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)
The main specialization of the UNI-CERT Training Center is the advanced training of quality managers and regulatory managers of suppliers, distributors, manufacturers of medical devices and personal protective equipment. In addition, regular internal training of our own employees is carried out. In addition to the main topics that are in constant demand among most market […]
ДетальнееSince 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. […]
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