iso13485的颁证部门是质量监督管理局吗？ 医疗器械GMP与ISO9000，ISO13485有何区别
ISO13485\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u662f\u4ec0\u4e48\uff1fISO13485\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb
\u60a8\u597d\uff0c\u533b\u7597\u5668\u68b0GMP\u4e0eISO9000\uff0cISO13485\u8fd9\u4e09\u8005\u7684\u5173\u7cfb\u662f\u8fd9\u6837\u7684\uff1a
\u533b\u7597\u5668\u68b0GMP\u2014\u2014\u5bf9\u4e2d\u56fd\u6765\u8bf4\uff0c\u662f\u9488\u5bf9\u4f53\u7cfb\u8003\u6838\u7684
ISO13485\u2014\u2014\u4e0d\u662f\u4e2d\u56fd\u7684\u4f53\u7cfb\u6cd5\u89c4\uff0c\u5728\u4e2d\u56fd\u9500\u552e\u4e0d\u8981\u6c42\uff1b
ISO9000\u2014\u2014\u4e0d\u662f\u9488\u5bf9\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u7684\u3002
\u4e0b\u9762\u6211\u5c06\u4e3a\u60a8\u7b80\u8ff0\u8fd9\u4e09\u8005\u7684\u7b80\u4ecb\uff0c\u5e0c\u671b\u5bf9\u60a8\u6709\u6240\u5e2e\u52a9\u3002
\u3010\u533b\u7597\u5668\u68b0GMP\u3011\uff1a
GMP\u662f\u82f1\u6587 GOOD MANUFACTURING PRACTICE \u7684\u7f29\u5199\uff0c\u4e2d\u6587\u542b\u4e49\u662f\u201c\u4ea7\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u201d\u3002\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u5c06GMP\u5b9a\u4e49\u4e3a\u6307\u5bfc\u98df\u7269\u3001\u836f\u54c1\u3001\u533b\u7597\u4ea7\u54c1\u751f\u4ea7\u548c\u8d28\u91cf\u7ba1\u7406\u7684\u6cd5\u89c4\u3002
GMP\u662f\u4e00\u5957\u9002\u7528\u4e8e\u5236\u836f\u3001\u98df\u54c1\u7b49\u884c\u4e1a\u7684\u5f3a\u5236\u6027\u6807\u51c6\uff0c\u8981\u6c42\u4f01\u4e1a\u4ece\u539f\u6599\u3001\u4eba\u5458\u3001\u8bbe\u65bd\u8bbe\u5907\u3001\u751f\u4ea7\u8fc7\u7a0b\u3001\u5305\u88c5\u8fd0\u8f93\u3001\u8d28\u91cf\u63a7\u5236\u7b49\u65b9\u9762\u6309\u56fd\u5bb6\u6709\u5173\u6cd5\u89c4\u8fbe\u5230\u536b\u751f\u8d28\u91cf\u8981\u6c42\uff0c\u5f62\u6210\u4e00\u5957\u53ef\u64cd\u4f5c\u7684\u4f5c\u4e1a\u89c4\u8303\u5e2e\u52a9\u4f01\u4e1a\u6539\u5584\u4f01\u4e1a\u536b\u751f\u73af\u5883\uff0c\u53ca\u65f6\u53d1\u73b0\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5b58\u5728\u7684\u95ee\u9898\uff0c\u52a0\u4ee5\u6539\u5584\u3002\u7b80\u8981\u7684\u8bf4\uff0cGMP\u8981\u6c42\u5236\u836f\u3001\u98df\u54c1\u7b49\u751f\u4ea7\u4f01\u4e1a\u5e94\u5177\u5907\u826f\u597d\u