ISO 15189 Medical Laboratory Quality and Competence

⇒ What is ISO 15189 (Medical Laboratories)?

ISO 15189:2022 specifies requirements for quality and competence in medical laboratories. It covers the laboratory’s management system and medical laboratory activities, including pre-examination, examination and post-examination processes.

The standard is used by accreditation bodies to assess and recognize laboratory competence. Medical laboratory accreditation differs from management system certification.

Read the official ISO 15189 overview. For training enquiries or information about IQRA’s service scope, contact our team.

Benefits of ISO 15189 Standard:

  • Increased Effectiveness of QMS
  • Risk Reduction
  • Higher Customer Satisfaction
  • International Recognition
  • Cost-Saving Processes

⇒ ISO 15189 Objectives?

  • Support reliable medical examination results through competent personnel and controlled laboratory processes.
  • Manage risks affecting laboratory services and patient care.
  • Maintain suitable equipment, records and traceability of results.
  • Monitor performance, investigate problems and improve laboratory processes.
  • Provide evidence of quality and competence for assessment by an appropriate accreditation body.