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ISO 9001 certification serves a way to prove that an organization has the ability to provide customers with conforming products and services consistently. Consistency can be ensured through adequate control of processes, but in the case of something unforeseen occurring, the concept proves to be relevant.

Newer versions of ISO standards such as ISO 9001:2015 and 14001:2015 are giving risk a more prominent place in quality and environmental management standards. These standards have made it a requirement for organizations getting certified to them to adopt risk-based thinking to their processes from planning to execution and performance evaluation.

Risk based thinking as a concept encourages proactive approach, rather than reactive approach in that, it requires systematic incorporation throughout the entire processes of an organization and its quality management system and not handling it as a standalone component, like the case of preventive action in previous version of ISO 9001 standard. The latest standard requires risk to be woven throughout the entire process of the organization, not a separate entity.

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The specific areas where risk appears in the new standard requirements include the following: 

  • Organizational context
  • Leadership
  • Planning
  • Operation
  • Performance evaluation
  • Improvement

Following a risk-based approach requires:

  • Determining the risk and opportunities associated with an organization’s processes.
  • Planning effective actions to address them.
  • Implementing them in an organization’s processes and its quality management system.
  • Evaluating their performance for effectiveness.

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Implementing Risk-Based Thinking 

  • Identification: Identify the risk and opportunities associated with an organization’s processes by taking into consideration the context of your organization..
  • Prioritization: The next step is to analyze and prioritize the identified risks and opportunities to determine what is acceptable and what is not.
  • Planning: Plan effective actions to address these risk, determining those that can be avoided, mitigated or eliminated
  • Implementation: Taking actions to implement the planned actions to address risks.
  • Evaluation: Evaluating the effectiveness of the actions.
  • Continual Improvement: Striving for excellence by incorporating on a consistent basis, any necessary modification, and repeating the cycle.


About the Author

Adebayo is a thought leader in continuous process improvement and manufacturing excellence. He is a Certified Six Sigma Master Black Belt (CSSMBB), Digital Manufacturing Professional and Management Systems Lead Auditor (ISO 9001, 45001 & ISO 22000) with strong experience leading various continuous improvement initiative in top manufacturing organizations. 

You can reach him here.

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