{"id":9665,"date":"2026-08-06T14:02:00","date_gmt":"2026-08-06T14:02:00","guid":{"rendered":"https:\/\/www.sanner-group.com\/%e5%85%b3%e4%ba%8e\/%e8%b4%a8%e9%87%8f\/"},"modified":"2026-09-29T15:58:04","modified_gmt":"2026-09-29T15:58:04","slug":"%e8%b4%a8%e9%87%8f","status":"publish","type":"page","link":"https:\/\/www.sanner-group.com\/zh-hans\/%E5%85%B3%E4%BA%8E\/%E8%B4%A8%E9%87%8F\/","title":{"rendered":"\u8d28\u91cf"},"content":{"rendered":"
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Sanner \u7684\u8d28\u91cf\u7ba1\u7406<\/h1>

130 \u591a\u5e74\u6765\uff0cSanner \u4e00\u76f4\u81f4\u529b\u4e8e\u5236\u9020\u5927\u6279\u91cf\u533b\u7597\u4fdd\u5065\u5305\u88c5\u548c\u533b\u7597\u4ea7\u54c1\uff0c\u59cb\u7ec8\u4fdd\u6301\u7740\u5ba2\u6237\u6240\u4fe1\u8d56\u7684<\/span>\u4e00\u81f4<\/span>\u8d28\u91cf\u3001\u53ef\u9760\u6027\u548c\u5408\u89c4\u6027\u3002<\/span><\/p>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n

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130 \u5e74\u7684\u5353\u8d8a\u5305\u88c5\u7ecf\u9a8c<\/h2><\/div>\n \n \n

Sanner \u7684\u533b\u7597\u4fdd\u5065\u5305\u88c5\u7b26\u5408 BRC \u5305\u88c5\u6750\u6599\u6807\u51c6\u548c ISO 15378 \u6807\u51c6\uff0c\u65e8\u5728\u4fdd\u62a4\u654f\u611f\u7684\u836f\u7269\u3001\u8bca\u65ad\u548c\u81b3\u98df\u8865\u5145\u5242\u4ea7\u54c1\u514d\u53d7\u6c34\u5206\u3001\u6c61\u67d3\u548c\u73af\u5883\u66b4\u9732\u7684\u5f71\u54cd\u3002 <\/span><\/span> <\/span><\/p>\n<\/div>\n \n \u67e5\u770b\u6211\u4eec\u7684\u5305\u88c5\u89e3\u51b3\u65b9\u6848<\/a>\n \n <\/div>\n <\/div>\n\n

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\u5c06\u8d28\u91cf\u878d\u5165\u6bcf\u4e00\u4ef6\u4ea7\u54c1 <\/h4> <\/div>\n \n
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Sanner \u7ef4\u6301\u7740\u4e00\u5957\u6db5\u76d6\u8bbe\u8ba1\u3001\u5f00\u53d1\u548c\u5236\u9020\u7684\u5168\u7403\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb (QMS)\uff0c\u652f\u6301\u4ece\u6982\u5ff5\u5230\u5546\u4e1a\u5316\u53ca\u4e0a\u5e02\u540e\u6d3b\u52a8\u7684\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002\u8be5 QMS \u91c7\u7528\u57fa\u4e8e\u98ce\u9669\u3001\u6d41\u7a0b\u9a71\u52a8\u7684\u65b9\u6cd5\uff0c\u7b26\u5408 ISO 13485:2016 \u53ca\u9002\u7528\u7684\u5168\u7403\u76d1\u7ba1\u8981\u6c42\u3002 <\/span><\/span> <\/span><\/p>\n <\/div>\n \n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<\/section>

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\u7ecf\u8fc7\u8ba4\u8bc1\u7684\u8d28\u91cf\u4f53\u7cfb<\/h2><\/div>\n \n

Sanner \u91c7\u7528\u7b26\u5408 ISO 13485:2016 \u6807\u51c6\u7684\u5168\u7403\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\uff0c\u6db5\u76d6\u8bbe\u8ba1\u3001\u5f00\u53d1\u548c\u5236\u9020\u5168\u8fc7\u7a0b\u3002Sanner \u7684\u8fd0\u8425\u6db5\u76d6\u83b7\u5f97 ISO 13485 \u8ba4\u8bc1\u7684\u8bbe\u65bd\u3001ISO 9001 \u8ba4\u8bc1\uff0c\u4ee5\u53ca\u5df2\u901a\u8fc7\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u548c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6ce8\u518c\u4e14\u5df2\u8bc1\u660e\u5177\u5907\u63a5\u53d7\u68c0\u67e5\u80fd\u529b\u7684\u5236\u9020\u57fa\u5730\u3002<\/span><\/span><\/p>\n<\/div>\n \n <\/div>\n <\/div>\n

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\u9002\u7528\u4e8e\u6bcf\u4e2a\u5730\u533a\u7684\u7edf\u4e00\u6846\u67b6<\/h2><\/div>\n \n

