{"id":11635,"date":"2019-06-22T15:46:34","date_gmt":"2019-06-22T06:46:34","guid":{"rendered":"https:\/\/www.fsz.co.jp\/?post_type=knowledge&#038;p=11635"},"modified":"2025-04-04T10:52:24","modified_gmt":"2025-04-04T01:52:24","slug":"11635","status":"publish","type":"news","link":"https:\/\/www.fsz.co.jp\/?news=11635","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u30fb\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u696d\u754c\u3068\u306f"},"content":{"rendered":"\n<p><img loading=\"lazy\" decoding=\"async\" width=\"80\" height=\"80\" class=\"wp-image-11666\" style=\"width: 80px;\" src=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/06\/bpixta_25188411_S-e1488319041514a.jpg\" alt=\"\">\u3000\u85ac\u6a5f\u6cd5\u3001\u4f53\u5236\u7701\u4ee4\u3001QMS\u7701\u4ee4\u3001GVP\u7701\u4ee4\u306b\u95a2\u9023\u3057\u305f\u54c1\u8cea\u7ba1\u7406\u76e3\u7763\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u30fb\u904b\u7528<br><br>\u533b\u7642\u6a5f\u5668\u30fb\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u696d\u754c\u3067\u306f\u3001\u88fd\u54c1\u54c1\u8cea\u3092\u78ba\u5b9f\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u624b\u6cd5\u3092\u6d3b\u7528\u3057\u305f\u88fd\u54c1\u306e\u8a2d\u8a08\u3001\u88fd\u9020\u306a\u3069\u3059\u3079\u3066\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306b\u308f\u305f\u3063\u305f<strong>\u54c1\u8cea\u7ba1\u7406\u76e3\u7763\u30b7\u30b9\u30c6\u30e0<\/strong>\u3092\u69cb\u7bc9\u3001\u6587\u66f8\u5316\u3057\u3066\u3001\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u65b9\u6cd5\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u304c\u6025\u52d9\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">QMS\u54c1\u8cea\u30a4\u30d9\u30f3\u30c8\u7ba1\u7406<\/h4>\n\n\n\n<p>\u85ac\u6a5f\u6cd5\u3001\u4f53\u5236\u7701\u4ee4\u3001QMS\u7701\u4ee4\u3001GVP\u7701\u4ee4\u306a\u3069\u306b\u95a2\u308f\u308b\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u4e8b\u8c61\u3084\u30a4\u30d9\u30f3\u30c8\u3092\u7ba1\u7406\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"706\" src=\"https:\/\/i2.wp.com\/www.fsz.co.jp\/wp-content\/uploads\/2019\/06\/iryou020-1024x706.png?fit=750%2C517&amp;ssl=1\" alt=\"\" class=\"wp-image-11636\" srcset=\"https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/06\/iryou020-1024x706.png 1024w, https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/06\/iryou020-1024x706-300x207.png 300w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption>\u54c1\u8cea\u7ba1\u7406\u76e3\u7763\u30b7\u30b9\u30c6\u30e0\u57fa\u6e96\u66f8\uff08\u6771\u4eac\u90fd\u5065\u5eb7\u5b89\u5168\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\uff09\u3088\u308a\u8ee2\u8f09<\/figcaption><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">\u53c2\u8003\u898f\u5247\u3001\u6587\u732e\u3001\u56e3\u4f53<\/h3>\n\n\n\n<p><strong>\u898f\u5247<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><a href=\"http:\/\/law.e-gov.go.jp\/htmldata\/H26\/H26F19001000094.html\">\u533b\u7642\u6a5f\u5668\u53c8\u306f\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53c8\u306f\u54c1\u8cea\u7ba1\u7406\u306b\u4fc2\u308b\u696d\u52d9\u3092\u884c\u3046\u4f53\u5236\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u306b\u3064\u3044\u3066<\/a>\uff08\u539a\u751f\u52b4\u50cd\u7701\uff09<\/li><li><a