About the company

Production and Quality

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Production and Quality

PRODUCTION

The tradition pertaining to manufacturing of diagnostic products 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 - diagnostic strips, microbiology kits and immunodiagnostic kits.

A new diagnostic product manufacturing plant was put in operation in 1986 (in 2003 the plant was subject to extensive refurbishment and modernization). The principal objective of modernization of the production facilities was ensuring of compliance with the demanding conditions stipulated in the EU legislation in connection with manufacturing of diagnostic products.

The production process is performed using modern blenders, homogenizers, lyophilizers, adjusting devices and packaging machines. The quality of production is ensured on the basis of implementation of the respective quality assurance system (ISO 9001:2008 certified by Lloyd Registered Quality Assurance) and ISO 13485.

The product portfolio of  Erba Lachema comprises more than 400 products to be used in clinical biochemistry, haematology and microbiology laboratories as well as in surgeries and for self-testing purposes.

QUALITY
Succes is imposible without ensuring of quality

Erba Lachema successfully passed the certification audit against the ISO 13485:2003 quality management system for medical devices including in vitro diagnostics. The certification audit was carried out by Lloyd's Register Quality Assurance, a leading international certification body.

The principal objective of Erba Lachema s.r.o. is to manufacture high-quality products and render services in a manner ensuring optimum fulfilment of the requirements and needs of the existing as well as prospective customers.
The company has managed to reach the aforementioned objective by the means of implementation and continuous improvement of the quality management system that currently proves to be a comprehensive system comprising:

  • Certified quality management system (in compliance with the ISO 9001 and ISO 13485 standards) featuring a procedural approach to the field of quality management, i.e. express identification of the processes, their mapping and descripttion, specification of AORs, determination of boundaries and interrelation of the processes as well as specification of the process criteria;
  • System documenting compliance with the EU Directive no. 98/79 (EC) that focuses on quality of specific products and ensures labelling of products using the CE logo

Quality Policy

  • We manufacture high-quality, safe and efficient products;
  • Customers may always rely on the quality, safety and efficiency of our products;
  • We meet the requirements and expectations of our customers and increase the level of  their satisfaction;
  • We improve the relations with our contractors and customers and make our contractors an integral part of the process of continuous improvement of the quality of our products;
  • Training and professional skills are the primary value of our employees.

Downloadable documents

Quality certificate:

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