{"id":30,"date":"2025-04-10T08:20:27","date_gmt":"2025-04-09T23:20:27","guid":{"rendered":"https:\/\/www.mjb.jp\/ISO17025n\/?page_id=30"},"modified":"2025-04-14T09:52:35","modified_gmt":"2025-04-14T00:52:35","slug":"product","status":"publish","type":"page","link":"https:\/\/www.mjb.jp\/iso13485n\/product.html","title":{"rendered":"\u5546\u54c1\u6848\u5185"},"content":{"rendered":"\r\n<h2 data-start=\"207\" data-end=\"287\"><strong data-start=\"216\" data-end=\"253\">\u300cISO 13485 \u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3010\u5b9f\u52d9\u5bfe\u5fdc\u30fb\u5b8c\u5168\u7248\u3011\u300d<\/strong><br data-start=\"253\" data-end=\"256\" \/>\u2015 \u533b\u7642\u6a5f\u5668QMS\u306b\u5bfe\u5fdc\u3057\u305f\u3001\u73fe\u5834\u3067\u5373\u4f7f\u3048\u308b\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8 \u2015<\/h2>\r\n<hr data-start=\"289\" data-end=\"292\" class=\"\" \/>\r\n<h3 data-start=\"294\" data-end=\"309\" class=\"\">ISO 13485:2016 \u306e\u8981\u6c42\u4e8b\u9805\u306b\u5bfe\u5fdc\u3057\u305f\u5185\u90e8\u76e3\u67fb\u7528\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3067\u3059\u3002<\/h3>\r\n<p data-start=\"311\" data-end=\"429\" class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3001\u8a2d\u8a08\u958b\u767a\u90e8\u9580\u306a\u3069\u3001\u533b\u7642\u6a5f\u5668QMS\u306b\u304b\u304b\u308f\u308b\u3059\u3079\u3066\u306e\u4f01\u696d\u5411\u3051\u306b\u3001\u5b9f\u52d9\u3067\u305d\u306e\u307e\u307e\u4f7f\u3048\u308b\u3088\u3046\u4f5c\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\r\n<h3 data-start=\"436\" data-end=\"452\" class=\"\">\u4e0b\u8a18\u306e\u65b9\u3001\u898b\u3066\u4e0b\u3055\u3044<\/h3>\r\n<ul data-start=\"454\" data-end=\"544\">\r\n<li data-start=\"454\" data-end=\"479\" class=\"\">\r\n<p data-start=\"456\" data-end=\"479\" class=\"\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u54c1\u8cea\u7ba1\u7406\u30fb\u54c1\u8cea\u4fdd\u8a3c\u62c5\u5f53\u8005<\/p>\r\n<\/li>\r\n<li data-start=\"480\" data-end=\"507\" class=\"\">\r\n<p data-start=\"482\" data-end=\"507\" class=\"\">ISO 13485\u306e\u8a8d\u8a3c\u53d6\u5f97\u30fb\u7dad\u6301\u3092\u76ee\u6307\u3059\u4f01\u696d<\/p>\r\n<\/li>\r\n<li data-start=\"508\" data-end=\"531\" class=\"\">\r\n<p data-start=\"510\" data-end=\"531\" class=\"\">QMS\u8cac\u4efb\u8005\u3001\u5185\u90e8\u76e3\u67fb\u54e1\uff08\u521d\u5fc3\u8005\u542b\u3080\uff09<\/p>\r\n<\/li>\r\n<li data-start=\"532\" data-end=\"544\" class=\"\">\r\n<p data-start=\"534\" data-end=\"544\" class=\"\">\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406\u90e8\u9580<\/p>\r\n<\/li>\r\n<\/ul>\r\n<h3 data-start=\"551\" data-end=\"573\" class=\"\">\u2463 \u7279\u5fb4\u30fb\u5546\u54c1\u5185\u5bb9\uff08\u69cb\u6210\u3068\u30dd\u30a4\u30f3\u30c8\uff09<\/h3>\r\n<div class=\"pointer-events-none relative left-[50%]! flex w-[100cqw] translate-x-[-50%] justify-center *:pointer-events-auto\">\r\n<div class=\"tableContainer horzScrollShadows\">\r\n<table