{"id":10221,"date":"2023-08-11T01:47:47","date_gmt":"2023-08-11T01:47:47","guid":{"rendered":"https:\/\/china-maching.com\/?p=10221"},"modified":"2023-08-29T01:56:50","modified_gmt":"2023-08-29T01:56:50","slug":"understanding-iso-13485","status":"publish","type":"post","link":"https:\/\/china-maching.com\/ja\/iso-13485-\u3092\u7406\u89e3\u3059\u308b\/","title":{"rendered":"ISO 13485 \u3092\u7406\u89e3\u3059\u308b: \u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b"},"content":{"rendered":"

ISO13485\u3068\u306f\u4f55\u3067\u3059\u304b?<\/h2>\n

ISO 13485 \u306f\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u7279\u6709\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0 (QMS) \u306e\u8981\u4ef6\u3092\u6982\u8aac\u3059\u308b\u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u898f\u683c\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u7d44\u7e54\u304c\u54c1\u8cea\u7ba1\u7406\u3078\u306e\u69cb\u9020\u5316\u3055\u308c\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u78ba\u7acb\u304a\u3088\u3073\u7dad\u6301\u3059\u308b\u305f\u3081\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3092\u63d0\u4f9b\u3057\u3001\u88fd\u54c1\u304c\u898f\u5236\u8981\u4ef6\u3068\u9867\u5ba2\u306e\u671f\u5f85\u3092\u4e00\u8cab\u3057\u3066\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p>\n

\u63a8\u5968\u8aad\u66f8: CNC \u306e\u54c1\u8cea\u7ba1\u7406\u306b\u95a2\u3059\u308b\u3059\u3079\u3066<\/a><\/strong><\/p>\n

ISO 13485 \u306e\u6982\u8981<\/h3>\n

ISO 13485 \u306f\u3001\u88fd\u9020\u696d\u8005\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3001\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u3092\u542b\u3080\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u3042\u3089\u3086\u308b\u7d44\u7e54\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u30cb\u30fc\u30ba\u306b\u5408\u308f\u305b\u305f QMS \u306e\u958b\u767a\u3068\u5b9f\u88c5\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u304a\u308a\u3001\u7d44\u7e54\u304c\u5b89\u5168\u3067\u52b9\u679c\u7684\u306a\u533b\u7642\u6a5f\u5668\u3092\u4e00\u8cab\u3057\u3066\u751f\u7523\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n

\u4e3b\u8981\u306a\u8981\u4ef6\u306e\u8981\u70b9 13485<\/h3>\n

ISO 13485 \u306f\u3001\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306b\u7d44\u7e54\u304c\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3044\u304f\u3064\u304b\u306e\u91cd\u8981\u306a\u8981\u4ef6\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8981\u4ef6\u306b\u306f\u3001\u7ba1\u7406\u8cac\u4efb\u3001\u6587\u66f8\u5316\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u88fd\u54c1\u306e\u5b9f\u73fe\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u30c8\u30d4\u30c3\u30af\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n

ISO 13485 \u306e\u6700\u3082\u91cd\u8981\u306a\u8981\u4ef6\u306e 1 \u3064\u306f\u3001\u7d44\u7e54\u304c\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u305f\u52b9\u679c\u7684\u306a QMS \u3092\u78ba\u7acb\u304a\u3088\u3073\u7dad\u6301\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u958b\u767a\u3001\u88fd\u9020\u3001\u6d41\u901a\u306b\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e\u6d3b\u52d5\u304c\u78ba\u5b9f\u306b\u7ba1\u7406\u3055\u308c\u308b\u3088\u3046\u306b\u3059\u308b\u305f\u3081\u306e\u3055\u307e\u3056\u307e\u306a\u30d7\u30ed\u30bb\u30b9\u3068\u624b\u9806\u306e\u5b9f\u88c5\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n

13485 \u306e\u305d\u306e\u4ed6\u306e\u91cd\u8981\u306a\u8981\u4ef6\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/h3>\n

\u7d44\u7e54\u306e\u5168\u4f53\u7684\u306a\u76ee\u6a19\u306b\u6cbf\u3063\u305f\u660e\u78ba\u306a\u54c1\u8cea\u76ee\u6a19\u3068\u54c1\u8cea\u30dd\u30ea\u30b7\u30fc\u3092\u78ba\u7acb\u3057\u3066\u3044\u307e\u3059\u3002
\n\u79c1\u305f\u3061\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u539f\u5247\u304c\u7d44\u7e54\u5185\u3067\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3055\u308c\u308b\u304b\u3092\u8aac\u660e\u3059\u308b\u30dd\u30ea\u30b7\u30fc\u3001\u624b\u9806\u3001\u304a\u3088\u3073\u4f5c\u696d\u6307\u793a\u3092\u6587\u66f8\u5316\u3057\u3066\u3044\u307e\u3059\u3002
\n\u5f53\u793e\u306f\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u3068\u88fd\u54c1\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306b\u5bfe\u3059\u308b\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3001\u8efd\u6e1b\u3059\u308b\u305f\u3081\u306b\u3001\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u30ea\u30b9\u30af\u8a55\u4fa1\u3092\u5b9f\u65bd\u3057\u3066\u3044\u307e\u3059\u3002
\n\u3053\u308c\u3089\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u304a\u3088\u3073\u8ca9\u58f2\u306b\u5f93\u4e8b\u3059\u308b\u3059\u3079\u3066\u306e\u5f93\u696d\u54e1\u304c\u9069\u5207\u306a\u8a13\u7df4\u3092\u53d7\u3051\u3001\u81ea\u3089\u306e\u8cac\u4efb\u3092\u5341\u5206\u306b\u8a8d\u8b58\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002
\n\u5f53\u793e\u306f\u3001\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u3068 QMS \u306e\u6709\u52b9\u6027\u3092\u5b9f\u8a3c\u3059\u308b\u305f\u3081\u306b\u9069\u5207\u306a\u8a18\u9332\u3092\u4fdd\u7ba1\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n

