Hello. I'm seeking advice on setting up an ISO 13485 quality system for a new entity with a headquarters in the US and a design/manufacturing site in Mexico. My understanding is that COFEPRIS requires that the QMS and documentation be in Spanish; however, for the US parent company the procedures will need to be in English. To me, it makes sense to have the system in English with specific procedures and documentation translated into Spanish for the Mexico site. However, others on our team want to have two copies of the documentation (i.e. batch record), one completed in English and one completed in Spanish. Does anyone have experience with this? Best practices to share? Thanks.
Mexico Medical Device QMS Spanish Translations?
- Thread starter kmottet
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We've had this request, but it was English in addition to our native tongue. We designed batch records forms where the translated aspect was put in a tiny but readable fontsize (6 pt) near (usually below) the main part of the translated text. Also reduce the line spacing of the relevant items so there isn't too much whitespace consuming 'real estate', and if necessary give the translation a lighter/greyish colour, which makes the main text stand out more for regular use.
Values were mostly measurements with the units pre-printed, and tickboxes (Y/N, or specific characteristics) which could be translated as well.
For SOPs we've had both double column and one-after-the-other setups.
Double column was preferred for change control, with certain images being merged into 1 column to gain size/resolution, then followed by double column again.
When the document became rather long, one-after-the-other was preferred, as too much flipping was disliked by production.
Values were mostly measurements with the units pre-printed, and tickboxes (Y/N, or specific characteristics) which could be translated as well.
For SOPs we've had both double column and one-after-the-other setups.
Double column was preferred for change control, with certain images being merged into 1 column to gain size/resolution, then followed by double column again.
When the document became rather long, one-after-the-other was preferred, as too much flipping was disliked by production.
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