class=\"min-w-full\" data-start=\"575\" data-end=\"842\">\r\n<thead data-start=\"575\" data-end=\"588\">\r\n<tr data-start=\"575\" data-end=\"588\">\r\n<th data-start=\"575\" data-end=\"582\">\u2705 \u7279\u5fb4<\/th>\r\n<th data-start=\"582\" data-end=\"588\">\u5185\u5bb9<\/th>\r\n<\/tr>\r\n<\/thead>\r\n<tbody data-start=\"607\" data-end=\"842\">\r\n<tr data-start=\"607\" data-end=\"646\">\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"607\" data-end=\"617\">\u5168\u8981\u6c42\u4e8b\u9805\u5bfe\u5fdc<\/td>\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"617\" data-end=\"646\">ISO13485:2016\u306e\u5168\u6761\u9805\uff084\u301c8\uff09\u306b\u6e96\u62e0<\/td>\r\n<\/tr>\r\n<tr data-start=\"647\" data-end=\"685\">\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"647\" data-end=\"658\">\u5b9f\u52d9\u3067\u5373\u4f7f\u7528\u53ef\u80fd<\/td>\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"658\" data-end=\"685\">\u8cea\u554f\u5f62\u5f0f\uff08YES\/NO\/\u89b3\u5bdf\u8a18\u9332\uff09\u3067\u4f7f\u3044\u3084\u3059\u3044<\/td>\r\n<\/tr>\r\n<tr data-start=\"686\" data-end=\"730\">\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"686\" data-end=\"698\">\u533b\u7642\u6a5f\u5668\u7279\u6709\u306e\u8996\u70b9<\/td>\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"698\" data-end=\"730\">\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u7121\u83cc\u51e6\u7406\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306a\u3069\u7279\u8a18\u4e8b\u9805\u3082\u30ab\u30d0\u30fc<\/td>\r\n<\/tr>\r\n<tr data-start=\"731\" data-end=\"765\">\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"731\" data-end=\"739\">\u8a18\u9332\u6b04\u4ed8\u304d<\/td>\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"739\" data-end=\"765\">\u8a3c\u62e0\u306e\u8a18\u5165\u6b04\u304c\u3042\u308a\u3001\u305d\u306e\u307e\u307e\u5831\u544a\u66f8\u306b\u8ee2\u7528\u53ef\u80fd<\/td>\r\n<\/tr>\r\n<tr data-start=\"766\" data-end=\"804\">\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"766\" data-end=\"775\">\u5f62\u5f0f<\/td>\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"775\" data-end=\"804\">\u88fd\u672c\u306e\u672c+\u540c\u4e00\u306e\u3082\u306e\u304cWORD\u306b\u53ce\u9332\uff08USB\uff09<\/td>\r\n<\/tr>\r\n<tr data-start=\"805\" data-end=\"842\">\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"805\" data-end=\"815\">\u521d\u5fc3\u8005\u3067\u3082\u5b89\u5fc3<\/td>\r\n<td class=\"max-w-[calc(var(--thread-content-max-width)*2\/3)]\" data-start=\"815\" data-end=\"842\">\u521d\u3081\u3066\u3067\u3082\u4f7f\u3044\u3084\u3059\u3044<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<\/div>\r\n<\/div>\r\n<h3 data-start=\"849\" data-end=\"866\" class=\"\">\u2464 \u7d0d\u54c1\u7269<\/h3>\r\n<p data-start=\"868\" data-end=\"874\" class=\"\">\uff21\uff14\u7248\u306b\u3057\u3066\u88fd\u672c\u3057\u3066\u304a\u6e21\u3057\u3057\u307e\u3059\u3002<\/p>\r\n<p