What is the primary purpose of a quality system review?

The primary purpose of a quality system review is to conduct an audit resulting from significant changes affecting product quality. This process is essential for ensuring that any alterations in processes, materials, or regulations are adequately evaluated for their impact on the quality of the products or services provided by the organization.

When significant changes occur, it is critical to determine whether these changes introduce risks or opportunities for improvement that could affect overall quality. A thorough audit helps to identify areas where adjustments may be needed, ensuring that the quality system remains effective and compliant with established standards. This proactive approach allows organizations to maintain high-quality outputs and continuously improve their processes in response to changes.

While compliance with government regulations and evaluations of employee performance are important aspects of quality management, they serve different purposes. Financial assessments are focused on the economic aspects of the organization rather than its quality processes. Therefore, conducting an audit due to significant changes directly connected to product quality aligns best with the primary aim of a quality system review.