ISO 15189 - Accreditation

What Is Accreditation?

Accreditation is a quality infrastructure established to support the reliability and validity of the work carried out by conformity assessment bodies and, therefore, of the conformity certificates they issue as a result of this work (test and inspection reports, calibration certificates, management system certificates, product certificates, personnel certificates, etc.).

The accreditation of conformity assessment bodies is carried out on the basis of globally recognized requirements set out in international standards that define the competence criteria for the relevant conformity assessment bodies, sector-specific requirements, and guidance documents issued by regional or international accreditation bodies.

THE ISO 15189 STANDARD AND US. The ISO 15189 standard was developed by adapting the ISO 17025 and ISO 9001:2000 standards for medical laboratories. The main purpose of ISO 15189 is the accreditation of medical laboratories and ensuring that test results are assured for patients and healthcare personnel.

ISO 15189 sets out the competence and quality requirements specific to medical laboratories. It is recognized that in every country there are particular requirements that can be applied to all or some of the activities of the professional staff working in this field.

The ISO 15189 standard has been established to meet the needs of all patients and of the clinical staff responsible for their care. These services include the arrangement of requests, sample collection, transport, storage, processing and analysis of clinical samples, together with the related validation, interpretation of results, preparation of reports and recommendations, as well as safety and ethical considerations in medical laboratory work. For this reason, being an Accredited Laboratory is a privilege.

Our Accredited Laboratory completed its accreditation work to meet the requirements of the ISO 15189 standard and, as of October 2021, has taken its place among accredited organizations and accredited laboratories. We are the only medical laboratory in Northern Cyprus accredited under ISO 15189, with sites in Nicosia and Kyrenia.

Accredited by the Turkish Accreditation Agency (TÜRKAK), our Accredited Laboratory supports its quality-focused service approach with its quality activities and, guided by the principle of “always better”, aims to increase its capacity to provide more reliable service with each passing day.