Statement of Commitment to Quality
Quality is established as an essential factor for the optimal functioning of the services offered by RADIOPHYSICAL TECHNIQUES. There is a firm commitment to maintain a Quality Management System based on the UNE EN ISO 13485 Standards, Royal Decree 192/2023, Regulation (EU) 2017/745 and Directive 93/42/EEC on medical devices. All this is arranged in order to comply with the legal and regulatory requirements in force, achieve the general objectives of the organization, provide customers with full satisfaction and serve as the maximum guarantee of quality.
To achieve these objectives, it is considered necessary that all personnel are involved in the application of the Quality System, taking it as a basis for the continuous improvement of the design, production, installation and services provided in the process of development and import of medical devices. It also requires knowledge of these objectives and the means to achieve them on the part of the entire organization. To this end, the coordination of the workforce will be maintained and favoured, having the necessary human and material resources to guarantee the highest quality. In the same way, extreme importance is given to constant updating in the training of personnel.
The organization has a deep understanding of products and their relevance to people’s health. The utmost caution is exercised in their application, identifying, evaluating and minimising any risk that may be associated with them. Strict compliance with regulatory requirements applicable to medical devices and manufacturing, distribution and after-sales service activities is maintained.
For all these reasons, it is established that the provisions of the Quality Manual are mandatory for all personnel, in all their departments and sections, and must be known and applied in each of the areas and activities affected.
