C
Hi everyone,
I'm new here *waves*.
I had a question regarding ISO 13485:2012. In 7.1 it states that "The organization shall establish documented requirements for risk management throughout product realization. Records from risk management shall be maintained".
So, what exactly does that mean? Basically an organization should have a document that states how they carry out risk managements, or? Has anyone in here written such a document and would like to share it with me? Or at least give me some advice about what such a document should/could include?
All the best and thanks in advance,
Cellardoor
I'm new here *waves*.

I had a question regarding ISO 13485:2012. In 7.1 it states that "The organization shall establish documented requirements for risk management throughout product realization. Records from risk management shall be maintained".
So, what exactly does that mean? Basically an organization should have a document that states how they carry out risk managements, or? Has anyone in here written such a document and would like to share it with me? Or at least give me some advice about what such a document should/could include?
All the best and thanks in advance,
Cellardoor