Define 'risk-based thinking' as per ISO 9001.

The concept of 'risk-based thinking' in ISO 9001 is fundamentally about proactively identifying and managing risks and opportunities within an organization's processes. This approach emphasizes the importance of understanding the potential events that could hinder the achievement of quality objectives, as well as recognizing opportunities that could enhance the effectiveness of the Quality Management System (QMS).

By integrating risk-based thinking into the QMS, organizations can focus their resources effectively, prioritize actions based on the likelihood of risks materializing, and reduce the chances of undesirable outcomes. This fosters a culture of continuous improvement and helps organizations to be more resilient in the face of uncertainties, ultimately contributing to higher customer satisfaction and improved overall performance.

The other options do not capture the primary intent of risk-based thinking. Evaluating employee performance, reducing operational costs, and improving product design are important aspects of an organization’s operations but are not the essence of risk-based thinking as defined by ISO 9001. This concept is more holistic and strategic, aimed at guiding decision-making processes throughout the organization.