The limited liability company Uni-CERT is accredited for certification of quality management systems (QMS) in accordance with the following standards:
A certified QMS provides the company with a range of advantages, namely:
As a result of changes in the legislation applicable to medical devices, a new requirement the domestic manufacturers have to face is that a QMS must be in place in accordance with DSTU ISO 13485. This standard can be applied by organisations engaged in the design, development, production, installation and servicing of medical devices.
A company certification involves an audit of the QMS documentation and of the manufacturing site. On the basis of the audit conclusion, a QMS certificate is granted for a period of 3 years.
The procedure for certification of a quality management system, from the submission of an application until the issuance of a certificate, is shown below:
QMS certification procedure
Application form (download)