When performing a document review, which aspect must be taken into account?

The correct choice emphasizes the importance of understanding both the context of the organization and the associated risks and opportunities during a document review. In ISO 9001, assessing these elements is crucial for effective quality management. The context of the organization involves understanding internal and external factors that may influence the QMS, which includes stakeholder needs and expectations.

Focusing specifically on risks and opportunities allows organizations to enhance desirable effects, prevent or reduce undesired effects, and achieve continual improvement. By identifying these risks and opportunities, the document review process becomes more robust, ensuring that the QMS can adapt and respond to potential changes in the operating environment.

While the clause order of the ISO standard and the context of the organization are certainly relevant aspects of a document review, they do not encompass the holistic view that takes into account risks and opportunities, which is foundational in achieving compliance with the standard and enhancing overall performance. Therefore, understanding the interplay between the context and the associated risks and opportunities is fundamental for the success of the quality management system.