ISO 15189:2012 Medical Laboratories - Requirements for Quality and Competence

ISO 15189:2012 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.

Why obtain ISO 15189?

• The only global standard for the accreditation of medical laboratory results;
• Based on good laboratory practices;
• Focused on technical specifications in medical laboratory;
• Process approach matching the pre-analytical, analytical, and post-analytical phases;
• Oriented to support accurate clinical decisions;
• Identification and traceability information of the different phases of the medical laboratory process;
• Monitoring and measuring of devices that significantly contribute to the trueness and uncertainty of the reported results;
• Training and competence assessment of the staff which is critical to good management and good laboratory practices, and;
• Infrastructure to correctly support the operation practices.