ISO 9001 - Clause 4.4 Quality Management System and its Processes

Clause 4.4 of the ISO 9001:2015 standard, titled "Quality Management System and its Processes," requires organizations to establish, implement, maintain, and continually improve a quality management system, including the processes needed and their interactions. Organizations must determine the processes required for the QMS, how they apply throughout the organization, and how they are integrated. This includes defining responsibilities, ensuring adequate resources, achieving process results, managing process interactions, and evaluating and improving processes. It emphasizes the importance of a process approach to achieve desired outcomes more efficiently, enhancing customer satisfaction and compliance with applicable requirements.