Milan | 11st May 2016

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

Consult all the other certificates obtained by SOLTEC