Ukrainian Scientific Institute of Certification

QMS Audit

13/08/2018

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:

  • Appoint Authorized representative of manufacturer on the territory of Ukraine, perform all legal formalities associated with this;
  • Draw up a Technical file in accordance with the requirements of the relevant regulations and related legislation;
  • Submit an Application and an accompanying dossier of documentation for the procedure, which also depends on the classification of the product, to the designated conformity assessment body;
  • Complete the procedure of documents examination (stage 1), respond to comments (if any);
  • Accept the objects, dates and the production audit plan (the 2nd stage of audit);
  • Organize a visit of auditors to the production site(s) (minimum 2 persons);
  • Eliminate the inconsistencies detected at the second stage of audit (if applicable);
  • Receive a report on the conducted audit and a certificate of conformity of the implemented QMS for the production of medical devices to the requirements of the Technical Regulations from the conformity assessment body;
  • Draw up Declaration of conformity to Technical regulation requirements;
  • Affix conformity mark and identification number of conformity assessment body on the label and instruction for use of medical device.

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 9.1.3.3 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 office@uni-cert.ua

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