7684\u751f\u4ea7\u8bbe\u5907\uff0c\u5408\u7406\u7684\u751f\u4ea7\u8fc7\u7a0b\uff0c\u5b8c\u5584\u7684\u8d28\u91cf\u7ba1\u7406\u548c\u4e25\u683c\u7684\u68c0\u6d4b\u7cfb\u7edf\uff0c\u786e\u4fdd\u6700\u7ec8\u4ea7\u54c1\u8d28\u91cf\uff08\u5305\u62ec\u98df\u54c1\u5b89\u5168\u536b\u751f\uff09\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u3002
\u4e2d\u56fd\u536b\u751f\u90e8\u4e8e1995\u5e747\u670811\u65e5\u4e0b\u8fbe\u536b\u836f\u53d1\uff081995\uff09\u7b2c35\u53f7"\u5173\u4e8e\u5f00\u5c55\u836f\u54c1GMP\u8ba4\u8bc1\u5de5\u4f5c\u7684\u901a\u77e5"\u3002\u836f\u54c1GMP\u8ba4\u8bc1\u662f\u56fd\u5bb6\u4f9d\u6cd5\u5bf9\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\uff08\u8f66\u95f4\uff09\u548c\u836f\u54c1\u54c1\u79cd\u5b9e\u65bdGMP\u76d1\u7763\u68c0\u67e5\u5e76\u53d6\u5f97\u8ba4\u53ef\u7684\u4e00\u79cd\u5236\u5ea6\u3002\u867d\u7136\u56fd\u9645\u4e0a\u836f\u54c1\u7684\u6982\u5ff5\u5305\u62ec\u517d\u836f\uff0c\u4f46\u53ea\u6709\u4e2d\u56fd\u548c\u6fb3\u5927\u5229\u4e9a\u7b49\u5c11\u6570\u51e0\u4e2a\u56fd\u5bb6\u662f\u5c06\u4eba\u7528\u836fGMP\u548c\u517d\u836fGMP\u5206\u5f00\u7684\u3002
\u836f\u54c1GMP\u8ba4\u8bc1\u5206\u4e3a\u56fd\u5bb6\u548c\u7701\u4e24\u7ea7\u8fdb\u884c\uff0c\u6839\u636e\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u54c1\u7ba1\u7406\u6cd5\u5b9e\u65bd\u6761\u4f8b\u300b\u7684\u89c4\u5b9a\uff0c\u7701\u7ea7\u4ee5\u4e0a\u4eba\u6c11\u653f\u5e9c\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u5e94\u5f53\u6309\u7167\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\u548c\u56fd\u52a1\u9662\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u89c4\u5b9a\u7684\u5b9e\u65bd\u529e\u6cd5\u548c\u5b9e\u65bd\u6b65\u9aa4\uff0c\u7ec4\u7ec7\u5bf9\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u7684\u8ba4\u8bc1\u5de5\u4f5c\uff1b\u7b26\u5408\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\u7684\uff0c\u53d1\u7ed9\u8ba4\u8bc1\u8bc1\u4e66\u3002\u5176\u4e2d\uff0c\u751f\u4ea7\u6ce8\u5c04\u5242\u3001\u653e\u5c04\u6027\u836f\u54c1\u548c\u56fd\u52a1\u9662\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u89c4\u5b9a\u7684\u751f\u7269\u5236\u54c1\u7684\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u7684\u8ba4\u8bc1\u5de5\u4f5c\uff0c\u7531\u56fd\u52a1\u9662\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u8d1f\u8d23\u3002
