What defines a nonconformity as major?

A nonconformity is considered major when it indicates a significant deviation from the requirements of the quality management system, which can potentially affect the organization's ability to achieve its objectives or comply with applicable regulations.

In the context of your answer, identifying several minor nonconformities that relate to the same element of the management system suggests a pattern that indicates a larger systemic issue. A collection of these minor nonconformities can signal that while each individually may not be severe, their collective impact could undermine the effectiveness of the management system and thus warrants classification as a major nonconformity.

Understanding this distinction is critical as it emphasizes the importance of addressing not only individual nonconformities but also recognizing when they aggregate to signify deeper systemic problems that could affect overall performance and compliance. This classification is essential as it guides organizations in prioritizing corrective action to ensure ongoing conformance and continuous improvement within the quality management system.