data-start=\"868\" data-end=\"874\">\uff37\uff4f\uff52\uff44\u7248\u306b\u53ce\u9332\u3001\uff35\uff33\uff22\u30d5\u30a1\u30a4\u30eb\u3067\u304a\u6e21\u3057\u3057\u307e\u3059\u3002<\/p>\r\n<ul data-start=\"876\" data-end=\"1088\">\r\n<li data-start=\"876\" data-end=\"1045\" class=\"\">\r\n<p data-start=\"878\" data-end=\"1045\" class=\"\">\u00a0\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\uff08Word\u5f62\u5f0f\uff09<\/p>\r\n<\/li>\r\n<\/ul>\r\n<p data-start=\"878\" data-end=\"1045\" class=\"\">\u3000\u251c\u2500 4. \u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u8981\u6c42\u4e8b\u9805<br data-start=\"926\" data-end=\"929\" \/>\u3000\u251c\u2500 5. \u7d4c\u55b6\u8005\u306e\u8cac\u4efb<br data-start=\"942\" data-end=\"945\" \/>\u3000\u251c\u2500 6. \u8cc7\u6e90\u306e\u7ba1\u7406<br data-start=\"957\" data-end=\"960\" \/>\u3000\u251c\u2500 7. \u88fd\u54c1\u5b9f\u73fe\uff08\u203b\u8a2d\u8a08\u958b\u767a\u3001\u8cfc\u8cb7\u3001\u88fd\u9020\u306a\u3069\uff09<br data-start=\"986\" data-end=\"989\" \/>\u3000\u251c\u2500 8. \u6e2c\u5b9a\u30fb\u5206\u6790\u30fb\u6539\u5584<br data-start=\"1004\" data-end=\"1007\" \/>\u3000\u2514\u2500 \u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u82e6\u60c5\u5bfe\u5fdc\u306a\u3069\u306e\u91cd\u70b9\u9805\u76ee\u5225\u30c1\u30a7\u30c3\u30af<\/p>\r\n<p data-start=\"1066\" data-end=\"1088\" class=\"\"><\/p>\r\n<h3 data-start=\"1095\" data-end=\"1113\" class=\"\">\u2465 \u30e1\u30ea\u30c3\u30c8<\/h3>\r\n<ul data-start=\"1115\" data-end=\"1214\">\r\n<li data-start=\"1115\" data-end=\"1141\" class=\"\">\r\n<p data-start=\"1117\" data-end=\"1141\" class=\"\">\u5185\u90e8\u76e3\u67fb\u306e\u6e96\u5099\u30fb\u5b9f\u65bd\u30fb\u5831\u544a\u66f8\u4f5c\u6210\u304c\u30b9\u30e0\u30fc\u30ba\u306b<\/p>\r\n<\/li>\r\n<li data-start=\"1142\" data-end=\"1165\" class=\"\">\r\n<p data-start=\"1144\" data-end=\"1165\" class=\"\">\u65b0\u4efb\u76e3\u67fb\u54e1\u3084QMS\u521d\u5fc3\u8005\u306e\u6559\u80b2\u30c4\u30fc\u30eb\u306b<\/p>\r\n<\/li>\r\n<li data-start=\"1166\" data-end=\"1189\" class=\"\">\r\n<p data-start=\"1168\" data-end=\"1189\" class=\"\">\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u76e3\u67fb\u3084\u6587\u66f8\u76e3\u67fb\u306b\u3082\u5fdc\u7528\u53ef\u80fd<\/p>\r\n<\/li>\r\n<li data-start=\"1190\" data-end=\"1214\" class=\"\">\r\n<p data-start=\"1192\" data-end=\"1214\" class=\"\">\u7b2c\u4e09\u8005\u8a8d\u8a3c\u6a5f\u95a2\u306e\u76e3\u67fb\u306b\u5411\u3051\u305f\u4e8b\u524d\u78ba\u8a8d\u306b\u3082\u6700\u9069<\/p>\r\n<\/li>\r\n<\/ul>\r\n<h3 data-start=\"1221\" data-end=\"1237\" class=\"\">\u2466 \u8cfc\u5165\u8005\u30ec\u30d3\u30e5\u30fc<\/h3>\r\n<blockquote data-start=\"1239\" data-end=\"1324\">\r\n<p data-start=\"1241\" data-end=\"1324\" class=\"\">\u300cISO 13485\u306e\u76e3\u67fb\u304c\u521d\u3081\u3066\u3067\u3082\u3001\u3053\u308c\u304c\u3042\u308c\u3070\u5b89\u5fc3\u3057\u3066\u5bfe\u5fdc\u3067\u304d\u307e\u3057\u305f\uff01\u300d<br