Management System Policy

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

• Design, development, manufacturing and sale 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 anesthesia and pulmonary ventilation support.
• Import, distribution and sale of active and non-active (non-implantable) medical devices, in vitro diagnostic products, and the assembly of hemorrhage control kits (KCS) and individual first-aid kits (KPA).

The Management of IES MEDICAL® is committed to meeting the requirements, maintaining the effectiveness, and continuously improving the Integrated Management System implemented based on the following international reference standards and the activities carried 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”.

The high level of specialization and extensive experience in our services have led numerous clients in the healthcare sector to place their trust in the services provided by our company. This results in a constant commitment, throughout all our activities, to service and product quality, environmental protection, and occupational health and safety at every stage of our processes.

Therefore, through this Integrated Management System Policy, the Management of IES MEDICAL® has established the following commitments:

❖ Implement the necessary measures to prevent and/or eliminate any factors that may negatively affect the quality of the activities carried out by IES MEDICAL®, or that may pose risks to medical devices, to the environment, or to occupational health and safety of company personnel, collaborating companies, or any interested parties involved in the activities performed by our organization.

❖ 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 to prevent work-related injuries and ill health, with all resources and means available within the Company.

❖ Ensure compliance with the legislation and regulations applicable to our activity, particularly those related to medical devices and in vitro diagnostic medical devices, the Environment, and Occupational Health and Safety, as well as any other requirement that, though not mandatory, has been voluntarily adopted as a commitment 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, and provide adequate training to ensure that personnel carry out their activities with the highest Quality standards, minimal environmental impact, and maximum levels of Occupational Health and Safety.

❖ Encourage our suppliers and subcontractors to comply with all provisions established by the company regarding the manufacturing and distribution of medical devices, Quality, Environment, and Occupational Health and Safety.

❖ Integrate all our activities within the philosophy of Continuous Improvement, providing innovative solutions to our clients, including those activities that directly or indirectly affect the Quality of our service, the surrounding Environment, or the Occupational Health and Safety of our Organization, or that influence customer satisfaction.

❖ Communicate this Policy to all personnel working for or on behalf of this organization, as well as to any interested parties who may deem it appropriate, and ensure its correct implementation at all levels of the organization.

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

Finally, this Integrated Management System Policy is reviewed annually by Management to ensure that its content remains fully valid, is aligned with the organization’s values, is consistent with IES MEDICAL®’s business strategy, and meets the expectations placed on us by our customers.

The Management
 

April 2025