\"ISO\"<\/p>\n

ISO 13485\u8a8d\u8a3c\u306e\u30e1\u30ea\u30c3\u30c8<\/h3>\n

ISO 13485 \u8a8d\u8a3c\u3092\u5c0e\u5165\u3057\u3066\u9054\u6210\u3059\u308b\u3068\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u7d44\u7e54\u306b\u3055\u307e\u3056\u307e\u306a\u30e1\u30ea\u30c3\u30c8\u304c\u3082\u305f\u3089\u3055\u308c\u307e\u3059\u3002\u6700\u3082\u91cd\u8981\u306a\u5229\u70b9\u306b\u306f\u6b21\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

\u9867\u5ba2\u306e\u4fe1\u983c\u306e\u5f37\u5316: ISO 13485 \u8a8d\u8a3c\u306f\u3001\u7d44\u7e54\u304c\u9867\u5ba2\u3068\u95a2\u4fc2\u8005\u306e\u9593\u3067\u4fe1\u983c\u3092\u7bc9\u304f\u306e\u306b\u5f79\u7acb\u3064\u54c1\u8cea\u306e\u8a3c\u3068\u306a\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u8db3\u5834\u3092\u6c42\u3081\u3066\u3044\u308b\u4e2d\u5c0f\u4f01\u696d\u3084\u65b0\u8208\u4f01\u696d\u306b\u3068\u3063\u3066\u7279\u306b\u4fa1\u5024\u304c\u3042\u308a\u307e\u3059\u3002
\n\u696d\u52d9\u52b9\u7387\u306e\u5411\u4e0a: ISO 13485 \u306f\u3001\u7d44\u7e54\u304c\u696d\u52d9\u3092\u5408\u7406\u5316\u3057\u3001\u7121\u99c4\u3092\u524a\u6e1b\u3057\u3001\u5168\u4f53\u7684\u306a\u52b9\u7387\u3092\u5411\u4e0a\u3055\u305b\u308b\u306e\u306b\u5f79\u7acb\u3064\u54c1\u8cea\u7ba1\u7406\u3078\u306e\u69cb\u9020\u5316\u3055\u308c\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002
\n\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u306e\u5f37\u5316: ISO 13485 \u3078\u306e\u6e96\u62e0\u306f\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u3068\u5bc6\u63a5\u306b\u95a2\u9023\u3057\u3066\u3044\u307e\u3059\u3002\u8a8d\u8a3c\u306f\u3001\u7d44\u7e54\u304c\u54c1\u8cea\u3068\u898f\u5236\u9806\u5b88\u306b\u5bfe\u3059\u308b\u53d6\u308a\u7d44\u307f\u3092\u5b9f\u8a3c\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u3001\u9806\u5b88\u9055\u53cd\u306b\u95a2\u9023\u3057\u305f\u7f70\u5247\u3084\u7f70\u91d1\u306e\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u307e\u3059\u3002
\n\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u30ea\u30b9\u30af\u306e\u4f4e\u6e1b: ISO 13485 \u306b\u57fa\u3065\u3044\u305f QMS \u3092\u5c0e\u5165\u3059\u308b\u3068\u3001\u7d44\u7e54\u306f\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u65e9\u3044\u6bb5\u968e\u3067\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3001\u958b\u767a\u30ea\u30b3\u30fc\u30eb\u306e\u30ea\u30b9\u30af\u3068\u95a2\u9023\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3067\u304d\u307e\u3059\u3002<\/p>\n

ISO 13485\u3068ISO 9001\u306e\u9055\u3044<\/h3>\n

\u4e00\u65b9\u3001ISO 13485 \u304a\u3088\u3073 ISO9001<\/a> QMS \u306e\u5b9f\u88c5\u30ac\u30a4\u30c9\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u30012 \u3064\u306e\u6a19\u6e96\u306b\u306f\u3044\u304f\u3064\u304b\u306e\u91cd\u8981\u306a\u9055\u3044\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

ISO 9001 \u306f\u3001\u3042\u3089\u3086\u308b\u696d\u754c\u5411\u3051\u306b\u8a2d\u8a08\u3055\u308c\u305f\u4e00\u822c\u7684\u306a\u54c1\u8cea\u7ba1\u7406\u6a19\u6e96\u3067\u3059\u3002\u7d44\u7e54\u306e\u30d7\u30ed\u30bb\u30b9\u306e\u5168\u4f53\u7684\u306a\u52b9\u7387\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u3067\u9867\u5ba2\u6e80\u8db3\u5ea6\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u3002\u4e00\u65b9\u3001ISO 13485 \u306f\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u7279\u5316\u3057\u3066\u304a\u308a\u3001\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u3068\u30ea\u30b9\u30af\u7ba1\u7406\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u3002<\/p>\n

ISO 13485 \u3078\u306e\u6e96\u62e0: \u898f\u5236\u304a\u3088\u3073\u6cd5\u7684\u7fa9\u52d9<\/h3>\n

