The essence of competence

Of course, DNA and RNA analyses should be inexpensive and performed with state-of-the-art technologies.

Nevertheless, the quality of the work is at least equally important. It is essential that testing is conducted by trained personnel without any delays and that results are 100% reliable. The steps required to produce these results should be fully traceable. Moreover, documented compliance with international quality standards may be needed. This requires competence. We can proudly say that multiple bodies, including the Dutch Accreditation Council (RvA), have endorsed our competence in genome and transcriptome analysis. In consecutive years, customers have rated our service with an average score of 8.5 or higher.

Quality options at GenomeScan

For many preclinical and clinical analyses, the minimal laboratory quality level is legally determined. The legal regulations also apply to subcontracted work. The referral lab must (or may) perform the study under OECD GLP, GCLP, ISO/IEC 17025, or ISO 15189. Hence, GenomeScan asks its customers to indicate which of the following options applies:

ISO/IEC 17025

GenomeScan has ISO/IEC 17025 accreditation for all its NGS services (RvA No.: L518) and may therefore perform NGS studies, DNA methylation assays and genotyping under the scope of this accreditation. The ISO/IEC 17025 criteria guarantee a level of quality assurance that is equal (and sometimes superior) to GLP. ISO/IEC 17025 is also the preferred quality level for GMP (Good Manufacturing Practice). The Dutch Accreditation Council (RvA) monitors the ISO/IEC 17025 compliance of GenomeScan and performs annual audits on site.

ISO 15189

This is an accreditation standard specially designed for diagnostic work on patient material. GenomeScan has obtained ISO 15189 accreditation in March 2019 and is now allowed to autonomously perform diagnostic testing (RvA No.: M308). The Dutch Accreditation Council (RvA) monitors the ISO 15189 compliance annually. Both ISO/IEC 17025 and ISO 15189 are widely considered as suitable quality assurance levels for subcontracted diagnostic tests. For IVDR performance studies (EU Regulation 2017/746), a QMS-based quality assurance (e.g. ISO 15189 or ISO/IEC 17025) is considered most appropriate.

OECD GLP

The GLP (Good Laboratory Practice) regulations require that “Regulatory studies” (studies performed to demonstrate safety or properties of a chemical or biological substance, and which are intended for submission to a regulatory authority)[1] must be conducted in compliance with the principles of OECD GLP. All studies qualified as Regulatory Study are reported to the national GLP compliance monitoring authority (The Dutch “Health and Youth Care Inspectorate (IGJ)”). OECD GLP and ISO/IEC 17025 are complementary guidelines that may both apply to the same project.

We do offer many flavors of quality, but ‘no-quality’ is never an option!

Accreditation certificates

  • ISO/IEC 17025:2005 accreditation certificate for download
  • The L518 scope of the ISO/IEC 17025 accreditation
  • ISO 15189:2012 accreditation certificate for download
  • The M308 scope of the ISO 15189 accreditation

Let’s get the conversation started for your next NGS project.

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