data-start=\"1280\" data-end=\"1283\" \/>\u300c\u8a2d\u8a08\u3084\u82e6\u60c5\u5bfe\u5fdc\u306a\u3069\u3001\u533b\u7642\u6a5f\u5668\u7279\u6709\u306e\u8981\u6c42\u3082\u7db2\u7f85\u3055\u308c\u3066\u3044\u3066\u975e\u5e38\u306b\u52a9\u304b\u308a\u307e\u3057\u305f\u3002\u300d<\/p>\r\n<\/blockquote>\r\n<hr data-start=\"1326\" data-end=\"1329\" class=\"\" \/>\r\n<h3 data-start=\"1331\" data-end=\"1349\" class=\"\">\u2467 \u4fa1\u683c\u30fb\u7d0d\u54c1\u5f62\u5f0f\u30fb\u30b5\u30dd\u30fc\u30c8<\/h3>\r\n<ul data-start=\"1351\" data-end=\"1457\">\r\n<li data-start=\"1351\" data-end=\"1368\" class=\"\">\r\n<p data-start=\"1353\" data-end=\"1368\" class=\"\">\u4fa1\u683c\uff1a60,000\u5186\uff08\u7a0e\u629c\uff09<\/p>\r\n<\/li>\r\n<li data-start=\"1244\" data-end=\"1279\" class=\"\">\r\n<p data-start=\"1246\" data-end=\"1279\" class=\"\">\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u3042\u3089\u304b\u3058\u3081\u88fd\u672c\u3002\u305d\u3057\u3066\u540c\u4e00\u306e\u3082\u306e\u3092Word\u5f62\u5f0f\u306eUSB\u30d5\u30a1\u30a4\u30eb\u3092\u540c\u5c01\u3002<\/p>\r\n<\/li>\r\n<li data-start=\"1244\" data-end=\"1279\">\u3054\u6ce8\u6587\u306e\u306e\u3061\u3001\u898b\u7a4d\u66f8\u3001\u8acb\u6c42\u66f8\u3092\u30e1\u30fc\u30eb\u306b\u3066\u9001\u4ed8\u3002<\/li>\r\n<li data-start=\"1280\" data-end=\"1302\" class=\"\">\r\n<p data-start=\"1282\" data-end=\"1302\" class=\"\">\u7d0d\u54c1\uff1a\u500b\u4eba\u306e\u65b9\u306f\u3001\u5165\u91d1\u306e\u78ba\u8a8d\u5f8c\u306b\u7d0d\u54c1\u3002\u6cd5\u4eba\u306e\u65b9\u306f\u3001\u3059\u3050\u306b\u7d0d\u54c1\u3002\u5546\u54c1\u5230\u7740\u5f8c\u306b\uff11\uff10\u65e5\u4ee5\u5185\u306b\u5165\u91d1\u3057\u3066\u4e0b\u3055\u3044\u3002<\/p>\r\n<\/li>\r\n<li data-start=\"1303\" data-end=\"1321\" class=\"\">\r\n<p data-start=\"1305\" data-end=\"1321\" class=\"\">\u30b5\u30dd\u30fc\u30c8\uff1a\u30e1\u30fc\u30eb\u76f8\u8ac7\u306b\u3066\uff13\u56de\u307e\u3067\u7121\u6599\u4ed8\u304d<\/p>\r\n<\/li>\r\n<\/ul>\r\n<h3 data-start=\"1464\" data-end=\"1478\" class=\"\">\u662f\u975e\u3001\u3054\u8cfc\u5165\u4e0b\u3055\u3044<\/h3>\r\n<h4 data-start=\"1328\" data-end=\"1347\"><strong data-start=\"1351\" data-end=\"1382\">\u300c\u3082\u3046\u8ff7\u308f\u306a\u3044\u3002\u3059\u3050\u306b\u4f7f\u3048\u308b\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\uff01\u300d<\/strong><\/h4>\r\n<h4 data-start=\"1482\" data-end=\"1546\"><strong data-start=\"1482\" data-end=\"1509\">\u5185\u90e8\u76e3\u67fb\u3092\u3001\u3082\u3063\u3068\u6b63\u78ba\u306b\u3001\u3082\u3063\u3068\u52b9\u7387\u7684\u306b\u3002<\/strong><\/h4>\r\n<p data-start=\"1482\" data-end=\"1546\">\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5b9f\u52d9\u3092\u652f\u3048\u308b\u3001\u73fe\u5834\u5bfe\u5fdc\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3002<\/p>\r\n<table width=\"972\">\r\n<tbody>\r\n<tr>\r\n<td rowspan=\"4\" width=\"53\">\r\n<p>\u898f\u683c\u8981\u6c42\u4e8b\u9805<\/p>\r\n<\/td>\r\n<td rowspan=\"4\" width=\"363\">\r\n<p>\u30c1\u3000\u30a7\u3000\u30c3\u3000\u30af\u3000\u9805\u3000\u76ee<\/p>\r\n<\/td>\r\n<td