Eiffage Energía, in its Electro-medical division (BIOMEDICAL), has obtained, through AENOR, the certification for its Quality Management System for Medical Products, in accordance with the standard UNE-EN ISO 13485:2016, introduced for activities of «Management and maintenance of medical equipment for electro-medical use».
It has also obtained, through AENOR, the certification for quality management under the new version of the standard UNE-EN ISO 9001: 2015 and the certification for environmental management under the new version of the standards UNE-EN ISO 14001: 2015.
In this way, Biomedical obtains formal and public recognition of its capacity to provide maintenance services for electro medical equipment in Health Centres, with a high degree of quality and of compliance with the requirements of the regulatory authorities and our customers.
The standard ISO 13485 is a standard recognised internationally for Quality Management Systems in the entire useful life of Medical Products. Its main objective is to enable organisations to provide and maintain safe and effective medical devices.
At Eiffage Biomedical, the main aspects to highlight in the implementation of these management standards have been:
– High qualification of the Biomedical personnel, an essential for quality service.
– Adaptation to the regulatory requirements of application and compliance with the requirements set by our customers.
– Inclusion of decision making based on risk, analysing the safety risks at all stages of the life cycle of the electro-medical equipment.
– Validation and verification of medical equipment to ensure the safety of patients and users, complying with strict periodic protocols of calibration and preventive maintenance.
– Ensuring the maximum availability of its equipment for Health Centres, reducing to a minimum technical downtime and ensuring its replacement or substitution
– Agile and effective communication with Health Authorities, equipment suppliers and Health Centres to report possible adverse effects detected during maintenance of the medical equipment.
– Environment protection and pollution prevention: Control of waste generated by our activities in Health Centres and compliance with environmental legislation.
With this quality system, the Electro-medical area of Eiffage Energía is reaching an optimisation of processes, ensuring the control of health risks and minimising the appearance of potential damages that jeopardize the safety of patients, users or society, thus contributing to a rigorous method of control of the service provided in the electro-medical area.
José Manuel Martínez, Eiffage Energía’s CEO, pointed out that «it is important that a company that provides and develops health services adapted to the demands of users be an example of quality management excellence in its own organisation».
This new certification thus joins the standards ISO 9001 for quality management system, ISO 14001 for environmental management system, implemented throughout the organisation.
With this new line of activity in the electro-medical sector, Eiffage Energía expands one of its strategic objectives ensuring the control of health risks and the quality of its services. One more step in its development as a national and international benchmark offering a 360° comprehensive service.