ISO 9001:2008 and ISO 13485:2012 SOLTEC Quality Management System Certificates

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Milan 15th May 2013

SOLTEC Srl manufacture of SONICA Ultrasonic cleaning Systems is delighted to announce that the Company's Quality Management System (QMS) has been credited with ISO 13485:2012 certification by CERMET:

The certifications obtained by our Company, represent an important commitment to the market, which began in 2004 with the certification of the Quality Management System according to ISO 9001-2008 (Certificate No. 04 100 0414 19 RWTÜV Systems GmbH) and subsequently completed through the development an additional system of quality management according to ISO 13485-2012 defining for manufacturers of medical devices further guarantee that their products are designed, manufactured and marketed in accordance with the standards set out in the regulation, in order to meet the specific requirements of the market and the laws of reference.
 
The ISO 13485 is a standard that has an affinity with the concepts defined in ISO 9001, increasing the specific value for the medical field requiring special attention on the relevant requirements for the safety of medical devices placed on the market.
 
SOLTEC chose Company CERMET, as an independent body for the certification of the entire Quality Management System, as notified to the CE marking in accordance with Directive 93/42/EEC and accredited by ACCREDIA for certification according to ISO 9001 and ISO 13485.

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