Dear,
one of he nonconformities in our latest audit was the fact that we don't have a SOP on infrastructure, so I now have to write one and need your help.
We have lots of IT-Guidelines, production instructions and machine maintenance instruction, but the Auditor wanted to see the "General, above all" document.
This is what he wrote: "According to section 6.3 of EN ISO 13485:2016, the organization shall document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of products. During the internal Audit such documentation which outlines
the requirements was not available."
So, as I have all the Information but struggle to put the SOP together - could you please provide a template/a copy of your SOP/whatever helps.
Thanks in advance!
one of he nonconformities in our latest audit was the fact that we don't have a SOP on infrastructure, so I now have to write one and need your help.
We have lots of IT-Guidelines, production instructions and machine maintenance instruction, but the Auditor wanted to see the "General, above all" document.
This is what he wrote: "According to section 6.3 of EN ISO 13485:2016, the organization shall document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of products. During the internal Audit such documentation which outlines
the requirements was not available."
So, as I have all the Information but struggle to put the SOP together - could you please provide a template/a copy of your SOP/whatever helps.
Thanks in advance!