rowspan=\"4\" width=\"344\">\r\n<p>\u8a18\u3000\u3000\u3000\u3000\u3000\u5165\u3000\u3000\u3000\u3000\u3000\u6b04<\/p>\r\n<\/td>\r\n<td colspan=\"4\" width=\"212\">\r\n<p>\u8a55\u3000\u3000\u3000\u4fa1<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td colspan=\"2\" width=\"106\">\r\n<p>\u9069\u3000\u5408<\/p>\r\n<\/td>\r\n<td colspan=\"2\" width=\"106\">\r\n<p>\u4e0d\u9069\u5408<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>\u9069\u5408<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u63a8\u5968\u4e8b\u9805<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u8efd\u5fae<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u91cd\u5927<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>\u25cb<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u25b3<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u00d7<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u00d7\u00d7<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"363\">\r\n<p>\u533b\u7642\u6a5f\u5668\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u3001\u3069\u306e\u3088\u3046\u306a\u5185\u5bb9\u3092\u542b\u3093\u3067\u3044\u307e\u3059\u304b\uff1f<\/p>\r\n<\/td>\r\n<td width=\"344\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"363\">\r\n<p>\u6587\u66f8\u7ba1\u7406\u306b\u3064\u3044\u3066\u306e\u624b\u9806\u306f\u3001\u3069\u3053\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/p>\r\n<\/td>\r\n<td width=\"344\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"363\">\r\n<p>\u5916\u90e8\u6587\u66f8\u306e\u7ba1\u7406\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3066\u4e0b\u3055\u3044\u3002<\/p>\r\n<\/td>\r\n<td width=\"344\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<p>&nbsp;<\/p>\r\n<table width=\"972\">\r\n<tbody>\r\n<tr>\r\n<td rowspan=\"4\" width=\"53\">\r\n<p>\u898f\u683c\u8981\u6c42\u4e8b\u9805<\/p>\r\n<\/td>\r\n<td rowspan=\"4\" width=\"363\">\r\n<p>\u30c1\u3000\u30a7\u3000\u30c3\u3000\u30af\u3000\u9805\u3000\u76ee<\/p>\r\n<\/td>\r\n<td rowspan=\"4\" width=\"344\">\r\n<p>\u8a18\u3000\u3000\u3000\u3000\u3000\u5165\u3000\u3000\u3000\u3000\u3000\u6b04<\/p>\r\n<\/td>\r\n<td colspan=\"4\" width=\"212\">\r\n<p>\u8a55\u3000\u3000\u3000\u4fa1<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td colspan=\"2\" width=\"106\">\r\n<p>\u9069\u3000\u5408<\/p>\r\n<\/td>\r\n<td colspan=\"2\" width=\"106\">\r\n<p>\u4e0d\u9069\u5408<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>\u9069\u5408<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u63a8\u5968\u4e8b\u9805<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u8efd\u5fae<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u91cd\u5927<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>\u25cb<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u25b3<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u00d7<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u00d7\u00d7<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>4<\/p>\r\n<\/td>\r\n<td