Quality system

GOST ISO 9001-2015 (ISO 9001: 2015)

To ensure that the company can fulfill the needs and expectations of consumers, LLC NTP TKA has developed, implemented and successfully operates a quality management system that meets the requirements of GOST ISO 9001-2015 (ISO 9001: 2015), which is certified by a  certificate compliance with K No. 012763.

ISO 9001 certification is carried out by an officially accredited third party that verifies the quality assurance system against standards and that the manufacturer has implemented it in good faith. The presence of the ISO 9001 certificate is a significant guarantee that all products supplied by the manufacturer will meet the declared quality.

You can familiarize yourself with the  company’s policy in the field of quality  and send your feedback on the quality of devices, suggestions, comments by writing to  info@tkaspb.ru  – your opinion is important to us.

The quality management system of medical devices is successfully functioning, which complies with the requirements of ISO 13485: 2016, which confirms the  certificate No. 71860 for the following certification area: Design and development, production, sale and maintenance of medical devices for in vitro diagnostics.

We make every effort to further improve the quality management system of LLC NTP TKA so that you can be sure that every device manufactured by our enterprise is of high quality at all stages of its production!

NTP “TKA” products have the following certificates  and declarations: 

Certificates and declarations of conformity,  confirming the compliance of products with all applicable requirements and allowing the sale of products on the territory of Kazakhstan, Armenia and the Republic of Belarus.

Eurasian Conformity (EAC ) is an appeal mark indicating that products labeled with it have passed all the assessment procedures established in the technical regulations of the European Economic Union EurAsEC. This means that it meets the requirements of all technical regulations applicable to this product.

Low Voltage Directive 2014/35 / EU (LVD).
Risk analysis is a new requirement under the LVD directive.
This document is an analysis of emerging risks that need to be considered in design and manufacturing.

Certificate of entry into the Register of Reliable Partners No. NP-SPB-13  –

non-state  register of Russian enterprises and entrepreneurs , the financial and economic situation of which testifies to their business reliability.
On the basis of the Law of the Russian Federation dated 07.07.1993 No. 5340-1 “On Chambers of Commerce and Industry in the Russian Federation”, the Russian Chamber of Commerce and Industry and territorial chambers of commerce and industry maintain a non-state Register of Russian enterprises and entrepreneurs, the financial and economic situation of which is evidenced about their reliability as partners for entrepreneurial activities in the Russian Federation and abroad.

  • official recognition as a reliable business partner with the receipt of the RF CCI Certificate;
  • the possibility of creating a positive image of the enterprise;
  • the ability to obtain reliable economic and financial information about potential partners;
  • the opportunity to adequately represent your company on the international market;
  • information support of the CCI of Russia and the St. Petersburg CCI in printed and electronic editions.

Data on the results of a special assessment of working conditions

April 18, 2018, on the basis of: Federal Law of the Russian Federation N 426-FZ “On a special assessment of working conditions”, order of the Ministry of Labor of Russia No. 33n dated 01.24.2014 “On approval of the Methodology for a special assessment of working conditions, the Classifier of harmful and (or) hazardous production factors, the form of a report on a special assessment of working conditions and instructions for filling it out ”, a special assessment of working conditions was carried out.
Consolidated statement of the results of the SOUT (* .pdf)

List of measures to improve working conditions.
According to the results of the SAWS, workplaces do not need to improve working conditions.