Hi all, I'm an internal auditor and my client has an ISO 9001:2015 QMS. They are a manufacturing company based in the UK. Prior to obtaining ISO 9001:2015 certification, they had a vast array of processes that have now been stored on their ERP system. However, these processes are not included in their QMS documentation and they try to keep them separate. These processes are in use and they describe in detail, to the work instruction level, certain operations that are only carried out rarely e.g. once per annum, e.g. shut down methodology for machinery that needs to be shut down for annual inspection. This is not routine work and so no one remembers all of the 50 - 100 steps of the complicated processes. I have never audited these processes and although they are mentioned in the MDR in a general way, listed as Annual Processes Guide Book, this Guide book has not been reviewed annually as specified, and there is no date on each of the complicated processes - so how is anyone to know if they are still correct or need revising etc? The client does not want to audit these Guide Books or all of the processes within them as they say it would take forever. My question is this - do they need to be audited annually? Or at all? Could they be audited over a planned period of 3 years as the CB's do for example? Thank you in advance for your advice!