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\u-29698?\u31243?\u-29708?\u26126?\b0\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u26412?\u-29698?\u31243?\u19987?\u20026?\u21307?\u30103?\u22120?\u26800?\u-30644?\u19994?\u30340?\u31649?\u29702?\u-32763?\u12289?\u21442?\u19982?\u20135?\u21697?\u-29762?\u-29791?\u12289?\u20307?\u31995?\u25512?\u-30644?\u21450?\u-26418?\u-27031?\u31649?\u29702?\u22242?\u-27105?\u30340?\u20154?\u21592?\u-32756?\u-29762?\u-29791?\u12290?\u23398?\u21592?\u23558?\u20840?\u-26782?\u23398?\u20064?ISO 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\u-29698?\u31243?\u-28646?\u-28729?\u23567?\u32452?\u27963?\u21160?\u12289?\u23457?\u26680?\u28436?\u32451?\u12289?\u20114?\u21160?\u-29784?\u-29766?\u21644?\u25945?\u32451?\u24335?\u-29698?\u31243?\u31561?\u26041?\u24335?\u28145?\u20837?\u29702?\u-30237?\u-26418?\u-27031?\u31649?\u29702?\u30340?\u21407?\u21017?\u12289?\u-28729?\u31243?\u21644?\u22312?\u20135?\u21697?\u-29762?\u-29791?\u21644?\u-29400?\u-28209?\u31649?\u29702?\u20307?\u31995?\u30340?\u24212?\u29992?\u12290?\par\pard\plain\s0\fi0\li0\ri0\sb60\sa60\sl300\plain\f0\fs24\b \u-29698?\u31243?\u30446?\u26631?\b0\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?\u32467?\u21512?\u20225?\u19994?\u20135?\u21697?\u20449?\u24687?\u-244?\u25484?\u25569?\u-26418?\u-27031?\u30340?\u27010?\u24565?\u20197?\u21450?\u-26418?\u-27031?\u31649?\u29702?\u22312?\u21307?\u30103?\u22120?\u26800?\u-30644?\u19994?\u30340?\u20316?\u29992?\u-229?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?\u20102?\u-30237?\u26032?\u26087?\u29256?\u-26418?\u-27031?\u31649?\u29702?\u30340?\u21306?\u21035?\u21644?\u24212?\u29992?\u-229?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u23398?\u20250?\u-26418?\u-27031?\u31649?\u29702?\u21644?\u-29400?\u-28209?\u31649?\u29702?\u20307?\u31995?\u30340?\u25972?\u21512?\u-244?\u-27512?\u23545?\u19981?\u21516?\u31867?\u22411?\u30340?\u20225?\u19994?\u23398?\u20250?\u22914?\u20309?\u-28709?\u-30644?\u26377?\u25928?\u30340?\u-26418?\u-27031?\u31649?\u29702?\u-244?\u25552?\u21319?\u20307?\u31995?\u30340?\u31649?\u29702?\u-32515?\u21147?\u12290?\par\pard\plain\s0\fi0\li0\ri0\sb60\sa60\sl300\plain\f0\fs24\b \u-29698?\u31243?\u23545?\u-29599?\b0\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?\u-29400?\u-28209?\u-28440?\u32463?\u29702?\u12289?\u27861?\u-30268?\u-28440?\u32463?\u29702?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?\u20135?\u21697?\u-29762?\u-29791?\u20154?\u21592?\u12289?\u24037?\u-32134?\u-29762?\u-29791?\u20154?\u21592?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?ISO 13485\u20307?\u31995?\u25512?\u-30644?\u20154?\u21592?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?\u20869?\u23457?\u20154?\u21592?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u-26418?\u-27031?\u31649?\u29702?\u22242?\u-27105?\u21450?\u20844?\u21496?\u31649?\u29702?\u20154?\u21592?\par\pard\plain\s0\fi0\li0\ri0\sb60\sa60\sl300\plain\f0\fs24\b \u-29698?\u31243?\u22823?\u32434?\b0\par\pard\plain\s0\fi400\li0\ri0\sb40\sa40\sl300\plain\f0\fs22\b Day 1 \u20869?\u23481?\b0\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 Course aims, objectives and structure \u-29698?\u31243?\u30446?\u26631?\u12289?\u23398?\u20064?\u30446?\u30340?\u21644?\u-29698?\u31243?\u26550?\u26500?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 Risk management: Terms and definitions \u-26418?\u-27031?\u31649?\u29702?\u-230?\u26415?\u-29715?\u21644?\u23450?\u20041?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 Risk management and the Quality Management System (QMS) \u-26418?\u-27031?\u31649?\u29702?\u21644?\u-29400?c\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 Risk management and the Medical Device Regulation (MDR)/In Vitro Diagnostic Regulation (IVDR)\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u-26418?\u-27031?\u31649?\u29702?\u21644?\u21307?\u30103?\u22120?\u26800?\u27861?\u-30268?(MDR)\u21644?\u20307?\u22806?\u-29750?\u26029?\u27861?\u-30268?(IVDR)\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 ISO 14971:2019 New Revision Change ISO 14971:2019 \u26032?\u29256?\u30340?\u21464?\u21270?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 ISO 14971:2019: General structure \u-28646?\u29992?\u32467?\u26500?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 Annexes and ISO/TR 24971 \u-27068?\u24405?\u21644?ISO/TR 24971\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 ISO 14971:2019: Application of risk management to medical devices\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 ISO 14971:2019\u21307?\u30103?\u22120?\u26800?\u-26418?\u-27031?\u31649?\u29702?\u24212?\u29992?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?Scope \u-31997?\u22260?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?General requirements for risk management systems \u-26418?\u-27031?\u31649?\u29702?\u20307?\u31995?\u-28646?\u29992?\u-30335?\u27714?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?Risk management process \u-26418?\u-27031?\u31649?\u29702?\u-28729?\u31243?\par\pard\plain\s0\fi400\li0\ri0\sb40\sa40\sl300\plain\f0\fs22\b Day 2\u20869?\u23481?\b0\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?Risk analysis \u-26418?\u-27031?\u20998?\u26512?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?Risk evaluation \u-26418?\u-27031?\u-29756?\u20215?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?Risk control \u-26418?\u-27031?\u25511?\u21046?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?Evaluation of overall residual risk \u32508?\u21512?\u21097?\u20313?\u-26418?\u-27031?\u-29756?\u20215?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?Risk management review \u-26418?\u-27031?\u31649?\u29702?\u-29756?\u23457?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8226?Production and post-production activities \u29983?\u20135?\u21644?\u29983?\u20135?\u21518?\u27963?\u21160?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 Risk Management Technique: FMEA Requirement\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u-26418?\u-27031?\u31649?\u29702?\u25216?\u26415?\u-230?\u26032?FMEA \u22522?\u26412?\u-30335?\u27714?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 Risk Management Audit Requirement & Most Frequent Mistakes\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u-26418?\u-27031?\u31649?\u29702?\u23457?\u26680?\u-30335?\u27714?\u21644?\u26368?\u24120?\u-30271?\u-27367?\u-29713?\par\pard\plain\s0\fi0\li0\ri0\sb60\sa60\sl300\plain\f0\fs24\b \u-31605?\u-32767?\u24072?\u20171?\u32461?\b0\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u28023?