The ISO 15189 standard consists of quality management requirements and technical competence standards for medical laboratories. The main purpose of ISO IEC 15189 is the accreditation of medical laboratories and the assurance of test results before patients and healthcare personnel.
ISO 15189 Specific Requirements for Quality and Competence of Medical Laboratories; The ISO 15189 standard consists of the regulation of ISO 17025 and ISO 9001:2000 Standards for Medical Laboratories.
The scope of the ISO 15189 standard;
ISO/IEC 15189 Setup
Measurement systems analysis
Process mapping and process management
measurement uncertainty
Calibration, validation and verification
internal audit management
Competent institution (NB) training
ISO 15189 Accreditation requirements;
The laboratory must have a system that meets the requirements of ISO 9001:2015 Quality Management System,
The laboratory must have calibrated devices and equipment in order to carry out tests,
Must have qualified personnel to work in the laboratory,
All deficiencies that will adversely affect the adequacy of the tests in the laboratory must be corrected.