Your browser version is outdated. We recommend that you update your browser to the latest version.

MALAYSIA STANDARD (ISO 15189:2014) FOR MEDICAL LABORATORIES
(Reference: MALAYSIAN STANDARD MS 15189:2014) – Medical laboratories – Requirements for quality and competence (Second revision) (IS) 15189:2012, IDT) © Copuright 2014 DEPARTMENT OF STANDARDS MALAYSIA
“The adoption of the ISO Standard as a Malaysian Standard was recommended by the Committee on Clinical laboratory Testing and In Vitro Diagnostic Test Systems under the authority of the Industry Standards Committee on Medical Devices and Facilities for Healthcare.” ……….
“This Malaysian Standard is identical with ISO 15189:2012, Medical laboratories – Requirements for quality and competence, published by the International Organisation for Standardization (ISO).” …………
“This International Standard is not intended to be used for the purpose of certification, however, a medical laboratory’s fulfilment of the requirements of this International Standard mean the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results.” …….
“This International Standard specifies requirements for quality and competence in medical laboratories.
This International Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.”

MEDISCAN ‘s MS 15189 ACCREDITATION

MediSCAN Laboratories is proud to have been accredited by the Department of Standard Malaysia on MS 15189 requirements, which means MediSCAN Laboratories “meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results”, and ensures MediSCAN laboratories is continuously being monitored and audited on the quality and competence of our laboratories.