ISO 9001:2015 Insight: Risk Based Thinking

by Breda Kearney | March 1, 2019 | Blog , ISO 9001:2015 , Quality , Risk Based Thinking , |

Risk Based Thinking (RBT) is a key concept that underpins ISO 9001:2015 and requires the organization to proactively identify and address reasonably foreseen issues that could impact negatively on the performance and effectiveness of the Quality Management System (QMS). Reasonably foreseen issues could include events that result in financial loss, damage to the organizations reputation, disruption to normal operations or loss of market share. The rationale for adopting RBT is that it will enable the organization to increase the likelihood of achieving the intended results of the QMS by ensuring that undesired effects are prevented or reduced.
Adoption of RBT requires the organization to address both strategic and process level risks.

  • When identifying strategic level risks consideration should be given to the organizations strategic direction and issues that might affect the ability to achieve the planned goals and objectives. Strategic level risks are identified as an output of the internal & external issue analysis and considering interested party requirements.
  • When identifying process level risks the organization can consider: What is the process trying to achieve and what could happen that might affect the ability to achieve the objectives/goals/intended results of the process

Application of Risk Based Thinking

ISO 9001:2015 Insight: Risk Based Thinking

One of the most common methodologies for risk management is Failure Mode Effect Analysis (FMEA), however the organization can use any method or tool.

If you would like to learn more about ISO 9001:2015, including the requirements related to Risks and Opportunities, Comply Guru offer Online ISO 9001:2015 Requirements Training that can be completed anytime, anywhere.

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