Implementation of a Process-Based Quality Management System

Introduction: The research addressed the design and implementation of a Quality Management System (QMS) in accordance with ISO 9001:2015, considering its importance in the contemporary organizational context. Quality was recognized as a fundamental strategic axis for improving competitiveness, operational efficiency, and customer satisfaction in a globalized environment. Development: The study focused on the principles, structures, and tools required by the standard, such as process maps, flowcharts, the PEPSC model, and the distinction between process and procedure. The types of processes—strategic, operational, and support—and their relationship to the value chain were identified. The basic elements of a process, process management, and the regulatory requirements distributed throughout the chapters of ISO 9001:2015 were also addressed. The process-based approach allowed activities to be organized in a logical, measurable, and results-oriented manner, strengthening quality control. Conclusions: It was concluded that the ISO 9001:2015 standard is an effective tool for structuring organizational processes, improving institutional performance, and establishing a cycle of continuous improvement. Leadership, planning, adequate support, and staff participation were key factors in the sustainability of the implemented system. The standardization of procedures and process management provided a solid foundation for auditing, evaluating, and optimizing operations, consolidating a culture of comprehensive quality.