ABSTRACT
Resources are regarded as support tools for the quality management system (QMS) to meet the organization's objectives. Human resources has a significant weight and effect on the realization processes, and the organization is required to determine and provide personnel necessary for the effective implementation, operation, and control of its quality management system and its processes. The resources of an organization enable its capabilities for maintaining the QMS: how the resources affect those professional capabilities and abilities of the organization. When planning activities for improvement, the organization shall review and determine which resources are required for achieving the goals of the improvement. The provision of resources also applies to the identification and allocation of adequate resources necessary for risk management activities. One critical step in building competence of human resources is establishing an effective training and certification process related to the activity of the role or the function for each role or function involved in the realization of the medical device.
