The Management of Thema in the provision of services for the medical and related sectors, considers Quality a strategic tool for the achievement of excellence and an objective to be pursued in all the organisation’s activities as well as a criterion for the prevention and involvement of both internal and external collaborators.
For the above, the Management of Thema intends to pursue modern management of Quality through an adequate organizational structure and an optimal organization of resources to achieve the satisfaction of its Customers, Learners, Beneficiaries and Interested Parties and to establish an effective collaboration with the same and with the suppliers, to obtain maximum efficiency through the integration of the various skills.
In this context, the Management is committed to operating in substantial compliance with UNI EN ISO 9001, EN ISO 13485:2016, ISO 21001 and the applicable regulatory requirements, as well as to acting in accordance with the principles of social responsibility to make an active and voluntary contribution to improving the social, economic environment in which the organisation operates.
With this Quality Policy, the Management also declares its utmost commitment by the entire organisation to the pursuit of:
– the maximum satisfaction of Customers, Learners and Beneficiaries of the products/services provided by the organisation and the Interested Parties involved, meeting their expectations and requirements, also with regard to the education and training of Learners, including special needs.
– Compliance with binding national and international regulations and technical standards.
– The pursuit of the fulfilment of requirements and the maintenance of effectiveness as well as the continuous improvement of the performance of the Quality Management System, processes and services.
– Attention to relevant developments in the educational/training, scientific and technical fields.
– The optimal management of the intellectual property.
– The involvement of all personnel and the exhortation to act through compliance with the Quality Management System.
– The education and training of personnel as strategic activities and essential conditions for the realisation of continuous improvement within the organisation.
With regard to the responsibilities assigned to the Person Responsible for Regulatory Compliance by MDR (EU) 2017/745, IVDR 2017/746 and its national transpositions as well as the Swiss Ordinance MedDO SR 812.13, the Management also declares its utmost commitment to ensuring that the Person Responsible for Regulatory Compliance does not suffer any disadvantages within the organisation regarding the proper execution of its tasks.
The Management, based on data relating to the needs of Customers, Learners, Beneficiaries and Interested Parties and, where possible, of comparisons with the capacity of the best competitors, annually establishes the areas and sectors on which to intervene as a priority in order to achieve Quality in all areas of the organisation, defining the relative objectives appropriately.
The Management undertakes to ensure that this Quality policy is understood, implemented and supported at every level of the organisation, in the consideration that the achievement and maintenance of the envisaged objectives are bound to the constant and active collaboration of all the organisation’s personnel.