C
costa58
Hi, we are a small company manufacturing IVDs (generally for veterinary/food safety) with no products requiring CE marking.
Looking at the ISO 13485/9001 clause 6.3 where it talks about maintenance of infrastructure, what exactly would constitute infrastructure required to achieve conformity to product requirements?
I mean, one could say that one needs a building, water and electricity. Internet access as well. Is it necessary to document maintenance requirements for the building, or the water supply?
Looking at the ISO 13485/9001 clause 6.3 where it talks about maintenance of infrastructure, what exactly would constitute infrastructure required to achieve conformity to product requirements?
I mean, one could say that one needs a building, water and electricity. Internet access as well. Is it necessary to document maintenance requirements for the building, or the water supply?