\u20891?\u-32214?\u31354?\u24037?\u31243?\u23398?\u-27038?\u24212?\u29992?\u30005?\u23376?\u19987?\u19994?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 ISO 13485 \u-25896?\u32423?\u23457?\u26680?\u21592?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 ISO 13485 \u20027?\u20219?\u23457?\u26680?\u21592?\u12289?\u-29774?\u24072?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 ISO 90015 \u20027?\u20219?\u23457?\u26680?\u21592?\u12289?\u-29774?\u24072?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 ISO 140015 \u20027?\u20219?\u23457?\u26680?\u21592?\u12289?\u-29774?\u24072?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 KiteMark \u20135?\u21697?\u-29788?\u-29759?\u23457?\u26680?\u21592?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 IECQ \u27880?\u20876? QC080000 \u20027?\u20219?\u23457?\u26680?\u21592?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u-31605?\u20975?\u20808?\u29983?\u-244?\u30446?\u21069?\u25285?\u20219?\u20013?\u22269?\u21306?\u-29774?\u24072?\u21644?\u20027?\u20219?\u23457?\u26680?\u21592?\u12290?\u-31605?\u20808?\u29983?\u20855?\u26377?\u-29400?\u-28209?\u31649?\u29702?\u-26490?\u22495?\u21313?\u20116?\u24180?\u20197?\u19978?\u30340?\u24037?\u20316?\u32463?\u-25972?\u-244?\u20854?\u20013?\u21313?\u20313?\u24180?\u-29788?\u-29759?\u26426?\u26500?\u26381?\u21153?\u32463?\u-25972?\u12290?\u22312?\u-29400?\u-28209?\u31649?\u29702?\u12289?\u27969?\u31243?\u31649?\u29702?\u12289?\u32489?\u25928?\u25913?\u-28709?\u12289?\u22242?\u-27105?\u31649?\u29702?\u19982?\u27807?\u-28646?\u12289?\u26377?\u23475?\u29289?\u-29400?\u31649?\u29702?\u12289?\u21307?\u30103?\u-29762?\u22791?\u-29400?\u-28209?\u31649?\u29702?\u31561?\u26041?\u-26782?\u26377?\u20016?\u23500?\u30340?\u22521?\u-29779?\u21644?\u23457?\u26680?\u32463?\u-25972?\u12290?\u22240?\u23545?\u31649?\u29702?\u20307?\u31995?\u-30335?\u27714?\u22343?\u26377?\u29420?\u29305?\u30340?\u29702?\u-30237?\u-244?\u21892?\u20110?\u32467?\u21512?\u20225?\u19994?\u31649?\u29702?\u23454?\u-27067?\u24773?\u20917?\u-244?\u23558?\u21508?\u31649?\u29702?\u20307?\u31995?\u-30835?\u20250?\u-29393?\u-28646?\u-244?\u24110?\u21161?\u20225?\u19994?\u21644?\u23398?\u21592?\u29702?\u-30237?\u31649?\u29702?\u-30335?\u27714?\u24182?\u19987?\u21270?\u20026?\u23454?\u-27067?\u24212?\u29992?\u12290?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u22312?\u22521?\u-29779?\u-28729?\u31243?\u20013?\u21313?\u20998?\u27880?\u-28211?\u20225?\u19994?\u21644?\u23398?\u21592?\u30340?\u29305?\u28857?\u21644?\u-26880?\u27714?\u-244?\u23558?\u20010?\u20154?\u30340?\u20016?\u23500?\u32463?\u-25972?\u21516?\u25945?\u23398?\u20869?\u23481?\u26377?\u26426?\u30340?\u32467?\u21512?\u-244?\u27880?\u-28211?\u23454?\u-29195?\u30340?\u25506?\u32034?\u-244?\u28145?\u20837?\u27973?\u20986?\u-244?\u20999?\u21512?\u23454?\u-27067?\u-244?\u22312?\u25480?\u-29698?\u-28729?\u31243?\u20013?\u20805?\u20998?\u20351?\u29992?\u23454?\u-27067?\u26696?\u20363?\u-244?\u23545?\u25480?\u-29698?\u20869?\u23481?\u-28709?\u-30644?\u-29774?\u-30237?\u12290?\u22521?\u-29779?\u24378?\u-29693?\u20114?\u21160?\u21644?\u23454?\u25112?\u28436?\u32451?\u-244?\u20351?\u23398?\u21592?\u22312?\u-29698?\u31243?\u20013?\u-32515?\u22815?\u22312?\u-32767?\u24072?\u30340?\u24341?\u23548?\u19979?