ISO13485\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u6807\u51c6\u57fa\u7840\u95ee\u7b54\uff1a <\/p>\n\n\n\n
1.\u8c01\u5236\u5b9a\u4e86ISO13485;2016\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u6807\u51c6? \u56fd\u9645\u6807\u51c6\u7ec4\u7ec7\uff08ISO\uff09<\/p>\n\n\n\n
2. ISO13485\u73b0\u884c\u7248\u672c\u4e3a\uff1f 2003\u65e7\u7248\u8bc1\u4e66\u4f55\u65f6\u5931\u6548? \u73b0\u884c\u7248\u672c\u4e3a2016\u5e74\u7248\u672c\uff0c2003\u5e74\u7248\u5c06\u4e8e2019\u5e742\u6708\u5931\u6548 <\/p>\n\n\n\n
3.\u8ddf ISO9001:2015\u662f\u5426\u76f8\u5bb9\uff1f \u73b0\u884c\u7684 ISO13485 :2016\u7cfb\u4f9d\u636e ISO9001 :2008\u4e4b\u67b6\u6784\u64b0\u5199\uff0c\u4e0e ISO9001 :2015\u4e4b\u67b6\u6784\u5e76\u4e0d\u76f8\u5bb9\uff0c\u4f46\u7ba1\u7406\u7cfb\u7edfPDCA\u4e4b\u67b6\u6784\u4e0e\u6982\u5ff5\u662f\u76f8\u901a\u7684\u3002 <\/p>\n\n\n\n
4.\u7ec4\u7ec7\u901a\u8fc7 ISO13485, \u662f\u5426\u4e5f\u53ef\u4ee5\u5ba3\u544a\u901a\u544a ISO9001? \u4e0d\u884c\uff0c\u4e24\u5957\u5173\u6ce8\u7684\u89d2\u5ea6\u4e0d\u540c\uff0cISO13485 \u6ce8\u91cd\u4ea7\u54c1\u4e4b\u5b89\u5168\u53ca\u529f\u6548\uff0cISO9001 \u5173\u6ce8\u7684\u662f\u54c1\u8d28\u3002<\/p>\n\n\n\n
5. \u54ea\u4e9b\u4ea7\u4e1a\u53ef\u4ee5\u7533\u8bf7 ISO13485? \u5b9a\u4e49\u4e3a\u533b\u7597\u5668\u6750\u6216\u53ca\u5176\u534a\u6210\u54c1\u59cb\u5f97\u7533\u8bf7 ISO13485\u3002 <\/p>\n\n\n\n
ISO13485 :2016\u6761\u6587\u9488\u5bf9\u533b\u7597\u5668\u6750\u6709\u4ee5\u4e0b\u89e3\u91ca\uff0c\u4e0d\u8fc7\u5404\u56fd\u5bf9\u5b9a\u4e49\u8fd8\u662f\u6709\u4e0d\u540c\u7a0b\u5ea6\u7684\u5dee\u5f02\u5316\u3002<\/p>\n\n\n\n
\u5236\u9020\u5546\u7684\u9884\u671f\u7528\u9014\u662f\u4e3a\u4e0b\u5217\u4e00\u4e2a\u6216\u591a\u4e2a\u7279\u5b9a\u533b\u7597\u76ee\u7684\u7528\u4e8e\u4eba\u7c7b\u7684\uff0c\u4e0d\u8bba\u5355\u72ec\u4f7f\u7528\u6216\u7ec4\u5408\u4f7f\u7528\u7684\u4eea\u5668\u3001\u8bbe\u5907\u3001\u5668\u5177\u3001\u673a\u5668\u3001\u7528\u5177\u3001\u690d\u5165\u7269\u3001\u4f53\u5916\u8bd5\u5242\u3001\u8f6f\u4f53\u6216\u5176\u4ed6\u76f8\u4f3c\u6216\u76f8\u5173\u7269\u54c1\u3002\u8fd9\u4e9b\u76ee\u7684\u662f\uff1a<\/p>\n\n\n\n
6.\u533b\u7597\u5668\u6750\u534a\u6210\u54c1\u5382\u5546\u662f\u5426\u53ef\u4ee5\u7533\u8bf7 ISO13485? \u53ef\u4ee5\uff0c\u4f46\u7533\u8bf7\u524d\u8981\u4e3e\u8bc1\u5176\u9884\u671f\u7528\u9014(\u642d\u8f7d\u5728\u533b\u7597\u5668\u6750\u54ea\u4e2a\u90e8\u4f4d) <\/p>\n\n\n\n
