last week i was on training of ISO13485.
this is the first time i am close to real quality very much.
from the 5 days training great quality professional knowledge has been exist in my brain
and i knew there are so many companys produce medical devices, such as artificial limb, false tooth, artificial skin and so on…hehe is it so horrible?
actually after the training you will be internal auditor who is responsible for any audit work in your company, but i think it is just possible. experience is major.
and the most surprise i got is the regulations.
in the company i am working now, there are so many regulations which we must follow when we conduct routine or accidental works. the regulations are very very precise and more than ISO13485 which issued by international standard organization and most MD company must keep to, no matter in quality management system or human resources management.
thus it can be seen that how developed European companys are. i think maybe most regualtions are created and perfected by these advanced companies.
anyway the training is useful..
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