Dáil Éireann Debate, Tuesday - 1 July 2025
303. Deputy Aengus Ó Snodaigh asked the Minister for Enterprise, Tourism and Employment the reason the Irish National Accreditation Board does not give accreditation for full genome testing, as in other EU member states, rather than giving accreditation on a condition-by-condition basis. [35885/25]
View answerThe Irish National Accreditation Board (INAB) offers accreditation for whole genome sequencing to one of two standards – either EN ISO/IEC 17025:2017 (non-medical testing and calibration) or EN ISO 15189:2022 (medical testing).
The requirements are outlined in the INAB policy document, ‘Policy for the accreditation of Whole Genome sequencing (WGS) and Next Generation sequencing (NGS) techniques’, which is available on the INAB website: www.inab.ie/inab-documents/mandatory-policy/policy-for-the-accreditation-of-whole-genome-sequencing-wgs-and-next-generation-sequencing-ngs-techniques.pdf
The medical laboratory’s competence to advise service users on interpretation of their test results is a key component of the standard, EN ISO 15189:2022. Therefore, accreditation is normally limited to a certain set of tests, to specific medical conditions, or to a list of targets. The provision of flexible scope of accreditation for laboratories is not mandatory and the degree of flexibility afforded by National Accreditation Bodies (NABs) to accredited laboratories varies across Europe.
European Cooperation for Accreditation (EA) policy sets out the requirements for, and risks to be considered by, NABs which wish to provide flexible scopes to their accredited laboratories. The INAB policy on flexible scope for EN ISO/IEC 17025:2017 and EN ISO 15189:2022 testing laboratories is available on the INAB website at: www.inab.ie/inab-documents/mandatory-policy/flexible-scope-of-accreditation-for-iso-17025-and-iso-15189-testing-laboratories-.pdf
The field of genetic testing is constantly evolving and a guidance document is being developed at European level by the European Cooperation for Accreditation (EA). An INAB representative sits on this working group and INAB policies regarding this field of testing are currently under review.