width=\"363\">\r\n<p>\u8a18\u9332\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u304b\uff1f\u5404\u8a18\u9332\u306e\u4fdd\u5b58\u671f\u9593\u306b\u3064\u3044\u3066\u3069\u3053\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/p>\r\n<\/td>\r\n<td width=\"344\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>\uff15<\/p>\r\n<\/td>\r\n<td width=\"363\">\r\n<p>\u300c\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3059\u3053\u3068\u306f\u5f53\u7136\u306e\u3053\u3068\u3068\u3057\u3066\uff0c\u9867\u5ba2\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3059\u3053\u3068\u306e\u91cd\u8981\u6027\u3092\u7d44\u7e54\u5185\u306b\u5468\u77e5\u3059\u308b\u300d\u306b\u3064\u3044\u3066\u3069\u306e\u3088\u3046\u306b\u793e\u5185\u306b\u5468\u77e5\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/p>\r\n<\/td>\r\n<td width=\"344\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"363\">\r\n<p>\u7d44\u7e54\u306e\u76ee\u7684\u3092\u6559\u3048\u3066\u4e0b\u3055\u3044\u3002<\/p>\r\n<\/td>\r\n<td width=\"344\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<p>&nbsp;<\/p>\r\n<table width=\"972\">\r\n<tbody>\r\n<tr>\r\n<td rowspan=\"4\" width=\"53\">\r\n<p>\u898f\u683c\u8981\u6c42\u4e8b\u9805<\/p>\r\n<\/td>\r\n<td rowspan=\"4\" width=\"363\">\r\n<p>\u30c1\u3000\u30a7\u3000\u30c3\u3000\u30af\u3000\u9805\u3000\u76ee<\/p>\r\n<\/td>\r\n<td rowspan=\"4\" width=\"344\">\r\n<p>\u8a18\u3000\u3000\u3000\u3000\u3000\u5165\u3000\u3000\u3000\u3000\u3000\u6b04<\/p>\r\n<\/td>\r\n<td colspan=\"4\" width=\"212\">\r\n<p>\u8a55\u3000\u3000\u3000\u4fa1<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td colspan=\"2\" width=\"106\">\r\n<p>\u9069\u3000\u5408<\/p>\r\n<\/td>\r\n<td colspan=\"2\" width=\"106\">\r\n<p>\u4e0d\u9069\u5408<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>\u9069\u5408<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u63a8\u5968\u4e8b\u9805<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u8efd\u5fae<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u91cd\u5927<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>\u25cb<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u25b3<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u00d7<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>\u00d7\u00d7<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>\uff15<\/p>\r\n<\/td>\r\n<td width=\"363\">\r\n<p>\u6226\u7565\u7684\u306a\u65b9\u5411\u6027\u306b\u3064\u3044\u3066\u6559\u3048\u3066\u4e0b\u3055\u3044<\/p>\r\n<\/td>\r\n<td width=\"344\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"363\">\r\n<p>\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u610f\u56f3\u3057\u305f\u7d50\u679c\u3068\u306f\u8aac\u660e\u3057\u3066\u4e0b\u3055\u3044<\/p>\r\n<\/td>\r\n<td width=\"344\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"363\">\r\n<p>\u5916\u90e8\u53ca\u3073\u5185\u90e8\u306e\u8ab2\u984c\u306b\u3064\u3044\u3066\u660e\u78ba\u306b\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/p>\r\n<\/td>\r\n<td