Quality and safety of our products

A number of Group companies have developed (or implemented) an “Integrated Management System Manual” that complies with the requirements of TUSSL [Testo Unico Salute e Sicurezza Lavoro - Consolidated Occupational Health and Safety Act] no. 81 of 2008. This manual describes the objectives and policies of the Quality Management System and how it is implemented. In addition, it lays down the general criteria for ensuring the safety and performance of products and services throughout their life cycle.

The companies El.En. SpA, DEKA M.E.L.A. S.r.l., Quanta System S.p.A., ASA S.r.l. and Asclepion GmbH have implemented a Quality Policy that ensures compliance with the regulations of the national Bodies of the countries in which they operate. 

It should be noted that there are 13 production sites, of which 8 relate to production for the industrial sector and 5 to production for the medical sector. 54% of the production sites are ISO 9001 certified while 100% of the production sites producing medical devices are ISO 13485 certified.

The responsible Quality departments, for which a managerial responsibility for product safety has been identified in each subsidiary, carry out daily safety risk assessments and promptly investigate incidents that occur and implement corrective actions promptly. The personnel in charge of these controls receive regular training on the activities that must be carried out in line with new regulations, recommendations, and best practices at national and international level, and they receive regular inspections by independent bodies on product safety and the correctness of the procedures and processes put in place, also in response to emergencies tested regularly to ensure product safety.

Depending on the geographical area and business sector, the various Group companies adhere to the following standards and regulations: