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With the purpose of qualifying at top market levels in terms of safety and reliability of the services provided, Servizi Italia has put in place an organisational structure that is aimed at proving that the activities carried out:
- provide a guarantee and evidence that the process can systematically offer Services complying with preset specifications, defined according to the customers’ requirements and applicable legal regulations.
- aim at increasing the level of customer satisfaction through an effective management of the environment and safety quality system and the commitment to continuous improvement.
- are oriented towards territorial and environmental protection, community health and safety, and prevention of pollution in compliance with the laws in force.
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This led to the respective certifications according to the following norms:
- UNI EN ISO 9001:2008 for the implementation of the Quality Management System.
- UNI EN ISO 13485:2004 for the implementation of a Quality Management System supporting the organisation for the design and development, production, installation and assistance of Medical Devices, as well as the design, development and provision of their related services.
- UNI EN ISO 14001:2004 for the implementation of an Environmental Management System supporting the organisation.
- UNI EN 471:2008 High-visibility garments for professional use, verification and control of high-visibility garments subject to washing and maintenance.
- UNI EN 14065:2004 Biocontamination control system “Laundry processed textiles”. Biocontamination control system assessed according to the RABC guidelines issued by FISEAUIL
CE Certification
In compliance with Legislative Decree No. 46 dated 24 February 1997 dealing with the implementation of European Directive 93/42/EEC on medical devices, Servizi Italia obtained from the notified body, the National Institute of Health, a certification stating that every example representing a specific production fulfils the provisions established by the above-mentioned Directive. This certification allows the CE marking of Medical Devices within the sterilisation stations before their use in the operating theatres of hospital facilities.