Diagnosis, prevention, medicine

Quality Management System

The high procedures discipline, control system established at all manufacturing stages, detailed coordination in all manufacturing process, marketing and after-sales service allowed us to introduce and certify the quality management system (QMS) in accordance to ISO 9001:2004 Standard (2001).

Later, Bureau Veritas Quality International recertified the QMS in accordance to ISO 9001:2000 Standard (certificate #154268 from 04.05.2004).

In 2006 JSC "Diaproph-Med" certified the QMS in accordance to ISO 13485:2003, which is related to additional requirements for manufacturers for in vitro diagnostic devices (certificate).

In 2012  JSC "Diaproph-Med" certified the QMS in accordance to DSTU ISO 13485:2005 (certificate 'UkrSEPRO’, certificate SE «Ukrmetrteststandard»).

In 2016 JSC "Diaproph-Med" recertified the QMS in accordance to EN ISO 13485:2012 + AC:2012 (certificate #D1159700002).

In 2017 JSC "Diaproph-Med" recertified the QMS in accordance to ДСТУ EN ISO 13485:2015 (certificate No.:UA.C.218-17).

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COMPANY MAIN GOALS ARE:

To ensure safety, sustained high quality of our products in accordance with consumer's expectations, established and legislative requirements.

To retain and consolidate leadership on the market and to achieve a positive self-image in new markets by product expansion, high quality of products, customer's requirements realization, technical support improvement.

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