\u3010ISO9000\u3011\uff1a
ISO9000\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb\u662f\u4f01\u4e1a\u53d1\u5c55\u4e0e\u6210\u957f\u4e4b\u6839\u672c\uff0cISO9000\u4e0d\u662f\u6307\u4e00\u4e2a\u6807\u51c6\uff0c\u800c\u662f\u4e00\u7c7b\u6807\u51c6\u7684\u7edf\u79f0\u3002\u662f\u7531TC176\uff08TC176\u6307\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6280\u672f\u59d4\u5458\u4f1a\uff09\u5236\u5b9a\u7684\u6240\u6709\u56fd\u9645\u6807\u51c6\uff0c\u662fISO12000\u591a\u4e2a\u6807\u51c6\u4e2d\u6700\u7545\u9500\u3001\u6700\u666e\u904d\u7684\u4ea7\u54c1\u3002
ISO\uff08\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7\uff09\u548c IAF \uff08\u56fd\u9645\u8ba4\u53ef\u8bba\u575b\uff09\u4e8e2008\u5e74\uff08\u620a\u5b50\u5e74\uff098\u670820\u65e5\u53d1\u5e03\u8054\u5408\u516c\u62a5\uff0c\u4e00\u81f4\u540c\u610f\u5e73\u7a33\u8f6c\u6362\u5168\u7403\u5e94\u7528\u6700\u5e7f\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6807\u51c6\uff0c\u5b9e\u65bdISO9001:2008\u8ba4\u8bc1\u3002
ISO9001:2008\u6807\u51c6\u662f\u6839\u636e\u4e16\u754c\u4e0a170\u4e2a\u56fd\u5bb6\u5927\u7ea6100\u4e07\u4e2a\u901a\u8fc7ISO9001\u8ba4\u8bc1\u7684\u7ec4\u7ec7\u76848\u5e74\u5b9e\u8df5\uff0c\u66f4\u6e05\u6670\u3001\u660e\u786e\u5730\u8868\u8fbeISO9001:2008\u7684\u8981\u6c42\uff0c\u5e76\u589e\u5f3a\u4e0eISO14001:2004\u7684\u517c\u5bb9\u6027\u3002
2008 \u7248 ISO9001\u300a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8981\u6c42\u300b\u56fd\u9645\u6807\u51c6\u8ba1\u5212\u4e8e 2008 \u5e74\u5e95\u53d1\u5e03 GB/T 19001-2008\u300a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8981\u6c42\u300b\u3002ISO9001:2008\u6807\u51c6\u53d1\u5e031\u5e74\u540e\uff0c\u6240\u6709\u7ecf\u8ba4\u53ef\u7684\u8ba4\u8bc1\u673a\u6784\u6240\u53d1\u653e\u7684\u8ba4\u8bc1\u8bc1\u4e66\u5747\u4e3aISO9001:2008\u8ba4\u8bc1\u8bc1\u4e66\uff1b\u5185\u5ba1\u5458\u5168\u79f0\u53eb\u5185\u90e8\u8d28\u91cf\u4f53\u7cfb\u5ba1\u6838\u5458\uff0c\u901a\u5e38\u7531\u65e2\u7cbe\u901aISO9001:2008\u56fd\u9645\u6807\u51c6\u53c8\u719f\u6089