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TECHTO production has passed ISO 9001 and ISO 13485
19. Oct 2022
Update

TECHTO production has passed ISO 9001 and ISO 13485

 

TECHTO production has passed ISO 9001 and ISO 13485 audit with positive result Our electronics manufacturing division – TECHTO Electronics – is growing steadily with more customers being added.

Next year we expect to start up a large international customer with medical device products, and we have therefore been working intensively since October 2021 to obtain ISO 13485 approval in parallel to the ISO 9001 approval, that was already planned.

The work has been continued, despite the war that started, when we were well into the first part of the project. In May, RINA was selected as the certificating body to do the external audit, and it all culminated with the external audit during a full week in September.

We have now received confirmation from RINA, that the result of the audit was positive. We can expect the certificate and final approval within the next 1-2 months.

Here you can see Natalia with our QA engineer Oleksandr and QA inspection Alina

 

The work to build our QA system towards ISO 13485 was really speeding up in January with our QA manager Natalia starting in TECHTO Electronics. Natalia has a background from the machine industry and food industry, always working with quality assurance and audit of QA systems. Some of our customers have already been in touch with Natalia on QA related matters. More will have the pleasure as Natalia is the contact person on requests regarding QA system and cases.

See video with Jesper Holst and Nathalia Hudyma talking about the audit and the work around our certification in the days after the audit