Evidence of risk-based thinking can be found all over a good quality management system (QMS).  From definition of the system itself, to the processing controls in place, to each action taken to improve the system and its processes. Therefore, no additional documentation should be needed to comply with upcoming ISO 9001 requirements demanding risk-based thinking.  While no additional procedures or forms will be needed, though a mention of risk-based thinking somewhere in QMS documentation seems appropriate. Continue reading →