ABSTRACT
Management responsibility lays out the principles and expected actions from the top management regarding their commitment to the quality management system (QMS). Management commitment should be regarded as a basis for self-evaluation of top management's status and its role within the QMS regarding its commitment. The top management is required to define a quality policy with the goal of demonstrating the commitment of the top management and the organization to the implementation of a QMS and to the maintenance of its effectiveness. According to the ISO 13485 Standard, leadership initiates unity of purpose, while establishing the direction and strategy of the organization. Customer focus is one of the quality principles that the ISO 13485 Standard is based upon. The standard sets this clause to ensure top management's leadership and commitment to meeting customers' as well as regulatory requirements.