width=\"344\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<td width=\"53\">\r\n<p>&nbsp;<\/p>\r\n<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<p>&nbsp;<\/p>\r\n<p>\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306f\u5168\uff16\uff14\u30da\u30fc\u30b8\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\uff37\uff4f\uff52\uff44\u3000A4\u7248\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\r\n\r\n\r\n\r\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden width=\"300\" height=\"150\" style=\"width: 100%; height: 600px;\" class=\"wp-block-file__embed\" data=\"https:\/\/www.mjb.jp\/iso13485n\/wp-content\/uploads\/2025\/04\/ISO1\uff13\uff14\uff18\uff15\u3000\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8-\u30b5\u30f3\u30d7\u30eb.pdf\" type=\"application\/pdf\" aria-label=\"ISO1\uff13\uff14\uff18\uff15\u3000\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8  \u30b5\u30f3\u30d7\u30eb\u306e\u57cb\u3081\u8fbc\u307f\u3002\"><\/object><a id=\"wp-block-file--media-a272ef79-a302-407e-a8ea-50b61a99eb39\" href=\"https:\/\/www.mjb.jp\/iso13485n\/wp-content\/uploads\/2025\/04\/ISO1\uff13\uff14\uff18\uff15\u3000\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8-\u30b5\u30f3\u30d7\u30eb.pdf\">ISO1\uff13\uff14\uff18\uff15\u3000\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8 \u30b5\u30f3\u30d7\u30eb<\/a><a href=\"https:\/\/www.mjb.jp\/iso13485n\/wp-content\/uploads\/2025\/04\/ISO1\uff13\uff14\uff18\uff15\u3000\u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8-\u30b5\u30f3\u30d7\u30eb.pdf\" class=\"wp-block-file__button wp-element-button\" download=\"\" aria-describedby=\"wp-block-file--media-a272ef79-a302-407e-a8ea-50b61a99eb39\">\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/a><\/div>\r\n","protected":false},"excerpt":{"rendered":"<p>\u300cISO 13485 \u5185\u90e8\u76e3\u67fb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3010\u5b9f\u52d9\u5bfe\u5fdc\u30fb\u5b8c\u5168\u7248\u3011\u300d\u2015 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[&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"swell_btn_cv_data":"","footnotes":""},"class_list":["post-30","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.mjb.jp\/iso13485n\/wp-json\/wp\/v2\/pages\/30","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.mjb.jp\/iso13485n\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.mjb.jp\/iso13485n\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.mjb.jp\/iso13485n\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mjb.jp\/iso13485n\/wp-json\/wp\/v2\/comments?post=30"}],"version-history":[{"count":10,"href":"https:\/\/www.mjb.jp\/iso13485n\/wp-json\/wp\/v2\/pages\/30\/revisions"}],"predecessor-version":[{"id":111,"href":"https:\/\/www.mjb.jp\/iso13485n\/wp-json\/wp\/v2\/pages\/30\/revisions\/111"}],"wp:attachment":[{"href":"https:\/\/www.mjb.jp\/iso13485n\/wp-json\/wp\/v2\/media?parent=30"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}