ISO 15189 : 2012 - MEDICAL LABORATORIES

ISO 15189 specifies the quality management system requirements particular to medical laboratories, stressing the importance of evidence, document control, and control of records and clinical material. ISO 15189 standards are based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. ISO 15189 advises the users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of health care staff.

   MEDICAL LABORATORIES STRUCTURE


   Managment Requirement


  •     Organization and management responsibilities
  •     Quality management system
  •     Document control
  •     Service agreements
  •     Corrective and preventive action
  •     Continual improvement
  •     Control of records

   Technical Requirement


  •     Personnel
  •     Accommodation and environmental conditions
  •     Chemical equipment
  •     Pre and Post Examination process
  •     Reporting of results
  •     Release of results
  •     Laboratory information management

   WHY WE NEED MEDICAL LABORATORIES?


  •     Recognition of testing competence
  •     Marketing advantage
  •     Benchmark for performance
  •     International recognition

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