u65bd\u8a08\u753b\u66f8\u300d\u306e\u7b56\u5b9a<\/p>\n<p>\u2460\u54c1\u8cea\u7ba1\u7406\u8005\u306f\u3001\uff12\u30f6\u6708\u524d\u307e\u3067\u306b\u5185\u90e8\u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u5185\u90e8\u76e3\u67fb\u54e1\u3092\u6307\u540d\u3059\u308b\u3002<\/p>\n<p>\u2461\u54c1\u8cea\u7ba1\u7406\u8005\u306f\u3001\u5185\u90e8\u76e3\u67fb\u5b9f\u65bd\u4e88\u5b9a\u306e\uff11\u30f6\u6708\u524d\u307e\u3067\u306b\u300c\u5185\u90e8\u76e3\u67fb\u5b9f\u65bd\u8a08\u753b\u66f8\u300d\u3092\u4f5c\u6210\u3059\u308b\u3002<\/p>\n<p>\u300c\u5185\u90e8\u76e3\u67fb\u5b9f\u65bd\u8a08\u753b\u66f8\u300d\u306b\u306f\u4ee5\u4e0b\u306e\u9805\u76ee\u3092\u542b\u3080\u3002<\/p>\n<p>\u5b9f\u65bd\u5834\u6240\u3001\u76e3\u67fb\u76ee\u7684\u3001\u76e3\u67fb\u57fa\u6e96\u3001\u76e3\u67fb\u65b9\u6cd5\u3001\u5b9f\u65bd\u4e88\u5b9a\u65e5\u3001\u88ab\u76e3\u67fb\u8005\u3001\u6642\u9593\u3001<\/p>\n<p>\uff29\uff33\uff2f\u8981\u6c42\u4e8b\u9805\u3001\u76e3\u67fb\u54e1<\/p>\n<p>\u2462\u54c1\u8cea\u7ba1\u7406\u8005\u306f\u4f5c\u6210\u3057\u305f\u300c\u5185\u90e8\u76e3\u67fb\u5b9f\u65bd\u8a08\u753b\u66f8\u300d\u3092\u793e\u9577\u306b\u63d0\u51fa\u3057\uff64\u627f\u8a8d\u3092\u5f97\u308b\u3002<\/p>\n<p>\u76e3\u67fb\u306f\u5185\u90e8\u76e3\u67fb\u54e1\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u54c1\u8cea\u7ba1\u7406\u8005\u304c\u5168\u88ab\u76e3\u67fb\u8005\u306b\u5bfe\u3057\u3066\u884c\u3046\u3002<\/p>\n<p>\u305f\u3060\u3057\u3001\u54c1\u8cea\u7ba1\u7406\u8005\u306b\u5bfe\u3057\u3066\u306f\u4ed6\u306e\u8005\u304c\u884c\u3046\u3002<\/p>\n<p>\u76e3\u67fb\u54e1\u306f\u81ea\u3089\u306e\u4ed5\u4e8b\u306f\u76e3\u67fb\u3067\u304d\u306a\u3044\u3002<\/p>\n<p>\uff13\uff09\u5185\u90e8\u76e3\u67fb\u5b9f\u65bd\u306e\u901a\u77e5<\/p>\n<p>\u54c1\u8cea\u7ba1\u7406\u8005\u306f\u5185\u90e8\u76e3\u67fb\u306e\u5b9f\u65bd\uff12\u9031\u9593\u524d\u307e\u3067\u306b\u300c\u5185\u90e8\u76e3\u67fb\u5b9f\u65bd\u8a08\u753b\u66f8\u300d\u3092\u3082\u3063\u3066\u3001\u88ab\u76e3\u67fb\u8005\u306b<\/p>\n<p>\u5185\u90e8\u76e3\u67fb\u306e\u5b9f\u65bd\u3092\u901a\u77e5\u3059\u308b\u3002<\/p>\n<p>\uff14\uff09\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\uff08\u4f5c\u6210\uff09\u78ba\u8a8d<\/p>\n<p>\u54c1\u8cea\u7ba1\u7406\u8005\u306f\u5185\u90e8\u76e3\u67fb\u306e\u5b9f\u65bd\u307e\u3067\u306b\u3001\u300c\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u300d\u3092\uff08\u4f5c\u6210\uff09\u78ba\u8a8d\u3057\u3001\u793e\u9577\u306e<\/p>\n<p>\u627f\u8a8d\u3092\u5f97\u308b\u3002<\/p>\n<p>\uff08\uff12\uff09\u5185\u90e8\u76e3\u67fb\u306e\u5b9f\u65bd\u30fb\u5831\u544a<\/p>\n<p>\uff11\uff09\u5185\u90e8\u76e3\u67fb\u306e\u5b9f\u65bd<\/p>\n<p>\u2460\u76e3\u67fb\u524d\u4f1a\u8b70\uff1a\u76e3\u67fb\u54e1\u3068\u88ab\u76e3\u67fb\u5074\u3067\u76e3\u67fb\u524d\u4f1a\u8b70\u3092\u884c\u3044\u3001\u300c\u5185\u90e8\u76e3\u67fb\u5b9f\u65bd\u8a08\u753b\u66f8\u300d\u3092<\/p>\n<p>\u3082\u3068\u306b\u3001\u76e3\u67fb\u306e\u76ee\u7684\u3001\u7bc4\u56f2\uff08\u5bfe\u8c61\u8005\u3001\u8a72\u5f53\u8981\u6c42\u4e8b\u9805\uff09\u3001\u5b9f\u65bd\u6642\u9593\u7b49\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/p>\n<p>\u2461\u76e3\u67fb\u306e\u5b9f\u65bd\uff1a\u76e3\u67fb\u54e1\u306f\u3001\u300c\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u300d\u306b\u57fa\u3065\u3044\u3066\u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u3002<\/p>\n<p>\u2462\u76e3\u67fb\u54e1\u4f1a\u8b70\uff1a\u76e3\u67fb\u7d42\u4e86\u5f8c\u3001\u76e3\u67fb\u54e1\u306f\u3001\u76e3\u67fb\u7d50\u679c\u53ca\u3073\u8a55\u4fa1\u306e\u3068\u308a\u307e\u3068\u3081\u3092\u884c\u3046\u3002<\/p>\n<p>\u305d\u306e\u969b\u3001\u63a8\u5968\u4e8b\u9805\u3001\u4e0d\u9069\u5408\u306f\u4ee5\u4e0b\u306e\u533a\u5206\u3067\u5206\u985e\u3059\u308b\u3002<\/p>\n<p>\uff41\uff09\u91cd\u5927\u306a\u4e0d\u9069\u5408\uff1a\u305d\u306e\u4e0d\u9069\u5408\u304c\u662f\u6b63\u3055\u308c\u306a\u3044\u3068\u54c1\u8cea\u304c\u4fdd\u8a3c\u3055\u308c\u306a\u3044\u5834\u5408\u3001\u3042\u308b\u3044<\/p>\n<p>\u306f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u304c\u6709\u52b9\u306b\u6a5f\u80fd\u3057\u306a\u3044\u5834\u5408\u3002<\/p>\n<p>\uff42\uff09\u8efd\u5fae\u306a\u4e0d\u9069\u5408\uff1a\u305d\u306e\u4e0d\u9069\u5408\u304c\u662f\u6b63\u3055\u308c\u306a\u304f\u3066\u3082\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3078<\/p>\n<p>\u306e\u5f71\u97ff\u304c\u3059\u304f\u306a\u3044\u304b\u3001\u3042\u308b\u3044\u306f\u76f4\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