Audit of the quality management system (QMS) is the main and the most frequently used route of passing the conformity assessment procedure of medical devices regardless of their classification.
After passing the conformity assessment through audit of manufacturing sites with the involvement of the conformity assessment body, a certificate of conformity of the implemented QMS for the production of medical devices with the requirements of the Technical Regulations for a period of 5 years is issued. To obtain the mentioned certificate you need:
It is important to note that during the validity of the certificate of conformity issued as a result of the procedure through the audit, it is necessary to conduct surveillance audits that, in accordance with the requirements of 220.127.116.11 DSTU ISO/IEC 17021-1:2015 should be carried out annually. Manufacturer have to inform conformity assessment body on each planned significant change in the QMS or in the scope of the certificate of conformity (product list, list of sites/facilities). The decision on the necessary actions to approve such changes is made by the conformity assessment body on the basis of the analysis of the submitted information.
The Ukrainian Scientific Institute of Certification conducts the conformity assessment procedure through the QMS audit procedure, relying solely on the obtained objective evidence and being completely independent and impartial in its decisions, fulfilling all aspects of Ukrainian legislation and guided by EU legislation. We have the best knowledge and experience in Ukraine for carrying out such a procedure and we carry out expert examination of documents and conduct audits in English, German, Ukrainian and Russian.
In order to receive individual information, you can contact us by phone at +38 (044) 227-41-46 or write to email@example.com
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