\u8a8d\u8a3c\u306e\u30e1\u30ea\u30c3\u30c8\u306b\u52a0\u3048\u3066\u3001ISO 13485 \u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u306f\u3001\u7d44\u7e54\u304c\u533b\u7642\u6a5f\u5668\u696d\u754c\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u5206\u91ce\u3067\u6cd5\u7684\u304a\u3088\u3073\u898f\u5236\u4e0a\u306e\u7fa9\u52d9\u3092\u679c\u305f\u3059\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u696d\u754c\u306e\u9ad8\u5ea6\u306b\u898f\u5236\u3055\u308c\u305f\u6027\u8cea\u3068\u533b\u7642\u6a5f\u5668\u306e\u4f7f\u7528\u306b\u4f34\u3046\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u8003\u616e\u3059\u308b\u3068\u3001\u3053\u308c\u306f\u7279\u306b\u91cd\u8981\u3067\u3059\u3002<\/p>\n

\"CNC
\u7d9a\u304d\u3092\u8aad\u3080<\/strong>CNC \u6a5f\u68b0\u7528 CAD \u88fd\u56f3\u306e\u7dcf\u5408\u30ac\u30a4\u30c9<\/span><\/div><\/a><\/div>

ISO 13485 \u306f\u3001\u7d44\u7e54\u304c\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u898f\u5236\u8981\u4ef6\u306b\u5b8c\u5168\u306b\u6e96\u62e0\u3059\u308b QMS \u3092\u78ba\u7acb\u304a\u3088\u3073\u7dad\u6301\u3059\u308b\u305f\u3081\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u898f\u683c\u3078\u306e\u6e96\u62e0\u306f\u3001\u7d44\u7e54\u304c\u54c1\u8cea\u3001\u898f\u5236\u9806\u5b88\u3001\u60a3\u8005\u306e\u5b89\u5168\u3078\u306e\u53d6\u308a\u7d44\u307f\u3092\u5b9f\u8a3c\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u3001\u975e\u6e96\u62e0\u306b\u95a2\u9023\u3057\u305f\u7f70\u5247\u3084\u7f70\u91d1\u306e\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3067\u304d\u307e\u3059\u3002<\/p>\n

\u3055\u3089\u306b\u3001\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8ca9\u58f2\u307e\u305f\u306f\u6d41\u901a\u306e\u627f\u8a8d\u3092\u5f97\u308b\u6761\u4ef6\u3068\u3057\u3066\u3001\u898f\u5236\u6a5f\u95a2\u306b\u3088\u3063\u3066 ISO 13485 \u3078\u306e\u6e96\u62e0\u304c\u8981\u6c42\u3055\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3068\u3001\u7d44\u7e54\u306f\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e\u898f\u5236\u3084\u57fa\u6e96\u3092\u5b8c\u5168\u306b\u9075\u5b88\u3057\u306a\u304c\u3089\u3001\u65b0\u3057\u3044\u5e02\u5834\u306b\u30a2\u30af\u30bb\u30b9\u3057\u3001\u4e8b\u696d\u3092\u62e1\u5927\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n

\u5805\u7262\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9<\/h2>\n

\u5805\u7262\u306a QMS \u306f\u3001\u8a2d\u8a08\u3001\u958b\u767a\u304b\u3089\u6d41\u901a\u3001\u5e02\u8ca9\u5f8c\u306e\u8abf\u67fb\u306b\u81f3\u308b\u307e\u3067\u3001\u533b\u7642\u6a5f\u5668\u4f1a\u793e\u306e\u696d\u52d9\u306e\u3042\u3089\u3086\u308b\u5074\u9762\u3092\u7db2\u7f85\u3059\u308b\u54c1\u8cea\u7ba1\u7406\u3078\u306e\u4f53\u7cfb\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u3059\u3002\u9069\u5207\u306b\u69cb\u9020\u5316\u3055\u308c\u305f QMS \u306f\u3001\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3066\u5bfe\u51e6\u3057\u3001\u9867\u5ba2\u3001\u60a3\u8005\u3001\u898f\u5236\u5f53\u5c40\u306e\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u6709\u52b9\u6027\u3092\u7d99\u7d9a\u7684\u306b\u5411\u4e0a\u3055\u305b\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

\u533b\u7642\u6a5f\u5668\u4f01\u696d\u306e\u54c1\u8cea\u7ba1\u7406\u4f53\u5236\u306e\u69cb\u7bc9<\/h3>\n

\u5805\u7262\u306a QMS \u306f\u3001\u54c1\u8cea\u76ee\u6a19\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u3001\u7ba1\u7406\u8cac\u4efb\u3001ISO 13485 \u306a\u3069\u306e\u3044\u304f\u3064\u304b\u306e\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n

\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u54c1\u8cea\u76ee\u6a19<\/h3>\n

\u54c1\u8cea\u76ee\u6a19\u306f\u3001\u9867\u5ba2\u3068\u898f\u5236\u306e\u671f\u5f85\u3092\u6e80\u305f\u3059\u9ad8\u54c1\u8cea\u306e\u88fd\u54c1\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002\u76ee\u6a19\u306f SMART (\u5177\u4f53\u7684\u3001\u6e2c\u5b9a\u53ef\u80fd\u3001\u9054\u6210\u53ef\u80fd\u3001\u95a2\u9023\u6027\u3001\u671f\u9650\u4ed8\u304d) \u3067\u3042\u308a\u3001\u4f01\u696d\u3068\u305d\u306e\u5f93\u696d\u54e1\u306b\u660e\u78ba\u306a\u671f\u5f85\u3092\u4e0e\u3048\u308b\u3082\u306e\u3067\u3042\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u76ee\u6a19\u306f\u3001\u88fd\u54c1\u8a2d\u8a08\u3001\u88fd\u9020\u52b9\u7387\u306e\u5411\u4e0a\u3001\u60a3\u8005\u306e\u5b89\u5168\u30ea\u30b9\u30af\u306e\u6700\u5c0f\u9650\u5316\u306b\u91cd\u70b9\u3092\u7f6e\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