href=\"http:\/\/law.e-gov.go.jp\/htmldata\/H16\/H16F19001000169.html\">\u533b\u7642\u6a5f\u5668\u53ca\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4<\/a>\uff08\u539a\u751f\u52b4\u50cd\u7701\uff09<\/li><li><a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a>\u3000\u533b\u7642\u6a5f\u5668\u2015\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u2015\u898f\u5236\u76ee\u7684\u306e\u305f\u3081\u306e\u8981\u6c42\u4e8b\u9805\uff08ISO\uff09<\/li><li><a href=\"https:\/\/www.jqa.jp\/service_list\/management\/service\/iso13485\/\">ISO 13485<\/a>\u3000\u533b\u7642\u6a5f\u5668\u2015\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u2015\u898f\u5236\u76ee\u7684\u306e\u305f\u3081\u306e\u8981\u6c42\u4e8b\u9805\uff08JQA\uff09<\/li><li><a href=\"http:\/\/www.webstore.jsa.or.jp\/webstore\/Com\/FlowControl.jsp?bunsyoId=ISO+13485%3A2016&amp;dantaiCd=ISO&amp;status=1&amp;pageNo=0\">ISO&nbsp;13485:2016<\/a>\u3000\u533b\u7642\u6a5f\u5668\u2015\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u2015\u898f\u5236\u76ee\u7684\u306e\u305f\u3081\u306e\u8981\u6c42\u4e8b\u9805\uff08\u4e00\u822c\u8ca1\u56e3\u6cd5\u4eba\u65e5\u672c\u898f\u683c\u5354\u4f1a\uff09<\/li><li><a href=\"http:\/\/www.webstore.jsa.or.jp\/webstore\/Com\/FlowControl.jsp%3FbunsyoId%3DJIS%2BQ%2B13485%253A2005%26dantaiCd%3DJIS%26status%3D1%26pageNo%3D0%26lang%3Djp\">JIS Q 13485:2005<\/a>\u3000\u533b\u7642\u6a5f\u5668\u2015\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u2015\u898f\u5236\u76ee\u7684\u306e\u305f\u3081\u306e\u8981\u6c42\u4e8b\u9805\uff08\u4e00\u822c\u8ca1\u56e3\u6cd5\u4eba\u65e5\u672c\u898f\u683c\u5354\u4f1a\uff09<\/li><li><a href=\"https:\/\/www.iso.org\/standard\/38193.html\">ISO 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href=\"http:\/\/www.tokyo-eiken.go.jp\/files\/k_iryou\/k-kanshi\/k_tejyuncheck\/eed9963ee59c852ce5703d7b05b6fdd41.docx\" target=\"_blank\" rel=\"noreferrer noopener\">\u54c1\u8cea\u7ba1\u7406\u76e3\u7763\u30b7\u30b9\u30c6\u30e0\u57fa\u6e96\u66f8<\/a>\uff08\u6771\u4eac\u90fd\u5065\u5eb7\u5b89\u5168\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\uff09<\/li><li><a href=\"https:\/\/www.google.co.jp\/url?sa=t&amp;rct=j&amp;q=&amp;esrc=s&amp;source=web&amp;cd=1&amp;cad=rja&amp;uact=8&amp;ved=0ahUKEwikyZ7xqsPSAhUTOrwKHcyhAGEQFggaMAA&amp;url=https%3A%2F%2Fwww.pmda.go.jp%2Freview-services%2Fgmp-qms-gctp%2Fqms%2F0006.html&amp;usg=AFQjCNE38DPomqsR16fPrv8NgMh3R8BxUQ&amp;bvm=bv.148747831,d.dGc\" target=\"_blank\" rel=\"noreferrer noopener\">\u54c1\u8cea\u30de\u30cb\u30e5\u30a2\u30eb\u30e2\u30c7\u30eb\uff08\u4f8b\uff09<\/a>\uff08PMDA \uff09<\/li><li><a href=\"http:\/\/www.tokyo-eiken.go.jp\/files\/k_iryou\/k-kanshi\/k_tejyuncheck\/4b1bb8f80b4503b31bff2db1e35147ab.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u4f53\u5236\u7701\u4ee4\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a>\u30fb\u9078\u4efb\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u3092\u9664\u304f\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7528\uff08\u6771\u4eac\u90fd\u5065\u5eb7\u5b89\u5168\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\uff09<\/li><li><a href=\"http:\/\/www.tokyo-eiken.go.jp\/files\/k_iryou\/k-kanshi\/k_tejyuncheck\/6576d05fa6dd6a3917de1f695445ae40.