ISO 15189 with its current version of 2012 specifies requirements for quality and competence in medical laboratories.

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.

Key Benefits of ISO 15189:2012

  • Promotes development of an international reputable image for your organization and laboratories through quality assurance and management Systems.
  • Promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both from an international and national perspective.
  • Fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery.
  • Promotes modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs.
  • Ultimately promoted the growth of customer satisfaction in organizations involved in medical laboratory testing.

Key Requirements of ISO 15189:2012

  • A well documented procedure analysis by the laboratories.
  • Training manual provided by the laboratories.
  • Effective detailed analysis of medical laboratory procedures in a bid to make sure that all weaknesses have been identified.
  • Detailed evaluation reports of the existing quality management system as well as other monitoring and evaluation reports.
  • A detail audit of management reviews.