Thanks for the examples. We have a system similar to that. I just want to clarify that external documents required for a food safety program do indeed have to be controlled? The new QA director is convinced otherwise...
Hi nichollaf,
The general topic has been discussed here before. IIRC, result was a lack of consensus. The topic was a favorite never-ending chestnut of the old iso9001 days.
i predict you will find an absolute, validatable, answer to yr question elusive.
IMEX the mandated requirements of a Documentation Control System are typically something like the DCS must (a) "satisfactorily" ensure that the correct / approved / most recent version of a (needed) document is available to the appropriate personnel and (b) it ensures compliance with any specific clauses in a relevant Standard. This usually leaves plenty of room for interpretation.
One simple (too simple?) option for documents in a QMS system is to make them all controlled. That's what i do. It clearly demands a reliably organized, validatable, distribution system also.