Accreditation of Medical Testing
INAB provides laboratory accreditation for medical laboratories to EN ISO 15189:2012 or EN ISO 15189:2022 “Medical Laboratories – Requirements for Quality and Competence”. The standard is closely based on the general laboratory accreditation standard ISO 17025, but incorporates essential elements for medical laboratories, in particular focusing on patient and clinical personnel needs. It addresses particular issues that include the provision of advisory services to clinicians, collection of patient samples, provision of testing in a medical emergency and the contribution of medical laboratory service to patient care.
Legislation (S.I. 360 of 2005) requires blood bank laboratories to operate to ISO 15189 by November 2008. These laboratories must also comply with additional requirements relating to blood traceability and haemovigilance (notification of serious adverse reactions and events) outlined in the INAB publication AML-BB.
INAB also accredits testing provided at the point of patient care to ISO 15189 in conjunction with ISO 22870 “Point of care testing (POCT) – requirements for quality and competence”.
Medical testing laboratories may also apply for a flexible scope of accreditation, where, under certain conditions, additional tests may be reported as accredited, without involving the extension to scope process. The laboratory shall apply for assessment and award of a flexible scope as outlined in INAB policy PS11.
INAB Accreditation Symbol
The Irish National Accreditation Board strongly mandates accredited organisations to use the accreditation symbol on their reports or certificates.
The accreditation symbol, ownership of which is vested in INAB, is a combination of the Board’s logo in association with the registration number and the accreditation standard. Reference is also made to the organisation’s scope of accreditation.
The use of the symbol is subject to strict criteria laid down in the INAB R1 Regulations.