Production and Quality

Success is impossible without ensuring of quality

 

The tradition pertaining to manufacturing of diagnostic products in our company reaches as far as to the year 1967 when the first clinical biochemistry kits were manufactured. The scope of the production activities was gradually extended by other product groups - urine diagnostic strips, microbiology kits and immunodiagnostic kits.
 

Erba Lachema s.r.o. became part of Erba group in 2009 which enlarged our portfolio by coagulation, hematology and diabetes product groups and gave us great worldwide expansion opportunity and support of strong medical device company.

New manufacturing program of diagnostic instruments production implemented in 2019 gave us opportunity to deliver to our customers full systems consisting of reagents and analyzers.
 

Current product portfolio of Erba Lachema comprises more than 400 reagents, controls, calibrators, consumables and diagnostic instruments to be used in clinical biochemistry, hematology and microbiology laboratories as well as in surgeries and for self-testing purposes.
 

Our main mission in Erba Lachema s.r.o. is to provide quality products and solutions which are reliable, accurate and affordable in a manner ensuring optimal fulfilment of the requirements and needs of the existing as well as prospective customers.
 

We have managed to reach this objective by implementation and continuous improvement of the Quality management system which has been ISO certified since 1998. Current Quality system ensures full compliance with ISO13485:2016 standard requirements as well as with EU Directive no.2017/746 IVDR for in-vitro medical devices certified by BSI certification company.

 

QUALITY POLICY
 

Erba Lachema s.r.o. is the producer of high-quality, safe, effective and user-friendly         in vitro medical devices in full compliance with legislation requirements and continuous improvement of implemented Quality management system. Erba Lachema relies on the education and technical erudition of its employees to constantly improve its relationships with customers.