Update of ISO 13485:2016 Certificate
16.04.202096

VD MAIS has successfully passed an external audit to update the certificate of compliance with ISO 13485:2016 standard. The standard defines QMS for manufacturers of medical devices and the parts.

Обновлен сертификат ISO 13485:2016

First ISO 13485:2003 certificate was obtained by VD MAIS in 2016, the company became the first and the only Ukrainian contract manufacturer of PCBAs certified in accordance to the requirements of the standard. In 2017, the firm’s QMS was certified for compliance with the updated ISO 13485:2016 standard.

In accordance to the requirements of the standard VD MAIS is regularly audited to extend certification terms. The current audit was provided on March 23-25, 2020 by the accredited organization Quality Austria – Trainings, Zertifizierungs und Begutachtungs GmbH from Vienna, Austria. The certificate received is valid until the end of September, 2023. The following activities are among the certified ones: contract manufacturing of electronic modules, supply of electronic components and systems, printed circuit boards, measuring equipment, equipment and materials for manufacturing, as well as the servicing of electronic modules, measuring and production equipment.

The Scientific-and-Production Firm VD MAIS pays paramount attention to the continuous improvement of the firm’s QMS. Compliance to the requirements of ISO standards correlates the market strategy of VD MAIS as a leading contract manufacturer of electronic products for various industries. Accredited bodies externally audited the firm’s QMS: DEKRA Certification GmbH, Stuttgart, Germany and its branch DEKRA Certification Sp.z.o., Wroclaw, Poland, and Quality AustriaTrainings, Zertifizierungs und Begutachtungs GmbH from Vienna, QMS of VD MAIS is certified according to ISO 13485, IATF 16949, ISO 9001 and ISO 14001.


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