Annual Report 2009/2010 Geschäftsbericht 2009/2010 ... - biolitec AG

44 Management Report Konzernlagebericht
Production
Our competence is highlighted by our long-standing experience in manufacturing of products for
medtech and biomedical purposes that require highest safety and quality standards. Due to the optimized
teamwork between the different departments such as purchasing, quality management and production
we are able to manufacture specialised products with short lead times.
The company implemented a number of measures to reduce transit times in order to increase operational
efficiency and reduce stocks.
Enhanced usage of the Microsoft Axapta program within the company’s structure as well as design and
workflow changes for the medical products in particular show a major increase in efficiency and workflow
management.
The company has its key production facilities in Germany, US and Latvia and delivers goods all over the
world from these locations.
All production and quality control facilities meet current standards.
Environmental and Quality Management
biolitec’s quality management is annually certified by DQS GmbH (German Society for Certification of
Management Systems) in accordance to DIN EN ISO 13485:2003 and DIN EN ISO 9001:2000 standard. In
accordance with the European Union Directive on medical devices (Annex II of Directive 93/42/EEC)
biolitec is entitled to use the CE label for products brought into use within the European Union. The
quality management system of the American subsidiaries complies with the requirements of the US
American Food and Drug Administration (FDA). All further subsidiaries are registered at national authorities
as far as required.
With our innovative medical products, we are committed to people and their health. Therefore, we regularly
evaluate and try to reduce all possible risks associated with our products.
Within the scope of our business activities we consider and comply with all relevant environment protection
directives.
Both production processes and the products of the company do not cause hazard to the environment
directly or indirectly. External inspection authorities regularly audit all production facilities as well as the
laboratories.
Subsidiaries
In the past financial year the founding of subsidiaries in Turkey, Spain and Uzbekistan was prepared.