Translation SOP for Medical Device Company

R

relad

Hello,
Can someone help me with examples of translation SOP?

Thank you.
 
R

relad

Re: Translation SOP

Yes, our external auditor asked us to show him such a procedure, when you give document for translation to external translation company you need a procedure that describing how you choose that kind of translation company and all the authorities they have in order to able to translate your doc's.
 
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R

relad

Re: Translation SOP

Hello Stijloor,
We are medical device company with ISO 13485.
 

yodon

Leader
Super Moderator
Re: Translation SOP

Maybe this is covered in the other threads but I'll toss in my $0.02 anyway.

There are several things in play with what your auditor said.

First, you are purchasing a service; therefore, you need to qualify & approve your provider. Are they qualified to translate medical device related information; i.e., technical matters versus casual conversation. Just because a person is a native speaker of the language into which you're translating doesn't mean that the translated (technical) material is correct! Learned that one!

Second, and this may be a bit of a contentious point, I consider the translation effort to be another "design output" that requires validation. How do you know you received a valid translation?

I'm not sure why an auditor would request an SOP in particular. I do believe you need to be able to demonstrate the above, though. An SOP (or WI) providing the guidelines for doing so certainly isn't a bad idea.
 

Sam Lazzara

Trusted Information Resource
My recommendation is to have a section of your document control procedure address language translations. Here is an example of simple SOP content I have used in the past. In this example, DCN means Document Change Notice, and SOP07 is my Suppliers SOP.

5. Product Information Translation Controls

The following controls apply to the translation of Company product information that directly or indirectly accompanies a product.
• Labeling directly accompanies the product.
• Product advertising and promotional materials indirectly accompany the product.

5.1. General
5.1.1. Document Control coordinates translation projects.
5.1.2. The DCN approvers ensure that the English versions of product information are effectively written to meet English-speaking user needs.
5.1.3. Regulatory Affairs ensures product information is compliant with the laws and regulations of the countries for which it is intended.

5.2. Translation Services
5.2.1. Language translation services are evaluated and approved in accordance with SOP07 before release of any documents based on their work.
5.2.2. Translation services are required to certify their work based on internal quality assurance measures applied, and provide translated documents in hard copy and in electronic format.

5.3. Translation Records
For each translation project, Document Control initiates a DCN to release the translated document. A copy of the translation certification is archived with the DCN.
 

Ronen E

Problem Solver
Moderator
"Show me the 'Shall'"

To what standard / regulation was that auditor auditing?... ISO 13485:2003 doesn't require such a procedure.

Why wouldn't proper Purchasing, Design Control and Document Control SOPs suffice? What makes translation so unique?
 
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