\u30ea\u30b9\u30af\u7ba1\u7406\u3068ISO 13485<\/h3>\n

\u30ea\u30b9\u30af\u7ba1\u7406\u306f\u3001\u6f5c\u5728\u7684\u306a\u5371\u967a\u3092\u7279\u5b9a\u3057\u3066\u8efd\u6e1b\u3057\u3001\u88fd\u54c1\u306e\u7d99\u7d9a\u7684\u306a\u6539\u5584\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u3001QMS \u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3059\u3002 ISO 13485 \u2013 \u533b\u7642\u6a5f\u5668 \u2013 \u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u7d44\u7e54\u5185\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u306e\u6982\u8981\u3092\u793a\u3059\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u305f\u3081\u306e\u5b9f\u8df5\u7684\u306a\u30ac\u30a4\u30c9\u3067\u3059\u3002\u3053\u306e\u57fa\u6e96\u306b\u306f\u3001\u9069\u5207\u306a\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u306b\u3088\u308b\u3001\u6f5c\u5728\u7684\u306a\u6709\u5bb3\u4e8b\u8c61\u306e\u8a55\u4fa1\u3001\u8a55\u4fa1\u3001\u76e3\u8996\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u9069\u5207\u306b\u5b9f\u88c5\u3055\u308c\u305f ISO 13485 \u30b7\u30b9\u30c6\u30e0\u306b\u3088\u308a\u3001\u98df\u54c1\u533b\u85ac\u54c1\u5c40 (FDA) \u306a\u3069\u306e\u898f\u5236\u6a5f\u95a2\u3078\u306e\u52b9\u679c\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002<\/p>\n

\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u8981\u4ef6\u3078\u306e\u78ba\u5b9f\u306a\u6e96\u62e0<\/h3>\n

\u60a3\u8005\u306e\u5b89\u5168\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f FDA \u306e 21 CFR Part 820 \u3084\u9069\u6b63\u88fd\u9020\u57fa\u6e96 (GMP) \u306a\u3069\u306e\u898f\u5236\u8981\u4ef6\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8981\u4ef6\u306f\u533b\u7642\u6a5f\u5668\u306e\u7a2e\u985e\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u305f\u3081\u3001\u3069\u306e\u898f\u5236\u6a5f\u95a2\u3084\u898f\u683c\u304c\u81ea\u793e\u306e\u88fd\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u304b\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/p>\n

\u7d4c\u55b6\u8cac\u4efb\u3068 ISO 13485<\/h3>\n

\u7ba1\u7406\u8cac\u4efb\u306f\u3001\u54c1\u8cea\u30dd\u30ea\u30b7\u30fc\u306e\u78ba\u7acb\u3001\u54c1\u8cea\u76ee\u6a19\u306e\u5b9a\u7fa9\u3001\u9069\u5207\u306a\u30ea\u30bd\u30fc\u30b9\u3068\u4eba\u54e1\u306e QMS \u3078\u306e\u5272\u308a\u5f53\u3066\u306e\u78ba\u4fdd\u306a\u3069\u3001QMS \u306e\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002 ISO 13485 \u306f\u3001\u898f\u5236\u6a5f\u95a2\u3078\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3057\u3001\u5805\u7262\u306a\u54c1\u8cea\u6587\u5316\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306e\u3001\u898f\u683c\u306e\u65bd\u884c\u3084\u6587\u66f8\u306e\u66f4\u65b0\u306e\u7ba1\u7406\u306a\u3069\u306e\u7ba1\u7406\u8cac\u4efb\u306e\u6982\u8981\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n

\u63a8\u5968\u8aad\u66f8: \u4e2d\u56fd CNC \u30a2\u30eb\u30df\u30cb\u30a6\u30e0\u90e8\u54c1: \u6700\u9ad8\u306e\u6a5f\u68b0\u52a0\u5de5\u30b5\u30fc\u30d3\u30b9\u3068\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u898b\u3064\u3051\u308b<\/a><\/strong><\/p>\n

ISO 13485 \u8a8d\u8a3c\u306e\u53d6\u5f97: \u76e3\u67fb\u30d7\u30ed\u30bb\u30b9<\/h2>\n

ISO 13485 \u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u7279\u6709\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u898f\u683c\u3067\u3059\u3002\u3053\u306e\u898f\u683c\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u4f1a\u793e\u306f\u5b89\u5168\u3067\u52b9\u679c\u7684\u306a\u88fd\u54c1\u3092\u88fd\u9020\u3059\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002\u307e\u305f\u3001\u9867\u5ba2\u304c\u8cfc\u5165\u3059\u308b\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u81ea\u4fe1\u3092\u6301\u3064\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u8a8d\u5b9a\u3092\u53d7\u3051\u308b\u3053\u3068\u306f\u56f0\u96e3\u306a\u4f5c\u696d\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u30ac\u30a4\u30c9\u3067\u306f\u3001\u76e3\u67fb\u306e\u6e96\u5099\u3001\u76e3\u67fb\u57fa\u6e96\u306e\u7406\u89e3\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u9054\u6210\u3001\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30ec\u30d3\u30e5\u30fc\u3068\u30ea\u30bd\u30fc\u30b9\u7ba1\u7406\u306b\u3088\u308b\u8a8d\u8a3c\u306e\u7dad\u6301\u306a\u3069\u3001ISO 13485 \u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u306e\u5305\u62ec\u7684\u306a\u6982\u8981\u3092\u8aac\u660e\u3057\u307e\u3059\u3002<\/p>\n

