\u533b\u7597\u8d28\u91cf\u4f53\u7cfbISO13485\u662f\u533b\u7597\u5668\u68b0\u884c\u4e1a\u8d28\u91cf\u7ba1\u7406\u7684\u91cd\u8981\u56fd\u9645\u6807\u51c6\uff0c\u5b83\u4e3a\u5236\u9020\u5546\u548c\u4f9b\u5e94\u5546\u63d0\u4f9b\u4e86\u4e00\u5957\u5168\u9762\u7684\u6846\u67b6\uff0c\u4ee5\u786e\u4fdd\u4ea7\u54c1\u5b89\u5168\u6709\u6548\u5e76\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u3002<\/p>\n<\/p>\n
\u5728\u5168\u7403\u5316\u7684\u533b\u7597\u5e02\u573a\u4e2d\uff0cISO13485\u8ba4\u8bc1\u4e0d\u4ec5\u662f\u4f01\u4e1a\u8d28\u91cf\u7ba1\u7406\u6c34\u5e73\u7684\u4f53\u73b0\uff0c\u66f4\u662f\u8fdb\u5165\u56fd\u9645\u5e02\u573a\u7684\u901a\u884c\u8bc1\uff0c\u5b83\u5e2e\u52a9\u7ec4\u7ec7\u5efa\u7acb\u6301\u7eed\u6539\u8fdb\u7684\u6587\u5316\uff0c\u63d0\u5347\u60a3\u8005\u5b89\u5168\u548c\u6ee1\u610f\u5ea6\u3002<\/p>\n<\/p>\n
\u533b\u7597\u8d28\u91cf\u4f53\u7cfbISO13485\u6982\u8ff0<\/strong><\/p>\n ISO13485\u6807\u51c6\u5168\u79f0\u4e3a\u300a\u533b\u7597\u5668\u68b0 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb \u7528\u4e8e\u6cd5\u89c4\u7684\u8981\u6c42\u300b\uff0c\u5b83\u57fa\u4e8eISO9001\u8d28\u91cf\u7ba1\u7406\u539f\u5219\uff0c\u4f46\u4e13\u95e8\u9488\u5bf9\u533b\u7597\u5668\u68b0\u884c\u4e1a\u7684\u72ec\u7279\u9700\u6c42\u800c\u8bbe\u8ba1\u3002<\/p>\n \u8be5\u6807\u51c6\u5f3a\u8c03\u98ce\u9669\u7ba1\u7406\u3001\u8fc7\u7a0b\u63a7\u5236\u548c\u6cd5\u89c4\u7b26\u5408\u6027\uff0c\u65e8\u5728\u786e\u4fdd\u533b\u7597\u5668\u68b0\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\uff0c\u4ece\u8bbe\u8ba1\u5f00\u53d1\u5230\u751f\u4ea7\u3001\u5206\u9500\u548c\u552e\u540e\u670d\u52a1\u3002<\/p>\n<\/p>\n ISO13485\u7684\u6838\u5fc3\u8981\u7d20\u4e0e\u8981\u6c42<\/strong><\/p>\n ISO13485\u6807\u51c6\u7684\u6838\u5fc3\u8981\u7d20\u5305\u62ec\u7ba1\u7406\u804c\u8d23\u3001\u8d44\u6e90\u7ba1\u7406\u3001\u4ea7\u54c1\u5b9e\u73b0\u4ee5\u53ca\u6d4b\u91cf\u3001\u5206\u6790\u548c\u6539\u8fdb\u3002<\/p>\n \u7ba1\u7406\u804c\u8d23\u90e8\u5206\u8981\u6c42\u6700\u9ad8\u7ba1\u7406\u5c42\u627f\u8bfa\u5efa\u7acb\u548c\u7ef4\u62a4\u8d28\u91cf\u4f53\u7cfb\uff0c\u786e\u4fdd\u4ee5\u987e\u5ba2\u4e3a\u5173\u6ce8\u7126\u70b9\uff0c\u5e76\u5b9a\u671f\u8fdb\u884c\u7ba1\u7406\u8bc4\u5ba1\uff1b\u8d44\u6e90\u7ba1\u7406\u6d89\u53ca\u4eba\u529b\u8d44\u6e90\u3001\u57fa\u7840\u8bbe\u65bd\u548c\u5de5\u4f5c\u73af\u5883\uff0c\u786e\u4fdd\u5458\u5de5\u5177\u5907\u5fc5\u8981\u7684\u80fd\u529b\u548c\u57f9\u8bad\u3002<\/p>\n \u4ea7\u54c1\u5b9e\u73b0\u8986\u76d6\u4e86\u8bbe\u8ba1\u5f00\u53d1\u3001\u91c7\u8d2d\u3001\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u7b49\u8fc7\u7a0b\uff0c\u5f3a\u8c03\u98ce\u9669\u7ba1\u7406\u548c\u9a8c\u8bc1\u6d3b\u52a8\uff1b\u6d4b\u91cf\u548c\u5206\u6790\u5219\u901a\u8fc7\u76d1\u63a7\u3001\u5ba1\u8ba1\u548c\u6570\u636e\u5206\u6790\u6765\u9a71\u52a8\u6301\u7eed\u6539\u8fdb\uff0c\u786e\u4fdd\u4f53\u7cfb\u7684\u6709\u6548\u6027\u3002<\/p>\n<\/p>\n \u5b9e\u65bdISO13485\u7684\u6b65\u9aa4\u4e0e\u597d\u5904<\/strong><\/p>\n \u5b9e\u65bdISO13485\u8d28\u91cf\u4f53\u7cfb\u901a\u5e38\u4ece gap analysis \u5f00\u59cb\uff0c\u8bc6\u522b\u73b0\u6709\u4f53\u7cfb\u4e0e\u6807\u51c6\u8981\u6c42\u4e4b\u95f4\u7684\u5dee\u8ddd\uff0c\u7136\u540e\u5236\u5b9a\u5b9e\u65bd\u8ba1\u5212\uff0c\u5305\u62ec\u6587\u6863\u7f16\u5199\u3001\u5458\u5de5\u57f9\u8bad\u548c\u8fc7\u7a0b\u4f18\u5316\u3002<\/p>\n \u8ba4\u8bc1\u8fc7\u7a0b\u6d89\u53ca\u5185\u90e8\u5ba1\u8ba1\u3001\u7ba1\u7406\u8bc4\u5ba1\u548c\u7b2c\u4e09\u65b9\u8ba4\u8bc1\u673a\u6784\u7684\u5ba1\u6838\uff0c\u6210\u529f\u8ba4\u8bc1\u540e\uff0c\u4f01\u4e1a\u53ef\u4ee5\u4eab\u53d7\u591a\u79cd\u597d\u5904\uff0c\u5982\u589e\u5f3a\u5ba2\u6237\u4fe1\u4efb\u3001\u51cf\u5c11\u4ea7\u54c1\u53ec\u56de\u98ce\u9669\u3001\u63d0\u9ad8\u8fd0\u8425\u6548\u7387\uff0c\u5e76\u66f4\u5bb9\u6613\u6ee1\u8db3\u5168\u7403\u76d1\u7ba1\u8981\u6c42\u5982\u6b27\u76dfMDR\u6216\u7f8e\u56fdFDA\u6cd5\u89c4\u3002<\/p>\n<\/p>\n ISO13485\u5728\u533b\u7597\u884c\u4e1a\u4e2d\u7684\u5e94\u7528\u6848\u4f8b<\/strong><\/p>\n \u8bb8\u591a\u9886\u5148\u7684\u533b\u7597\u5668\u68b0\u516c\u53f8\uff0c\u5982\u7f8e\u6566\u529b\u6216\u5f3a\u751f\uff0c\u5df2\u6210\u529f\u5b9e\u65bdISO13485\uff0c\u5e76\u5c06\u5176\u6574\u5408\u5230\u65e5\u5e38\u8fd0\u8425\u4e2d\u3002<\/p>\n \u4f8b\u5982\uff0c\u4e00\u5bb6\u751f\u4ea7\u690d\u5165\u5f0f\u8bbe\u5907\u7684\u5236\u9020\u5546\u901a\u8fc7 adopting