Management System Policy

International Emergency Services, S.L. (IES MEDICAL®) is a company located in the Bizkaia Technology Park in Derio (Bizkaia), whose activity includes:

• The design, development, manufacturing and sales of sterile and non-sterile ventilation consumables used for ventilation support and airway ventilation instruments.
• Distribution and technical service of airway ventilation instruments and mechanical ventilators for anaesthesia and pulmonary ventilation support.
• Importation, distribution and sale of active and non-active (non-implantable) medical devices, in vitro diagnostic products, and the assembly of haemorrhage control kits (HCK) and individual first aid kits (IFAK).

The Management of IES MEDICAL® is committed to meeting the requirements, maintaining effectiveness, and continuously improving the Integrated Management System implemented in accordance with the following international reference standards and the activities it carries out:

ISO 13485 “Medical devices — Quality management systems — Requirements for regulatory purposes”,
ISO 9001 “Quality management systems — Requirements”,
ISO 14001 “Environmental management systems — Requirements with guidance for use”,
ISO 45001 “Occupational health and safety management systems — Requirements with guidance for use”.

Our high level of specialisation and extensive experience has earned the trust of a wide range of healthcare clients. This leads us to ensure that, in all our activities, our commitment to service quality, manufactured products, environmental protection, and occupational health and safety becomes a constant in the company’s operations.

For all these reasons, the Management of IES MEDICAL®, through this Integrated Management System Policy, has established the following commitments:

❖ Implement the necessary measures to prevent and/or eliminate all factors that may negatively affect the quality of the activities carried out by IES MEDICAL®, or that may involve risks in medical devices, environmental risks, or risks to the health and safety of company personnel, collaborating companies, or any interested parties in contact with our organisation's activities.
❖ Improve the performance of the Integrated Management System, as well as prevent harm, reduce environmental impact and prevent pollution. Provide safe and healthy working conditions for the prevention of work-related injuries and health deterioration, using all resources and means available in the company.
❖ Ensure compliance with legislation and regulations applicable to our activity, particularly those related to medical devices and in vitro medical devices, the environment, and occupational health and safety, as well as any other requirement that, while not mandatory, is voluntarily adopted by IES MEDICAL®.
❖ Promote the participation and involvement of all employees in the operation of the Integrated Management System and in the development and implementation of this Policy, as well as provide adequate training to staff so they can perform their tasks with the highest standards of quality, minimal environmental impact, and in full safety.
❖ Encourage our suppliers and subcontractors to comply with all requirements established by the company regarding the manufacturing and distribution of medical devices, quality, environmental protection, and occupational health and safety.
❖ Include all our activities within the philosophy of Continuous Improvement, providing innovative solutions to our customers, including those activities that directly or indirectly affect the quality of our service, our local environment, and the health and safety of our organisation, or influence customer satisfaction.
❖ Communicate this Policy to all personnel working for or on behalf of this organisation, as well as to all interested parties who may request it, and ensure its correct implementation at all levels.

To achieve these commitments, the Management will establish and document realistic, measurable annual objectives.

Finally, this Integrated Management System Policy is reviewed annually by the Management to ensure that its content remains fully valid, aligned with the organisation’s values, coherent with IES MEDICAL®’s corporate strategy, and consistent with customer expectations.