The development of ISO 15189:2012 was motivated by the recognition of the crucial role that medical laboratories play in the diagnosis, treatment, and monitoring of disease. With the growing demand for highquality laboratory services, the standard was created to provide a framework for ensuring consistent quality and competence in the delivery of these services.
The ISO 15189:2012 standard covers all aspects of laboratory operations, from pre-analytical processes to reporting of test results, and provides a basis for accreditation by a recognized accreditation body. The standard is intended to benefit both medical laboratories and the patients they serve and is now widely recognized as the benchmark for quality and competence in medical laboratory services.
What does ISO15189:2012 mean for a diagnostic laboratory?
ISO specifies the general requirements for quality management systems, as well as the technical and organizational requirements for the pre-examination, examination, and post-examination processes. The purpose of ISO 15189:2012 is to ensure that medical laboratories provide accurate, reliable, and timely results to their clients and that the laboratory's services meet customer requirements. Adherence to ISO 15189:2012 is a way for a diagnostic laboratory to demonstrate our commitment to quality and to assure patients and healthcare providers of our laboratory's competence.
What are the obligations of our laboratory-accredited ISO 15189?
Our ISO 15189:2012 accredited laboratory has several obligations to maintain its certification. By meeting these obligations, our laboratory ensures that it consistently produces accurate and reliable results, which is critical for our patient’s care.