ISO 13485¡G2016 ÂåÀø¾¹§÷«~½èºÞ²z¨t²Î
ISO 13485¡G2016 ÂåÀø¾¹§÷«~½èºÞ²z¨t²Î ¥D¾É½]®Öû°ö°V½Òµ{
|
¥D¾É½]®Öû°ö°V½Òµ{
½Òµ{¤¶²Ð
¤F¸ÑÂåÀø¾¹§÷«~½èºÞ²z¨t²Î (ISO 13485:2016) ªº¥Øªº¡BºÞ²z¨t²Î¼Ð·Çn¨D¡BºÞ²z¨t²Î½]®Ö¡B²Ä¤T¤èÅçÃÒ½]®Ö»P«ùÄò§ïµ½ºÞ²z¨t²Î¤§¦³®Ä©Ê¯à¬°²Õ´±a¨Óªº¦n³B ¤F¸Ñ ISO 19011ºÞ²z¨t²Î½]®Ö«ü¤Þ »P ISO 17021 ÅçÃÒ½]®Ö¼Ð·Ç¤¤¡A°Ñ»P¦U¤èªº¨¤¦â»P³d¥ô¡A¥H¤Î½]®Öû¦p¦ó³W¹º¡B°õ¦æ¡B³ø§i»P°lÂÜÂåÀø¾¹§÷«~½èºÞ²z¨t²Î½]®Ö °ö¾i¨ã³Æ²Å¦XÂåÀø¾¹§÷³æ¤@½]®Öpµe (MDSAP, Medical Device Single Audit Program)¡B ISO 19011ºÞ²z¨t²Î½]®Ö«ü¤Þ »P ISO 17021 ÅçÃÒ½]®Ö¼Ð·Çn¨D¡A°õ¦æÂåÀø¾¹§÷«~½èºÞ²z¨t²Î½]®Ö³W¹º¡B°õ¦æ¡B³ø§i»P°lÂܪº¯à¤O¡C
½Òµ{¯S¦â/¥Ø¼Ð
ùþ½Òµ{¥Ø¼Ð
-
¤F¸ÑÂåÀø¾¹§÷«~½èºÞ²z¨t²Î (ISO 13485:2016) ªº¥Øªº¡BºÞ²z¨t²Î¼Ð·Çn¨D¡BºÞ²z¨t²Î½]®Ö¡B²Ä¤T¤èÅçÃÒ½]®Ö»P«ùÄò§ïµ½ºÞ²z¨t²Î¤§¦³®Ä©Ê¯à¬°²Õ´±a¨Óªº¦n³B
-
¤F¸Ñ ISO 19011ºÞ²z¨t²Î½]®Ö«ü¤Þ »P ISO 17021 ÅçÃÒ½]®Ö¼Ð·Ç¤¤¡A°Ñ»P¦U¤èªº¨¤¦â»P³d¥ô¡A¥H¤Î½]®Öû¦p¦ó³W¹º¡B°õ¦æ¡B³ø§i»P°lÂÜÂåÀø¾¹§÷«~½èºÞ²z¨t²Î½]®Ö
-
°ö¾i¨ã³Æ²Å¦XÂåÀø¾¹§÷³æ¤@½]®Öpµe (MDSAP, Medical Device Single Audit Program)¡B ISO 19011ºÞ²z¨t²Î½]®Ö«ü¤Þ »P ISO 17021 ÅçÃÒ½]®Ö¼Ð·Çn¨D¡A°õ¦æÂåÀø¾¹§÷«~½èºÞ²z¨t²Î½]®Ö³W¹º¡B°õ¦æ¡B³ø§i»P°lÂܪº¯à¤O¡C
ùþ½Òµ{¯S¦â
-
¤F¸Ñ¦p¦ó³z¹L½]®Ö¤u¨ã¡Aµû¦ôÂåÀø¾¹§÷«~½èºÞ²z¨t²Î (ISO 13485) ªº¦³®Ä©Ê¡A»P¨ó§U¶i¦æ«ùÄò§ïµ½
-
¤F¸ÑÂåÀø¾¹§÷«~½èºÞ²z¨t²Î (ISO 13485:2016) n¨D
-
¤F¸Ñ½]®Öû¦p¦ó®Ú¾Ú ISO 19011 / ISO 17021µ¥½]®Ö¼Ð·Ç¡A¶i¦æ½]®Ö³W¹º¡B¹ê¬I¡B³ø§i¡B°lÂÜÂåÀø¾¹§÷«~½èºÞ²z¨t²Î (ISO 13485)
