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Home » Clinical Trials » Think accreditation and have confidence in the reliability of health, safety and environmental services

Rosemary Hayden

Manager, Irish National Accreditation Board (INAB)

Accreditation is the independent assessment of conformity assessment bodies (CABs) to ensure their independence, impartiality and competence to carry out conformity assessment tasks.

The Irish National Accreditation Board (INAB) is the national body with responsibility for accreditation in Ireland. It accredits medical and testing laboratories, biobanks, certification/verification/inspection bodies and reference material producers. It provides accreditation in accordance with the relevant International Organisation for Standardisation ISO 17000 series of standards.

Accreditation for medical laboratories

INAB provides laboratory accreditation for medical laboratories to  ISO 15189:2012 or ISO 15189:2022 Medical Laboratories – Requirements for Quality and Competence’. This standard incorporates essential elements for medical laboratories; in particular, focusing on patient and clinical personnel needs.

It addresses specific 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 a medical laboratory service to patient care.

Legislation (S.I. 360 of 2005) requires blood bank laboratories to operate to  ISO 15189. These laboratories must also comply with additional requirements relating to blood traceability and haemovigilance.

Accreditation for biobanks

Accreditation of biobanks to the standard ISO 20387:2018 ‘Biotechnology – Biobanking – general requirements for biobanks’ is available. This standard applies to all organisations performing biobanking, including biobanking of biological material from multicellular organisms (eg. human, animal, fungus and plant) and microorganisms for research and development.

This standard incorporates essential elements
for medical laboratories in particular focusing
on patient and clinical personnel needs.

How and why accreditation can help your business

  • Test results are accepted worldwide.
  • It ensures public confidence in the reliability of activities that impact health, welfare, security and the environment. Accreditation is used to identify bodies competent for the implementation of government policies and regulations.
  • It is a tool for decision-making and risk management.
  • It offers consumer confidence by ensuring consistently high-quality and safety standards of products or services purchased.

Manager Rosemary Hayden encourages policymakers to include accreditation as a requirement for policy implementation and advocates that accredited services are considered in the awarding of tenders and funding grants.

Be part of a team of technical assessors/experts

Are you a medical professional looking to expand your knowledge of ISO 15189:2022? INAB is recruiting for technical assessors/experts as follows:

  • Consultant pathologists in the areas of blood transfusion, andrology, assisted reproduction, chemical pathology, genetics, haematology, histopathology and cytopathology, immunology and microbiology and virology.
  • Experienced medical scientists in the disciplines of assisted reproduction, chemical pathology, genetics, immunology and microbiology and virology.

For more information on becoming an assessor, log on to
If interested, please email [email protected] with ‘Assessor expression of interest’.

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