Fermentas was the first restriction enzyme manufacturer that implemented the ISO9001 quality management system in 1996.

In 2008, Fermentas became the first molecular biology company to manufacture in class D clean-room facilities qualified and certified according to EU directives and ISPE guidelines.

Fermentas quality assurance is carried out according to ISO9001 quality and ISO14001 environmental management systems, guaranteeing batch-to-batch reproducibility.

Manufacturing in Class D cleanroom facilities together with ISO9001 and ISO14001 management systems guarantees lot-to-lot consistency.

In 2010, Company has obtained and maintains ISO13485 certification covering the following activities: Research and Developement, Manufacturing and Sales of in vitro diagnostic medical devices.

ISO9001 – quality management system Download PDF (467 KB)	ISO14001 – environmental management system Download PDF (476 KB)
ISO13485 – quality management system Download PDF (2351 KB)	ISO13485 – quality management system Download PDF (1135 KB)
ISO13485 – quality management system Download PDF (1043 KB)