Is there a regulatory requirement (either ISO 13485 or FDA CFR) to have a written SOP/work instruction for each piece of laboratory equipment, available in the immediate vicinity of the equipment in the lab? Or is it enough to have a scanned copy of the manufacturer's "Quick Start" guide (or equivalent) nearby? Currently our company has a combination of in-house written "mini IFUs" for equipment, and scanned copies of the manufacturers' quick start guides. I would like to find out if this is acceptable, or if these mini IFUs for equipment need to be standardized/controlled. Thanks!