7.ISO13485\u6709\u54ea\u4e9b\u9a8c\u8bc1\u673a\u6784\u53ef\u9a8c\u8bc1\uff1f ISO13485\u8ba4\u8bc1\u516c\u53f8\u6709\u5f88\u591a\uff0c\u53ef\u4ee5\u5728\u56fd\u5bb6\u8ba4\u76d1\u59d4\u5b98\u7f51\u67e5\u8be2\u3002 <\/p>\n\n\n\n
8.\u54ea\u95f4\u9a8c\u8bc1\u673a\u6784\u6bd4\u8f83\u9002\u5408\u6211\u4eec\u516c\u53f8\uff1f \u8981\u770b\u9500\u552e\u533a\u57df\u800c\u8ba2\uff0c\u53ef\u53c2\u8003\u4e0a\u9898\uff1b\u4e0d\u8fc7\u56e0\u8003\u91cf\u7a3d\u6838\u5458\u8d44\u683c\u3001\u670d\u52a1\u529b\u3001\u516c\u4fe1\u529b\u56e0\u7d20\uff0c\u5efa\u8bae\u591a\u8be2\u95ee\u6bd4\u8f83\u3002 <\/p>\n\n\n\n
9. \u4f55\u8c13 DMR? \u533b\u7597\u5668\u6750\u4e3b\u6863\u6848\uff0cDevice Master Record, \u4f9d\u636eISO13485\u6761\u6587\u8981\u6c42\uff0c \u5e94\u5305\u542b\u4ee5\u4e0b\u5185\u5bb9\uff1a <\/p>\n\n\n\n
10.\u82e5\u4e00\u4e2a\u533b\u7597\u5668\u6750\uff0c\u6709\u591a\u4e2a\u7cfb\u5217\uff0cDMR\u9700\u8981\u5448\u73b0\u591a\u4efd\u5417\uff1f \u4e0d\u9700\uff0c\u5f97\u4ee5\u7cfb\u5217\u627f\u8ba4\u65b9\u5f0f\u64b0\u5199\u3002 <\/p>\n\n\n\n
11.\u4ec0\u4e48\u662fDHF? \u533b\u7597\u5668\u6750\u8bbe\u8ba1\u5f00\u53d1\u5386\u53f2\u6863\u6848\uff08Design History File\uff0cDHF \uff09\u5e94\u4fdd\u6301\u6bcf\u4e00\u533b\u7597\u5668\u6750\u7c7b\u578b\u6216\u533b\u7597\u5668\u6750\u65cf\u7684\u8bbe\u8ba1\u4e0e\u5f00\u53d1\u6587\u4ef6\uff0c\u6b64\u6587\u4ef6\u5e94\u5305\u62ec\u6216\u5f15\u7528\u4e3a\u8bc1\u5b9e\u7b26\u5408\u8bbe\u8ba1\u4e0e\u5f00\u53d1\u8981\u6c42\u6240\u4ea7\u751f\u7684\u8bb0\u5f55\uff0c\u4ee5\u53ca\u8bbe\u8ba1\u4e0e\u5f00\u53d1\u53d8\u66f4\u7684\u8bb0\u5f55\u3002 <\/p>\n\n\n\n
12.\u4ec0\u4e48\u662fDHR? \u533b\u7597\u5668\u6750\u5386\u53f2\u7eaa\u5f55\uff08Device History Record, DHR\uff09\u4e3a\u533b\u7597\u5668\u6750\u6bcf\u6279\u6b21\u4e4b\u751f\u4ea7\u7eaa\u5f55 <\/p>\n\n\n\n
13.\u4f55\u8c13MDSAP? \u533b\u7597\u5668\u6750\u5355\u4e00\u7a3d\u6838\u8ba1\u5212(MDSAP)\u5df2\u5728\u6fb3\u6d32\u3001\u5df4\u897f\u3001\u52a0\u62ff\u5927\u53ca\u7f8e\u56fd\u8bd5\u884c\uff0c\u83b7\u5f97\u6b64\u8bc1\u5f97\u4ee5\u5728\u8fd9\u4e9b\u56fd\u5bb6\u8fdb\u53e3\u533b\u7597\u5668\u6750\uff0c\u4e0d\u9700\u53e6\u5916\u67e5\u8bc1\u3002\u53ef\u5408\u5e76 ISO13485 \u8bc1\u4e66\u7533\u8bf7\u3002 \u4e0d\u8fc7\uff0c\u5185\u5730\u9a8c\u8bc1\u673a\u6784\u8d77\u6b65\u7a0d\u665a\uff0c\u82e5\u8981\u542f\u52a8\u7a3d\u6838\u53ca\u62a5\u4ef7\u987b\u9884\u7559\u7f13\u51b2\u65f6\u95f4\uff0c\u9a8c\u8bc1\u673a\u6784\u6536\u4ef6\u540e\u56e0\u4e3a\u7533\u8bf7\u8d44\u683c\uff0c\u4e0d\u4e00\u5b9a\u53ef\u4ee5\u9a6c\u4e0a\u542f\u52a8\u9a8c\u8bc1\u3002 <\/p>\n\n\n\n
