qmt is now ISO9001 and ISO13485 certified in Switzerland and France

03.11.2020

qmt is now ISO9001 and ISO13485 certified in Switzerland and France

qmt certifies its organization in Switzerland and France

ISO9001 and ISO13485 for all of qmt

A success that concludes the integration work qmt started in January 2020

qmt announced on January 9, 2020 the integration of Qualimatest and SAPHIR to create qmt . Since that date the entire qmt team has been involved in implementing this integration. We are pleased to announce that this work has ended with the passing of ISO9001 and ISO13485 certifications for all of qmt (recertification of QMT SUISSE SA and new certification of QMT FRANCE SAS).

We now have a single organization deployed on two sites in Switzerland and France. We can carry out projects in compliance with ISO9001 quality standards and ISO13485 medical standards for both Swiss and French customers.

Creation of qmt

ISO13485

ISO 9001 and 13485: the 2 certified qmt sites!

I am very proud to announce that our two sites QMT France and QMT Switzerland have brilliantly obtained ISO 9001 and ISO 13485 certification.

These certifications are the result of several months of intense work by the teams in order to improve our qmt management system. This period was punctuated by questions, discussions, questioning, sometimes disagreements, but always the desire to do well.

The result is a solid base which will allow us to continue to progress by relying on the 7 principles of ISO9001 to which I fully adhere: customer orientation, management responsibility, staff involvement, 'process approach, continuous improvement, evidence-based decision making and relationship management with interested parties.

However, let us keep in mind that our certified management system is not an end in itself, but a means which should allow us to bring more value and quality to our customers.

Well done to the qmt team!

Ludovic Bazin
Director France

ISO13485 certification

Quality management system specific to the medical devices sector

Regulations impose increasingly stringent requirements at every stage of a product's lifecycle, including service and delivery. Organizations must be able to demonstrate the effectiveness of their quality management processes and implement best practices in all of their activities. ISO 13485, an internationally recognized standard, establishes the requirements for a quality management system specific to the medical devices sector
More information on the ISO website

qmt demonstrates, through its ISO13485 certification, recognized expertise in the development and implementation of quality control systems for the medical sector. The requirements of ISO 13485 apply to companies designing control systems for use in medical devices. All along the value chain, qmt products are designed, developed and manufactured with the aim of being safer and more efficient. Particular rigor is applied to the traceability and risk analysis of vision systems intended for the medical sector. The risk analysis is integrated into the risk management file of the product object. The formal validation of the software according to GAMP (Good Automated Manufacturing Practice) or other must be detailed and transmitted.