Language of procedures when operating in multiple countries

[sbosnl]

Hello all,

I have a questions regarding the written language of all documents within the ISO 13485:2016 system.

Case is that we work in several countries throughout Europe, each have their local office but all working on same ERP, with same processes and have the same scope.

Is it ok if we have 1 documented system in English for all users (so procedures, records, work instructions, ..) or should this all be in national language?
In case it can all be in English, I guess we have to demonstrate that all our employees have a certain level of English understanding (4.2.4.)

Hope you can help me (us) out.

Thanks in advance!

 

[Randy]

You gotta be careful because simple words such as "should" have different meaning in different languages and countries

 

[Colin]

I have seen cases where the manual and procedures are in English but any work instructions and the forms are in the local language. It is often the case that the 'shop floor' employees don't tend to read procedures but WI's and forms they use regularly.

 

[Sidney Vianna]

Is it ok if we have 1 documented system in English for all users (so procedures, records, work instructions, ..) or should this all be in national language?

When you are "engineering" your processes, you must consider how those processes will be effectively deployed, which includes the need for the workforce to be made aware of the process and can demonstrate understanding in order to operationalize it.

Depending on the complexity of the processes, the command of the English language and a few other variables, you could support an English-version procedure with flowcharts in different languages. A flowchart is, typically, much easier to develop and revise than a traditional, text-based procedure. Maybe this "simple" flowchart, together with the "official procedure" can serve the purpose of conveying the process methodology and criteria through multiple languages.

Other aids, such as screen captures, pictures, etc. can also be used.

But, always remember, the goal is to have a documented system, not a system of documents.

Good luck. Bon chance. Boa sorte. Viel Glück ...

 

[sbosnl]

Thank you all for replying!
Our main processes will be written in English with multi language flowcharts. Specific processes (Risk Based) will be in national language.

Kind regards