Deviations may arise as a result of but not limited to: material/product – contaminated, out of specification machine/equipment –  failed calibration,  validated operating parameters violated method/procedure – approved process not followed personnel error – not appropriately trained or failing to … Continue reading ISO 9001 / ISO 13485 clause 8.3 | ISO 22716 Cosmetics GMP clause 13 – Control of Nonconforming Product / Deviations