risk assessment

Risk Assessment in the Context of ISO Standards

Risk is inherent in any activity—it’s simply a part of doing business. That’s why the most recent version of the ISO 9001 standard has included risk assessment throughout each section. Whereas risk was formerly considered almost exclusively in its own clause titled “Preventive Action” (refer to ISO 9001:2008, Clause 8.5.3), it is now engrained throughout ISO 9001. So, that puts a heavier focus on risk-based thinking for organizations designing quality management systems (QMS) to comply with these standards. Continue reading for a closer look at risk-based thinking within ISO standards.

What is risk-based thinking?
Risk-based thinking is an approach to establishing processes, controls, and improvements in a QMS. It is also not limited solely to negative outcomes—risk may account for positive opportunities as well. Risk-based thinking should be applied in an organizational context as well as within leadership roles, planning, operation, performance evaluation, and improvement.

How is risk-based thinking different from risk management?
In defining risk-based thinking, you might wonder how it’s different from risk management. While the two go hand in hand, risk management requires a more formal assessment of risk, which is not a requirement in the current ISO standard. This means there’s flexibility in identifying, preventing, and assessing risks, but there are no rigid requirements for how that is executed.

What modern risk-based thinking strategies can you incorporate in your QMS?
With the flexibility of risk-based thinking, you can adapt a wide range of strategies to meet the needs of your organization. This is where modern QMS software can assist. Risk assessment processes lend themselves well to automation, which will eventually improve your entire organizational structure while reducing necessary resources for ISO conformity.

At Trident Quality Management Solutions, we are here to help with implementation and support of ISO compliant quality management systems. Contact Trident QMS today to get started. Dial 520-314-4343 or drop us a line on our website. We offer flexible, remote solutions and free assessments, so don’t hesitate to reach out today!


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