ISO13485\uff0c\u6539\u8fdb\u4e86\u8bbe\u8ba1\u63a7\u5236\u6d41\u7a0b\uff0c\u51cf\u5c11\u4e86\u7f3a\u9677\u7387\uff0c\u5e76\u52a0\u901f\u4e86\u4ea7\u54c1\u4e0a\u5e02\u65f6\u95f4\uff1b\u53e6\u4e00\u4e2a\u6848\u4f8b\u662f\u4e2d\u5c0f\u578b\u521d\u521b\u4f01\u4e1a\uff0c\u5229\u7528\u8be5\u6807\u51c6\u5efa\u7acb\u7a33\u5065\u7684\u8d28\u91cf\u4f53\u7cfb\uff0c\u4ece\u800c\u5438\u5f15\u6295\u8d44\u5e76\u62d3\u5c55\u56fd\u9645\u5e02\u573a\u3002<\/p>\n<\/p>\n \u6311\u6218\u4e0e\u672a\u6765\u53d1\u5c55\u8d8b\u52bf<\/strong><\/p>\n \u5b9e\u65bdISO13485\u5e76\u975e\u6ca1\u6709\u6311\u6218\uff0c\u5e38\u89c1\u95ee\u9898\u5305\u62ec\u9ad8\u6210\u672c\u3001\u6587\u6863\u590d\u6742\u6027\u548c\u5458\u5de5\u62b5\u6297\u53d8\u5316\uff0c\u4f46\u901a\u8fc7\u4f7f\u7528\u6570\u5b57\u5316\u5de5\u5177\u548c\u54a8\u8be2\u4e13\u5bb6\uff0c\u4f01\u4e1a\u53ef\u4ee5\u514b\u670d\u8fd9\u4e9b\u969c\u788d\u3002<\/p>\n \u672a\u6765\uff0c\u968f\u7740\u4eba\u5de5\u667a\u80fd\u3001\u7269\u8054\u7f51\u548c\u4e2a\u6027\u5316\u533b\u7597\u7684\u5174\u8d77\uff0cISO13485\u6807\u51c6\u4e5f\u5728\u4e0d\u65ad\u6f14\u5316\uff0c\u4f8b\u5982\u878d\u5165\u66f4\u591a\u7f51\u7edc\u5b89\u5168\u548c\u6570\u636e\u5206\u6790\u8981\u6c42\uff0c\u4ee5\u5e94\u5bf9\u65b0\u5174\u6280\u672f\u5e26\u6765\u7684\u98ce\u9669\uff0c\u786e\u4fdd\u533b\u7597\u8d28\u91cf\u4f53\u7cfb\u4fdd\u6301\u524d\u6cbf\u548c\u6709\u6548\u3002<\/p>\n<\/p>\n \u603b\u4e4b\uff0c\u533b\u7597\u8d28\u91cf\u4f53\u7cfbISO13485\u662f\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4e0d\u53ef\u6216\u7f3a\u7684\u57fa\u77f3\uff0c\u5b83\u901a\u8fc7\u7cfb\u7edf\u5316\u7684\u65b9\u6cd5\u63d0\u5347\u4ea7\u54c1\u8d28\u91cf\u548c\u60a3\u8005\u5b89\u5168\uff0c\u5e2e\u52a9\u4f01\u4e1a navigate \u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u5e76\u5b9e\u73b0\u53ef\u6301\u7eed\u53d1\u5c55\u3002<\/p>\n<\/p>\n 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[…]<\/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":[687],"class_list":["post-4363","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\/4363","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=4363"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4363\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4363"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4363"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4363"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}