\u8be5\u4f01\u4e1a\u7ba1\u7406\u72b6\u51b5\u7684\u4eba\u5458\u62c5\u4efb\u3002\u6309\u7167ISO9001:2008\u65b0\u6807\u51c6\u7684\u8981\u6c42\uff0c\u51e1\u662f\u63a8\u884cISO9001:2008\u65b0\u6807\u51c6\u7684\u7ec4\u7ec7\u6bcf\u5e74\u81f3\u5c11\u9700\u8fdb\u884c\u4e00\u6b21\u5185\u90e8\u8d28\u91cf\u5ba1\u6838\uff0c\u6240\u4ee5\uff0c\u51e1\u662f\u63a8\u884cISO9001:2008\u7684\u7ec4\u7ec7\uff0c\u901a\u5e38\u90fd\u9700\u8981\u57f9\u517b\u4e00\u6279\u5185\u5ba1\u5458\u3002\u5185\u5ba1\u5458\u53ef\u4ee5\u7531\u5404\u90e8\u95e8\u4eba\u5458\u517c\u804c\u62c5\u4efb\uff0c\u56e0\u6b64\u5185\u5ba1\u5458\u5728\u4e00\u4e2a\u7ec4\u7ec7\u5185\u5bf9\u8d28\u91cf\u4f53\u7cfb\u7684\u6b63\u5e38\u8fd0\u884c\u548c\u6539\u8fdb\u8d77\u7740\u91cd\u8981\u7684\u4f5c\u7528\u3002
\u3010ISO13485\u3011\uff1a
ISO13485\uff1a2003\u6807\u51c6\u7684\u5168\u79f0\u662f\u300a\u533b\u7597\u5668\u68b0 \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb \u7528\u4e8e\u6cd5\u89c4\u7684\u8981\u6c42\u300b\uff08Medical device-Quality management system-requirements for regulatory\uff09\u3002\u8be5\u6807\u51c6\u7531SCA/TC221\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u548c\u901a\u7528\u8981\u6c42\u6807\u51c6\u5316\u6280\u672f\u59d4\u5458\u4f1a\u5236\u5b9a\uff0c\u662f\u4ee5ISO9001\uff1a2000\u4e3a\u57fa\u7840\u7684\u72ec\u7acb\u6807\u51c6\u3002\u6807\u51c6\u89c4\u5b9a\u4e86\u5bf9\u76f8\u5173\u7ec4\u7ec7\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8981\u6c42\uff0c\u4f46\u5e76\u4e0d\u662fISO9001\u6807\u51c6\u5728\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4e2d\u7684\u5b9e\u65bd\u6307\u5357\u3002
\u8be5\u6807\u51c6\u81ea1996\u5e74\u53d1\u5e03\u4ee5\u6765\uff0c\u5f97\u5230\u5168\u4e16\u754c\u5e7f\u6cdb\u7684\u5b9e\u65bd\u548c\u5e94\u7528\uff0c\u65b0\u7248ISO13485\u6807\u51c6\u4e8e2003\u5e747\u67083\u65e5\u6b63\u5f0f\u53d1\u5e03\u3002\u4e0eISO9001\uff1a2000\u6807\u51c6\u4e0d\u540c\uff0cISO13485\uff1a2003\u662f\u9002\u7528\u4e8e\u6cd5\u89c4\u73af\u5883\u4e0b\u7684\u7ba1\u7406\u6807\u51c6\uff1a\u4ece\u540d\u79f0\u4e0a\u5373\u660e\u786e\u662f\u7528\u4e8e\u6cd5\u89c4\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8981\u6c42\u3002\u533b\u7597