ABSTRACT
The organization is required to maintain the effectiveness of the quality management system (QMS) in accordance with the requirements of the ISO 13485 Standard and applicable regulatory requirements. Role of the organization—The role of the organization determines which quality and regulatory activities and controls the organization must plan and implement in its QMS. The identification of applicable regulatory requirements is a critical phase in developing the QMS because the regulatory requirements will shape your QMS and its elements and operations. The effectiveness of a QMS depends much on the ability of an organization to achieve planned results—the expectations of the interested parties. The ISO 13485 Standard requires documentation of the processes, operations, and activities that make up the QMS. Determining the sequence of processes means determining the sequence of different activities of different elements involved in the process and constructing the workflow in the organization.