ISO 13485 \u8a8d\u8a3c\u5be9\u67fb\u306e\u6e96\u5099<\/h3>\n

ISO 13485 \u8a8d\u8a3c\u3078\u306e\u6700\u521d\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u3001\u76e3\u67fb\u306e\u6e96\u5099\u3067\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u6a19\u6e96\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u3001\u73fe\u5728\u306e\u30d7\u30ed\u30bb\u30b9\u306e\u30ae\u30e3\u30c3\u30d7\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3092\u96c7\u3046\u304b\u3001\u7d4c\u9a13\u8c4a\u5bcc\u306a\u54c1\u8cea\u4fdd\u8a3c\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306e\u6307\u5c0e\u3092\u6c42\u3081\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u4f01\u696d\u306f\u3001\u898f\u683c\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0 (QMS) \u3082\u78ba\u7acb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 QMS \u306b\u306f\u3001\u4f01\u696d\u304c\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u3069\u306e\u3088\u3046\u306b\u78ba\u4fdd\u3059\u308b\u304b\u3092\u6982\u8aac\u3059\u308b\u30dd\u30ea\u30b7\u30fc\u3001\u624b\u9806\u3001\u4f5c\u696d\u6307\u793a\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5f93\u696d\u54e1\u306f QMS \u306b\u95a2\u3059\u308b\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u53d7\u3051\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u8a18\u9332\u3092\u4fdd\u5b58\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

ISO 13485\u306e\u76e3\u67fb\u57fa\u6e96\u3092\u7406\u89e3\u3059\u308b<\/h3>\n

ISO 13485 \u76e3\u67fb\u57fa\u6e96\u306f\u3001\u898f\u683c\u306e\u7279\u5b9a\u306e\u8981\u4ef6\u306b\u57fa\u3065\u3044\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8981\u4ef6\u306f\u3001\u8a2d\u8a08\u3001\u958b\u767a\u304b\u3089\u751f\u7523\u3001\u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u307e\u3067\u306e\u88fd\u54c1\u958b\u767a\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u30ab\u30d0\u30fc\u3057\u307e\u3059\u3002\u76e3\u67fb\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u4f01\u696d\u306e\u57fa\u6e96\u3078\u306e\u6e96\u62e0\u3092\u8a55\u4fa1\u3057\u3001\u6539\u5584\u306e\u4f59\u5730\u304c\u3042\u308b\u9818\u57df\u3092\u7279\u5b9a\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u76e3\u67fb\u4eba\u306f\u5f93\u696d\u54e1\u306b\u9762\u63a5\u3057\u3001\u6587\u66f8\u3092\u78ba\u8a8d\u3057\u3001\u624b\u9806\u3092\u89b3\u5bdf\u3057\u3066\u3001\u4f1a\u793e\u304c\u57fa\u6e96\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3057\u307e\u3059\u3002<\/p>\n

\"\u30d5\u30a3\u30ec\u30c3\u30c8\u534a\u5f84:
\u7d9a\u304d\u3092\u8aad\u3080<\/strong>\u30d5\u30a3\u30ec\u30c3\u30c8\u534a\u5f84: \u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068\u3059\u3079\u3066<\/span><\/div><\/a><\/div>

\"ISO\"<\/p>\n

\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u304a\u3051\u308b ISO 13485 \u6e96\u62e0\u306e\u9054\u6210<\/h3>\n

ISO 13485 \u3078\u306e\u6e96\u62e0\u3092\u9054\u6210\u3059\u308b\u306b\u306f\u3001\u4f01\u696d\u306f\u6b21\u306e\u624b\u9806\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

\u898f\u683c\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059 QMS \u3092\u78ba\u7acb\u3057\u307e\u3059\u3002
\nQMS \u306b\u3064\u3044\u3066\u5f93\u696d\u54e1\u3092\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3057\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306e\u8a18\u9332\u3092\u4fdd\u7ba1\u3057\u307e\u3059\u3002
\n\u6a19\u6e96\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u306a\u3044\u30d7\u30ed\u30bb\u30b9\u3092\u7279\u5b9a\u3057\u3001\u662f\u6b63\u63aa\u7f6e\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002
\n\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u5185\u90e8\u76e3\u67fb\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002
\n\u898f\u683c\u3092\u78ba\u8a8d\u3057\u3001\u30d7\u30ed\u30bb\u30b9\u306e\u30ae\u30e3\u30c3\u30d7\u3092\u7279\u5b9a\u3057\u3066\u3001ISO 13485 \u8a8d\u8a3c\u76e3\u67fb\u306e\u6e96\u5099\u3092\u3057\u307e\u3059\u3002
\n\u7d4c\u9a13\u8c4a\u5bcc\u306a\u54c1\u8cea\u4fdd\u8a3c\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u307e\u305f\u306f\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3068\u5354\u529b\u3057\u3066\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002<\/p>\n

ISO 13485 \u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3068\u3001\u6570\u591a\u304f\u306e\u30e1\u30ea\u30c3\u30c8\u304c\u5f97\u3089\u308c\u307e\u3059\u3002\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u304c\u4fdd\u8a3c\u3055\u308c\u3001\u9867\u5ba2\u306e\u4fe1\u983c\u304c\u5411\u4e0a\u3057\u3001\u58f2\u4e0a\u306e\u5897\u52a0\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30ec\u30d3\u30e5\u30fc\u3068ISO 13485\u8a8d\u8a3c<\/h3>\n

