Product Review

ISO 9001:2015 introduced risk based thinking as an essential part of quality management. While ISO 9001 always advocated mitigating and avoiding risk, implementing Risk based thinking is a challenge.
Partially this is because ISO 9001:2015 sees the risk as both positive and negative (positive risk is referred as opportunity) and the organization is expected to address both aspects.
On the other hand, the traditional QMS auditors are not that familiar with risk analysis
The ISO 9001:2015 gives company flexibility in figuring out, how much work to do to address risk and opportunities and what risk management methodologies to use and how much documented information to keep.
When transitioning the QMS to the new ISO 9001:2015 requirements, risk management related issues raise a lot of question. We had some of those questions answered by field experts and arranged them in this publication.