MyGenome Sdn Bhd has been granted accreditation for MS ISO 15189. This accreditation is part of our commitment to maintain the highest standards of quality, accuracy, and reliability. Through this accreditation, our laboratory practices are now synchronized with the structure adopted in 80 over countries throughout the world. Thus, opening up doors to endless opportunities for MyGenome Laboratory especially in venturing into international collaborations.
What is ISO 15189?
ISO 15189 is an internationally recognised standard for the quality and competency of medical laboratories. The main feature of ISO 15189 is a robust quality management system that comprehensively covers all aspects of the pathology testing procedure. ISO 15189 mainly focuses on patient safety, risk mitigation and operational efficiency.
Why ISO 15189 is Important?
ISO 15189 accreditation serves as a mark of competence, showing a laboratory’s commitment to deliver proficient and high-quality services. This demonstrates certainty to patients relying on test results for the purpose of early detection, management, prevention, and treatment of any conditions. Moreover, ISO 15189 structurally emphasises on almost every aspect of the laboratory including the management system, personnel qualification, test procedures, environmental monitoring, reporting procedures, risk management, document control and several other continual improvement factors.
The Tale of ISO 15189 Accreditation:
ISO 15189 accreditation for medical laboratories emerged from the convergence of two international standards: ISO 9001, focusing on quality management systems and ISO 17025, assessing technical competence in laboratories. In 2003, the first edition of an International Standard, the ISO 15189 “Medical laboratories” was issued by Technical Committee, ISO/TC 212, addressing the specific needs of medical laboratories globally. This standard was first adopted by Standard Malaysia in the year 2004. Currently, laboratories accredited with ISO 15189 have their certificates and test reports recognized almost worldwide.
*The International Organization for Standardization (ISO) is the international Standard-setting body. They are comprised of national Standards organisations as their representatives.