\u5668\u68b0\u5728\u56fd\u9645\u4e0a\u4e0d\u4ec5\u53ea\u662f\u4e00\u822c\u7684\u4e0a\u5e02\u5546\u54c1\u5728\u5546\u4e1a\u73af\u5883\u4e2d\u8fd0\u884c\uff0c\u5b83\u8fd8\u8981\u53d7\u5230\u56fd\u5bb6\u548c\u5730\u533a\u6cd5\u5f8b\u3001\u6cd5\u89c4\u7684\u76d1\u7763\u7ba1\u7406\uff0c\u5982\u7f8e\u56fd\u7684FDA\u3001\u6b27\u76df\u7684MDD\uff08\u6b27\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff09\u3001\u4e2d\u56fd\u7684\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b\u3002\u56e0\u6b64\uff0c\u8be5\u6807\u51c6\u5fc5\u987b\u53d7\u6cd5\u5f8b\u7ea6\u675f\uff0c\u5728\u6cd5\u89c4\u73af\u5883\u4e0b\u8fd0\u884c\uff0c\u540c\u65f6\u5fc5\u987b\u5145\u5206\u8003\u8651\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u7684\u98ce\u9669\uff0c\u8981\u6c42\u5728\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5b9e\u73b0\u5168\u8fc7\u7a0b\u4e2d\u8fdb\u884c\u98ce\u9669\u7ba1\u7406\u3002\u6240\u4ee5\u9664\u4e86\u4e13\u7528\u8981\u6c42\u5916\uff0c\u53ef\u4ee5\u8bf4ISO13485\u5b9e\u9645\u4e0a\u662f\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u73af\u5883\u4e0b\u7684ISO9001\u3002
\u7f8e\u56fd\u3001\u52a0\u62ff\u5927\u548c\u6b27\u6d32\u666e\u904d\u4ee5ISO 9001\uff0c\u3001EN 46001\u6216 ISO 13485\u4f5c\u4e3a\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb\u7684\u8981\u6c42\uff0c\u5efa\u7acb\u533b\u7597\u5668\u68b0\u8d28\u91cf\u4fdd\u8bc1\u4f53\u7cfb\u5747\u4ee5\u8fd9\u4e9b\u6807\u51c6\u4e3a\u57fa\u7840\u3002\u533b\u7597\u5668\u68b0\u8981\u8fdb\u5165\u5317\u7f8e\uff0c\u6b27\u6d32\u6216\u4e9a\u6d32\u4e0d\u540c\u56fd\u5bb6\u7684\u5e02\u573a\uff0c\u5e94\u9075\u5b88\u76f8\u5e94\u7684\u6cd5\u89c4\u8981\u6c42\u3002
非也，是有认证资格的认证公司！如一楼说的这几家公司都具备，想少花钱，尽量找国内没名气的。质监也做的，人家那是挣外快，哈哈
是具有认证资格的第三方认证机构颁发的；
绛旓細ISO13485鏄鍖荤枟鍣ㄦ璐ㄩ噺绠＄悊浣撶郴鏍囧噯銆傝嚜1996骞村彂甯冧互鏉ワ紝寰楀埌鍏ㄤ笘鐣屽箍娉涚殑瀹炴柦鍜屽簲鐢ㄣ侷SO13485鏄傜敤浜庢硶瑙勭幆澧冧笅鐨勭鐞嗘爣鍑嗭紱浠庡悕绉颁笂鍗虫槑纭槸鐢ㄤ簬娉曡鐨勮川閲忕鐞嗕綋绯昏姹傘傚尰鐤楀櫒姊板湪鍥介檯涓婁笉浠呭彧鏄竴鑸殑涓婂競鍟嗗搧鍦ㄥ晢涓氱幆澧冧腑杩愯锛屽畠杩樿鍙楀埌鍥藉鍜屽湴鍖烘硶寰嬨佹硶瑙勭殑鐩戠潱绠＄悊锛屽缇庡浗鐨凢DA銆佹鐩熺殑MDD锛堟鐩...
绛旓細ISO 13485鏄鍖荤枟鍣ㄦ鐨勮川閲忕鐞嗕綋绯昏璇併侷SO 13485鏄笓闂ㄩ拡瀵瑰尰鐤楀櫒姊拌涓氬埗瀹氱殑璐ㄩ噺绠＄悊浣撶郴鏍囧噯锛屽叾鐩爣鏄‘淇濆尰鐤楀櫒姊扮殑璁捐銆佺敓浜с佸寘瑁呫佸偍瀛樸佽繍杈撳拰瀹夎绛夌幆鑺傜殑璐ㄩ噺鍜屽畨鍏ㄣ傝鏍囧噯寮鸿皟瀵瑰尰鐤楀櫒姊板叏鐢熷懡鍛ㄦ湡鐨勬帶鍒讹紝纭繚浜у搧鑳藉婊¤冻鐢ㄦ埛鐨勯渶姹傦紝骞惰兘澶熶繚璇佸畨鍏ㄦу拰鏈夋晥鎬с傝鏍囧噯骞挎硾搴旂敤浜庡叏鐞冨尰鐤楀櫒姊...
