鏂扮枂浣撶郴璁よ瘉鐨勫熀鏈敞鎰忎簨欏?
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鏂扮枂浣撶郴璁よ瘉錛孖SO13485錛?003<<鍖葷枟鍣ㄦ璐ㄩ噺綆＄悊浣撶郴鐢ㄤ簬娉曡鐨勮姹?gt;>鏍囧噯錛屾槸浠SO9001錛?000鏍囧噯涓哄熀紜�錛屽簲鐢ㄤ簬鍖葷枟鍣ㄦ涓撶敤鐨勭嫭绔嬫爣鍑嗭紝寮鴻皟婊¤凍鍖葷枟鍣ㄦ娉曡瑕佹眰錛屼簬2003騫?鏈?5鏃ュ彂甯冦�?/span>鏂扮枂浣撶郴璁よ瘉錛?/span>鍥藉椋熷搧鑽搧鐩戠潱綆＄悊灞�宸叉寜絳夊悓閲囩敤鐨勫師鍒欒漿鍖栦負琛屼笟鏍囧噯YY/T0287-2003銆傚湪嬈ф床甯傚満涓婏紝鍖葷枟鍣ㄦ鐢熶駭鍘傚晢鏃╁凡琚己鍒惰姹傞�氳繃璁よ瘉鏈烘瀯鐨凜E璁よ瘉銆傚皢閫忓交鐨勮瑙ｅ尰鐤楀櫒姊拌涓氳璇佽姹傦紝浣挎偍鍏ㄩ潰鎺屾彙鏈夊叧ISO13485錛?003鐨勭浉鍏寵姹傦紝鏈夋晥鐨勮繘琛屼綋緋誨唴瀹″伐浣溿�?/span>鏂扮枂浣撶郴璁よ瘉錛?/span>鎻愰珮鍖葷枟鍣ㄦ鐢熶駭浼佷笟璐ㄩ噺綆＄悊姘村鉤錛屽寮哄浗闄呯珵浜夊姏錛屼績榪涘尰鐤楀櫒姊拌涓氳鑼冨寲綆＄悊銆?/span>
1.ISO13485:2003鐨勬爣鍑嗗緩绔嬩簬ISO9001:2000鐨勬ā寮忔鏋朵箣涓娿�?/span>鏂扮枂浣撶郴璁よ瘉錛?/span>
2.ISO13485:2003渚濇嵁絎﹀悎鍚勭被鍏ㄧ悆娉曡鐨勮川閲忎綋緋昏姹傜殑妯″紡寤虹珛銆?/span>鏂扮枂浣撶郴璁よ瘉錛?/span>
3.鐢變簬閲嶇偣鐨勬敼鍙樻垚涓虹浉鍏蟲硶瑙勭殑瑕佹眰妯″紡錛孖SO13485:2003鐨勭紪鍐欒�呭皢ISO9001:2000涓己璋冨鎴鋒弧鎰忓害鐨勯儴鍒嗗垹闄ゃ�?/span>
4.ISO13485騫舵湭琚獸DA閲囩撼錛孎DA浠嶅皢緇х畫鍧氭寔鍏剁嫭绔嬬殑璐ㄩ噺浣撶郴娉曡錛圦SR錛夈�備絾鏄紝FDA鍙備笌緙栧啓ISO13485:2003鐨勪漢鍛樼‘淇′粬浠殑鏍囧噯鍜孖SO13485:2003鍙互騫惰銆傚洜姝わ紝涓�瀹剁鍚圛SO13485:2003瑕佹眰鐨勫叕鍙鎬篃寰堝鏄撹揪鍒癋DAQSR瑕佹眰銆?/span>鏂扮枂浣撶郴璁よ瘉錛?/span>
5.TR14969鏄嬌鐢ㄥ拰鎵цISO13485:2003鐨勬寚鍗椼�?/span>鏂扮枂浣撶郴璁よ瘉錛?/span>
6.ISO13485:2003騫墮潪渚濈収鍟嗕笟鎺ㄨ繘妯″紡鑰屾槸渚濈収浣滀負淇濇寔榪囩▼鏈夋晥鎬х殑宸ュ叿妯″紡鑰屽緩绔嬨�?/span>
7.涓嶪SO9001:2000涓嶅悓錛孖SO13485:2003涓嶅厑璁稿埗閫犲巶鍟嗗悎鐞嗙殑瑁佸噺鏂囦歡銆備負浜嗙‘淇濆叕鍙哥鍚堣鍒欒姹傦紝ISO13485:2003鏄懼緱鏇村叿璇存槑鎬у茍瑕佹眰鏌愪簺榪囩▼鏂囦歡浠嶉渶寤虹珛銆?/span>鏂扮枂浣撶郴璁よ瘉錛?/span>
8.椋庨櫓綆＄悊涔熸槸ISO13485:2003涓竴涓潪甯稿叧閿殑鍥犵礌銆?/span>鏂扮枂浣撶郴璁よ瘉錛?/span>
9.鍦↖SO13485:2003鍜孖SO9004:2000(璐ㄩ噺綆＄悊浣撶郴鍩虹鏍囧噯)涔嬮棿娌℃湁閲嶅ぇ鑱旂郴銆?/span>
10.ISO13485:2003鍜屽叾浠栤�滈潪璐ㄩ噺鈥濈鐞嗕綋緋誨ISO14001鍜孫HSAS18001鐩稿吋瀹廣�?/span>
