What must an organization document regarding its QMS according to ISO 9001?

Documenting the scope of the Quality Management System (QMS) and its boundaries is essential for an organization according to ISO 9001. This requirement ensures that the organization clearly defines what the QMS covers, including the specific processes, products, services, and organizational units involved in the operation of the QMS. By identifying the scope and boundaries, the organization can delineate areas that fall within the QMS, allowing for focused resource allocation and consistent management of quality across various aspects of operations.

This documentation also aids in establishing a clear understanding of the internal and external factors that can impact the QMS and the organization’s ability to consistently provide products and services that meet customer and regulatory requirements. Thus, it becomes a foundational element around which other quality processes and objectives are built.

The other choices, although important for business operations, do not pertain directly to the specific requirements for QMS documentation as outlined in ISO 9001. For instance, marketing strategies, employee performance evaluations, and financial projections, while significant for the overall functionality and strategy of a business, do not define the quality management system itself or its operation.