ISO 17100 (Requirements for Translation Services) International Translations

Reference to ISO17100.- Does anyone have a copy of this Standard. I am happy to buy it from BSI but I would like to know, before I do, if the requirements go beyond my current practice: WE have a procedure whereby we can get our Distributor in a particular country to translate Brochures and IfUs for us, but then an independent person has to certify the accuracy of the translation. Also, do translation entities need to be certified to this Standard?

Thanks for any advice on this.

Below is the ToC for the ISO 17100:2015 document so you can "compare" with your current practice. As for the "mandate" for certification, it does not come from the standard. No ISO standard can mandate certification, per ISO Directives.

Thanks Sidney. Good information.

Secondary question...
can we have translations made as described earlier without meeting the requirements of this Standard. It seems that the Standard is pro-translation bodies, whereas our distributor will have better knowledge of medical/technical terminology within the source language and therefore is in a better position to translate the document.

Is there an avenue where we don't need to recognize this Standard?

Any ISO standard is of voluntary application, unless a relevant interested party makes it mandatory.

Is anyone aware of a certification body accredited to audit to ISO 17100?

Hi all,
Does anyone have recommendations on Certification Bodies for this standard?
It's not offered by our ISO 9001 CB sadly. Without any accredited CBs to this standard it's a bit of a google minefield?!

Bifften said:

Hi all,
Does anyone have recommendations on Certification Bodies for this standard?
It's not offered by our ISO 9001 CB sadly. Without any accredited CBs to this standard it's a bit of a google minefield?!

Click to expand...

Have you seen this? Scope for ISO 13485 Certification of a Translation Service Provider