C
Calmed
During our last ISO 13485 audit, we received a NC for not providing a procedure for disaster recovery plan. I've looked thru ISO 14644 and not found a good foundation for a plan. I found IEST-RP-CC041: Recovery from Disruption to Cleanroom and Other Controlled Environments but this is still under development. Anyone have any templates they would be willing to share or can point me to a site where I can gather some information? (Have not had much luck with consultants).
Background: We are a small company which assembles non-sterile class II medical devices and our ISO Class 8 clean room is less than two years old.
Background: We are a small company which assembles non-sterile class II medical devices and our ISO Class 8 clean room is less than two years old.