Quality standards
Services according to international quality standards
We set high quality standards forour services and products. As our partner, you can rely on the application of international quality standards right from placing your orders up to delivery of the final product / service.
We operate according to the following guidelines:
- EN ISO 9001:2008
- EN ISO 13485
- GLP
The key factors in our QM systems are:
- regular training of personnel
- qualification and maintenance of quality-relevant laboratory equipment
- validation of analytical methods according to international guidelines
- traceability of sample and data management
- long-term archiving of documents
- risk management
- deviation management
- change control
- CAPA
Our customers are welcome to assess our facilities and their quality standards on-site any time.
EN ISO 13485
Since November 2009 the departement Biomedical Technologies and Monitoring has been certified according to EN ISO 13485:2003. Several medical products have been developed and CE certified since then:
- the dermal OFM probe
- the OFM pump and
- OFM supplementary tools
The implementation of the complete quality management system for medical devices represents a major milestone for our institute.
GLP - Good Laboratory Practice
Our analytical laboratory is GLP-certified. Our group "Bioanalysis and Metabolomics" develops analytical methods and validates methods for research projects as well as for contract services. We focus on full traceability of the analysis.
Based on the QM system of JOANNEUM RESEARCH's EN ISO 9001:2008, the additional compliance with the OECD GLP principles is the prerequisite for documented traceability and maintenance of the high laboratory quality standards.