14. \u6211\u7684\u8bc1\u4e66\u4e0a\u6ca1\u6709\u8ba4\u8bc1\u673a\u6784(Accreditation Body)\u4e4bLOGO\uff0c\u8fd9\u5f20\u8bc1\u4e66\u6709\u6548\u5417\uff1f \u4e00\u822c\u8fd9\u6837\u7684\u60c5\u51b5\u53ef\u80fd\u662f\u5047\u7684\uff0c\u5efa\u8bae\u614e\u9009\u9a8c\u8bc1\u673a\u6784\uff0c\u6b63\u89c4\u673a\u6784\u53ef\u4ee5\u901a\u8fc7\u8ba4\u76d1\u59d4\u67e5\u8be2 <\/p>\n\n\n\n
15. \u901a\u8fc7 ISO13485\u540e\uff0c\u53ef\u4ee5\u5ba3\u544a\u901a\u8fc7GMP? \u4e0d\u884c\uff0c\u867d\u7136\u6761\u6587\u5185\u5bb9\u96f7\u540c\uff0c\u4f46\u67e5\u8bc1\u5355\u4f4d\u4e0d\u540c\uff0cGMP\u662f\u7531\u536b\u798f\u90e8\u4ee3\u67e5\u673a\u6784\u67e5\u8bc1\uff0c\u4e09\u5e74\u5f97\u590d\u67e5\u4e00\u6b21\u3002 <\/p>\n\n\n\n
16.GMP\u53ef\u4ee5\u548c ISO13485\u5171\u540c\u7533\u8bf7\u5417\uff1f \u53ef\u4ee5\uff0c\u4f46\u8981\u5148\u786e\u5b9a\u9009\u62e9\u7684\u9a8c\u8bc1\u673a\u6784\u3002<\/p>\n\n\n\n
17.\u4f55\u8c13CAPA? \u77eb\u6b63\u9884\u9632\u63aa\u65bd Corrective Action Preventative Action (CAPA)\u3002 <\/p>\n\n\n\n
18.ISO13485\u8981\u5199\u54c1\u8d28\u624b\u518c\u5417\uff1f \u8981\uff0c\u6761\u6587\u8981\u6c42\u9700\u8981\u6709\u54c1\u8d28\u624b\u518c\u3002 <\/p>\n\n\n\n
19.ISO13485\u9700\u8981\u6709\u7ba1\u7406\u4ee3\u8868\u5417\uff1f \u8981\uff0c\u6761\u6587\u8981\u6c42\u9700\u8981\u6709\u7ba1\u7406\u4ee3\u8868\u3002 <\/p>\n\n\n\n
20.\u533b\u7597\u5668\u6750\u4e34\u5e8a\u8bd5\u9a8c\u9700\u8981\u9075\u5b88\u4ec0\u4e48\u89c4\u5b9a\uff1f \u5728\u53f0\u6e7e\uff0c\u533b\u7597\u5668\u6750 \u4e4b\u4e34\u5e8a\u8bd5\u9a8c\u987b\u9075\u5b88 \u201c\u533b\u7597\u5668\u6750\u4e34\u5e8a\u4f5c\u4e1a\u89c4\u8303\u201d\u3002 <\/p>\n\n\n\n
21. \u5236\u7a0b\u82e5\u76f8\u540c\uff0c\u533b\u7597\u5668\u6750\u53ef\u4ee5\u4e0e\u836f\u6750\u5171\u7ebf\u5236\u4f5c\u5417\uff1f \u4e0d\u884c\uff0c\u53f0\u6e7e\u6cd5\u89c4\u8981\u6c42\u201c\u4e13\u5382\u4e13\u7167\u201d\u3002 <\/p>\n\n\n\n
22.\u751f\u4ea7\u533b\u7597\u5668\u6750\u7684\u73af\u5883\u4e00\u5b9a\u8981\u662f\u65e0\u5c18\u5ba4\u5417\uff1f \u4e0d\u4e00\u5b9a\uff0c\u770b\u751f\u4ea7\u4ea7\u54c1\uff0c\u82e5\u9700\u8981\u5efa\u7acb\u65e0\u5c18\u5ba4\uff0c\u9700\u53e6\u53c2\u7167 ISO14644 \u89c4\u5b9a\u3002 <\/p>\n\n\n\n
23. \u7535\u5668\u7c7b\u4ea7\u54c1\u8bc1\u660e\u5b89\u5168\u6027\u53ef\u7528\u54ea\u4e2a\u6cd5\u89c4\uff1f \u53ef\u4f7f\u7528 IEC 60601 \u76f8\u5173\u6cd5\u89c4\uff0c\u59d4\u8bf7\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u6d4b\u8bd5\u3002 <\/p>\n\n\n\n