\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30ec\u30d3\u30e5\u30fc\u306f\u3001ISO 13485 \u8a8d\u8a3c\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u306a\u8981\u7d20\u3067\u3059\u3002\u30ec\u30d3\u30e5\u30fc\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u3001QMS \u306e\u6709\u52b9\u6027\u306e\u8a55\u4fa1\u3068\u6539\u5584\u9818\u57df\u306e\u7279\u5b9a\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u7d4c\u55b6\u8005\u306f QMS \u3092\u5b9a\u671f\u7684\u306b\u898b\u76f4\u3057\u3001\u5fc5\u8981\u306a\u5909\u66f4\u3092\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001QMS \u304c\u898f\u683c\u306e\u8981\u4ef6\u3068\u4f01\u696d\u306e\u5909\u5316\u3059\u308b\u30cb\u30fc\u30ba\u306b\u5408\u308f\u305b\u3066\u6700\u65b0\u306e\u72b6\u614b\u306b\u4fdd\u305f\u308c\u307e\u3059\u3002<\/p>\n

ISO 13485\u306e\u30ea\u30bd\u30fc\u30b9\u7ba1\u7406<\/h3>\n

\u30ea\u30bd\u30fc\u30b9\u7ba1\u7406\u306f\u3001ISO 13485 \u8a8d\u8a3c\u306e\u3082\u3046 1 \u3064\u306e\u91cd\u8981\u306a\u5074\u9762\u3067\u3059\u3002\u4f01\u696d\u306f\u3001\u8cc7\u683c\u306e\u3042\u308b\u4eba\u6750\u3001\u6a5f\u5668\u3001\u65bd\u8a2d\u306a\u3069\u3001\u898f\u683c\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u5099\u3048\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30ea\u30bd\u30fc\u30b9\u306e\u30cb\u30fc\u30ba\u3092\u7279\u5b9a\u3057\u3001\u305d\u308c\u306b\u5fdc\u3058\u3066\u30ea\u30bd\u30fc\u30b9\u3092\u5272\u308a\u5f53\u3066\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f01\u696d\u306f\u3001\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u30ea\u30bd\u30fc\u30b9\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u76e3\u8996\u304a\u3088\u3073\u6e2c\u5b9a\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3082\u5fc5\u8981\u3067\u3059\u3002<\/p>\n

\u63a8\u5968\u8aad\u66f8: CMM \u691c\u67fb: \u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068\u3059\u3079\u3066<\/a><\/strong><\/p>\n

\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306e ISO 13485 \u306e\u5229\u70b9\u3068\u5f71\u97ff<\/h2>\n

ISO 13485 \u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u81ea\u793e\u306e\u88fd\u54c1\u304c\u898f\u5236\u8981\u4ef6\u3068\u9867\u5ba2\u306e\u671f\u5f85\u3092\u78ba\u5b9f\u306b\u6e80\u305f\u3059\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u304a\u3088\u3073\u904b\u7528\u3059\u308b\u305f\u3081\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002 ISO 13485 \u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u306e\u91cd\u8981\u306a\u5229\u70b9\u3068\u5f71\u97ff\u306e\u4e00\u90e8\u3092\u4ee5\u4e0b\u306b\u793a\u3057\u307e\u3059\u3002<\/p>\n

ISO 13485 \u306b\u3088\u308b\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u306e\u5408\u7406\u5316<\/h3>\n

ISO 13485 \u3092\u5c0e\u5165\u3059\u308b\u3068\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u304c\u5408\u7406\u5316\u3055\u308c\u3001\u88fd\u54c1\u958b\u767a\u306b\u95a2\u9023\u3059\u308b\u30a8\u30e9\u30fc\u3001\u9045\u5ef6\u3001\u30b3\u30b9\u30c8\u306e\u53ef\u80fd\u6027\u304c\u524a\u6e1b\u3055\u308c\u307e\u3059\u3002\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u6a19\u6e96\u5316\u3059\u308b\u3068\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306e\u5404\u6bb5\u968e\u304c\u898f\u5236\u8981\u4ef6\u3068\u696d\u754c\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u78ba\u5b9f\u306b\u6e80\u305f\u3057\u306a\u304c\u3089\u3001\u52b9\u7387\u3068\u751f\u7523\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n

\"ISO13485\"<\/p>\n

ISO 13485 \u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u5411\u3051\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/h3>\n

ISO 13485 \u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0 (QMS) \u306f\u3001\u8a2d\u8a08\u3068\u958b\u767a\u3001\u751f\u7523\u3001\u8a2d\u7f6e\u3001\u30b5\u30fc\u30d3\u30b9\u3001\u4f7f\u7528\u7d42\u4e86\u3092\u542b\u3080\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u30ab\u30d0\u30fc\u3059\u308b\u533b\u7642\u6a5f\u5668\u88fd\u9020\u3078\u306e\u4f53\u7cfb\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u3053\u306e\u5305\u62ec\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u3088\u308a\u3001\u88fd\u54c1\u958b\u767a\u306e\u5404\u6bb5\u968e\u3067\u898f\u5236\u8981\u4ef6\u3068\u9867\u5ba2\u306e\u671f\u5f85\u304c\u78ba\u5b9f\u306b\u6e80\u305f\u3055\u308c\u3001\u9ad8\u54c1\u8cea\u3067\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u88fd\u54c1\u304c\u63d0\u4f9b\u3055\u308c\u307e\u3059\u3002<\/p>\n

ISO 13485\u3067\u9867\u5ba2\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059<\/h3>\n

