ISO 15189:2012 - Medical / Clinical Laboratories Accreditation

This standard is used for accreditation of clinical lab competence. It enables labs to establish proficient operational procedures, meet client expectations and improve service.This standard makes a significant template for evaluating the technical ability of medical labs and management of their service and staff. This  Standard  included provision of advice to 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.

While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

Benefits of ISO 15189 Accreditation:

  • Improved national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.
  • Having a basis for most other quality systems related to laboratories, such as Good Laboratory Practices.
  • Mutual Recognition Agreement (MRA) amongst various countries test report is acceptable without repetition of analysis.
  • Laboratory will be participating in Inter laboratory Comparison program so that quality level of the lab with respect to other accredited lab can be determined.
  • Quality control checks will be carried out periodically by which system is always maintained.
  • Assurance to clients of good laboratory practice
  • Meets purchaser or regulatory specifications
  • Decision makers can rely on test results
  • Saves money by getting it right the first time

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