24. ISO13485 :2016 \u4e2d\u201c\u8f6f\u4f53\u786e\u6548 Software validating\u201d\u662f\u6307\u6240\u6709\u8f6f\u4f53\u90fd\u9700\u8981\u786e\u6548\u5417\uff1f \u5728\u4ee5\u5f80ISO 13485 \u4e2d\u672a\u8981\u6c42\u201c\u8f6f\u4f53\u786e\u6548\u201d\uff0c\u4f46\u5728\u65b0\u7248\u6761\u65874.1.6\u4e2d\u8981\u6c42\u786e\u6548\uff0c\u53ea\u8981\u662f\u4e0e\u4ea7\u54c1\u54c1\u8d28\u6709\u5173\u7684\u8f6f\u4f53\uff0c\u7686\u9700\u8981\u8f6f\u4f53\u786e\u6548\uff0c\u975e\u4ee5\u5f80\u7684\u5236\u7a0b\u8f6f\u4f53\u624d\u9700\u8981\uff0c\u5728\u65b0\u7248\u6761\u65877.6\u4ea6\u8bf4\u660e\u76d1\u7763\u4e0e\u6d4b\u91cf\u4e4b\u7535\u8111\u8f6f\u4f53\u4e5f\u9700\u8981\u8fdb\u884c\u786e\u6548\uff0c\u4f46\u5f97\u4f9d\u98ce\u9669\u7ba1\u7406\u4e4b\u539f\u5219\u5224\u5b9a\u9700\u8981\u786e\u6548\u7684\u8f6f\u4f53\u3002 <\/p>\n\n\n\n
25. ISO13485\u7684\u98ce\u9669\u89c2\u5ff5\u4e0e ISO9001\u7684\u98ce\u9669\u6982\u5ff5\u76f8\u540c\u5417\uff1f \u4e0d\u540c\uff0cISO13485\u7684\u98ce\u9669\u6307\u7684\u662f\u673a\u7387\u4e0e\u4e25\u91cd\u5ea6\u7684\u4e58\u79ef\uff0cISO9001\u7684\u98ce\u9669\u5219\u662f\u8425\u8fd0\u98ce\u9669\u6982\u5ff5\u3002<\/p>\n\n\n\n
26. \u574a\u95f4\u54ea\u8fb9\u6709 ISO13485\u6761\u6587\u4e0b\u8f7d\u4f5c\u4e3a\u5b66\u4e60\uff1f ISO13485-2016\u4e2d\u6587\u53ef\u767e\u5ea6\uff0c\u6dd8\u5b9d\u3002<\/p>\n\n\n\n
27.\u533b\u7597\u5668\u6750\u8bb0\u5f55\u4fdd\u5b58\u6709\u7279\u6b8a\u89c4\u5b9a\u5417\uff1f \u6709\uff0c\u6761\u6587\u89c4\u5b9a\u7ec4\u7ec7\u4fdd\u5b58\u8bb0\u5f55\u7684\u671f\u9650\uff0c\u5e94\u81f3\u5c11\u4e3a\u7ec4\u7ec7\u6240\u89c4\u5b9a\u7684\u533b\u7597\u5668\u6750\u751f\u547d\u5468\u671f\uff0c\u4f46\u4ece\u7ec4\u7ec7\u653e\u884c\u4ea7\u54c1\u7684\u65e5\u671f\u8d77\u4e0d\u5c11\u4e8e 2\u5e74\uff0c\u6216\u6309\u9002\u7528\u7684\u6cd5\u89c4\u8981\u6c42\u89c4\u5b9a\u3002 <\/p>\n\n\n\n
28.\u533b\u7597\u5668\u6750\u6709\u89c4\u5b9a\u6587\u4ef6\u7684\u4f5c\u5e9f\u4fdd\u5b58\u5e74\u9650\uff1f \u6709\uff0c\u7ec4\u7ec7\u5e94\u81f3\u5c11\u4fdd\u5b58\u4e00\u4efd\u4f5c\u5e9f\u7684\u6587\u4ef6\uff0c\u5e76\u786e\u5b9a\u5176\u4fdd\u5b58\u671f\u9650\uff0c\u8fd9\u4e2a\u671f\u9650\u5e94\u786e\u4fdd\u81f3\u5c11\u5728\u7ec4\u7ec7\u6240\u89c4\u5b9a\u7684\u533b\u7597\u5668\u6750\u751f\u547d\u5468\u671f\u5185\u3002 ISO13485 :2016\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u6807\u51c6\u8fdb\u9636\u95ee\u7b54 <\/p>\n\n\n\n
