about us

The Ukrainian Scientific Institute of Certification was founded in 2010. The Institute specialized in examination of registration documents on medicinal products and medical devices, including the assessment of the conformity of technical files with the requirements of the European legislation.

In 2015, when the technical regulations on medical devices became mandatory, the Institute management, having taken into account the qualification and knowledge of its employees, decided to extend its scope of activities and to obtain from the Ministry of Economic Development and Trade of Ukraine appointment to carry out the assessment of devices conformity with the requirements of the Ukrainian legislation.

In accordance with the accreditation certificate No. 80103 of 02.09.2020 and the scope of accreditation, UNI-CERT LLC is authorized to conduct activity on the certification of quality management systems (QMS) according to the following standards:

  • ДСТУ EN ISO 9001:2018 Системи управління якістю. Вимоги (EN ISO 9001:2015, IDT; ISO 9001:2015, IDT); ДСТУ EN ISO 9001:2015 Системи управління якістю. Вимоги (ISO 9001:2015, IDT); ISO 9001:2015 Quality management systems – Requirements;
  • ДСТУ ISO 22000:2019 «Системи управління безпечністю харчових продуктів. Вимоги до будь-якої організації в харчовому ланцюгу» (ІSО 22000:2018, IDТ); ISO 22000:2018 Food safety management systems – Requirements for any organization in the food chain; ДСТУ ISO 22000:2007 Системи управління безпечністю харчових продуктів. Вимоги до будь-яких організацій харчового ланцюга (ІSО 22000:2005, IDТ); ISO 22000:2005 Food safety management systems – Requirements for any organization in the food chain;
  • ДСТУ EN ISO 13485:2018 Вироби медичні. Система управління якістю. Вимоги до регулювання (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT); ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.

 

In accordance with the accreditation certificate No. 1O302 of 04.09.2020 and the scope of accreditation, UNI-CERT LLC carries out activity to assess the conformity of products in the following areas:

  • medical devices;
  • medical devices for in vitro diagnostics;
  • individual protection means.

 

The accumulated experience, qualification and knowledge of our employees and an effective management system (MS) in place make us competent and ready to address the issues relating to conformity assessment, including the certification of products and quality management systems. In addition, our employees are well-versed in the Ukrainian and international legislation, including regulations in the original language.

We would be happy to answer your questions, please contact us.

OUR PRINCIPLES
Independence

The notified body is independent and impartial; its decisions are based solely on objective evidence of conformity.

Competence

The personnel involved in the conformity assessment process are equipped with appropriate qualification, expertise and professional experience.

Confidentiality

The notified body observes confidentiality of any proprietary information of the client.

Openness

The notified body provides the interested parties with access to information about its audit process, conformity assessment, its status, and to non-confidential information about the conclusions of specific conformity assessments.

Responsiveness to complaints

The notified body ensures that each and every complaint is handled in accordance with the established procedures, thus protecting its clients and applicants against errors.

Responsibility

The responsibility for conformity with the requirements rests with the client. The notified body has the responsibility to carry out the unbiased assessment of evidence of conformity.

Any assessment is based on sampling within a quality management system and therefore is not a guarantee of 100% conformity with requirements.

our team