{"id":4779,"date":"2022-05-31T15:00:10","date_gmt":"2022-05-31T07:00:10","guid":{"rendered":"https:\/\/maxsuntranslation.com\/maxsun-granted-iso-13485-2016-medical-devices-quality-management-systems-certification\/"},"modified":"2022-06-06T10:34:54","modified_gmt":"2022-06-06T02:34:54","slug":"maxsun-granted-iso-13485-2016-medical-devices-quality-management-systems-certification","status":"publish","type":"post","link":"https:\/\/maxsuntranslation.com\/zh-hans\/maxsun-granted-iso-13485-2016-medical-devices-quality-management-systems-certification\/","title":{"rendered":"\u660e\u6c55\u7ffb\u8bd1\u901a\u8fc7ISO 13485:2016\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1"},"content":{"rendered":"\n<p>2022\u5e745\u6708\uff0c\u6df1\u5733\u5e02\u660e\u6c55\u7ffb\u8bd1\u6709\u9650\u516c\u53f8\u6b63\u5f0f\u901a\u8fc7\u4e86<a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" data-wpel-link=\"external\" rel=\"follow external noopener noreferrer\">ISO 13485: 2016\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb<\/a>\u8ba4\u8bc1\u3002\u6b64\u6b21\u8ba4\u8bc1\u901a\u8fc7\uff0c\u6807\u5fd7\u7740\u660e\u6c55\u7ffb\u8bd1\u5728\u533b\u5b66\u4e0e\u533b\u7597\u5668\u68b0\u4e13\u4e1a\u670d\u52a1\u9886\u57df\u8fbe\u5230\u4e86\u56fd\u9645\u6807\u51c6\u7684\u9886\u5148\u6c34\u5e73\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" width=\"468\" height=\"687\" src=\"https:\/\/maxsuntranslation.com\/wp-content\/uploads\/2022\/05\/ming-shan-fan-yi-tong-guo-iso134852016-yi-liao-qi-xie-zhi.png\" alt=\"\u660e\u6c55\u7ffb\u8bd1\u901a\u8fc7ISO 13485-2016\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\" class=\"wp-image-4782\" srcset=\"https:\/\/maxsuntranslation.com\/wp-content\/uploads\/2022\/05\/ming-shan-fan-yi-tong-guo-iso134852016-yi-liao-qi-xie-zhi.png 468w, https:\/\/maxsuntranslation.com\/wp-content\/uploads\/2022\/05\/ming-shan-fan-yi-tong-guo-iso134852016-yi-liao-qi-xie-zhi-204x300.png 204w\" sizes=\"(max-width: 468px) 100vw, 468px\" \/><\/figure>\n\n\n\n<p><strong>\u76f8\u5173\u6587\u7ae0<\/strong>: <\/p>\n\n\n\n<p><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/maxsun-granted-iso-17100-2015-translation-service-certification\/\" target=\"_blank\" rel=\"noreferrer noopener follow\" data-wpel-link=\"internal\"><strong><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/maxsun-granted-iso-17100-2015-translation-service-certification\/\" target=\"_blank\">\u660e\u6c55\u7ffb\u8bd1\u901a\u8fc7ISO 17100:2015\u7ffb\u8bd1\u670d\u52a1\u4f53\u7cfb\u8ba4\u8bc1<\/a><\/strong><\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/how-iso-standard-translations-help-ce-mdr-certification\/\" target=\"_blank\" rel=\"noreferrer