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u4f53\u5236\u7701\u4ee4\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a>\u30fb\u9078\u4efb\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7528\uff08\u6771\u4eac\u90fd\u5065\u5eb7\u5b89\u5168\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\uff09<\/li><li><a href=\"https:\/\/www.pref.saitama.lg.jp\/a0707\/kiki\/documents\/2.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\uff31\uff2d\uff33\u4f53\u5236\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a>\u3010\u533b\u7642\u6a5f\u5668\u30fb\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8a31\u53ef\u3011\uff08\u57fc\u7389\u770c\uff09<\/li><li><a href=\"http:\/\/ecompliance.co.jp\/MedicalDevice\/ISO13485\/ISO13485_2016.html\">ISO-13485\u6539\u5b9a\u306e\u8981\u70b9<\/a>\uff08\u682a\u5f0f\u4f1a\u793e\u30a4\u30fc\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\uff09<\/li><\/ol>\n\n\n\n<p><strong>\u56e3\u4f53<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><a href=\"http:\/\/www.mhlw.go.jp\/\">\u539a\u751f\u52b4\u50cd\u7701<\/a><\/li><li><a href=\"http:\/\/www.meti.go.jp\/\">\u7d4c\u6e08\u7523\u696d\u7701<\/a><\/li><li><a rel=\"noreferrer noopener\" href=\"http:\/\/www.jsa.or.jp\/\" target=\"_blank\">\u4e00\u822c\u8ca1\u56e3\u6cd5\u4eba\u65e5\u672c\u898f\u683c\u5354\u4f1a<\/a>\uff08JSA\uff09Japanese Standards Association<\/li><li><a rel=\"noreferrer noopener\" href=\"https:\/\/www.jqa.jp\/\" target=\"_blank\">\u4e00\u822c\u8ca1\u56e3\u6cd5\u4eba \u65e5\u672c\u54c1\u8cea\u4fdd\u8a3c\u6a5f\u69cb<\/a>\uff08JQA\uff09Japan Quality Assurance Organization<\/li><li><a rel=\"noreferrer noopener\" href=\"https:\/\/www.pmda.go.jp\/index.html\" target=\"_blank\">\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb<\/a>\uff08PMDA\uff09Pharmaceuticals and Medical Devices Agency<\/li><li><a rel=\"noreferrer noopener\" href=\"http:\/\/www.tokyo-eiken.go.jp\/\" target=\"_blank\">\u6771\u4eac\u90fd\u5065\u5eb7\u5b89\u5168\u7814\u7a76\u30bb\u30f3\u30bf\u30fc<\/a><\/li><li><a href=\"https:\/\/www.iso.org\/home.html\">\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb<\/a>\uff08ISO\uff09International Organization for Standardization<\/li><li><a rel=\"noreferrer noopener\" href=\"https:\/\/www.fda.gov\/\" target=\"_blank\">\u30a2\u30e1\u30ea\u30ab\u98df\u54c1\u533b\u85ac\u54c1\u5c40<\/a>\uff08FDA\uff09The Food and Drug Administration<\/li><\/ol>\n","protected":false},"featured_media":11666,"template":"","news_category":[74],"class_list":["post-11635","news","type-news","status-publish","has-post-thumbnail","hentry","news_category-fszblog-pharma"],"_links":{"self":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news\/11635","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/types\/news"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/media\/11666"}],"wp:attachment":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11635"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fnews_category&post=11635"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}