Alvimedica established its quality management systems (ISO 13485:2012) with the intention of satisfying the conditions laid down by international standards for performing the services in its field of operation. The company has documented these systems and assures their sustainability and continuous improvement.
The (main) work and supporting processes are determined within the scope of the Quality Management System. The efficient execution and controlling of these processes is ensured throughout the Quality Management System Procedures in which process charts and activities/formulation of the operational processes are specified in detail.
The interaction between the work processes and the supporting processes, which provide direct support at the same, are designated within the scope of the main functions and form the main activities of the establishment which includes the owners of the work processes.
The process of Human Resources – in the form of recruitment and development of human resources – the process of Data Processing – in the form of procurement, development and continuity of the resources of data processing software and hardware – and the process of Quality Management – in the form of the establishment, efficient application and improvement of the Quality Management System and the realization of the management obligations – provide input to all sections and processes that may be relevant and utilize all outputs that may be considered as input.
The monitoring/measurements/verifications to be conducted during the relevant stages of the activities are defined in the procedures. The monitoring, measuring and analysis of the processes are realized with the performance indicators as indicated in the process charts. In the event of deviations from the targets specified for the performance indicators, corrective actions are initiated.
The processes and all of the procedures defining such processes and other quality system documents are compatible with the requirements of the quality system standards and each other, and are of a complementary nature.
For the application, monitoring and supporting of the control of the processes, qualified-trained personnel, appropriate facilities, work environments, automations, communication tools and software are implemented.