noopener follow\" data-wpel-link=\"internal\"><\/a><strong><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/how-iso-standard-translations-help-ce-mdr-certification\/\" target=\"_blank\" data-wpel-link=\"internal\" rel=\"follow noopener noreferrer\">ISO\u6807\u51c6\u7ffb\u8bd1\u670d\u52a1\u5982\u4f55\u52a9\u529b\u533b\u7597CE MDR\u4f53\u7cfb\u8ba4\u8bc1<\/a><\/strong><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 id=\"h-iso-13485\">\u4ec0\u4e48\u662fISO 13485\u8ba4\u8bc1\uff1f<\/h2>\n\n\n\n<p>\u4e8e1996\u5e74\u9996\u6b21\u53d1\u5e03\u7684ISO 13485\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u76ee\u524d\u4e3b\u8981\u6d89\u53ca\u7684\u4e3b\u8981\u4ea7\u54c1\u548c\u6280\u672f\u9886\u57df\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul><li>\u975e\u6709\u6e90\u533b\u7597\u8bbe\u5907<\/li><li>\u975e\u690d\u5165\u5f0f\u6709\u6e90\u533b\u7597\u5668\u68b0<\/li><li>\u690d\u5165\u5f0f\u6709\u6e90\u533b\u7597\u5668\u68b0<\/li><li>\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0<\/li><li>\u5bf9\u533b\u7597\u5668\u68b0\u7684\u706d\u83cc\u65b9\u6cd5<\/li><li>\u5305\u542b\/\u4f7f\u7528\u7279\u5b9a\u7269\u8d28\/\u6280\u672f\u7684\u533b\u7597\u5668\u68b0<\/li><li>\u533b\u7597\u5668\u68b0\u6709\u5173\u670d\u52a1<\/li><\/ul>\n\n\n\n<p>\u8be5\u4f53\u7cfb\u662f\u4ee5ISO 9001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4e3a\u57fa\u7840\u7684\u72ec\u7acb\u6807\u51c6\u4f53\u7cfb\u3002\u76f8\u5bf9\u4e8e\u9002\u7528\u8303\u56f4\u8986\u76d6\u5168\u884c\u4e1a\u7684ISO 9001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\uff0cISO 13485\u8ba4\u8bc1\u4f53\u7cfb\u662f\u66f4\u8fdb\u4e00\u6b65\u9488\u5bf9\u533b\u7597\u5668\u68b0\u5236\u9020\u884c\u4e1a\u5efa\u7acb\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6807\u51c6\uff0c\u8fd9\u4e24\u4e2a\u6807\u51c6\u4e2d\u867d\u7136\u5b58\u5728\u4e00\u4e9b\u76f8\u7c7b\u4f3c\u7684\u8981\u6c42\u548c\u5185\u5bb9\uff0c\u4f46\u662fISO 13485\u8ba4\u8bc1\u662f\u4e0e\u533b\u7597\u5668\u68b0\u884c\u4e1a\u6df1\u5ea6\u7ed3\u5408\u7684\u884c\u4e1a\u6807\u51c6\uff0c\u56e0\u6b64\u5373\u4fbf\u662f\u5177\u5907ISO 9001\u7684\u7ba1\u7406\u8d44\u8d28\u8ba4\u8bc1\uff0c\u4e5f\u8fdc\u4e0d\u7b49\u4e8e\u80fd\u591f\u76f4\u63a5\u8fbe\u5230ISO 13485\u6240\u8981\u6c42\u7684\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u6807\u51c6\u3002<\/p>\n\n\n\n<p><strong>\u4ec0\u4e48\u6837\u7684\u4f01\u4e1a\u53ef\u4ee5\u7533\u8bf7\uff1f<\/strong><\/p>\n\n\n\n<p>ISO 