\u32467?\u21512?\u24037?\u20316?\u20013?\u30340?\u20855?\u20307?\u20107?\u20363?\u-28709?\u-30644?\u28145?\u24230?\u20998?\u26512?\u19982?\u24605?\u-32765?\u-244?\u27880?\u-28211?\u23398?\u20064?\u21560?\u25910?\u21518?\u-28820?\u21270?\u25104?\u23454?\u-27067?\u-30644?\u21160?\u30340?\u-32515?\u21147?\u12290?\u30495?\u27491?\u25552?\u21319?\u23398?\u21592?\u30340?\u-32515?\u21147?\u-244?\u20419?\u-28709?\u24037?\u20316?\u32489?\u25928?\u30340?\u25104?\u26524?\u12290?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u23457?\u26680?\u31995?\u21015? \u20225?\u19994?\u31649?\u29702?\u31995?\u21015?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8251? ISO13485 \u20869?\u23457?\u21592?\u12289?\u20027?\u20219?\u23457?\u26680?\u21592?\u12289?ISO 14971 \u8251?OHSAS 18001 \u20869?\u23457?\u21592?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8251? ISO 9001 \u20869?\u23457?\u21592?\u12289?\u20027?\u20219?\u23457?\u26680?\u21592? \u8251?\u20225?\u19994?\u20869?\u-28440?\u25511?\u21046?\u19982?\u-26418?\u-27031?\u31649?\u29702?(ERM)\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8251? ISO 14001 \u20869?\u23457?\u21592?\u12289?\u20027?\u20219?\u23457?\u26680?\u21592? \u8251?\u19994?\u21153?\u27969?\u31243?\u31649?\u29702?(BPM) \u8251? IMS \u25972?\u21512?\u31649?\u29702?\u20307?\u31995? \u8251?\u26377?\u23475?\u29289?\u-29400?\u31649?\u29702?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u-28440?\u20998?\u23458?\u25143?\u-230?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8251?\u-28207?\u-30835?\u19994?\u-230?\u21326?\u-30835?\u-29372?\u20135? \u20449?\u-28738?\u-29372?\u20135? \u20449?\u-28738?\u-29759?\u21048? \u24037?\u21830?\u-27402?\u-30644?\u25968?\u25454?\u20013?\u24515? \u20892?\u19994?\u-27402?\u-30644? \u24314?\u-29762?\u-27402?\u-30644? \u27888?\u24247?\u20154?\u23551? \u20013?\u20449?\u-27402?\u-30644?\u-28463?\u24030?\u-27402?\u-30644?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8251?\u26381?\u21153?\u19994?\u-230?\u20013?\u-28708?\u29289?\u27969? \u20013?\u22806?\u-28720?\u29289?\u27969? \u22823?\u30000?\u24555?\u-28654? \u20013?\u22269?\u22269?\u-27067?\u-32214?\u31354? \u30334?\u23433?\u23621? \u19996?\u26041?\u-32214?\u31354? \u22235?\u24029?\u-32214?\u31354?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u8251?\u21046?\u-28640?\u19994?\u-230?\u25308?\u-32717? \u26045?\u20048?\u-28791? \u27966?\u29790?\u26684? \u26045?\u27905?\u21307?\u30103? \u30334?\u29305?\u21307?\u30103? \u21019?\u29983?\u21307?\u30103? GE \u21307?\u30103? \u21490?\u-29349?\u20811? \u20255?\u21019?\u21147? \u-30337?\u-27160?\u23376? \u24052?\u22885?\u31859?\u29305? \u24378?\u29983?\par\pard\plain\s0\fi400\li0\ri0\sb80\sl300\plain\f0\fs22 \u26031?\u-28738?\u20811?\u21548?\u21147? \u-28784?\u26032?\u-28784?\u29031? \u27494?\u27721?\u26480?\u22763?\u-28506? \u30887?\u-28694? \u23453?\u-27486?\u22269?\u-27067? GE \u21307?\u30103? Schneider \u22799?\u26222?\par\pard\plain\s0\fi0\li0\ri0\sb60\sa60\sl300\plain\f0\fs24\b \u25105?\u-30335?\u25253?\u21517?\b0\par\pard\plain\s0\fi400\li0\ri0\plain\f0\fs22 \u21672?\u-29726?\u30005?\u-29731?\u-230?027-5111 9925 , 027-5111 9926\par\pard\plain\s0\fi400\li0\ri0\plain\f0\fs22 \u20540?\u29677?\u25163?\u26426?\u-230?18971071887    \u-28498?\u31665?\u-230?Service@mingketang.com\par}