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ISO 15189:2012 Accreditation of Medical Laboratories

Medical Laboratory Quality and Qualification Requirements


Medical laboratory services are necessary for patient care, and therefore they should be available to meet the needs of all patients and the clinic staff responsible for the care of these patients. Such services, safety and ethical considerations in medical laboratories, as well as subsequent interpretation, reporting and advice, together with requests for inspection, patient preparation, patient identification, sample collection, transport of clinical specimens, storage, processing and includes arrangements for the review. In order to show that the quality and reliability of medical laboratories, their services meet certain requirements and requirements, certification is carried out in accordance with international standards. ISO 15189 is the international standard that sets the requirements for quality and qualification in medical laboratories.


This standard is not intended to be used for certification purposes, but the medical laboratory to fulfill the requirements of this standard, which are required for delivery in a consistent manner in the laboratory as technical and management system that meets the requirements of the qualification requirements for technical means. The ISO 15189 standard, which was developed with the participation of the medical, scientific and clinical communities and includes requirements for laboratories to demonstrate their ability to provide timely, accurate and reliable results, contains certain criteria.


• To provide advice on the types of samples and tests that may be required.
* Interaction with laboratory and clinical staff responsible for the quality of service to clinic employees applying for patient samples for testing.
• To give opinions about the test results according to the diagnosis and patient care.
• Providing information on sample collection or collection procedures, sample containers and sample volumes.
• Ethical practice.


Accreditation to ISO 15189 medical laboratory staff qualifications, equipment, reagents and materials, quality assurance, analytical, pre-analytical and post-analytical factors, including an examination of an independent assessment.


ISO 15189 can be used by medical laboratories to improve their quality management systems and assess their own competence. It can also be used by clients of medical laboratories, regulatory authorities and accreditation bodies to verify or recognize its competence.

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ISO Certification