Looking to set up a small lab. We already have a small unit associated to HLA typing so have the QMS requirements already in place and up and running against 13485. My question is how can we easily assess what the responsibilities are against staff who can sign off virology studies, can this be made by staff with the knowledge and experience to do so or does it need to be a recognised lab or qualified organisation that should sign the studies off. Providing we have all the validation and verification and associated documents to prove the product and its intended use, is there any reason why we cant do this ourselves?