Turck duotec S.A. successfully certified in EN ISO 13485:2012 standard
Turck duotec S.A., based in Delémont, Switzerland, has been successfully certified in accordance with the EN ISO 13485:2012 standard by optimising its quality management system for medical products.
This certification demonstrates that Turck duotec S.A. fulfils the continuously increasing quality standards of the industry. The certification has become essential for companies that are in the business of developing and manufacturing medical products.
“Customers in the medical technology industry have a particularly strict set of quality and safety requirements when it comes to manufacturing their products and product components. These requirements concern the risks of potential impurities arising during production processes, for example. It is important here that we can map the quality of the solutions that we offer,” says Victor Callegari, Director Business Development.
The issue of quality management has already been of great importance for Turck duotec S.A. for some time now. The company recently became the first Swiss company to be certified in accordance with the new ISO 9001:2015 standard in October 2015.
The EN ISO 13485 standard defines the harmonised regulatory requirements for quality management systems used by medical product manufacturers. The standard is internationally recognised and sets guidelines for the construction, development, production, installation, maintenance and distribution of medical products. Its principal objective is to ensure the compliance and improvement of the quality of products and services. The EN ISO 13485 standard is largely based on the structure of the DIN EN ISO 9001 standard, but it includes several new requirements that are specific to the medical product industry – regarding risk management, traceability, sterile production conditions and recalls, for example