QA standards at least in Australia, is focused on procedures and paper flow. It has nothing to do with quality of product at the end. It has nothing to do with even if proper process takes place, what it means is the flow of events is docuemented and is followed.
One could be producing the same crap product day in and day out but you could still meet the needs of the QA policy.
So the paperwork could be perfect, but the actual product like in this case could be flawed.
Regards
Col