Manual Translation procedure for the translation of manuals into other languages

K

KAMay

#1
Hi All,

In a recent audit, it was observed that we don't have a procedure for the translation of our manuals into other languages. We have a lot of customers in Korea and one of our closer customers had translated the manual for the company many years ago. Obviously the accuracy of their translation is completely unverifiable and something that was discussed with our auditor.

How do you go about translating your manuals (a quick google search threw up a lot of ISO certified translators - recommendations would be appreciated) and how do your procedures allow for you to verify that the translations are accurate?

Thanks!
 
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chris1price

Trusted Information Resource
#2
Re: Manual Translation

Hi

We use an agency for the bulk of our translations, they are ISO 9001 certified and provide a "certificate" for the work. Whether these have any value is debatable!

Once we have the translated copy, we have a native speaker review and ammend it as needed. This is usually a local sales person, distributor or clinician. Most agencies are pretty good, but where it gets technical or medical, someone who understands your products needs to review it.

We then fold the comments into the original to make the final version. Following type setting, it is then reviewed for obvious typos and format errors.

Chris
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Re: Manual Translation procedure for the translation of our manuals into other langua

Hi All,

In a recent audit, it was observed that we don't have a procedure for the translation of our manuals into other languages. <snip>
Just to confirm - Is this a medical device?

What standard were you being audited against?
 
K

KAMay

#4
Re: Manual Translation procedure for the translation of our manuals into other langua

sorry Marc, yes it's a medical device (we are 9001 and 13485 certified)
 

chris1price

Trusted Information Resource
#5
Re: Manual Translation procedure for the translation of our manuals into other langua

There is a Meddev guidance document (2.5/5) which says:

"As part of the quality system or of the documents defining the manufacturing process, the manufacturer should have procedures for ensuring accurate translation of e.g. labelling, instructions for use and product claims in marketing material.

These are especially important for user instructions where the safety and claimed performance of the device may be compromised through inadequate translation."

This is possibly one of the shortest regulatory documents I have ever seen!

Chris
 
K

KAMay

#6
Re: Manual Translation procedure for the translation of our manuals into other langua

I have been trying to find where that was written all day. Thanks :)

If only all the regulations were as short!

I guess I just need to write up a new procedure to cover it - something similar to yours Chris, along the lines of sending it to a certified translation service and then talking back with our customers to ensure it all makes sense
 

yodon

Staff member
Super Moderator
#7
Re: Manual Translation procedure for the translation of our manuals into other langua

Be careful about amending based on a native speaker's review - especially for a medical device. You run the risk of introducing less-than-professional terms or phrases. Then there's all sorts of localizations that could factor in.

We've done it a bit differentl - had the native speaker do the initial translation then have it validated by a professional service. They ensure all the idiomatic expressions are removed and replaced by 'proper' terminology (both proper for professionalism and proper for medical devices). Having the 'certified' translation also shows validation of the labeling.

I would recommend that, if you go the route you mention (professional --> native) to be sure to run any recommended updates back through the professional organization just to confirm the changes are acceptable and proper.
 
K

KAMay

#8
Re: Manual Translation procedure for the translation of our manuals into other langua

Be careful about amending based on a native speaker's review - especially for a medical device. You run the risk of introducing less-than-professional terms or phrases. Then there's all sorts of localizations that could factor in.
good point, is the second verification even necessary? Is using a certified translation company enough?
 
D

DrM2u

#9
Re: Manual Translation procedure for the translation of our manuals into other langua

I take it that you have to be in compliance with EC and ISO 13485 at the same time?!? I don't recall ISO 13485 requiring such a procedure but EC has it, as Chris has indicated. I would also suggest to get some feedback from your 'legal' department regarding the procedure. In US lawyers would grasp for straws to win a case and you don't want meanings to get lost in translations.
 
K

KAMay

#10
Re: Manual Translation procedure for the translation of our manuals into other langua

I take it that you have to be in compliance with EC and ISO 13485 at the same time?!?
yes - sorry for the initial lack of info, we have to be compliant with the European MEDDEV too
 
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