{"id":1017,"date":"2020-10-03T12:18:45","date_gmt":"2020-10-03T04:18:45","guid":{"rendered":"http:\/\/qhdrz.com\/?p=1017"},"modified":"2020-10-03T12:23:46","modified_gmt":"2020-10-03T04:23:46","slug":"iso13485%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e8%b4%a8%e9%87%8f%e7%ae%a1%e7%90%86%e4%bd%93%e7%b3%bb%e4%bb%8b%e7%bb%8d","status":"publish","type":"post","link":"https:\/\/qhdrz.com\/?p=1017","title":{"rendered":"ISO13485\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4ecb\u7ecd"},"content":{"rendered":"\n<p>\u201c\u533b\u7597\u5668\u68b0\u201d\u662f\u6307\u4efb\u4f55\u7528\u4f5c\u8bca\u65ad\u3001\u9884\u9632\u53ca\u6cbb\u7597\u75be\u75c5\u7684\u4ea7\u54c1\uff0c\u5c0f\u81f3\u4f24\u53e3\u6577\u6599\u3001\u5fc3\u810f\u8d77\u640f\u5668\uff0c\u5927\u81f3\u7259\u79d1\u6905\u3001\u7ef4\u6301\u751f\u547d\u4eea\u5668\u4ee5\u53ca\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7b49\u3002<br><br>\u5728\u5927\u90e8\u5206\u56fd\u5bb6\uff0c\u653f\u5e9c\u90fd\u4f1a\u5bf9\u8fd9\u4e9b\u533b\u7597\u4ea7\u54c1\u4f5c\u51fa\u89c4\u5b9a\uff0c\u4ee5\u514d\u751f\u4ea7\u5546\u7c97\u5236\u6ee5\u9020\uff0c\u5371\u5bb3\u5e02\u6c11\u5065\u5eb7\u5b89\u5168\u3002\u4e0d\u5c11\u533b\u7597\u5668\u68b0\u4f1a\u88ab\u653e\u5165\u4eba\u4f53\uff0c\u9664\u4e86\u7528\u4f5c\u68c0\u67e5\u8eab\u4f53\u3001\u6cbb\u7597\u75be\u75c5\u5916\uff0c\u6709\u4e9b\u8fd8\u4f1a\u957f\u671f\u7559\u5728\u75c5\u4eba\u4f53\u5185\uff0c\u6bd4\u5982\u4eba\u9020\u9acb\u5173\u8282\u3001\u5fc3\u8840\u7ba1\u652f\u67b6\u3001\u4eba\u9020\u5fc3\u74e3\u6216\u5fc3\u810f\u8d77\u640f\u5668\u7b49\u3002<br><br>ISO 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13485\u6807\u51c6\u9002\u7528\u4e8e\u4efb\u4f55\u53c2\u4e0e\u533b\u7597\u5668\u68b0\u751f\u547d\u5468\u671f\u7684\u673a\u6784\uff0c\u7531\u8bbe\u8ba1\u3001\u751f\u4ea7\u3001\u505c\u6b62\u8fd0\u4f5c\u5230\u5f03\u7f6e\uff0c\u4ee5\u81f3\u50a8\u5b58\u3001\u5206\u53d1\u3001\u5b89\u88c5\u3001\u7ef4\u4fee\u4ee5\u53ca\u63d0\u4f9b\u76f8\u5173\u670d\u52a1\uff0c\u3002\u57282003\u5e74\u7684\u7248\u672c\u4e2d\uff0cISO 13485\u6807\u51c6\u5df2\u7ecf\u4f9d\u636e\u6cd5\u89c4\u52a0\u5165\u57fa\u4e8e\u98ce\u9669\u7684\u6982\u5ff5\uff0c\u800c2016\u5e74\u65b0\u7248\u66f4\u52a0\u5f3a\u4e86\u8fd9\u65b9\u9762\u7684\u5185\u5bb9\u3002<br><br>\u867d\u7136ISO 13485\u6807\u51c6\u7684\u5efa\u7acb\u57fa\u4e8eISO 9001\u6807\u51c6\uff0c\u4f46\u7531\u4e8e\u524d\u8005\u4ee5\u7b26\u5408\u6cd5\u89c4\u4e3a\u6838\u5fc3\u6027\u8d28\uff0c\u56e0\u6b64\u5e76\u672a\u5305\u542bISO 9001\u6807\u51c6\u7684\u5185\u5bb9\u3002\u4f8b\u5982ISO 13485\u6807\u51c6\u5e76\u6ca1\u6709\u50cfISO 