9888À­Ë¹Î¬¼Ó˹

9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ÎÒÃǵķþÎñ

×÷ΪÖйúµÚÈý·½¼ì²âÓëÈÏÖ¤·þÎñµÄ¿ªÍØÕߺÍÁìÏÈÕߣ¬CTI9888À­Ë¹Î¬¼Ó˹¼ì²âΪȫÇò¿Í»§ÌṩһվʽĥÁ·¡¢²âÊÔ¡¢Ð£×¼¡¢ÈÏÖ¤¼°ÊÖÒÕ·þÎñ¡£

9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ÐÐÒµ½â¾ö¼Æ»®

·þÎñÄÜÁ¦ÒÑÖÜÈ«ÁýÕÖµ½·ÄÖ¯´ò°ç¼°Ð¬°ü¡¢Ó¤Í¯Íæ¾ß¼°¼Ò¾ÓÉúÑÄ¡¢µç×ÓµçÆ÷¡¢Ò½Ñ§¿µ½¡¡¢Ê³Îï¼°Å©²úÆ·……µÈÐÐÒµµÄ¹©Ó¦Á´ÉÏÏÂÓΡ£

9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ÌØÉ«·þÎñ

ÖÜÈ«°ü¹ÜÆ·ÖÊÓëÇå¾²£¬Íƶ¯ºÏ¹æÓëÁ¢Ò죬ÕÃÏÔÆ·ÅƾºÕùÁ¦£¬ÊµÏÖ¸ü¸ßÖÊÁ¿¡¢¸ü¿µ½¡¡¢¸üÇå¾²¡¢¸üÂÌÉ«µÄ¿ÉÒ»Á¬Éú³¤¡£

¼ÓÈëÎÒÃÇ
È˲ÅÕþ²ß
ÕÐÏÍÄÉÊ¿
9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
È˲ÅÕþ²ß
°ü¹ÜÔ±¹¤»ù±¾È¨ÒæÓ븣Àû£»ÌṩרҵÊÖÒÕÅàѵ£¬Ôö½øÔ±¹¤Éú³¤£»¿ªÕ¹¸»ºñ¶à²ÊµÄ»î¶¯£¬Æ½ºâÔ±¹¤ÊÂÇéÓëÉúÑÄ¡£
9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ÕÐÏÍÄÉÊ¿
½Ó´ý¼ÓÈë9888À­Ë¹Î¬¼Ó˹¼ì²â¸÷ÈËÍ¥£¬ÎÒÃǽ«ÎªÄã´î½¨Ò»¸ö³ä·ÖÑéÕ¹²Å»ª£¬ÊµÏÖÖ°ÒµÀíÏëµÄÎę̀¡£
9888À­Ë¹Î¬¼Ó˹(¹É·Ý)ÓÐÏÞ¹«Ë¾-¹Ù·½ÍøÕ¾
ȨÍþ¹«Õý ת´ïÐÅÈÎ
ÕÃÏÔÆ·ÖÊ ´´Á¢¼ÛÖµ
ISO 13485Ò½ÁÆÆ÷еÖÊÁ¿¹ÜÀíϵͳÅàѵ¹ûÕæ¿Î

Ò½ÁÆÆ÷еÊÇÖ±½Ó¹ØÏµµ½È˵ÄÇå¾²ºÍ¿µ½¡µÄÌØÊâ²úÆ·£¬ÆäÖÊÁ¿µÄ»ù±¾ÒªÇóÊÇÇå¾²ÓÐÓá£Ò½ÁÆÆ÷еµÄÇå¾²ÐÔÓÐÓÃÐÔ²»µ«ÒªÓÐÆä×Ô¼º²úÆ·µÄÊÖÒչ淶×÷°ü¹Ü£¬²¢ÇÒ±ØÐèÒªÓÐÒ½ÁÆÆ÷еµÄÉú²úÆóÒµÓÐÓõÄÖÊÁ¿ÏµÍ³×÷°ü¹Ü¡£

ISO 13485Ò½ÁÆÆ÷еÖÊÁ¿¹ÜÀíϵͳÅàѵ¹ûÕæ¿Î

Ò»¡¢¿Î³ÌÅä¾°£º

Ò½ÁÆÆ÷еÊÇÖ±½Ó¹ØÏµµ½È˵ÄÇå¾²ºÍ¿µ½¡µÄÌØÊâ²úÆ·£¬ÆäÖÊÁ¿µÄ»ù±¾ÒªÇóÊÇÇå¾²ÓÐÓá£Ò½ÁÆÆ÷еµÄÇå¾²ÐÔÓÐÓÃÐÔ²»µ«ÒªÓÐÆä×Ô¼º²úÆ·µÄÊÖÒչ淶×÷°ü¹Ü£¬²¢ÇÒ±ØÐèÒªÓÐÒ½ÁÆÆ÷еµÄÉú²úÆóÒµÓÐÓõÄÖÊÁ¿ÏµÍ³×÷°ü¹Ü¡£

