Quality system & certifications

Villa Sistemi Medicali constantly makes its Quality System one of the key elements to be recognized as a leader in the manufacture and the sale of medical radiological systems, with a solid and extensive distribution network worldwide.

Aware of the importance of product quality in an increasingly competitive market, Villa Sistemi Medicali has been acknowledged with the following certifications over the years:

1998: consolidating its know-how in radiology field and foreseeing needs of a market in evolution, Villa Sistemi Medicali obtains its first certification of Quality System according to ISO 9001:1994 and EN 46001:1996 standards;
2001: Villa Sistemi Medicali is one of the first companies in Italy to obtain the certification according to ISO 9001:2000 standard;
2005: Quality System certified according to ISO 13485:2003 standard;
2010: Quality System certified according to ISO 9001:2008 standard;
2013: Quality System certified according to EN ISO 13485:2012 standard;
2018: Quality System certified according to ISO 9001:2015 and ISO 13485:2016 standards.

For most of its products, Villa Sistemi Medicali obtained the required certifications to be active in leading international markets; for example, FDA certification for United States market, ISO 13485:2003 plus Canadian deviation certification for marketing in Canada and Russian Registration for marketing in Russian territory. Other worldwide recognized voluntary certifications (e.g. ETL, MET) assure a major reliability of our products.

In this way, the accurate control of factory process quality becomes a significant advantage that Villa Sistemi Medicali assures for its own commercial partners and customers in order to keep reliability, diagnostic quality and competitiveness of its medical products, with the aim to become one of the main reference points in the international radiology field.

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