13485\u6807\u51c6\u662f\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\u5236\u9020\u884c\u4e1a\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6807\u51c6\uff0c\u4f46\u5e76\u4e0d\u662f\u53ea\u6709\u533b\u7597\u884c\u4e1a\u5185\u7684\u7ec8\u7aef\u8bbe\u5907\u5236\u9020\u4f01\u4e1a\u624d\u53ef\u4ee5\u7533\u8bf7\uff0c\u5b9e\u9645\u4e0a\u8be5\u6807\u51c6\u5728\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5185\u53ef\u4ee5\u8986\u76d6\u7684\u8303\u56f4\u6709\uff1a\u8bbe\u8ba1\u548c\u5236\u9020\u5546\u3001\u7ecf\u8425\u5546\u3001\u670d\u52a1\u4f9b\u5e94\u5546\u3001\u8f6f\u786c\u4ef6\u5f00\u53d1\u5546\u4ee5\u53ca\u96f6\u90e8\u4ef6\u548c\u6750\u6599\u4f9b\u5e94\u5546\u3002\u56e0\u6b64ISO 13485\u8ba4\u8bc1\u901a\u8fc7\u6574\u5408\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5185\u4e0d\u540c\u7c7b\u578b\u7684\u4e0a\u4e0b\u6e38\u4f01\u4e1a\u8d28\u91cf\u7ba1\u7406\u6807\u51c6\uff0c\u4e0d\u4ec5\u5728\u5ba2\u6237\u4e0e\u4f01\u4e1a\u4e4b\u95f4\uff0c\u4e5f\u5728\u4e0d\u540c\u7c7b\u578b\u7684\u4f01\u4e1a\u4e4b\u95f4\u63d0\u4f9b\u4e86\u80fd\u591f\u76f8\u4e92\u5bf9\u9f50\u8d28\u91cf\u9700\u6c42\u7684\u89c4\u8303\u9014\u5f84\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u4e3a\u533b\u7597\u5668\u68b0\u884c\u4e1a\u63d0\u4f9b\u4e13\u4e1a\u8bed\u8a00\u670d\u52a1\u7684\u7ffb\u8bd1\u516c\u53f8\u4f5c\u4e3a\u4e0a\u4e0b\u6e38\u73af\u8282\u4e2d\u7684\u4f9b\u5e94\u5546\u540c\u6837\u53ef\u4ee5\u7533\u8bf7ISO 13485\u8ba4\u8bc1\uff0c\u8fd9\u4e5f\u6807\u5fd7\u7740\u901a\u8fc7\u8ba4\u8bc1\u7684\u7ffb\u8bd1\u516c\u53f8\u80fd\u591f\u4e3a\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u63d0\u4f9b\u8fbe\u5230\u56fd\u9645\u884c\u4e1a\u6807\u51c6\u7684\u4e13\u4e1a\u7ffb\u8bd1\u670d\u52a1\u3002<\/p>\n\n\n\n<h2 id=\"h-iso-13485-1\">\u4e3a\u4ec0\u4e48\u7ffb\u8bd1\u516c\u53f8\u9700\u8981ISO 13485\uff1f<\/h2>\n\n\n\n<p>\u7ffb\u8bd1\uff0c\u6216\u8005\u5305\u542b\u7ffb\u8bd1\u5728\u5185\u4e3a\u6574\u4f53\u7684\u8bed\u8a00\u670d\u52a1\uff0c\u4f5c\u4e3a\u4e0e\u533b\u7597\u5668\u68b0\u76f8\u5173\u7684\u670d\u52a1\u4e5f\u88ab\u5305\u542b\u5728\u8ba4\u8bc1\u9886\u57df\u4e4b\u4e2d\u3002\u800cISO 13485\u8ba4\u8bc1\u7684\u6838\u5fc3\u5728\u4e8e\u201c\u89c4\u5b9a\u4e86\u4e00\u4e2a\u4e13\u4e1a\u7ec4\u7ec7\u9700\u8981\u8bc1\u660e\u5176\u80fd\u591f\u901a\u8fc7\u8fbe\u5230\u89c4\u8303\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08Quality Management