The presence of a certified Quality Management System (QMS) provides the company with a number of advantages:
A company certification involves an audit of the QMS documentation and manufacturing sites. On the basis of the audit conclusion, a QMS certificate is granted for a period of 3 years.
The UNI-CERT LLC is accredited for certification of management systems according to standards:
We also offer certification of management systems in the voluntary sphere in the following areas:
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 according to 9001
QMS certification according to ISO 9001 for health care institutions
QMS certification according to ISO 13485
QMS certification according to ISO 14001
QMS certification according to ISO 15189
QMS certification according to ISO 22000
QMS certification according to ISO 45001
Application form (download)
Since 1 July 2015, it has been a mandatory requirement that medical devices, before being placed on the Ukrainian market and/or put into service, must be subject to the assessment of conformity with the Technical regulations (TR) (approved by Resolutions No. 753, 754, 755 of the CMU of 2 October 2013). Clause 21 of Resolution No. […]
Read moreThe National Accreditation Agency of Ukraine confirmed the technical competence of the UNI-CERT Testing Laboratory against DSTU ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories (ISO/IEC 17025:2017, IDT) with an Accreditation certificate No. 201394 dated 20 April 2021). The laboratory’s scope of activities covers the testing of the following products: medical devices, namely […]
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