How to Identify Risk Controls in ISO 9001:2015

In today’s rapidly changing business environment, organizations must proactively manage risks to ensure the quality of their products and services. ISO 9001:2015, the internationally recognized quality management system standard, places a strong emphasis on risk-based thinking. One of the key components of this approach is the identification and implementation of risk controls. In this blog post, we will explore how to identify risk controls in ISO 9001:2015, helping organizations enhance their quality management systems and ultimately achieve better outcomes.

Understanding Risk-Based Thinking in ISO 9001:2015

ISO 9001:2015 introduced the concept of risk-based thinking to help organizations identify, assess, and mitigate risks that could affect the achievement of their quality objectives. This shift in focus encourages organizations to be proactive rather than reactive in managing quality-related risks.

Risk controls are measures and actions put in place to manage or mitigate identified risks effectively. These controls help ensure that processes and systems run smoothly, reducing the likelihood of quality issues or disruptions.

Identifying Risk Controls

  1. Risk Assessment: To identify risk controls effectively, you first need to conduct a thorough risk assessment. This involves:

    a. Identifying potential risks: Brainstorm and document potential risks that could impact the quality of your products or services. These risks could include supply chain disruptions, equipment failures, or changes in regulatory requirements.

    b. Assessing risk severity: Evaluate the potential consequences of each risk and their likelihood of occurring. Assign a risk severity rating to prioritize them.

  2. Determining Risk Controls: Once you have identified and assessed the risks, you can then determine appropriate risk controls:

    a. Preventive Controls: These controls aim to prevent the identified risks from occurring. For example, regular equipment maintenance can prevent equipment failures.

    b. Detective Controls: Detective controls are used to identify risks as they occur. This could include quality inspections or monitoring of key performance indicators.

    c. Corrective Controls: In the event that a risk materializes, corrective controls are implemented to mitigate the impact. For example, if a supplier faces a disruption, having alternative suppliers in place is a corrective control.

    d. Mitigative Controls: Mitigative controls are measures taken to reduce the severity of a risk’s impact. This could include having backup systems or contingency plans.

    e. Strategic Controls: These controls involve long-term strategies to manage risks. Developing a comprehensive risk management plan is an example of a strategic control.

  3. Documentation and Implementation: Once you’ve determined the appropriate risk controls, it’s crucial to document them in your quality management system. This documentation should include:

    a. Clear descriptions of the controls.

    b. Responsible parties for implementing and monitoring the controls.

    c. Timelines for implementing and reviewing the controls.

    d. Criteria for measuring the effectiveness of the controls.

  4. Monitoring and Review: ISO 9001:2015 emphasizes the importance of ongoing monitoring and review of risk controls. Regularly assess the effectiveness of your risk controls and make adjustments as needed. This helps ensure that your organization stays proactive in managing quality-related risks.

Conclusion

Identifying risk controls in ISO 9001:2015 is a fundamental step in implementing a robust quality management system that can adapt to an ever-changing business environment. By conducting thorough risk assessments, determining appropriate controls, documenting them, and continuously monitoring and reviewing their effectiveness, organizations can not only meet ISO 9001:2015 requirements but also enhance their overall quality performance and customer satisfaction. Embracing risk-based thinking is a proactive approach that can lead to improved decision-making and sustained success in today’s competitive landscape.