Certifications

Our Quality Management System precisely defines our operational processes, their sequences, and interactions. It manages the conditions and methods required for effective operation in a predetermined manner. It continually monitors the availability of resources and information. Last but not least, it comprehensively measures, analyzes, and documents the processes.

 

ISO 14001 is part of the ISO 14000 series of standards dealing with Environmental Management Systems (EMS). It was created to ensure that a company's activities and processes: (a) Minimize their negative impact on the environment (e.g., adverse effects on air, land, and water); (b) Comply with applicable laws, regulations, and other environmental requirements; and (c) Continuously improve in these areas.

​

​

​

ISO 13485 is a comprehensive quality management system for the design and manufacture of medical devices. The latest version of the standard, released on March 1, 2016, supersedes previous documents such as EN 46001 and EN 46002, as well as the earlier versions of ISO 13485 and ISO 13488. It provides a framework to ensure the quality and safety of medical devices throughout their lifecycle.

​

​