29. \u7a3d\u6838\u5458\u770b\u5b8c\u73b0\u573a\u544a\u77e5\u4e00\u5b9a\u8981\u5efa\u7acb\u201c\u866b\u9f20\u7ba1\u7406\u7a0b\u5e8f\u201d\uff0c\u800c\u6211\u4eec\u516c\u53f8\u7684\u4ea7\u54c1\u4ec5\u662f\u534a\u6210\u54c1\uff0c\u4e14\u540e\u7eed\u5de5\u7a0b\u8fd8\u4f1a\u6709\u53e6\u5916\u7684\u52a0\u5de5\u884c\u4e3a\uff1f \u8fd9\u6837\u7684\u6761\u6587\u7a3d\u6838\u5e76\u4e0d\u5408\u7406\uff0c\u6761\u65876.4\u8981\u6c42\u8bf4\u660e \u201c\u5982\u679c\u5de5\u4f5c\u73af\u5883\u7684\u6761\u4ef6\u80fd\u5bf9\u4ea7\u54c1\u54c1\u8d28\u6709\u4e0d\u5229\u5f71\u54cd\u201d\uff0c\u624d\u9700\u53e6\u5916\u7ba1\u5236\u3002 <\/p>\n\n\n\n
30. \u7a3d\u6838\u5458\u770b\u5b8c\u73b0\u573a\u540e\uff0c\u544a\u77e5\u4eba\u5458\u4e00\u5b9a\u8981\u201c\u5065\u5eb7\u68c0\u67e5\u201d\uff0c\u800c\u6211\u4eec\u516c\u53f8\u7684\u4ea7\u54c1\u4ec5\u662f\u534a\u6210\u54c1\uff0c\u800c\u540e\u7eed\u8fd8\u6709\u53e6\u5916\u7684\u52a0\u5de5\u884c\u4e3a\uff1f \u8fd9\u6837\u7684\u6761\u6587\u7a3d\u6838\u5e76\u4e0d\u5408\u7406\uff0c\u6761\u65876.4\u8981\u6c42\u8bf4\u660e \u201c\u5982\u679c\u5de5\u4f5c\u73af\u5883\u7684\u6761\u4ef6\u80fd\u5bf9\u4ea7\u54c1\u54c1\u8d28\u6709\u4e0d\u5229\u5f71\u54cd\u201d\uff0c\u624d\u9700\u53e6\u5916\u7ba1\u5236\u3002 <\/p>\n\n\n\n
31.\u7a3d\u6838\u5458\u770b\u5b8c\u7814\u53d1\u6587\u4ef6\u540e\uff0c\u544a\u77e5\u7814\u53d1\u5fc5\u987b\u8fdb\u884c IEC 62366-1\u53ef\u7528\u6027\u5206\u6790\uff1f \u8fd9\u6837\u7684\u6761\u6587\u7a3d\u6838\u5e76\u4e0d\u5408\u7406\uff0c\u6761\u65877.3.3 \u4e8e\u5907\u6ce8\u680f\u4f4d\u8bf4\u660e\u7ec4\u7ec7\u53ef\u4f7f\u7528IEC 62366-1\u53ef\u7528\u6027\u5206\u6790\uff0c\u5e76\u975e\u5f3a\u5236\u8981\u6c42\u3002\u4f46\u5efa\u8bae\u533b\u7597\u5668\u6750\u6210\u54c1\u5382\u5546\u5e94\u505a\u8fc7\u4e00\u6b21IEC 62366-1\u53ef\u7528\u6027\u5206\u6790\u3002 <\/p>\n\n\n\n
32.\u6211\u7684\u8bc1\u4e66\u662fBSI\u6838\u53d1\u7684\uff0c\u82f1\u56fd\u8131\u6b27\u540e\u4f1a\u4e0d\u4f1aBSI\u8bc1\u4e66\u4e0d\u80fd\u5728\u6b27\u76df\u88ab\u8ba4\u53ef\uff1f \u76ee\u524d\u5c1a\u65e0\u6d88\u606f\u6307\u51fa\u6709\u5f71\u54cd\uff0c\u53ef\u7ee7\u7eed\u4f7f\u7528\u3002 <\/p>\n\n\n\n
33.\u4f55\u8c13QSR? \u7f8e\u56fd\u54c1\u8d28\u7cfb\u7edf\u6cd5\u89c4(Quality System Regulation, QSR)\uff0cQSR 21 CFR 820 \u5c31\u662f\u5e38\u89c1\u7684FDA\u67e5\u5382\u533b\u7597\u5668\u6750\u7684\u6cd5\u89c4\uff0c\u7531FDA\u5b98\u5458\u4eb2\u81ea\u67e5\u8bc1\uff0c\u4e0d\u8fc7\u6162\u6162\u5e94\u8be5\u4f1a\u88ab MDSAP\u53d6\u4ee3\u3002 <\/p>\n\n\n\n