\u9867\u5ba2\u6e80\u8db3\u5ea6\u306f\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u91cd\u8981\u306a\u5074\u9762\u3067\u3042\u308a\u3001\u9867\u5ba2\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u306f\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u8ab2\u984c\u3067\u3059\u3002 ISO 13485 \u306f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u9867\u5ba2\u306e\u8981\u4ef6\u3092\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306b\u7d44\u307f\u8fbc\u3080\u3053\u3068\u3092\u53ef\u80fd\u306b\u3059\u308b\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002 ISO 13485 \u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u671f\u5f85\u3092\u6e80\u305f\u3059\u3001\u307e\u305f\u306f\u305d\u308c\u3092\u8d85\u3048\u308b\u88fd\u54c1\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u9867\u5ba2\u6e80\u8db3\u5ea6\u3092\u5411\u4e0a\u3055\u305b\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002<\/p>\n

\u533b\u7642\u6a5f\u5668\u898f\u5236\u304a\u3088\u3073ISO 13485\u3078\u306e\u6e96\u62e0<\/h3>\n

\u533b\u7642\u6a5f\u5668\u306f\u9ad8\u5ea6\u306b\u898f\u5236\u3055\u308c\u3066\u304a\u308a\u3001\u30e1\u30fc\u30ab\u30fc\u306f ISO 13485 \u3092\u542b\u3080\u3055\u307e\u3056\u307e\u306a\u898f\u5236\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u898f\u5236\u3092\u9075\u5b88\u3059\u308b\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u6cd5\u7684\u554f\u984c\u3084\u98a8\u8a55\u88ab\u5bb3\u3092\u56de\u907f\u3057\u306a\u304c\u3089\u5b89\u5168\u3067\u52b9\u679c\u7684\u306a\u88fd\u54c1\u3092\u751f\u7523\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3055\u3089\u306b\u3001ISO 13485 \u3068\u9023\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u898f\u683c\u9593\u306e\u77db\u76fe\u3084\u91cd\u8907\u3092\u56de\u907f\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u6700\u7d42\u7684\u306b\u306f\u5168\u4f53\u7684\u306a\u52b9\u7387\u306e\u5411\u4e0a\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/p>\n

ISO 13485\u306b\u5bfe\u3059\u308b\u30c8\u30c3\u30d7\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u306e\u78ba\u4fdd<\/h3>\n

QMS \u306e\u5c0e\u5165\u306b\u306f\u7d44\u7e54\u306e\u30c8\u30c3\u30d7\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u3088\u308b\u591a\u5927\u306a\u53d6\u308a\u7d44\u307f\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001ISO 13485 \u306e\u5c0e\u5165\u3082\u4f8b\u5916\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u898f\u683c\u3067\u306f\u3001\u4f01\u696d\u306e\u30c8\u30c3\u30d7\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u5bfe\u3057\u3001\u7d99\u7d9a\u7684\u306a\u6539\u5584\u3001\u4e0d\u9069\u5408\u306e\u9632\u6b62\u3001\u898f\u5236\u8981\u4ef6\u306e\u9075\u5b88\u306e\u78ba\u4fdd\u306a\u3069\u3001ISO 13485 \u3067\u6982\u8aac\u3055\u308c\u3066\u3044\u308b\u54c1\u8cea\u76ee\u6a19\u306b\u53d6\u308a\u7d44\u3080\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002 ISO 13485 \u306b\u5bfe\u3059\u308b\u7d4c\u55b6\u9663\u306e\u7a76\u6975\u306e\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u5b89\u5168\u6027\u3068\u9867\u5ba2\u6e80\u8db3\u5ea6\u3092\u512a\u5148\u3059\u308b\u54c1\u8cea\u306e\u6587\u5316\u3092\u69cb\u7bc9\u3067\u304d\u307e\u3059\u3002<\/p>\n

\u63a8\u5968\u8aad\u66f8: AS9100 \u3092\u7406\u89e3\u3059\u308b: \u822a\u7a7a\u5b87\u5b99\u54c1\u8cea\u7ba1\u7406\u898f\u683c<\/a><\/strong><\/p>\n

\u3088\u304f\u3042\u308b\u8cea\u554f\uff1a<\/h2>\n

\"ISO13485\"<\/p>\n

Q: ISO 13485\u3068\u306f\u4f55\u3067\u3059\u304b?<\/h3>\n

A: ISO 13485 \u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u8981\u4ef6\u3092\u898f\u5b9a\u3057\u305f\u56fd\u969b\u898f\u683c\u3067\u3059\u3002<\/p>\n

Q: ISO 13485 \u306f ISO 9001 \u3068\u3069\u3046\u9055\u3046\u306e\u3067\u3059\u304b?<\/h3>\n

A: ISO 13485 \u306f\u533b\u7642\u6a5f\u5668\u696d\u754c\u5411\u3051\u306b\u7279\u5225\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001ISO 9001 \u306f\u3042\u3089\u3086\u308b\u696d\u754c\u306b\u9069\u7528\u3067\u304d\u308b\u3088\u308a\u4e00\u822c\u7684\u306a\u54c1\u8cea\u7ba1\u7406\u898f\u683c\u3067\u3059\u3002<\/p>\n

Q: ISO 13485 \u8a8d\u8a3c\u306e\u8981\u4ef6\u306f\u4f55\u3067\u3059\u304b?<\/h3>\n

