Having already been awarded ISO 13485 certification for manufacturers of medical devices, SOLTEC has now also been certified ISO 9001:2015 by the internationally-recognized KIWA CERMET certification body.
The new certification is for the Design & Production of Ultrasonic Cleaning and Thermal Disinfection Systems in the medical and industrial sectors, for the Design and Production of Ultrasonic Extractors for Environmental Analysis and finally for the distribution of Chemical Cleaning and Disinfection Solutions.
This certification is a cornerstone for any modern company, internationally recognized for the quality of its products, and was issued in accordance with the technical specifications in the new ISO 9001:2015 reference standard, first published only in September 2015.
“It is essential for us to adapt immediately to the new ISO 9001:2015 standard in order to take increasing responsibility for quality and risk assessment with regard to the products we manufacture, the services we provide and the Organization itself”, says Stefano Guidi, Chairman of the Board at Milan’s SOLTEC Srl.
“In less than eight months since the new ISO 9001:2015 was published, SOLTEC has managed to earn certification, one of the first companies in Italy to do so, which we see as a recognition of the excellence of our Corporate Quality System and risk management processes” - adds Guidi, “and the only way to meet the increasingly pressing needs of our many customers in the medical, pharmaceutical and industrial industries.”
The main changes introduced in the new standard can be summarized as follows:
Greater involvement of company management, with the introduction of the concept of Leadership so as to assign specific responsibilities to those in key roles within the company, and promote quality management within the Organization.
Introduction of a “High-Level Structure” setup for greater compatibility with other certification schemes.
The introduction of a “Risk-Based Thinking” approach. Rather than using standard requirements across the board, each Company analyzes its own risks in detail, planning an appropriate management system for its needs. The new approach involves identifying the risks inherent in the business process and setting out appropriate measures for the company to take if it is to manage them properly, and finding the right solutions and countermeasures to address them.
Eng. Paolo Rissone
Quality Assurance Manager
SOLTEC Srl
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Consult all the other certificates obtained by SOLTEC
Our demanding customers require the best products and services at the highest quality standards in the industry of Ultrasonic Cleaners.
In many countries worldwide, SOLTEC Company successfully combines a global presence.
We are close to our customers and help them meet their needs.
On the local distributors' shelves, customers will find SOLTEC-SONICA Ultrasonic Cleaners, accessories and special cleaning fluids for ultrasonic cleaning, for which our top quality demand is always guaranteed.
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It has the ability to use 6.5 litres and is particularly indicated for the treatment of surgical instruments before sterilization in the autoclave.
The touch screen allows the control of all the automatic cycle functions of the system, from the ultrasonic cleaning parameters , to the activation of a rinsing system with pressure spray nozzles, to the thermal disinfection and drying cycle.
Let's take a detailed look into the cycle function of TRENDMATIC TD.
Phase one. Filling and washing:
The system fills the tank with clean water and automatically measures the detergent. The internal heating device in the tank heats it to the desired temperature and starts the ultrasonic cleaning
Phase two. Discharge:
At the end of the ultrasound washing phase, the system discharges the water in less than a minute through a pump.
Phase three: Automatic multiple rinses with vigorous water movement:
An incredible innovation patented by SOLTEC. The TRENDMATIC TD applies between 1 to 5 rinses with clean water, eliminating every possible detergent residue from the surface of the surgical instruments.
Phase four. Thermal Disinfection at 93°C. for 3 minutes
The thermal disinfection at 93°Celsius for three minutes and the contemporary “ThermoDry” drying – also patented by SOLTEC – sonica TRENDMATIC TD guarantees a thermal disinfection cycle with a A0 minimum value of 3500.
At the end, the final ventilation permits the elimination of humidity in the washing tank and the cooling of the instruments at the end of the cycle.
SONICA TRENDMATIC TD brings about important advantages with respect to the traditional systems present in today's market:
It is completely AUTOMATIC.
It is safe:
All the phases are carried out with clean water – avoiding every possible risk of contamination.
It rigorously respects all the phases foreseen by the protocol of treating surgical instruments before sterilization.
It reduces professional risk during the handling of the infected instruments.
The insertion of a password determined by a person responsible for health services, avoids access to the set up functions.
SONICA TRENDMATIC TD is efficient
It guarantees superior results thanks to the ultrasound and to the “sweep system technology”.
Moreover, after only two rinses, the anionic surfactants residues are less than the analytical quantitative traceable limit .
SONICA TRENDMATIC TD It is economical:
It reduces the time and overall working costs.
For each washing cycle, only 60 ml of detergent is used.
SONICA TRENDMATIC TD – The innovative Ultrasound System with Thermal Disinfection cycle.
Now completely automatic.
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 9001-2000 (Certificate No. 04100 20041419 RWTÜV Systems GmbH) and subsequently completed through the development of 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.
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