ISO 13485 Medical devices is the most integrated standard of designing and manufacturing of medical devices and

guaranteeing service, especial applied to ISO 9001 and Quality System Regulation, QSA/GMP). IS0 13485 was developed
by Quality Management of medical devices and technical committee of universal requirements, consisted of all criteria of
GMP. It is not a "standalone" document and must contain IS09001,
Medical devices exported to Europe must meet the requirements of direction of EU 93/42/EEC.
Implementing IS013485 can be regarded as one of the choice to meet the direction 93/42/EEC.
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Tiu chun Y khoa ISO 13485 l tiu chun tch hp nht gia thit k v sn xut cc Thit b Y Khoa v dch v bo
m, c bit p dng cho ISO 9001 v Cc iu l h thng cht lng QSA/GMP.ISO 13485 c pht trin bi T
chc Cht Lng v Tiu Chun Y Khoa v nhng yu cu ph cp nht ca U Ban i hi kin thc chuyn mn ,bao
gm tt c Tiu Chun ca GMP. N khng nhng l ti liu chun m cn bao gm ISO 9001.
Thit b Y t xut qua Chu u phi p ng nhng yu cu bt buc ca EU 93/42/EEC
p dng ISO 13485 c th p ng mt trong nhng yu cu ca EU 93/42/EEC
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