9001\u6807\u51c6\u4e00\u6837\u8981\u6c42\u673a\u6784\u6301\u7eed\u6539\u5584\u5176\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u4ee5\u53ca\u8bc4\u4f30\u5176\u5ba2\u6237\u6ee1\u610f\u5ea6\uff0c\u4f46\u8981\u6c42\u673a\u6784\u8bc4\u4f30\u5176\u533b\u7597\u5668\u68b0\u4f7f\u7528\u8005\u7684\u610f\u89c1\uff0c\u5305\u62ec\uff1a\u533b\u7597\u5668\u68b0\u662f\u5426\u8fbe\u5230\u9884\u671f\u7684\u4f7f\u7528\u8981\u6c42\uff1f\u533b\u7597\u5668\u68b0\u662f\u5426\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\uff1f\u5269\u4f59\u98ce\u9669\u662f\u5426\u53d7\u5230\u63a7\u5236\uff1f\u6709\u6ca1\u6709\u53d1\u73b0\u65b0\u7684\u98ce\u9669\uff1f<br><br>\u300aISO 14971\u533b\u7597\u5668\u68b0\u2014\u98ce\u9669\u7ba1\u7406\u7684\u5e94\u7528\u300b\u4f5c\u4e3a\u4e0eISO 13485\u4e92\u8865\u7684\u6807\u51c6\uff0c\u63cf\u8ff0\u4e86\u5982\u4f55\u5728\u533b\u7597\u5668\u68b0\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\uff0c\u8fdb\u884c\u7cfb\u7edf\u5316\u7684\u98ce\u9669\u7ba1\u7406\u3002<\/p>\n\n\n\n<h2>ISO 13485:2016\u4fee\u6539\u5185\u5bb9<\/h2>\n\n\n\n<p>\u6b64\u6b21\u4fee\u8ba2ISO 13485\u6807\u51c6\u7684\u4e3b\u8981\u76ee\u7684\u662f\u53cd\u6620\u6700\u65b0\u7684\u79d1\u6280\u53d1\u5c55\uff0c\u4ee5\u53ca\u56de\u5e94\u751f\u4ea7\u5546\u53ca\u76d1\u7ba1\u673a\u6784\u65e5\u76ca\u63d0\u5347\u7684\u671f\u671b\uff0c\u5e76\u63a8\u52a8\u76d1\u7ba1\u673a\u6784\u3001\u5ba1\u6838\u673a\u6784\u548c\u533b\u7597\u5668\u68b0\u751f\u4ea7\u5546\u63d0\u5347\u76f8\u5173\u8981\u6c42\u7684\u900f\u660e\u5ea6\uff0c\u4ee5\u4fbf\u4e92\u76f8\u534f\u8c03\u3002\u6b64\u6807\u51c6\u9002\u7528\u4e8e\u53c2\u4e0e\u533b\u7597\u5668\u68b0\u751f\u547d\u5468\u671f\u4e2d\u67d0\u4e2a\u6216\u591a\u4e2a\u9636\u6bb5\u7684\u673a\u6784\uff0c\u5f53\u4e2d\u5305\u62ec\u8bbe\u8ba1\u3001\u5f00\u53d1\u3001\u751f\u4ea7\u3001\u50a8\u5b58\u3001\u5206\u53d1\u3001\u5b89\u88c5\u548c\u7ef4\u4fee\uff0c\u4ee5\u53ca\u8bbe\u8ba1\u3001\u5f00\u53d1\u548c\u63d0\u4f9b\u76f8\u5173\u6d3b\u52a8\uff08\u5982\u6280\u672f\u652f\u63f4\uff09\u3002\u76f8\u8f83\u4e8e\u65e7\u7248\u672c\uff0c\u65b0\u7248\u672c\u52a0\u5f3a\u4e86\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4e0e\u6cd5\u89c4\u8981\u6c42\u7684\u4e92\u52a8\u3001\u6807\u51c6\u5728\u4ea7\u54c1\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\u7684\u9002\u7528\u8303\u56f4\uff08\u5982\u5305\u62ec\u8be5\u533b\u7597\u5668\u68b0\u7684\u5206\u9500\u5546\u53ca\u8fdb\u53e3\u5546\uff09\uff0c\u4e8e\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4e2d\u66f4\u5e7f\u6cdb\u5730\u7eb3\u5165\u98ce\u9669\u7ba1\u7406\u7684\u539f\u5219\u3002<\/p>\n\n\n\n<p>\u9664\u975e\u6709\u7279\u522b\u6307\u660e\uff0c\u5426\u5219ISO 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