I really feel like an idiot, even ASKING such a question! The company I've come to work for recently is migrating from 9000 to 13485, and I've been very busy putting all of the various modifications to the QMS necessary to succeed. We're hand picking a few products to which we want to apply the full 13485 documentation requirements, so we have some records to audit, and I'm reading through our manual and procedures to ensure nothing gets missed.
Our Q Manual says, in several places, that "customer drawings are controlled..." Yet, when I go into a customer quote file, where their drawings are stapled to quotes, notes, and other assorted job sepcific docs, not one drawing that I can find is actually stamped "controlled". We've been ISO 9000 certified for something like 10 years, so I'm sure doc control has been audited many many times.
Can something as simple as a storage location specify control, even if it's not necessarily worded that way in our procedures or Q Manual?
For the record, we do NOT scan them and file them into a secured area on the server, either, so it's not like we maintain controlled electronic copies, instead, nor do we have a separate file area just for drawings. They're ONLY found in these quote files, and NOT stamped...
Should I schedule the next three weeks to go through every file cabinet and stamp drawings??!! This just seems weird, to me.
Our Q Manual says, in several places, that "customer drawings are controlled..." Yet, when I go into a customer quote file, where their drawings are stapled to quotes, notes, and other assorted job sepcific docs, not one drawing that I can find is actually stamped "controlled". We've been ISO 9000 certified for something like 10 years, so I'm sure doc control has been audited many many times.
Can something as simple as a storage location specify control, even if it's not necessarily worded that way in our procedures or Q Manual?
For the record, we do NOT scan them and file them into a secured area on the server, either, so it's not like we maintain controlled electronic copies, instead, nor do we have a separate file area just for drawings. They're ONLY found in these quote files, and NOT stamped...
Should I schedule the next three weeks to go through every file cabinet and stamp drawings??!! This just seems weird, to me.