ISO 9001 Risk Management

ISO 9001:2015 includes requirements for a risk-based approach to quality management, which means that organizations must identify and manage risks to ensure that their products and services meet customer requirements and are delivered in a consistent and reliable manner.

The risk management process in ISO 9001:2015 includes the following steps:

  • Risk identification: Identify potential risks to the quality of products and services, including risks related to internal processes, external factors, and stakeholder needs and expectations.
  • Risk analysis: Evaluate the likelihood and potential impact of each identified risk. This can include using tools such as risk matrices, failure mode and effects analysis (FMEA), or other qualitative or quantitative methods.
  • Risk evaluation: Prioritize risks based on their likelihood and potential impact. This can include determining which risks require immediate action, which risks can be monitored, and which risks can be accepted.
  • Risk treatment: Develop and implement actions to address identified risks. This can include implementing controls to prevent or mitigate risks, monitoring risks to detect changes, and developing contingency plans to address unforeseen events.
  • Risk monitoring and review: Continuously monitor and review the effectiveness of risk management activities. This can include reviewing risk management plans, analyzing data related to risk management, and updating risk management activities as needed.

By following these steps, organizations can identify and manage risks to quality and ensure that their products and services meet customer and regulatory requirements. Risk management is an ongoing process that must be integrated into an organization's quality management system and applied to all relevant processes and activities.

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