ISO 15189 - Accreditation
What is Accreditation?
Accreditation is a quality infrastructure created to support the reliability and validity of the studies carried out by the conformity assessment bodies and therefore the conformity confirmation certificates (test and inspection reports, calibration certificates, management system documents, product documents, personnel documents, etc.) issued as a result of these studies.
The accreditation of conformity assessment bodies is carried out on the basis of international standards that determine the qualification criteria for the relevant conformity assessment bodies, requirements specific to the relevant sector, and requirements that are accepted worldwide, determined in the guide documents determined by regional or international accreditation bodies.
ISO 15189 STANDARD AND WE…
The ISO 15189 standard consists of the regulation of ISO 17025 and ISO 9001:2000 Standards for Medical Laboratories. The main purpose of ISO 15189 is the accreditation of medical laboratories and the assurance of test results before patients and healthcare personnel.
ISO 15189 sets out the qualification and quality requirements specific to medical laboratories. It is accepted that there are special conditions that can be applied according to the activities of all or some of the professional personnel working in this field in each country.
The ISO 15189 standard was established to meet the requirements of all patients and clinical personnel responsible for their care. These services include issuance of requests, sampling, transportation, storage, processing and analysis of clinical specimens, as well as validation, evaluation of results, preparation of reports and recommendations, in addition to safety and ethics in medical laboratory studies. For this reason, it is a privilege to be an Accredited Laboratory.
Our Accredited Laboratory has completed accreditation studies in order to meet ISO 15189 standards, and as of October 2021, accredited institutions have taken its place among accredited laboratories. Wellcare laboratories is the only medical laboratory in Northern Cyprus accredited with ISO15189, located in Nicosia and Kyrenia.
Our Accredited Laboratory, which has been accredited by the Turkish Accreditation Agency (TÜRKAK), aims to increase its capacity to provide more reliable service day by day, based on the principle of “always for the better” by supporting its quality service understanding with its quality studies.
