DE

ISO 9001:2008

DIN EN ISO 9001:2008 - a globally recognised standard.

Our quality management system is certified in accordance with the DIN EN ISO 9001:2008 standard. Recognised in over 130 countries, this global standard establishes the general requirements for quality management systems. In so doing, it covers all steps in the process, such as the design, development, production, installation and maintenance of products or services, as well as quality management itself.

DIN EN ISO 9001:2008 is a process-oriented standard which supports seamless project management.

The standard describes present conditions at our company in detail and makes processes transparent for business partners.

ISO 13485:2003 + AC:2007 for medical products

Since late 2009, our quality management system has also been certified for medical products in accordance with DIN EN ISO 13485:2003 + AC:2007. This standard extends ISO-9001 quality management system to include special requirements for the manufacture of medical products.

An important element of ISO 13485 is the risk management section. It serves to promptly identify risks potentially caused by the medical product or the processes used, thereby ensuring that such risks are eliminated in the development phase and in later product life stages.

Our ISO certificates

medical All-In-One Computer

provides maximum flexibility for OR integration

Medical keyboard and mouse

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 |  Last Update: 05.02.2015 10:38