Prima Strategies

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ISO 9001:2015 Risk-based Thinking Requirements


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 service.

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 risk.

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 satisfaction.

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 specified.

By the end of this course, participants should be able to:

  • Determine risks that can affect the organization’s ability to meet objectives (Clause 4)
  • Gain awareness on key stakeholders’ role and commitment towards risk based approach (Clause 5)
  • Plan and take action to address risks and opportunities ( Clause 6)
  • Establish a process which identifies and addresses risk in its operations (Clause 8)
  • Consider risks and opportunities when determining what needs to be monitored, measured, analyzed and     evaluated (Clause 9)
  • Improve by responding to changes in risk and opportunities (Clause 10)
  • Apply risk-based thinking to key business processes
  • Identify processes that pose unacceptable level of risks to the QMS and performance objectives
  • Complete a risk register with action plans
  • Justify how action plans will prevent or mitigate the impact of associated risks


Key personnel responsible in risk management activities and key QMS personnel



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