2017 通過ISO 13485 醫療器材品質管理系統認證
- 文章分類: 最新消息
- 4/11/2017
經過517天的努力,從完全不懂什麼是ISO精神的菜鳥我們,無數份文件的修改,無數個說完再見路上小心後隔不到6個小時後又見面的爆肝夜晚,初審時滿篇紅字的挫折....我們熬過了!我們成長了!我們更得到了!
To all those who have helped us along the way and encouraged us:
Thank you, we did it!
ISO13485是醫療器材品質管理系統的最高精神。
在台灣,法規並沒有規範醫材廠商必須申請ISO13485的證照,但為了要提供最完善、最高規格的產品及設計,我們自主性申請該認證。517天看起來有點長,因為我們對每個細節都要求到完善,而且ISO13485規範真的不是蓋的(慘笑~);517天看起來有點短,因為我們是最有默契、最有向心力、績效最好的團隊,再加上我們有最好的輔導老師及稽核單位!謝謝ISO路上所有協助過我們的朋友,不論是被我們一直追著要資料的廠商,或是陪我們一起熬夜爆肝的輔導老師,更或是很仁慈但又很嚴謹的不斷給我們方向的稽核老師,還有說一句「加油!」的你/妳們! 我們做到了!
肽湛一向秉持著專業的態度、嚴謹的精神,一路走來都沒有改變,更謝謝肽湛所有的同伴們,妳/你們真的是最棒的!!
After 517 days of hard work…we are ISO13485 certified!!!
ISO13485 is a Quality Management System (QMS) Standard for Medical Devices.
Even though medical device manufacturers are not mandated by law to be ISO13485 certified in Taiwan, to ensure our product quality, we voluntarily applied for certification.To all those who have helped us along the way and encouraged us:
Thank you, we did it!
Peptide Cham have always strived to be professional and provide products of the highest quality. This will never change.
Thanks to all our friends and co-workers at Peptide Cham, you are truly THE BEST!