Sanner \u5728\u5317\u7f8e\u3001\u6b27\u6d32\u548c\u4e9a\u6d32\u7684\u6240\u6709\u5206\u652f\u673a\u6784\u5747<\/span>\u5728<\/span>\u5168\u7403\u8d28\u91cf\u65b9\u9488\u4e0b\u7684\u7edf\u4e00\u8d28\u91cf\u6846\u67b6\u5185\u8fd0\u884c\uff0c\u5e76\u62e5\u6709\u4e0e\u5176\u5de5\u4f5c\u8303\u56f4\u76f8\u4e00\u81f4\u7684\u7279\u5b9a\u751f\u4ea7\u57fa\u5730\u7684 ISO \u8ba4\u8bc1\u548c\u673a\u6784\u6ce8\u518c\u3002\u8fd9\u79cd\u7ed3\u6784\u786e\u4fdd\u4e86\u6240\u6709\u5730\u533a\u7684\u4e00\u81f4\u4ea7\u54c1\u8d28\u91cf\u3001\u76d1\u7ba1\u5408\u89c4\u6027\u548c\u8d28\u91cf\u76d1\u7763\u3002<\/span><\/p>\n<\/div>\n \n <\/div>\n <\/div>\n

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\u6570\u636e\u5b8c\u6574\u6027\u4e0e\u53ef\u8ffd\u6eaf\u6027<\/h2><\/div>\n \n

\u7ecf\u8fc7\u9a8c\u8bc1\u4e14\u7b26\u5408 21 CFR Part 11 \u8981\u6c42\u7684\u7cfb\u7edf\u3001\u53d7\u63a7\u7684\u7535\u5b50\u8bb0\u5f55\u4ee5\u53ca\u6b63\u5f0f\u7684\u6570\u636e\u6cbb\u7406\u653f\u7b56\uff0c\u786e\u4fdd\u4e86\u53ef\u8ffd\u6eaf\u6027\u3001\u4fdd\u5bc6\u6027\u548c\u76d1\u7ba1\u5408\u89c4\u6027\u3002\u5f3a\u5927\u7684\u7f51\u7edc\u5b89\u5168\u63a7\u5236\u548c\u77e5\u8bc6\u4ea7\u6743\u4fdd\u62a4\u63aa\u65bd\u4fdd\u969c\u4e86\u5168\u7403\u4e1a\u52a1\u4e2d\u7684\u5ba2\u6237\u6570\u636e\u548c\u6280\u672f\u4fe1\u606f\u3002 <\/span><\/span> <\/span><\/p>\n<\/div>\n \n <\/div>\n <\/div>\n

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\u57fa\u4e8e\u98ce\u9669\u7684\u8d28\u91cf\u4f53\u7cfb<\/h2><\/div>\n \n

Sanner \u7684 QMS \u91c7\u7528\u57fa\u4e8e\u98ce\u9669\u3001\u6d41\u7a0b\u9a71\u52a8\u7684\u65b9\u6cd5\uff0c\u8d2f\u7a7f\u4ece\u6982\u5ff5\u5230\u5546\u4e1a\u5316\u53ca\u4e0a\u5e02\u540e\u6d3b\u52a8\u7684\u5404\u4e2a\u9636\u6bb5\uff0c\u652f\u6301\u6db5\u76d6\u8bbe\u8ba1\u3001\u5f00\u53d1\u548c\u5236\u9020\u7684\u5b8c\u6574\u4ea7\u54c1\u751f\u547d\u5468\u671f\u3002<\/span><\/span> <\/span><\/p>\n<\/div>\n \n <\/div>\n <\/div>\n

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\u7ec4\u5408\u4ea7\u54c1\u4e0e\u5168\u7403\u76d1\u7ba1\u5408\u89c4 <\/h2><\/div>\n \n

\u8be5 QMS \u7684\u6784\u5efa\u65e8\u5728\u6ee1\u8db3\u5168\u7403\u76d1\u7ba1\u8981\u6c42\uff0c\u5305\u62ec\u9488\u5bf9<\/span>\u7ec4\u5408\u4ea7\u54c1\u7684 21 CFR Part 4\u300121 CFR Part 820<\/span> (QMSR)<\/span>\u3001\u6b27\u76df MDR 2017\/745 \u4ee5\u53ca\u9002\u7528\u7684 ICH Q10 \u539f\u5219\u3002<\/span><\/p>\n<\/div>\n \n <\/div>\n <\/div>\n <\/div>\n\n

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\n <\/span>\n \n \u7ecf\u8fc7\u8ba4\u8bc1\u7684\u8d28\u91cf\u4f53\u7cfb <\/button>\n \n \u9002\u7528\u4e8e\u6bcf\u4e2a\u5730\u533a\u7684\u7edf\u4e00\u6846\u67b6 <\/button>\n \n \u6570\u636e\u5b8c\u6574\u6027\u4e0e\u53ef\u8ffd\u6eaf\u6027 <\/button>\n \n \u57fa\u4e8e\u98ce\u9669\u7684\u8d28\u91cf\u4f53\u7cfb <\/button>\n \n \u7ec4\u5408\u4ea7\u54c1\u4e0e\u5168\u7403\u76d1\u7ba1\u5408\u89c4 <\/button>\n <\/div>\n <\/div>\n <\/section>
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\u5168\u7403\u8d28\u91cf <\/h2><\/div>\n \n \n

