What does a quality system consist of?

A quality system is a structured framework that defines how an organization ensures that its products or services consistently meet customer expectations and regulatory requirements. The core elements of a quality system include the organizational structure that delineates roles and responsibilities, processes which outline the steps needed to achieve quality objectives, and resources necessary to implement and maintain these processes effectively.

The organizational structure is critical as it ensures that there are designated individuals or teams responsible for quality management. This structure facilitates communication and coordination among different functions within the organization, allowing for a seamless approach to maintaining quality standards.

Processes are the specific activities and workflows that are put into place to achieve desired outcomes, including standard operating procedures and protocols that guide the work. These processes are essential for ensuring consistency and compliance with quality objectives throughout the organization.

While the other options mention important components that can support a quality system, such as assessment criteria, client feedback, and regulatory compliance, they do not encapsulate the fundamental components of a quality system as comprehensively as the organizational structure and processes do. A quality system relies on these foundational elements to operate effectively and achieve its overarching goal of delivering high-quality results.