SOLTEC Company Quality Management System certification in accordance with the ISO 9001:2015 and ISO 13485:2016 standards
The certifications obtained by our company demonstrate our deep commitment to the market; the process began in 2004 with the certification of the Company Quality System in accordance with the ISO 9001-2000 standard (Certification No. 04100 20041419 RWTÜV Systems GmbH) and was later completed through the development of an additional quality management system in accordance with the ISO 13485-2012 standard, which represents an additional guarantee that the products of medical device manufacturers are designed, manufactured and marketed according to the standards established by the standard itself, in order to meet the specific requirements demanded by the market and the relevant laws.
ISO 13485 is a standard that contains similar concepts to those defined in ISO 9001, increasing its specific value for the medical sector by calling for special attention to be paid to requirements that are pertinent to the safety of medical devices placed on the market.
Current certifications | Current declarations of conformity | Previous certifications | Previous declarations of conformity
Our current ISO certifications, as issued by ICIM Spa, expire on 21 May 2025:
UNI EN ISO 9001:2015 Design and manufacture of
ultrasonic cleaning and thermal disinfection systems for the medical
and industrial sectors. Design and manufacture of ultrasonic
extractors for environmental analysis. Distribution of chemical
solutions for cleaning and disinfection
IQNET
certified for ISO 9001:2015
UNI EN ISO 13485:2016 Design and manufacture of ultrasonic cleaning and thermal disinfection devices for the medical sector. Distribution of chemical solutions for cleaning and disinfection of medical devices
IQNET certified for ISO 13485:2016
EC Quality Assurance System certification in accordance with Directive 93/42/EEC (MDD) with expiry on 21 May 2023 and extended until 31 December 2028 under EU Regulation 2023/607
MED 31044 certification - Equipment for the disinfection of medical devices – Risk class: II b – Models: SONICA S.A.M. 3 L and SONICA TRENDMATIC 9TD - certification number MED 31044 KIWA CERMET notified body no. 0476
Quality System – REG. EU 2017/745 – Acquisition of MDR contract by ICIM Letter of Declaration of 22 May 2023
EC declarations of conformity for SONICA ultrasonic cleaning devices, series S3 - S4 – SONICA S.A.M. 3 and SONICA TRENDMATIC
EC 0476 which refers exclusively to the product listed in the Certification Reg.No: MED 31044 - Equipment for the disinfection of medical devices - Brand SOLTEC Model SONICA S.A.M.3 L and TRENDMATIC 9 TD
Declaration of conformity SONICA S.A.M. 3 Basic – SONICA S.A.M. 3 Basic USB 18 LT – SONICA S.A.M. 3 Basic USB – SONICA TRENDMATIC 9 LT – SONICA TRENDMATIC 18 LT
Declaration of conformity for SONICA series S3 and series S4 ultrasonic cleaning devices