ISO 15189

ISO 15189:2012 Certification

In the medical laboratories, the quality and reliability is one of the most desired attribute for better test results. It is essential for the medical laboratories to ensure that they have an efficient system that evaluates the competence and accuracy of the test results provided by them. The ISO 15189:2012 certification is a quality standard that is designed by ISO and is meant to provide a system that gives all the requirements that are necessary for the better quality and competence of the test results provided by a medical laboratory. The ISO 15189:2012 certificate is used for development of a quality management system and evaluates their quality and reliability on their own. The certification can be a very good means of conveying the competence and quality assurance to the customers, boards and the regulatory agencies.

The ISO 15189:2012 provides the list of requirements that a medical laboratory has to fulfill in order to deliver competence and quality of test results. The standard basically helps in developments of an efficient QMS that helps in ensuring that the test results are best accuracy and quality and hence attain better customer satisfaction. The fields of medical laboratory that need to fulfill all the ISO 15189:2012 certification requirements include Clinical Biochemistry Toxicology Endocrinology, Hematology - Blood Transfusion, Microbiology Virology Parasitology Serology, Histopathology Cytology Mortuaries, Immunology,  Genetics and Andrology. The ISO 15189:2012 certification includes the implementation of software, hardware and equipments that are essential or better accuracy of test results, In addition to that the laboratory also need to design a particular protocol which includes proper documentation improvement of turnaround time TAT for reviews of the documents and improving the efficiency of the staff. 

The best thing about this standard is that it is in accordance with the standards that are country specific and hence can be applied to any laboratory in any part of the world. The standard aims to create a global standard that applies to every laboratory that is providing the medical testing faculties to the customers. The standard helps in delivering competence as well as reliability of results to the customers which in turn, increases the confidence of the customers.

UCS  is a certification agency that provides efficient certification services to the medical laboratories for ISO 15189.  We have a very simple and smooth certification process at a very minimal ISO 15189:2012 certification cost.  In addition to the certification, we also provide the documentation of the procedures and training of the Lab staff for better efficiency.