Bul. Patrijarha Dimitrija 24, 11090 Belgrade

Quality & Certifications

Certified Management Systems

Hygienx DOO operates an integrated management system certified against four international standards, covering the production and trade of in vitro diagnostic medical devices (vacuum blood collection tubes). All four certificates are issued by StandCert d.o.o., Belgrade, a body accredited by the Accreditation Body of Serbia (ATS) under ISO/IEC 17021‑1 and a member of the IAF Multilateral Recognition Arrangement.

ISO 9001:2015

Quality Management System

Our systematic approach to process control, product consistency and customer satisfaction across every stage of manufacturing.

ISO 14001:2015

Environmental Management System

Our commitment to responsible resource use, waste reduction and continuous improvement of environmental performance.

ISO 45001:2018

Occupational Health & Safety Management System

A structured approach to hazard prevention and risk management that keeps our production floor safe for every employee.

ISO/IEC 27001:2022

Information Security Management System

Protects the confidentiality, integrity and availability of information assets, including product design data and customer records. Statement of Applicability issued 10 Jun 2026.

Certification scope: Production and trade of in vitro diagnostic medical devices (vacuum blood collection tubes). Certification remains valid subject to satisfactory completion of scheduled surveillance audits. These certificates apply to Hygienx DOO’s management systems and do not, by themselves, constitute certification of individual products.