System\uff0cQMS\uff09\u63d0\u4f9b\u59cb\u7ec8\u6ee1\u8db3\u5ba2\u6237\u548c\u6cd5\u89c4\u8981\u6c42\u7684\u533b\u7597\u8bbe\u5907\u548c\u76f8\u5173\u670d\u52a1\u3002\u201d<\/p>\n\n\n\n<p>\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4f5c\u4e3a\u4e0e\u4eba\u7c7b\u751f\u547d\u5065\u5eb7\u6700\u4e3a\u5bc6\u5207\u76f8\u5173\u7684\u884c\u4e1a\uff0c\u4e00\u76f4\u90fd\u4fdd\u6709\u8d85\u9ad8\u7684\u8d28\u91cf\u7ba1\u7406\u6807\u51c6\uff0c\u540c\u65f6\u5404\u56fd\u548c\u4e0d\u540c\u533a\u57df\u7684\u5e02\u573a\u4e5f\u957f\u671f\u5bf9\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5b9e\u65bd\u6700\u4e3a\u4e25\u683c\u7684\u8ba4\u8bc1\u4e0e\u51c6\u5165\u5236\u5ea6\u3002\u800c\u5728\u8fd9\u4e2a\u6d77\u5916\u8ba4\u8bc1\u51c6\u5165\u4e0e\u4ea7\u54c1\u9500\u552e\u7684\u8fc7\u7a0b\u4e2d\uff0c\u533b\u7597\u5668\u68b0\u7c7b\u5382\u5546\u5c31\u5fc5\u987b\u901a\u8fc7\u9ad8\u8d28\u91cf\u7684\u591a\u8bed\u8a00\u7ffb\u8bd1\u670d\u52a1\u786e\u4fdd\u4ea7\u54c1\u76f8\u5173\u7684\u8d44\u6599\u548c\u5185\u5bb9\u65e2\u80fd\u987a\u5229\u901a\u8fc7\u5404\u7c7b\u6280\u672f\u8ba4\u8bc1\u8fdb\u5165\u76ee\u6807\u5e02\u573a\uff0c\u4e5f\u80fd\u7ecf\u5f97\u8d77\u6765\u81ea\u4e0d\u540c\u8bed\u8a00\u6587\u5316\u80cc\u666f\u7684\u7528\u6237\u7684\u5b9e\u9645\u68c0\u9a8c\u3002<\/p>\n\n\n\n<p>\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u884c\u4e1a\u6765\u8bf4\uff0c\u5728\u9762\u5bf9\u8bed\u8a00\u670d\u52a1\u5e02\u573a\u4e2d\u5404\u7c7b\u4f9b\u5e94\u5546\u7684\u5408\u4f5c\u9009\u62e9\u65f6\uff0c\u901a\u8fc7ISO 13485\u8fd9\u4e2a\u4e13\u4e1a\u7684\u8ba4\u8bc1\u6807\u51c6\u53ef\u4ee5\u66f4\u4fbf\u6377\u5feb\u901f\u5730\u627e\u5230\u5177\u5907\u884c\u4e1a\u8d44\u8d28\u7684\u4f9b\u5e94\u5546\u3002\u5177\u6709ISO 13485\u8ba4\u8bc1\u8d44\u8d28\u7684\u7ffb\u8bd1\u516c\u53f8\u610f\u5473\u7740\uff1a<\/p>\n\n\n\n<ul><li>\u5177\u5907\u8fbe\u5230\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4e13\u4e1a\u5316\u56fd\u9645\u6807\u51c6\u8981\u6c42\u7684\u5168\u9762\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09<\/li><li>\u5df2\u5efa\u7acb\u4e0e\u533b\u7597\u5668\u68b0\u884c\u4e1a\u5ba2\u6237\u7684\u6b63\u5f0f\u5408\u4f5c\u5173\u7cfb<\/li><\/ul>\n\n\n\n<p>\u56e0\u6b64\u5982\u679c\u60a8\u662f\u533b\u7597\u5668\u68b0\u5236\u9020\u4f01\u4e1a\u7684\u8d1f\u8d23\u4eba\u5e76\u6b63\u5728\u4e1a\u52a1\u56fd\u9645\u5316\u7684\u8fc7\u7a0b\u4e2d\u5bfb\u627e\u5177\u5907\u4e13\u4e1a\u8d44\u8d28\u7684\u8bed\u8a00\u670d\u52a1\u4f9b\u5e94\u5546\u8fdb\u884c\u5408\u4f5c\uff0c\u90a3\u4e48ISO 13485\u8ba4\u8bc1\u5c06\u662f\u60a8\u4fe1\u5fc3\u7684\u4fdd\u8bc1\u3002<\/p>\n\n\n\n<p>\u660e\u6c55\u901a\u8fc7\u5341\u5e74\u4ee5\u4e0a\u7684\u884c\u4e1a\u5b9e\u8df5\u4e0e\u6c89\u6dc0\uff0c\u6c47\u805a\u8bed\u8a00\u670d\u52a1\u9886\u57df<strong><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/translators\/\" target=\"_blank\" rel=\"noreferrer noopener