绛旓細ISO 13485鏄尰鐤楀櫒姊拌川閲忕鐞嗕綋绯汇傝浣撶郴鏄负浜嗚鑼冨尰鐤楀櫒姊颁紒涓氱殑璐ㄩ噺绠＄悊娲诲姩锛岀‘淇濆尰鐤楀櫒姊扮殑瀹夊叏鎬у拰鏈夋晥鎬с備笅闈㈣缁嗕粙缁ISO 13485鐨鐩稿叧鍐呭锛氫竴銆両SO 13485姒傝堪 ISO 13485鏄尰鐤楀櫒姊拌涓氱殑涓椤瑰浗闄呮爣鍑嗭紝鏃ㄥ湪寤虹珛鍖荤枟鍣ㄦ浼佷笟鐨勮川閲忕鐞嗕綋绯昏姹傘傝鏍囧噯鍩轰簬杩囩▼鏂规硶锛屽己璋冨鍖荤枟鍣ㄦ浜у搧鐢熷懡鍛ㄦ湡鐨勫叏杩囩▼...
绛旓細iso13485浣撶郴鏄寚鍖荤枟鍣ㄦ璐ㄩ噺绠＄悊浣撶郴鏍囧噯锛屾棬鍦ㄤ负鍖荤枟鍣ㄦ鍒堕犲晢鍜屼緵搴斿晢鎻愪緵涓濂楃鐞嗕綋绯绘爣鍑嗭紝浠ョ‘淇濆叾浜у搧鐨勮川閲忓拰瀹夊叏鎬с傝鏍囧噯鐢卞浗闄呮爣鍑嗗寲缁勭粐锛圛SO锛夊埗瀹氾紝缁忚繃澶氬勾鐨勫彂灞曪紝鐜板凡鎴愪负鍏ㄧ悆鑼冨洿鍐呭尰鐤楀櫒姊拌涓氬箍娉涢噰鐢ㄧ殑璐ㄩ噺绠＄悊浣撶郴鏍囧噯涔嬩竴銆ISO13485浣撶郴鐨勬牳蹇冭姹傚寘鎷川閲忕鐞嗕綋绯荤殑寤虹珛銆佸疄鏂姐佷繚鎸...
绛旓細闅忕潃鍘嗗彶鐨勬紨杩涳紝鍥介檯鏍囧噯鍖栫粍缁嘔SO瀵瑰師鏈夌殑鏍囧噯杩涜浜嗚凯浠ｏ紝鎺ㄥ嚭浜ISO13485:2003鐗堛傚湪鍖荤枟璁惧鍒堕犱笟锛岃澶氬巶鍟嗗湪鏋勫缓璐ㄩ噺绠＄悊浣撶郴鏃讹紝寮濮嬪皢ISO9001:2000鏍囧噯鍜孖SO13485:2003鏍囧噯锛屼互鍙奀E璁よ瘉锛岃涓轰竴濂楀叏闈㈢殑瑙ｅ喅鏂规銆傚浜庡尰鐤楀櫒姊拌涓氭潵璇达紝ISO 13485鏍囧噯锛屾垜鍥界瓑鏁堣浆鎹负YY/T0287锛屾槸鍏惰川閲忕鐞嗕綋绯...
绛旓細鍦ISO13485璁よ瘉娴佺▼涓紝鍒濇璁よ瘉鏄叧閿楠ゃ傞鍏堬紝浼佷笟闇鎻愪氦銆奍SO13485璁よ瘉鍒嗙敵璇疯〃銆嬪強鐩稿叧鏉愭枡鑷砐X璁よ瘉涓績锛屼腑蹇冧細瀵规枃浠惰繘琛屽垵姝ュ鏍革紝纭榻愬叏鍚庡彂鏀俱婂彈鐞嗛氱煡涔︺嬨傝嫢璧勬枡涓嶅叏锛岃璇佹祦绋嬪皢鏃犳硶缁х画銆備紒涓氶渶涓庤璇佷腑蹇冪璁㈠悎鍚屽苟缂寸撼鍏ㄩ璁よ瘉璐癸紝闅忓悗锛屾鏌ョ粍浼氶氱煡鐜板満妫鏌ワ紝涓鍛ㄥ墠鍏竷璇︾粏璁″垝銆傜幇鍦...
