Quality Management System
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The Company has been certified UNI EN ISO 9001:2008 and UNI EN ISO 13485:2004 for over 10 years; the latter certification is specific to medical devices. The certifications have been granted to the activities which are related to the clinical engineering services, starting from the design to the supply of all the related integrated management technology. Furthermore, the workshops specialising in the maintenance of the endoscopy equipment are also subject to certification. The companies operating in the Group have quality management systems in compliance with UNI EN ISO 9001:2008, quality standards and are certified by internationally recognised entities. In Italy, EBM - in the policy for the integration of quality standards – was the first to implement an environmental management system obtaining the certification provided for by the provision UNI EN ISO 14001:2004. All the other companies operating in the Medical Equipment and Devices Business Unit, also in the other foreign countries (United Kingdom, Spain, Portugal, France, Belgium, the Netherlands and Germany) are certified in compliance with UNI EN ISO 13485:2004, a specific provision relating to medical devices. The other companies of the Group which operate in the e-Health Systems and Solutions Business Unit, and in particular those which operate in the medical IT segment (PCS, Caribel) and in the telemedicine and telecare segment (Tesan and its participated company Tesantelevita), have a quality system which is certified according to the ISO 9001 provision. Finally, the Company has started a certification procedure for the services and products offered in the e-Health Systems and Solutions Business Unit, with the goal of achieving such certification during the course of next year.
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