ÏÖÔÚ×éÖ¯¿ÉÒÔÒÀ¾ÝISO 13485:2016°æ±ê×¼½¨Éèϵͳ»òÕß×ÔԸ׷ÇóµÚÈý·½ÈÏÖ¤¡£ISO 13485±ê×¼ÊÇÊÊÓÃÓÚÒ½ÁÆÆ÷еµÄÖÊÁ¿¹ÜÀíϵͳ±ê×¼£¬ÆäÈ«³ÆÊÇ¡¶Ò½ÁÆÆ÷е ÖÊÁ¿¹ÜÀíϵͳ ÓÃÓÚ¹æÔòµÄÒªÇó¡·¡£ISO 13485±ê×¼½ÓÄÉÁË»ùÓÚISO 9001±ê×¼PDCAµÄÏà¹ØÀíÄî¡£

Ïà½ÏÓÚISO 9001±ê×¼ÆÕÊÊÓÚËùÓÐÀàÐ͵Ä×éÖ¯£¬ISO 13485Ö÷ÒªÕë¶ÔÓëÒ½ÁÆÆ÷еÉè¼Æ¿ª·¢¡¢Éú²ú¡¢Öü´æºÍÁ÷ͨ¡¢×°ÖᢷþÎñºÍ×îÖÕÍ£Óü°´¦Öóͷ£µÈÏà¹ØÐÐÒµµÄ×éÖ¯¡£Æä½ÓÄÉISO9001£º2008µÄÕ½ڼܹ¹£¨·ÇISO9001£º2015£©£¬ÔÚ´Ë»ù´¡ÉÏÈÚºÏÁËFDA QRS820µÈÌìϸ÷¹úϵͳ¹æÔòÒªÇó¼°Ä¿½ñ×îÐÂÊÖÒÕ¹æÔòÒªÇó¡£

 

¶þ¡¢ÅàѵÖ÷Ìâ

ISO13485:2016Ò½ÁÆÆ÷еÖÊÁ¿¹ÜÀíϵͳÅàѵ

 

Èý¡¢¿Î³Ì¸ÙÒª

   µÚÒ»Ì죺

ISO13485»ù´¡ÖªÊ¶½â˵

ISO13485£º2016ʵÑéÁ÷³Ì

ISO13485:2003ÓëISO13485:2016Ö÷Òª²î±ð

ISO13485:2016ÓëISO9001:2015¶ÔÓ¦¹ØÏµ

ISO13485:2016±ê×¼Ã÷È·

 

     µÚ¶þÌ죺

ISO13485£º2016ÄÚ²¿ÉóºË

Ò½ÁÆÆ÷еΣº¦ÆÊÎö£¨ISO14971)

ISO13485:2016ÓëGMP¹æÔòÅäºÏµãºÍ²î±ðµãÆÊÎö½â¶Á

ISO13485ϵͳÔËÐг£¼ûµÄÎÊÌâ

ISO13485£º2016ÄÚÉóÔ±ÅàѵÉóºË

 

 

ËÄ¡¢ÅàѵËùÔÚ

ÏßÉÏÅàѵ

 

Îå¡¢ÅàѵÄÚÈݼ°¿Îʱ

Åàѵ¹²2Ì죬ÌìÌì6Сʱ£¬¹²12Сʱ

¿ª¿Îʱ¼ä£ºÔçÉÏ9:00-12£º00

                     ÏÂÖç14:00-17£º00

 

Áù¡¢ÅàѵÓöÈ

Åàѵ·Ñ£º1500Ôª/ÈË

ÓöȰüÀ¨£º½²Ê¦·Ñ¡¢¿Î±¾·Ñ¡¢Ö¤Êé·Ñ

±¨Ãûµç»°£º400-830-5800

ÓÊ    Ï䣺ctisz@cti-cert.com

 

¹ØÓÚCTI9888À­Ë¹Î¬¼Ó˹ÈÏÖ¤

ÉîÛÚ9888À­Ë¹Î¬¼Ó˹¹ú¼ÊÈÏÖ¤ÓÐÏÞ¹«Ë¾£¨¼ò³Æ“CTI9888À­Ë¹Î¬¼Ó˹ÈÏÖ¤”£©£¬ÊÇ9888À­Ë¹Î¬¼Ó˹µÄÈ«×Ê×Ó¹«Ë¾¡£

CTI9888À­Ë¹Î¬¼Ó˹ÈÏÖ¤½¨ÉèÓÚ1993Ä꣬¹«Ë¾ÒѾ­ÀÛ¼ÆÎªÁè¼Ý ÊýÍò ¼Ò ÖÐ Íâ Æó Òµ ¡¢Éç »á ÍÅ Ìå µÈ »ú ¹¹ °ä ·¢ ÁËISO9001¡¢ISO14001¡¢ISO45001¡¢ISO22000 ¡¢HACCP¡¢ISO50001¡¢ÖªÊ¶²úȨ¹ÜÀíϵͳÈÏÖ¤Ö¤Ê飬Åàѵ ѧԱ½üÍòÃû¡£

Ïà¹ØÍÆ¼ö
ÍøÕ¾µØÍ¼