considers quality
to be a fundamental aspect of its strategy.

Quality Policy

The General Management of Surgika considers quality to be a fundamental aspect of its strategy and promotes a commitment to quality at all levels of the organisation. Aware of its role, the company disseminates and supports the commitment to meet the requirements of the Quality Management System and to continuously improve its effectiveness whist transmitting the importance of knowledge management to the entire structure.

To this end, a Quality Management System has been established in accordance with the UNI EN ISO 9001:2015 and UNI EN ISO13485:2016 standards as well as the Basic Requirements of the Medical Devices Directive 93/42/EEC and European Regulation 745/2017 (MDR) for the CE marking.

The objectives that SURGIKA aims to achieve and is committed to consolidating are:

Manufacturing and selling medical devices, striving to offer a product that stands out for its quality and service in order to guarantee customer satisfaction, the applicable regulatory requirements and the safety and performance specifications of the devices;

Continuous improvement of business processes in compliance with current regulations and applicable regulatory requirements:

  • Internal by taking care of the professionalism and satisfaction of employees within the defined company objectives and among them, the dissemination of environmental culture and quality;
  • External, in order to be able to have complete customer satisfaction, both in terms of quality, improving timeliness in the provision of services, flexibility and punctuality of information.

To ensure compliance with the principles set out, the company undertakes to:

  • Ensure the efficient and effective management and continuous improvement of the Quality Management System, through the constant surveillance of the systems, through audits and Management Reviews (for all management systems adopted by the company, the field of application is related to the production of solutions for the operating room that include gowns, specialised drapes, sterile infusion systems, surgical instruments, in addition to elastomeric pumps);
  • Enhance the quality of the finished product through the introduction of the necessary organisational and technical tools;
  • Inform all people who work for or on behalf of the organisation about the company policy document.

All Surgika personnel must play an active and conscious role in pursuing these goals.

Anyone who participates in the company’s activities must understand and implement the company’s Quality Policy and actively support it. Management is aware of the collaboration that all employees can bring to permanently pursue the company objectives and expects from the function managers and all staff a constant commitment to maintaining the focus of their activity on the defined priorities.