34. \u4f55\u8c13QSD\uff1f \u8f93\u5165\u533b\u7597\u5668\u6750\u54c1\u8d28\u7cfb\u7edf\u6587\u4ef6\uff08Quality System Documentation\uff09\u3002 \u4f9d\u300a\u836f\u7269\u5236\u9020\u4e1a\u8005\u68c0\u67e5\u529e\u6cd5\u300b\u7b2c10\u6761\u89c4\u5b9a\uff0c\u7b26\u5408\u533b\u7597\u5668\u6750\u4f18\u826f\u5236\u9020\u89c4\u8303\u4e4b\u8bc1\u660e\u6587\u4ef6\uff0c\u4ea6\u5373\u300aQSD \u8ba4\u53ef\u767b\u5f55\u51fd\u300b\uff0c\u6709\u6548\u671f\u95f4\u4e3a3\u5e74\u3002 <\/p>\n\n\n\n
35. ISO13485 \u7533\u8bf7\u8fc7\u4e86\u53ef\u4ee5\u8bc1\u660e\u901a\u8fc7\u7f8e\u56fdFDA? \u53ef\u4ee5\u505a\u5230\uff0c\u53ea\u8981\u9a8c\u8bc1 ISO13485\u65f6\u52a0\u9a8c MDSAP\u5c31\u53ef\u4ee5\u3002\u4e0d\u8fc7\uff0c\u9700\u6ce8\u610f\u4e0d\u662f\u6bcf\u4e2a\u8ba4\u8bc1\u673a\u6784\u90fd\u53ef\u4ee5\u9a8c MDSAP\u3002 <\/p>\n\n\n\n
36.\u56fd\u5185ISO13485\u7a3d\u6838\u5458\u6700\u591a\u7684\u9a8c\u8bc1\u673a\u6784\u662f\u54ea\u95f4\uff1f \u8fd9\u4e2a\u53ef\u5411\u56fd\u5bb6\u8ba4\u76d1\u59d4\u6216\u8005\u8ba4\u8bc1\u673a\u6784\u76f4\u63a5\u8be2\u95ee\u3002 <\/p>\n\n\n\n
37. ISO14971 \u53ef\u4ee5\u5355\u72ec\u9a8c\u8bc1\u5417\uff1f ISO 14971\u4e3a ISO13485\u4f5c\u4e3a\u533b\u6750\u98ce\u9669\u8bc4\u4f30\u7684\u5de5\u5177\uff0c\u4e0d\u662f\u9a8c\u8bc1\u6807\u51c6\u3002 <\/p>\n\n\n\n
38. ISO14971\u73b0\u884c\u7248\u672c\u662f\u591a\u5c11\uff1f \u76ee\u524d\u6700\u65b0\u7248\u672c\u4e3a ISO14971 :2007\uff0c\u6b27\u76df\u4e5f\u6709\u53e6\u4e00\u7248\u672c EN ISO14971:2012\uff0c\u4e24\u4e2a\u7248\u672c\u5185\u5bb9\u5e76\u65e0\u592a\u591a\u5b9e\u8d28\u5dee\u5f02\u3002 <\/p>\n\n\n\n
39. \u7533\u8bf7 ISO13485\u65f6\uff0c\u5916\u5305\u5546\u548c\u534f\u529b\u5382\u5546\u9700\u901a\u8fc7 ISO13485\u5417\uff1f \u65e0\u5f3a\u5236\u89c4\u5b9a\uff0c\u4f46\u9a8c\u8bc1\u673a\u6784\u901a\u5e38\u4f1a\u89c6\u72b6\u51b5\uff0c\u7a3d\u6838\u65f6\u67e5\u9a8c\u8d35\u516c\u53f8\u7684\u6838\u5fc3\u5916\u5305\u5382\u5546\uff08\u5982\u6709\u706d\u83cc\u884c\u4e3a\u65f6\uff0c\u4e00\u5b9a\u8981\u67e5\u8bc1\u706d\u83cc\u5236\u7a0b\u5de5\u5382\uff09\u3002 <\/p>\n\n\n\n
40. \u5236\u7a0b\u4e00\u5b9a\u8981\u505a3Q\u9a8c\u8bc1\uff1f \u5efa\u8bae\u8981\uff0c\u533b\u6750\u516c\u53f8\u5236\u7a0b\u7a33\u5b9a\u5ea6\u76f8\u8f83\u5176\u4ed6\u751f\u4ea7\u884c\u4e3a\u5bf9\u516c\u53f8\u66f4\u4e3a\u91cd\u8981\uff0c3Q\u9a8c\u8bc1\u662f\u4e00\u79cd\u5236\u7a0b\u4fdd\u969c\u3002 <\/p>\n\n\n\n