-
¤F¸Ñ¦p¦ó¹B¥ÎÂåÀø¾¹§÷·ÀIºÞ²z¼Ð·Ç ISO 14971ºÞ²zÂåÀø¾¹§÷·ÀI
-
¤F¸Ñ³Ì·s½]®Ö§Þ¥©¡Bn¨D¡Aº¡¨¬½]®Öûn¨D
½Òµ{¹ï¶H
• ÂåÀø¾¹§÷«~½è§@·~¡BºÞ²z¬ÛÃö±M·~¤H¤h¡A¥]§t¤uµ{®v¡BÅU°Ý»P¸g²z¤H...µ¥ • ÂåÀø¾¹§÷¶}µo°Ó¡B¥N²z°Ó¡B¨ÑÀ³°Ó»PªA°È´£¨Ñ°Ó • ¥ô¦ó±q¨Æ ISO 9001 ¡BISO 13485 ÂåÀø¾¹§÷«~½èºÞ²z¨t²ÎºÞ²z½]®Ö¤Hû • ISO 9001 ¡BISO 13485 ÂåÀø¾¹§÷«~½èºÞ²z¨t²Î¥Nªí • ´M¨D°ê»Ú½]®Öûµù¥Uªº±M·~¤H¤h
Á¿®v²¤¶
Á¿®v¬° TSKG»{©w¤§Á¿®v
½Òµ{¤jºõ
¥H¬ï´¡Ó®×¬ã°Qªº±Ð¾Ç¤è¦¡¡A»´ÃP¦a¤F¸ÑISO13485 ±ø´Ún¨D¤Î½]®Ö¬yµ{¡A½T«O½]«Oû³z¹ý²z¸Ñ¨ä¾³d¡A¨ÃÀò±o¦³§U¨äÂЦæºÞ²z¨t²Î©Ò½á¤©Â¾³d©Ò»Ýªº±M·~ª¾ÃÑ¡G
-
ÂåÀø¾¹§÷«~½èºÞ²z¨t²Îªºì«h
-
ºÞ²z¨t²Î¡u³W¹º-°õ¦æ-¬d®Ö-¦æ°Ê¡v(PDCA) ¤Î¬yµ{¾É¦V¤èªk
-
°Q½×ÂåÀø¾¹§÷«~½èºÞ²z¨t²Î (ISO 13485) ªº¥Øªº¡B¦n³B
-
°Q½× ISO 13485 »P ISO 9001 ¼Ð·Ç¤§¶¡ªºÃö«Y
-
ISO 13485 ±ø´Ú¦U¶µn¨D¸Ñ»¡
-
°Q½×¦p¦ó¹B¥ÎÂåÀø¾¹§÷·ÀIºÞ²z¼Ð·Ç ISO 14971ºÞ²zÂåÀø¾¹§÷·ÀI
-
°Q½×ÂåÀø¾¹§÷¬ÛÃö³W½d
-
½]®Ö³N»y/ ½]®Ö/ ³W¹º
-
¶i¦æ°_©l·|ij¡B»`¶°¡BÃÒ¹ê½]®Ö/ ½]®Ö´£°Ý§Þ¥©/ ³X½Í©M½]®Ö§Þ¥©½m²ß
-
½]®Öµo²{/ ½]®Öµ²½×/ ¶i¦æµ²§ô·|ij/½]®Ö«áÄò¦æ°Ê/ ½]®Ö§@·~½m²ß
-
½Òµ{Á`µ²/ °ÝÃD´£°Ý/ ½]®Öû½Òµ{»{ÃÒ¦Ò¸Õ(¥i¤¤¤å§@µª¡A¦Ò¸Õ®É¶¡2 ¤p®É)
»ù®æ
¶O ¥Î¡G¨C¤H 50,000 ¤¸(¥»½Òµ{¥]§t¤¤¤å¦Ò¸Õ´úÅç¡A¦X®æªÌ±N±Â¤© TKSG °ê»Ú»{¥i^¤åÃÒ®Ñ)
Y¥u§¹¦¨½Òµ{¡A¦Ò¸Õ¥¼³q¹L¡A¹{µo°Ñ¥[½Òµ{ÃÒ®Ñ(e-Certificate, PDF)¡A½Òµ{µ²§ô«á 12 Ӥ뤺¡A¦³¤@¦¸§K¶O«¦Ò¾÷
·|¡C
¶K¤ß´£¿ô
ª`·N¨Æ¶µ¡G½Ð°Ñ¥[¾Çû¦Û³Æµ§°O«¬¹q¸£(»Ýn¯à¤Wºô)
ªþ¥ó
2017050812 ISO 13485¡G2016 ÂåÀø¾¹§÷«~½èºÞ²z¨t²Î ¥D¾É½]®Öû°ö°V½Òµ{.pdf