ISO 9001:2015 standard states that risk-based thinking is essential for
achieving an effective quality management system (QMS).
The new ISO 9001:2015 standard explicitly
expects an organization to identify and address risks affecting its product and
Besides identifying the risks, the new ISO standard expects organizations to address opportunities for improvement based on the risk analysis.
Risk is often seen as negative. Risk-based thinking can also help identify opportunities i.e positive
The main objectives of ISO 9001:
2015 is to provide confidence in the organization’s ability to consistently
provide customers with conforming goods and services and to enhance customer
The concept of “risk” relates to the uncertainty in achieving those objectives.
This course is designed for the key
stakeholders to initiate identification of both risks and opportunities within
their QMS and identify the related clause where risk management compliance is
By the end of this course, participants should be able to:
Key personnel responsible in risk management activities and key QMS personnel