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 ISO15189. Hence, GenomeScan asks its customers to indicate which of the following options applies:
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.
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.
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) 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.
For clinical trials, it is necessary to perform the study in compliance with GCLP (Good Clinical Laboratory Practice) guidelines. GenomeScan maintains compliance with WHO GCLP guidelines and the ‘EMA Reflection paper’ (EMA 2012). GCLP may be combined with ISO/IEC 17025 assurance under the scope of accreditation.
Below, a decision tree is provided, which helps to find the optimal quality format. Please do not hesitate to contact GenomeScan if you have questions on the quality of our services, the GenomeScan quality management system or the applicable quality regulations (firstname.lastname@example.org).
We do offer many flavors of quality, but ‘no-quality’ is never an option!
- 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
 A study is defined as a “Regulatory study” if these 3 requirements are fulfilled:
- The study involves a non-clinical experiment or set of non-clinical experiments in which an item is examined in order to obtain data on its properties or safety (or both) with respect to human health, animal health or the environment;
- The results of the study are, or are intended, for submission to the appropriate regulatory authorities; and;
- Compliance with the OECD GLP principles is required by the appropriate regulatory authorities.