Our top preparedness for the current crisis and provision of high-quality supplies of medical devices confirmed by an international certification company

Our top preparedness for the current crisis and provision of high-quality supplies of medical devices confirmed by an international certification company

In the previous days, two audits aimed at ISO 9001, 14001, 45001 and ISO 13485 have been carried out in ZAT by the DNV GL certification company that specializes in global provision of quality and risk management.

Control Management

The audit aimed at verifying compliance with the requirements of standard ISO 9001, 14001 and 45001 related to checking the company’s Integrated Management System (IMS). IMS is an internationally standardized system targeted at continuous development of a company, particularly of its organization, process management, environmental protection and occupational safety. The audit also focused on the approach of the company in handling the current COVID-19-related situation. The auditors highly appreciated preparedness of ZAT for the arisen circumstances, its developed crisis scenarios as well as willingness to use the experience obtained for further company’s development and strengthening its stable market position.  

The auditors ranked ZAT among the best prepared companies in the market handling well the coronavirus crisis. They mainly appreciated timely introduced and efficient measures for the protection of employees not only health wise but also in terms of maintaining employment and all positions within the company. Efficient use of electronic documentation as well as overall use of SW tools and their online functions were also highly evaluated,” added Mr. Petr Kolečkář, Quality Manager and Deputy Director - Services Department of ZAT.  

Medical Devices

The second audit aimed at verifying compliance with the requirements of standard ISO 13485, in other words at the company management system for providing high-quality supplies of medical devices as well as at the CE mark of the StimSmart therapeutic device produced and supplied by ZAT.
Even this audit was a very successful one, no shortcomings were detected in none of the audited parts. Our company proved once again its competences for this specific field that can be used not only within the Medical and Industrial Electronics divisions,“ adds Petr Kolečkář.

With respect to the current situation as well as to the fact that some of the auditors come from abroad, the audits were carried out remotely using the MS Teams tool.