Sanner \u5185\u90e8\u7f51\u7edc\u4e2d\u7684\u6240\u6709\u8bbe\u8ba1\u4e2d\u5fc3\u548c\u5236\u9020\u8bbe\u65bd\uff08\u5305\u62ec\u5728\u5317\u7f8e\u3001\u6b27\u6d32\u548c\u4e9a\u6d32\u7684\u4e1a\u52a1\uff09\u5747<\/span>\u5728<\/span>\u5168\u7403\u8d28\u91cf\u65b9\u9488\u4e0b\u7684\u8fd9\u4e00\u7edf\u4e00\u6846\u67b6\u5185\u8fd0\u884c\uff0c\u540c\u65f6<\/span>\u4fdd\u6301<\/span>\u4e0e\u5176\u5de5\u4f5c\u8303\u56f4\u76f8\u4e00\u81f4\u7684\u7279\u5b9a\u5de5\u5382 ISO \u8ba4\u8bc1\u548c\u5236\u9020\u673a\u6784\u6ce8\u518c\u3002\u8fd9\u79cd\u7ed3\u6784\u786e\u4fdd\u4e86\u6240\u6709\u5730\u533a\u7684\u4e00\u81f4\u4ea7\u54c1\u8d28\u91cf\u3001\u76d1\u7ba1\u5408\u89c4\u6027\u548c\u8d28\u91cf\u76d1\u7763\u3002<\/span><\/span> <\/span><\/p>\n<\/div>\n \n \u67e5\u770b\u8d28\u91cf\u6587\u4ef6<\/a>\n \n <\/div>\n <\/div>\n\n \n <\/div>\n <\/div>\n<\/section>

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\u8d28\u91cf\u6587\u5316<\/h2><\/div>\n \n \n

\u904d\u5e03\u5168\u7403\u4e1a\u52a1\u7684\u6301\u7eed<\/span>\u6539\u8fdb<\/span><\/span>\u8d28\u91cf<\/span>\u6587\u5316\u4f7f\u6d41\u7a0b\u4fdd\u6301\u654f\u9510\uff0c\u5e76\u8f85\u4ee5\u4f9b\u5e94\u5546\u5408\u89c4\u63a7\u5236\u4ee5\u53ca\u5bf9\u4e0d\u65ad\u53d8\u5316\u7684\u76d1\u7ba1\u9884\u671f\u7684\u4e3b\u52a8\u76d1\u6d4b\u3002<\/span><\/span><\/p>\n<\/div>\n \n \u67e5\u770b Sanner \u5730\u70b9<\/a>\n \n <\/div>\n <\/div>\n\n

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\u6ce8\u5851\u8d28\u91cf<\/h2><\/div>\n \n \n

\u5728\u9009\u62e9\u6240\u6709\u539f\u6750\u6599\u65f6\uff0cSanner \u7684\u57fa\u672c\u8981\u6c42\u662f\u5b83\u4eec\u5fc5\u987b<\/span>\u7b26\u5408\u76f8\u5173\u7684\u98df\u54c1\u6307\u5357\uff08\u5305\u62ec FDA \u548c\u6b27\u76df\uff0c\u4f8b\u5982 1935\/2004\/EG\u300110\/2011\/EG\u300121 CFR 177.1520\uff09\u3002\u5bf9\u4e8e\u6211\u4eec\u7528\u4e8e\u5236\u836f\u548c\u533b\u7597\u6280\u672f\u9886\u57df\u7684\u521d\u7ea7\u5305\u88c5\uff0c\u8fd8\u9700\u7b26\u5408\u76f8\u5173\u7684 USP \u548c<\/span>PhEur<\/span>\u7ae0\u8282\u4ee5\u53ca ISO 10993\u3002\u6211\u4eec\u4f1a\u4ee5\u7b26\u5408\u6027\u58f0\u660e\u6216<\/span>\u65e0\u5f02\u8bae<\/span>\u786e\u8ba4\u4e66\u7684\u5f62\u5f0f\u5411\u5ba2\u6237\u63d0\u4f9b\u5408\u89c4\u6027\u8bc1\u660e\u3002<\/span><\/span><\/p>\n<\/div>\n \n \n <\/div>\n <\/div>\n\n \n <\/div>\n <\/div>\n<\/section>

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\u5ba2\u6237\u4fe1\u606f\u4e0e ISO \u8ba4\u8bc1<\/h2> <\/div>\n \n \n
\n \u524d\u5f80\u4e0b\u8f7d\u4e2d\u5fc3<\/a>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<\/section>\n
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\u7acb\u5373\u8054\u7cfb\u6211\u4eec\u7684\u56e2\u961f<\/h3> <\/div>\n \n \n
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