ISO/IEC 17025 for proven excellence
The ISO/IEC 17025 (L518) accreditation is an international standard for laboratory excellence. It is awarded for laboratories that show proven competency and accuracy. Reaching this level of competence has asked much effort from all our employees but has been instrumental for our high customer satisfaction rate.
Our customers use our data to diagnose patients, to develop new pharmaceuticals or for crop improvement. The R&D and diagnostic communities depend on our constant and high data-quality. Regular internal and external audits show that all our workflows are set up such that even small non-conformances are detected immediately. Due to the traceability of all our actions, we work closely with technology providers such as Illumina and Roche to signal and solve global technical and reagent issues.
All our current Next Generation Sequencing (NGS) and methylation micro-array services are ISO/IEC 17025 (L518) accredited. The exact scope of our accreditation can be found on www.rva.nl/en (L518). You can recognize ISO 17025 accredited services by the RVA logo (Dutch for: Board of Accreditation) depicted on your quotation.
Before becoming a new service, all innovations must be tested with customer samples after extensive internal validation. These R&D projects fall outside of our ISO scope. This will be discussed with you well before the start of your R&D project. Of course these innovative research projects are treated with the same care as projects performed under the scope.
The clinical interpretation service is currently outside the ISO 17025 scope
At present, clinical interpretation (determining a diagnosis) is performed by external specialists of carefully selected partners such as the Leiden University Medical Centre (LUMC), Erasmus Medical Centre (EMC) and Diploid. This allows us to work with the best medical specialists from very diverse fields of expertise.
Our medical partners operate according to the accreditation of their own department such as ISO/IEC 15189. The clinical interpretation of the data falls outside the direct control of our Quality Management System and therefore we can not claim full responsibility and thus accreditation for this part of our service. For diagnostic projects, only data generation and analysis (as offered under the names ‘Data’ (FASTQ files) and ‘+Analysis’ packages (VCF files)) are performed under the GenomeScan ISO 17025 (L518) scope. When accreditation for the clinical interpretation is relevant for you, we establish a direct company-client relationship between you and the Medical Centres. This ensures that the whole workflow is ISO/IEC 15189 accredited.