\u533b\u7597\u4f53\u7cfbISO13485\u8ba4\u8bc1\u662f\u533b\u7597\u5668\u68b0\u884c\u4e1a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u91cd\u8981\u56fd\u9645\u6807\u51c6\uff0c\u5b83\u4e3a\u7ec4\u7ec7\u63d0\u4f9b\u4e86\u786e\u4fdd\u4ea7\u54c1\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u6846\u67b6\u3002<\/p>\n<\/p>\n
\u5728\u5168\u7403\u5316\u7684\u533b\u7597\u5e02\u573a\u4e2d\uff0c\u83b7\u5f97ISO13485\u8ba4\u8bc1\u4e0d\u4ec5\u6709\u52a9\u4e8e\u4f01\u4e1a\u63d0\u5347\u5185\u90e8\u7ba1\u7406\u6548\u7387\uff0c\u8fd8\u80fd\u589e\u5f3a\u5ba2\u6237\u4fe1\u4efb\u548c\u56fd\u9645\u7ade\u4e89\u529b\u3002<\/p>\n<\/p>\n
\u533b\u7597\u4f53\u7cfbISO13485\u8ba4\u8bc1\u6982\u8ff0<\/strong><\/p>\n ISO13485\u662f\u4e13\u95e8\u9488\u5bf9\u533b\u7597\u5668\u68b0\u884c\u4e1a\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6807\u51c6\uff0c\u5b83\u57fa\u4e8eISO9001\u7684\u539f\u5219\uff0c\u4f46\u66f4\u4fa7\u91cd\u4e8e\u533b\u7597\u5668\u68b0\u7684\u7279\u6b8a\u8981\u6c42\uff0c\u5982\u98ce\u9669\u7ba1\u7406\u548c\u76d1\u7ba1\u5408\u89c4\u3002<\/p>\n<\/p>\n \u8be5\u8ba4\u8bc1\u9002\u7528\u4e8e\u6240\u6709\u6d89\u53ca\u533b\u7597\u5668\u68b0\u8bbe\u8ba1\u3001\u751f\u4ea7\u3001\u5b89\u88c5\u548c\u670d\u52a1\u7684\u7ec4\u7ec7\uff0c\u65e0\u8bba\u5176\u89c4\u6a21\u5927\u5c0f\u3002<\/p>\n<\/p>\n \u901a\u8fc7\u5b9e\u65bdISO13485\uff0c\u4f01\u4e1a\u53ef\u4ee5\u7cfb\u7edf\u5316\u5730\u63a7\u5236 processes\uff0c\u51cf\u5c11\u9519\u8bef\u548c\u53ec\u56de\u98ce\u9669\uff0c\u4ece\u800c\u4fdd\u969c\u60a3\u8005\u5b89\u5168\u3002<\/p>\n<\/p>\n \u533b\u7597\u4f53\u7cfbISO13485\u8ba4\u8bc1\u7684\u91cd\u8981\u6027<\/strong><\/p>\n \u5728\u533b\u7597\u9886\u57df\uff0c\u4ea7\u54c1\u8d28\u91cf\u76f4\u63a5\u5173\u7cfb\u5230\u4eba\u7c7b\u5065\u5eb7\uff0c\u56e0\u6b64ISO13485\u8ba4\u8bc1\u88ab\u89c6\u4e3a\u8fdb\u5165\u5168\u7403\u5e02\u573a\u7684\u6572\u95e8\u7816\u3002<\/p>\n<\/p>\n \u5b83\u5e2e\u52a9\u7ec4\u7ec7\u6ee1\u8db3\u6cd5\u89c4\u8981\u6c42\uff0c\u4f8b\u5982\u6b27\u76df\u7684MDR\u548c\u7f8e\u56fd\u7684FDA\u89c4\u5b9a\uff0c\u907f\u514d\u6cd5\u5f8b\u7ea0\u7eb7\u548c\u5e02\u573a\u51c6\u5165\u969c\u788d\u3002<\/p>\n<\/p>\n \u6b64\u5916\uff0c\u8ba4\u8bc1\u8fd8\u80fd\u4fc3\u8fdb\u6301\u7eed\u6539\u8fdb\uff0c\u901a\u8fc7\u5b9a\u671f\u5ba1\u6838\u548c\u53cd\u9988\u673a\u5236\uff0c\u4f01\u4e1a\u53ef\u4ee5\u4e0d\u65ad\u4f18\u5316\u8fd0\u8425\uff0c\u964d\u4f4e\u6210\u672c\u5e76\u63d0\u9ad8\u6548\u7387\u3002<\/p>\n<\/p>\n \u533b\u7597\u4f53\u7cfbISO13485\u8ba4\u8bc1\u7684\u5b9e\u65bd\u6b65\u9aa4<\/strong><\/p>\n \u5b9e\u65bdISO13485\u8ba4\u8bc1\u901a\u5e38\u4ece\u9ad8\u5c42\u627f\u8bfa\u5f00\u59cb\uff0c\u7ba1\u7406\u5c42\u5fc5\u987b\u5e26\u5934\u5236\u5b9a\u8d28\u91cf\u65b9\u9488\u548c\u76ee\u6807\u3002<\/p>\n<\/p>\n \u63a5\u4e0b\u6765\uff0c\u7ec4\u7ec7\u9700\u8981\u8fdb\u884c\u5dee\u8ddd\u5206\u6790\uff0c\u8bc6\u522b\u73b0\u6709\u4f53\u7cfb\u4e0e\u6807\u51c6\u8981\u6c42\u4e4b\u95f4\u7684\u5dee\u5f02\uff0c\u5e76\u5236\u5b9a\u884c\u52a8\u8ba1\u5212\u6765 address \u8fd9\u4e9b\u5dee\u8ddd\u3002<\/p>\n<\/p>\n \u57f9\u8bad\u5458\u5de5\u662f\u5173\u952e\u6b65\u9aa4\uff0c\u786e\u4fdd\u6240\u6709\u76f8\u5173\u4eba\u5458\u7406\u89e3\u6807\u51c6\u8981\u6c42\u548c\u81ea\u5df1\u7684\u89d2\u8272\uff0c\u4ece\u800c\u6709\u6548\u53c2\u4e0e\u8d28\u91cf\u7ba1\u7406\u3002<\/p>\n<\/p>\n \u7136\u540e\uff0c\u5efa\u7acb\u6587\u6863\u5316\u7684 procedures\uff0c\u5305\u62ec\u8d28\u91cf\u624b\u518c\u3001\u7a0b\u5e8f\u6587\u4ef6\u548c\u8bb0\u5f55\uff0c\u4ee5\u63d0\u4f9b evidence of compliance\u3002<\/p>\n<\/p>\n \u5185\u90e8\u5ba1\u6838\u548c\u7ba1\u7406\u8bc4\u5ba1\u662f\u6301\u7eed\u6539\u8fdb\u7684\u4e00\u90e8\u5206\uff0c\u5e2e\u52a9\u7ec4\u7ec7\u76d1\u63a7\u4f53\u7cfb performance \u5e76\u505a\u51fa\u5fc5\u8981\u8c03\u6574\u3002<\/p>\n<\/p>\n \u6700\u540e\uff0c\u9009\u62e9 accredited \u8ba4\u8bc1\u673a\u6784\u8fdb\u884c\u5916\u90e8\u5ba1\u6838\uff0c\u901a\u8fc7\u540e\u5373\u53ef\u83b7\u5f97\u8ba4\u8bc1\uff0c\u4f46\u9700\u5b9a\u671f surveillance \u5ba1\u6838\u4ee5\u7ef4\u6301 status\u3002<\/p>\n<\/p>\n \u533b\u7597\u4f53\u7cfbISO13485\u8ba4\u8bc1\u7684\u6311\u6218\u4e0e\u89e3\u51b3\u65b9\u6848<\/strong><\/p>\n \u8bb8\u591a\u7ec4\u7ec7\u5728\u5b9e\u65bdISO13485\u65f6\u9762\u4e34\u8d44\u6e90\u9650\u5236\u3001\u5458\u5de5 resistance \u6216\u590d\u6742\u6cd5\u89c4\u7684\u6311\u6218\u3002<\/p>\n<\/p>\n \u89e3\u51b3\u65b9\u6848\u5305\u62ec\u5bfb\u6c42\u4e13\u4e1a\u54a8\u8be2\u3001\u5229\u7528\u6280\u672f\u5de5\u5177\u81ea\u52a8\u5316 processes\uff0c\u4ee5\u53ca\u57f9\u517b\u8d28\u91cf\u6587\u5316\u4ee5\u589e\u5f3a\u56e2\u961f engagement\u3002<\/p>\n<\/p>\n \u901a\u8fc7\u5206\u9636\u6bb5\u5b9e\u65bd\u548c\u8bbe\u5b9a realistic \u65f6\u95f4\u8868\uff0c\u4f01\u4e1a\u53ef\u4ee5\u9010\u6b65 overcome \u969c\u788d\uff0c\u5b9e\u73b0\u5e73\u6ed1\u8fc7\u6e21\u5230\u8ba4\u8bc1\u3002<\/p>\n<\/p>\n \u533b\u7597\u4f53\u7cfbISO13485\u8ba4\u8bc1\u7684\u672a\u6765\u8d8b\u52bf<\/strong><\/p>\n \u968f\u7740\u533b\u7597\u6280\u672f\u5feb\u901f\u53d1\u5c55\uff0c\u5982AI\u548c\u7269\u8054\u7f51\u8bbe\u5907\u7684\u5174\u8d77\uff0cISO13485\u6807\u51c6\u4e5f\u5728\u4e0d\u65ad\u66f4\u65b0\u4ee5\u9002\u5e94\u65b0\u98ce\u9669\u3002<\/p>\n<\/p>\n \u672a\u6765\uff0c\u8ba4\u8bc1\u53ef\u80fd\u4f1a\u66f4\u5f3a\u8c03\u7f51\u7edc\u5b89\u5168\u3001\u6570\u636e\u9690\u79c1\u548c\u4f9b\u5e94\u94fe\u900f\u660e\u5ea6\uff0c\u8981\u6c42\u7ec4\u7ec7\u4fdd\u6301\u654f\u6377\u548c\u524d\u77bb\u6027\u3002<\/p>\n<\/p>\n \u6570\u5b57\u5316\u5de5\u5177\u5c06 play \u66f4\u5927\u89d2\u8272\uff0c\u4f8b\u5982\u4f7f\u7528\u4e91-based QMS \u8f6f\u4ef6\u7b80\u5316\u5408\u89c4\u6d41\u7a0b\uff0c\u63d0\u9ad8\u54cd\u5e94\u901f\u5ea6\u3002<\/p>\n<\/p>\n \u603b\u4e4b\uff0c\u533b\u7597\u4f53\u7cfbISO13485\u8ba4\u8bc1\u662f\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u4e0d\u53ef\u6216\u7f3a\u7684\u4e00\u90e8\u5206\uff0c\u5b83\u4e0d\u4ec5\u786e\u4fdd\u5408\u89c4\uff0c\u8fd8\u9a71\u52a8\u521b\u65b0\u548c\u5168\u7403\u6269\u5f20\u3002<\/p>\n<\/p>\n \u901a\u8fc7\u62e5\u62b1\u8fd9\u4e00\u6807\u51c6\uff0c\u7ec4\u7ec7\u53ef\u4ee5\u4e3a\u60a3\u8005\u63d0\u4f9b\u66f4\u5b89\u5168\u7684 products\uff0c\u540c\u65f6\u5728\u7ade\u4e89\u6fc0\u70c8\u7684\u5e02\u573a\u4e2d\u8131\u9896\u800c\u51fa\u3002<\/p>\n<\/p>\n \u514d\u8d23\u58f0\u660e\uff1a\u4ec5\u4f9b\u53c2\u8003\uff0c\u672c\u6587\u4f5c\u8005\u53ca\u53d1\u5e03\u5e73\u53f0\u4e0d\u627f\u62c5\u56e0\u53c2\u8003\u672c\u6587\u5185\u5bb9\u800c\u4ea7\u751f\u7684\u4efb\u4f55\u8d23\u4efb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":" \u533b\u7597\u4f53\u7cfbISO13485\u8ba4\u8bc1\u662f\u533b\u7597\u5668\u68b0\u884c\u4e1a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u91cd\u8981\u56fd\u9645\u6807\u51c6\uff0c\u5b83\u4e3a\u7ec4\u7ec7\u63d0\u4f9b\u4e86\u786e\u4fdd\u4ea7\u54c1\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u6846 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[684],"class_list":["post-4360","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-iso13485"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4360","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4360"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4360\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4360"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4360"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4360"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}