41.\u6211\u4eec\u516c\u53f8\u5236\u7a0b\u5f88\u7b80\u5355\uff0c\u9a8c\u8bc1\u516c\u53f8\u544a\u77e5\u7535\u52a8\u87ba\u4e1d\u8d77\u5b50\u8981\u505a\u5236\u7a0b\u786e\u6548\uff1f \u662f\u5426\u505a\u786e\u6548\u4f9d\u636e\u8fc7\u8d35\u516c\u53f8\u8bc4\u4f30\u7684\u98ce\u9669\uff0c\u9a8c\u8bc1\u516c\u53f8\u5f3a\u5236\u8981\u6c42\u4e14\u5236\u7a0b\u76f8\u5bf9\u7b80\u5355\u4f3c\u4e4e\u4e0d\u5408\u7406\u3002 <\/p>\n\n\n\n
42. \u98ce\u9669\u8bc4\u4f30\u62a5\u544a\u64b0\u5199\u9700\u8981\u6709\u4e13\u5bb6\u5417\uff1f \u4f9d\u6761\u6587\u89c4\u5b9a\u662f\u9700\u8981\u7684\uff0c\u6761\u6587\u544a\u77e5\u98ce\u9669\u8bc4\u4f30\u5e94\u7531\u4e13\u5bb6\u8fdb\u884c\u6216\u59d4\u6258\u4e13\u4e1a\u673a\u6784\u4ee3\u4e3a\u8bc4\u4f30\uff0c\u4f46\u73b0\u51b5\u82e5\u90fd\u4e0d\u53ef\u884c\uff0c\u5927\u90e8\u5206\u9a8c\u8bc1\u673a\u6784\u53ef\u63a5\u53d7\u4ee5 ISO14971\u8bad\u7ec3\u8d44\u683c\u6765\u8bc1\u660e\u3002 <\/p>\n\n\n\n
43. \u5173\u4e8e\u65b0\u7248 ISO13485\u8bbe\u8ba1\u5f00\u53d1\u6709\u6ca1\u6709\u4ec0\u4e48\u7279\u5b9a\u8981\u6c42\uff1f \u8bbe\u8ba1\u5f00\u53d1\u9700\u8981\u660e\u786e\u7684\u9a8c\u8bc1\u53ca\u786e\u6548\u8ba1\u5212\uff0c\u5305\u62ec\uff1a\u5141\u6536\u51c6\u5219\u3001\u62bd\u6837\u5927\u5c0f <\/p>\n\n\n\n
44.ISO13485 :2003 \u8bc1\u4e66\u7684\u5931\u6548\u65f6\u95f4\u4e3a\u4f55\uff1f ISO13485 :2003\u5931\u6548\u65e5\u671f\u4e3a2019\u5e743\u6708\uff0c\u9a8c\u8bc1\u673a\u6784\u4e8e2018\u5e74\u5e95\u5747\u5df2\u7ec8\u6b62\u53d7\u7406\u65e7\u7248\u672c\u4e4b\u9a8c\u8bc1\u3002 <\/p>\n\n\n\n
45.\u533b\u7597\u5668\u6750\u4e00\u5b9a\u8981\u6d4b\u8bd5\u751f\u7269\u76f8\u5bb9\u6027( ISO10993)\u5417\uff1f \u4e0d\u4e00\u5b9a\uff0c\u9700\u63f4\u5f15 ISO10993 \u76f8\u5173\u89c4\u8303\uff0c\u5e76\u89c6\u98ce\u9669\u7b49\u7ea7\u3002 <\/p>\n\n\n\n
46.\u574a\u95f4\u5df2\u6709\u7c7b\u4f3c\u4ea7\u54c1\uff0c\u53ef\u4e0d\u53ef\u4ee5\u514d\u505a\u751f\u7269\u76f8\u5bb9\u6027\u8bd5\u9a8c\uff1f \u53ef\u4ee5\uff0c\u53ea\u8981\u80fd\u4e3e\u8bc1\u5236\u7a0b\u3001\u6750\u6599\u7684\u4e00\u81f4\u6027\uff0c\u662f\u53ef\u4ee5\u514d\u505a\u751f\u7269\u76f8\u5bb9\u6027\u8bd5\u9a8c\u3002<\/p>\n\n\n\n
47. \u5982\u4f55\u8bc4\u4f30\u4ea7\u54c1\u662f\u5426\u9700\u8fdb\u884c\u751f\u7269\u76f8\u5bb9\u6027\u8bd5\u9a8c\uff1f \u6309\u6807\u51c6\u5224\u65ad<\/p>\n\n\n\n
48.\u533b\u7597\u5668\u6750\u534a\u6210\u54c1\u82e5\u9884\u671f\u7528\u9014\u4e0d\u660e\uff0c\u662f\u5426\u53ef\u7533\u8bf7 ISO13485? \u4e0d\u884c\uff0c\u9700\u4e86\u89e3\u4ea7\u54c1\u7528\u9014\u540e\u4f7f\u5f97\u7533\u8bf7\uff1f <\/p>\n\n\n\n