follow\" data-wpel-link=\"internal\">\u7cbe\u82f1\u8d44\u6e90<\/a><\/strong>\uff0c\u53ef\u5411\u5404\u7c7b\u4f01\u4e1a\u5ba2\u6237\u63d0\u4f9b<strong><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/translation-services\/\" target=\"_blank\" rel=\"noreferrer noopener follow\" data-wpel-link=\"internal\">\u4e13\u4e1a\u7684\u8bed\u8a00\u670d\u52a1<\/a><\/strong>\uff0c\u5305\u62ec<a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/translation-services\/translation-and-localization\/\" target=\"_blank\" data-wpel-link=\"internal\" rel=\"follow noopener noreferrer\">\u7ffb\u8bd1\u4e0e\u672c\u5730\u5316<\/a>\u3001<strong><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/translation-services\/technical-writing\/\" target=\"_blank\" rel=\"noreferrer noopener follow\" data-wpel-link=\"internal\">\u6280\u672f\u5199\u4f5c\u3001\u8425\u9500\u6587\u6848\u521b\u5199\u3001\u53e3\u8bd1<\/a><\/strong>\u3001\u4ee5\u53ca<strong><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/translation-services\/subtitling-and-voiceover\/\" target=\"_blank\" rel=\"noreferrer noopener follow\" data-wpel-link=\"internal\">\u5b57\u5e55\u7ffb\u8bd1<\/a><\/strong>\u4e0e\u914d\u97f3\u7b49\u7b49\uff0c\u5e2e\u52a9\u4f01\u4e1a\u89e3\u51b3\u5168\u7403\u5316\u6218\u7565\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\u7684\u5404\u7c7b\u95ee\u9898\uff0c\u901a\u8fc7\u8bed\u8a00\u521b\u9020\u4ef7\u503c\u3002\u622a\u6b62\u76ee\u524d\uff0c\u660e\u6c55\u5df2\u5206\u522b\u901a\u8fc7<strong><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/maxsun-granted-iso-17100-2015-translation-service-certification\/\" target=\"_blank\" rel=\"noreferrer noopener follow\" data-wpel-link=\"internal\">ISO&nbsp;9001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1<\/a><\/strong>\u548c<strong><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/maxsun-granted-iso-17100-2015-translation-service-certification\/\" target=\"_blank\" rel=\"noreferrer noopener follow\" data-wpel-link=\"internal\">ISO&nbsp;17100\u7ffb\u8bd1\u670d\u52a1\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1<\/a><\/strong>\uff0c\u662f\u60a8\u5728\u8bed\u8a00\u670d\u52a1\u9886\u57df\u4e13\u4e1a\u503c\u5f97\u4fe1\u4efb\u7684\u53ef\u9760\u4e4b\u9009\u3002\u6b32\u4e86\u89e3\u8be6\u60c5\uff0c<strong><a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/contact-us\/\" target=\"_blank\" rel=\"noreferrer noopener follow\" data-wpel-link=\"internal\">\u6b22\u8fce\u7559\u8a00\u54a8\u8be2<\/a><\/strong>\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\n\n\n<h2 id=\"h--4\">\u8054\u7cfb\u6211\u4eec<\/h2>\r\n<a href=\"https:\/\/maxsuntranslation.com\/zh-hans\/about-us\/\" data-wpel-link=\"internal\" 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