How should changes to the Quality Management System be documented?

The correct choice emphasizes the necessity of maintaining relevant documented information when changes to the Quality Management System (QMS) are made. According to ISO 9001, organizations must establish, implement, and maintain a management system that is adequately documented to ensure consistency and traceability. Documenting changes helps to provide a clear and formal record of what adjustments were made, the reasons behind these changes, and the implications for the quality management practices in the organization.

Documented information serves several purposes:

1. Consistency: It ensures that all stakeholders are aware of changes, enabling consistency across processes and preventing misunderstandings.

2. Traceability: It provides a historical reference that can be essential for audits, performance evaluation, and continual improvement activities.

3. Compliance: It aids in demonstrating compliance with ISO requirements and regulatory standards, which often demand clear documentation of all aspects of the management system, including changes.

While other options suggest alternatives, they do not align with the ISO 9001 requirement for systematic documentation practices in managing changes to the QMS. Therefore, maintaining relevant documented information is the recognized best practice in this context.