ISO 15189: Medical Laboratory Management System

ISO 15189 specifies requirements for quality and competence particular to medical laboratories. This standard is helpful for medical laboratories in developing their Lab Management System and assessing their own competence and for use by accreditation bodies in confirming or recognizing the competence of medical laboratories. ISO 15189 also addresses issues such as the Technical Competence of Personnel, Proficiency Testing, ILC, Standard Test Methods, Estimation of Uncertainty Measurement, Reporting System, Record Keeping, Traceability, Calibration etc.

ISO 15189 is applicable to all Medical laboratories(Chemistry, Haematology, Microbiology, Molecular Biology, Histopathology etc.) regardless of the number of personnel or the extent of the scope of testing activities.

Main Areas covered in this standard by QMS.9000

  • Development of Lab Policies and Procedures based on standard’s requirements
  • Development of system for environmental controls to ensure near perfect testing areas
  • System for Maintenance and Calibration of equipments
  • Ensuring use of best available Testing methods
  • Pre Examination , Examination and Post Examination Procedures
  • Application of Internal Quality Controls to ensure higher quality of test results
  • Preparation to participate in Inter-lab Comparison / Proficiency Testing Activities
  • Development of Purchase Inspection system
  • Ensuring acquisition of “right” chemical/solutions/equipment/accessories for the lab
  • Better control of Samples and Certified Reference Material / Standards
  • System for Estimation of Uncertainty
  • System for Reporting Test results based on Standard requirements
  • Application of statistical techniques
  • Review and Application of PNAC’s Policies and related regulatory requirements


The standard is recommended for Medical Laboratories.

Related Trainings

  1. Introductory session on ISO 15189 (1 Day)
  2. Advanced training on ISO 15189 with exercises and workshop (3 Days)