49. \u6309\u6469\u5668\u6750\u5728\u53f0\u6e7e\u536b\u798f\u90e8\u5206\u7c7b\u4e0d\u662f\u533b\u7597\u5668\u6750\uff0c\u662f\u5426\u53ef\u7533\u8bf7 ISO13485 \u4e0d\u4e00\u5b9a\uff0c\u53ea\u8981\u6709\u5176\u4ed6\u56fd\u5bb6\u5217\u4e3a\u533b\u7597\u5668\u6750\uff0c\u90fd\u53ef\u4ee5\u5411\u9a8c\u8bc1\u673a\u6784\u63d0\u51fa\u7533\u8bf7\uff0c\u4f46\u987b\u63d0\u4ea4\u8bc1\u660e\u8d44\u6599 <\/p>\n\n\n\n
50. \u516c\u53f8\u8ba1\u5212\u5bfc\u5165 ISO13485\uff0c\u4f46\u4e0d\u77e5\u9053\u8981\u600e\u4e48\u5f00\u59cb\uff0c\u6beb\u65e0\u5934\u7eea? \u627e\u4e13\u4e1a\u7684\u7b2c\u4e09\u65b9\u673a\u6784\u534f\u52a9<\/p>\n","protected":false},"excerpt":{"rendered":"
ISO13485\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u6807\u51c6\u57fa\u7840\u95ee\u7b54\uff1a 1.\u8c01\u5236\u5b9a\u4e86ISO13485;2016\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\u6807\u51c6? \u56fd\u9645\u6807\u51c6\u7ec4\u7ec7\uff08ISO\uff09 2. ISO13485\u73b0\u884c\u7248\u672c\u4e3a\uff1f 2003\u65e7\u7248\u8bc1\u4e66\u4f55\u65f6\u5931\u6548? \u73b0\u884c\u7248\u672c\u4e3a2016\u5e74\u7248\u672c\uff0c2003\u5e74\u7248\u5c06\u4e8e2019\u5e742\u6708\u5931\u6548 3.\u8ddf ISO9001:2015\u662f\u5426\u76f8\u5bb9\uff1f \u73b0\u884c\u7684 ISO13485 :2016\u7cfb\u4f9d\u636e ISO9001 :2008\u4e4b\u67b6\u6784\u64b0\u5199\uff0c\u4e0e ISO9001 :2015\u4e4b\u67b6\u6784\u5e76\u4e0d\u76f8\u5bb9\uff0c\u4f46\u7ba1\u7406\u7cfb\u7edfPDCA\u4e4b\u67b6\u6784\u4e0e\u6982\u5ff5\u662f\u76f8\u901a\u7684\u3002 4.\u7ec4\u7ec7\u901a…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[15],"tags":[],"_links":{"self":[{"href":"https:\/\/qhdrz.com\/index.php?rest_route=\/wp\/v2\/posts\/1163"}],"collection":[{"href":"https:\/\/qhdrz.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/qhdrz.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/qhdrz.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/qhdrz.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1163"}],"version-history":[{"count":1,"href":"https:\/\/qhdrz.com\/index.php?rest_route=\/wp\/v2\/posts\/1163\/revisions"}],"predecessor-version":[{"id":1164,"href":"https:\/\/qhdrz.com\/index.php?rest_route=\/wp\/v2\/posts\/1163\/revisions\/1164"}],"wp:attachment":[{"href":"https:\/\/qhdrz.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1163"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/qhdrz.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1163"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/qhdrz.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1163"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}