绛旓細ISO13485鏍囧噯鏄傜敤浜庡尰鐤楀櫒姊版硶瑙勭幆澧冧笅鐨勮川閲忕鐞嗕綋绯绘爣鍑嗐傚叾鍏ㄧО鏄婂尰鐤楀櫒姊拌川閲忕鐞嗕綋绯荤敤浜庢硶瑙勭殑瑕佹眰銆嬨傚畠閲囩敤浜嗗熀浜嶪SO9001鏍囧噯涓璓DCA鐨勭浉鍏崇悊蹇碉紝鐩歌緝ISO9001鏍囧噯閫傜敤浜庢墍鏈夌被鍨嬬殑缁勭粐锛孖SO13485鏇村叿鏈変笓涓氭э紝閲嶇偣閽堝涓庡尰鐤楀櫒姊拌璁″紑鍙戙佺敓浜с佽串瀛樺拰娴侀氥佸畨瑁呫佹湇鍔″拰鏈缁堝仠鐢ㄥ強澶勭疆绛夌浉鍏宠涓氱殑...
绛旓細ISO13485鏄鍖荤枟鍣ㄦ琛屼笟璐ㄩ噺绠＄悊浣撶郴鏍囧噯锛屾槸鍖荤枟鍣ㄦ琛屼笟鏈鍏锋潈濞佹х殑鍥介檯璐ㄩ噺浣撶郴鏍囧噯銆傞伒寰鏍囧噯鐨勫尰鐤楀櫒姊板埗閫犲晢灏辫兘琛ㄦ槑浠栦滑宸茬粡寤虹珛浜嗚川閲忎繚璇佷綋绯绘潵淇濋殰鍏紬鐨勫畨鍏ㄤ笉鍙楀埌渚靛銆侷SO13485鏄湪ISO9000鍩虹涓婂鍔犱簡鍖荤枟鍣ㄦ琛屼笟鐨勭壒娈婅姹傦紝瀵逛骇鍝佺殑鏍囪瘑銆佽繃绋嬫帶鍒剁瓑鏂归潰鎻愬嚭浜嗘洿涓ユ牸鐨勬帶鍒惰姹傘傞氳繃璇ヨ璇...
绛旓細2011-3-29 鍋歩so13485澶氬皯閽憋紵2011-3-9 ISO13485璁よ瘉鐨勫叕璇佹庝箞鍋 1 2011-3-20 DNV鎵鏈変笟鍔¤鍋滀簡锛屾垜鍙稿皢璁″垝3鏈堜腑鍙婂洓鏈堜腑杩涜ISO13485璁よ瘉锛屾槸鍚﹁兘...2011-3-18 鍒堕犱紒涓氬浣曠潃鎵嬫帹琛孖SO13485绠＄悊浣撶郴 鏇村鍏充簬ISO13485鐨闂>> 绛夊緟鎮ㄦ潵鍥炵瓟del0鍥炵瓟骞挎眽鍒伴潚鐧芥睙鍩庢箻楠戞懇鎵樿溅瑕佸涔呮椂闂达紝鏄...
绛旓細ISO 13485鏄鍥介檯鍖荤枟鍣ㄦ琛屼笟鐨勪笓鐢ㄨ川閲忕鐞嗕綋绯绘爣鍑嗐傚彲鑳藉緢澶氫汉閮戒笉澶竻妤氳繖鏄竴涓粈涔堣璇佹爣鍑嗭紝浠婂ぉ鎴戝氨缁欏ぇ瀹朵粙缁iso13485璁よ瘉锛屽笇鏈涘澶у鏈夊府鍔!ISO13485璁よ瘉鐨勬剰鎬 璇ユ爣鍑嗚嚜1996骞村彂甯冧互鏉ワ紝寰楀埌鍏ㄤ笘鐣屽箍娉涚殑瀹炴柦鍜屽簲鐢紝鏂扮増ISO13485鏍囧噯浜2003骞7鏈3鏃ユ寮忓彂甯冦備笌ISO9001锛2000鏍囧噯涓嶅悓锛孖SO13...