A: ISO 13485 \u8a8d\u8a3c\u306e\u8981\u4ef6\u306b\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165\u3001\u7ba1\u7406\u30ec\u30d3\u30e5\u30fc\u306e\u5b9f\u65bd\u3001\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u78ba\u7acb\u3001\u304a\u3088\u3073\u898f\u5236\u8981\u4ef6\u306e\u9075\u5b88\u306e\u78ba\u4fdd\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n

Q: ISO 13485 \u306e\u76ee\u7684\u306f\u4f55\u3067\u3059\u304b?<\/h3>\n

A: ISO 13485 \u306e\u76ee\u7684\u306f\u3001\u610f\u56f3\u3055\u308c\u305f\u76ee\u7684\u306b\u5bfe\u3057\u3066\u5b89\u5168\u306a\u533b\u7642\u6a5f\u5668\u306e\u4e00\u8cab\u3057\u305f\u8a2d\u8a08\u3001\u958b\u767a\u3001\u751f\u7523\u3001\u8a2d\u7f6e\u3001\u7d0d\u54c1\u3092\u4fdd\u8a3c\u3059\u308b\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/p>\n

Q: ISO 13485 \u306b\u304a\u3051\u308b\u7ba1\u7406\u8cac\u4efb\u306e\u5f79\u5272\u306f\u4f55\u3067\u3059\u304b?<\/h3>\n

A: \u7d4c\u55b6\u8cac\u4efb\u306f ISO 13485 \u306e\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002ISO 13485 \u3067\u306f\u3001\u30c8\u30c3\u30d7\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u304c\u54c1\u8cea\u3078\u306e\u53d6\u308a\u7d44\u307f\u3092\u5b9f\u8a3c\u3057\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u6709\u52b9\u6027\u306b\u5bfe\u3057\u3066\u8cac\u4efb\u3092\u8ca0\u3046\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n

Q: ISO 13485 \u306f\u54c1\u8cea\u3092\u3069\u306e\u3088\u3046\u306b\u4fdd\u8a3c\u3057\u307e\u3059\u304b?<\/h3>\n

A: ISO 13485 \u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u958b\u767a\u3001\u751f\u7523\u3001\u8a2d\u7f6e\u3001\u7d0d\u5165\u3092\u76e3\u8996\u304a\u3088\u3073\u5236\u5fa1\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u3001\u307e\u305f\u4e0d\u9069\u5408\u306e\u7ba1\u7406\u3068\u5b9a\u671f\u7684\u306a\u76e3\u67fb\u306e\u5b9f\u65bd\u3092\u7d44\u7e54\u306b\u8981\u6c42\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u54c1\u8cea\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p>\n

Q: ISO 13485 \u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3068\u306f\u4f55\u3067\u3059\u304b?<\/h3>\n

A: ISO 13485 \u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u7d44\u7e54\u304c\u54c1\u8cea\u76ee\u6a19\u3092\u9054\u6210\u3057\u3001\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u30dd\u30ea\u30b7\u30fc\u3001\u76ee\u6a19\u3001\u30d7\u30ed\u30bb\u30b9\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3059\u308b\u4e00\u9023\u306e\u76f8\u4e92\u306b\u95a2\u9023\u307e\u305f\u306f\u76f8\u4e92\u4f5c\u7528\u3059\u308b\u8981\u7d20\u3067\u3059\u3002<\/p>\n

Q: ISO 13485 \u6e96\u62e0\u3068\u306f\u4f55\u3067\u3059\u304b?<\/h3>\n

A: ISO 13485 \u6e96\u62e0\u3068\u306f\u3001\u7d44\u7e54\u304c ISO 13485 \u6a19\u6e96\u3067\u6307\u5b9a\u3055\u308c\u305f\u8981\u4ef6\u3092\u9075\u5b88\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u6307\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165\u3068\u7dad\u6301\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n

Q: \u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u898f\u5236\u8981\u4ef6\u306f\u4f55\u3067\u3059\u304b?<\/h3>\n

A: \u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u8981\u4ef6\u306f\u56fd\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u304c\u3001\u901a\u5e38\u3001\u88fd\u54c1\u767b\u9332\u3001\u30e9\u30d9\u30eb\u8868\u793a\u8981\u4ef6\u3001\u5b89\u5168\u6027\u304a\u3088\u3073\u6027\u80fd\u8a66\u9a13\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n

Q: ISO 13485 \u306e\u30ea\u30bd\u30fc\u30b9\u7ba1\u7406\u8981\u4ef6\u306f\u4f55\u3067\u3059\u304b?<\/h3>\n

A: ISO 13485 \u306e\u30ea\u30bd\u30fc\u30b9\u7ba1\u7406\u8981\u4ef6\u306b\u306f\u3001\u5fc5\u8981\u306a\u30ea\u30bd\u30fc\u30b9\u306e\u6c7a\u5b9a\u3068\u63d0\u4f9b\u3001\u30a4\u30f3\u30d5\u30e9\u30b9\u30c8\u30e9\u30af\u30c1\u30e3\u306e\u78ba\u7acb\u3001\u8981\u54e1\u306e\u80fd\u529b\u306e\u78ba\u4fdd\u3001\u304a\u3088\u3073\u9069\u5207\u306a\u4f5c\u696d\u74b0\u5883\u306e\u7dad\u6301\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>","protected":false},"excerpt":{"rendered":"

What is ISO 13485? ISO 13485 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. It provides a framework for organizations to establish and maintain a structured approach to quality management, ensuring that their products consistently meet regulatory requirements and customer expectations. Recommended […]<\/p>\n","protected":false},"author":2,"featured_media":10226,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10221","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cnc-machining-blog"],"yoast_head":"\nUnderstanding ISO 13485: Ensuring Quality in the Medical Device Industry - 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