Do Quality System Documents have to be in English (for USFDA onsite inspection)

A

altair123

#1
Hello!

Do we have to provide an English translation of all of our Quality System Documentation?

Our 510(k) submission and the Technical Construction File for CE Marking Audit are in English but most of our work procedures are in Korean.
 
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antoine.dias

Quite Involved in Discussions
#2
Procedure language

It does not look normal to me that an organisation can be obliged to translate procedures and instructions for the auditor's sake.
Those documents should be in the language of the ones that have to work accordingly.

I do not know if USFDA is an exception to that "rule" or not.

I hope not.

Best regards,
Antoine
 
A

altair123

#4
Thank you very much for replying.

We were just wondering whether we have to provide English translation or not. In the QSIT inspection guide for USFDA field staff, they are told to verify compliance with Quality System Regulation requirements. How will the inspector know that what is in the company's quality manual is in compliance with the QSR (CFR21 Part820) if there is no English translation?

We would appreciate it if somebody whose Quality Manual is not in English could share his/her experiences with USFDA inspections
 
K

keung830

#6
There are 4 levels of document which mentioned in iso9000. There are
record, working instruction, quality procedure and quality manual.
I think record and working instruction are not necessary rendering to English,
and the others should be renderred to English, In particularly, Quality Manual.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#7
The internation language of business is English. Having said that, documentation is written in the language that it is used. Too much could get lost in translation, and you would not want an observation for that.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#8
Statistical Steven said:
The internation language of business is English. Having said that, documentation is written in the language that it is used. Too much could get lost in translation, and you would not want an observation for that.

:agree1: I agree 100% here.

I've never audited internationally but I would think that the burden is on the auditor/registrar to provide someone who can read/speak the language of the auditee.
 
G

Gert Sorensen

#9
As far as I know you are not obliged to maintain your Q-system documents in English. However, when being audited by FDA you will need to provide a translation of the documents into english upon demand. So, it is far easier to have the documentation ready in english at all times, than to translate under pressure :)
 
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