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4.ISO13485\u-230?2016\u26032?\u29256?\u20462?\u-29790?\u30340?\u26415?\u-29715?\u-244?\u23450?\u20041?\u21644?\u23457?\u26680?\u21407?\u21017?\u-229?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 5.ISO9001:2015 \u19982?ISO13485:2016\u30340?\u20851?\u31995?\u-229?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 6.\u-28729?\u28193?\u26399?\u-27056?\u21644?\u-26880?\u-30335?\u21738?\u20123?\u20934?\u22791?\u30340?\u-29372?\u28304?\u-229?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 7.\u21307?\u30103?\u22120?\u26800?\u-30644?\u19994?\u-29400?\u-28209?\u31649?\u29702?\u20307?\u31995?\u22522?\u30784?\u24212?\u29992?\u-229?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 8.ISO13485\u-29400?\u-28209?\u20307?\u31995?\u21307?\u30103?\u22120?\u26800?\u29992?\u20110?\u27861?\u-30268?\u30446?\u30340?\u30340?\u20307?\u31995?\u-30335?\u27714?\u-229?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 9.ISO13485\u26631?\u20934?\u22312?\u20855?\u20307?\u20225?\u19994?\u24212?\u29992?\u20013?\u30340?\u29305?\u28857?\u-229?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 10.ISO13485\u26631?\u20934?\u23545?\u24212?\u30340?\u25991?\u20214?\u-30335?\u27714?\u-229?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 11.ISO13485\u26631?\u20934?\u23545?\u24212?\u30340?\u-28729?\u31243?\u25511?\u21046?\u12290?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u31532?\u20108?\u-28440?\u20998?\u-230?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 1.ISO 13485\u26631?\u20934?-\u21307?\u30103?\u22120?\u26800?\u30340?\u25351?\u20196?\u-30335?\u27714?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 A\u12289?\u25351?\u20196?\u19982?\u20307?\u31995?\u30340?\u20851?\u31995?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 B\u12289?\u25351?\u20196?\u19982?\u20135?\u21697?\u26631?\u20934?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 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