ISO 15189:2012, Medical Laboratory Management System 

ISO 15189 is a global initiative that aims at creating a standard measure of quality in medical laboratories. The standard has developed initiatives to promote competence and responsibility in medical laboratory processes, equipments and outcomes. ISO 15189 was developed by the International Standards Organizations Technical Committee and has been implemented in over 200 countries. The process involves testing of the effectiveness of laboratory equipments and the impact those particular equipment have on the processes in the labs and their outcomes.

The following are the basic requirements for ISO 15189 certification:

  • A well documented procedure analysis by the laboratories.
  • Training manual provided by the laboratories.
  • ISO 15189 requires an 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

The ISO 15189 certification has a set of very unique benefits and the main objective of certification is quality assurance.

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