ISO 15189 Compliance: Ensuring Laboratory Excellence with a Modern EQMS Solution

Whitepaper | March, 2023

ISO 15189 accreditation involves an independent assessment of the medical laboratory with a total of 531 accredited tests, including Inter Laboratory Comparison (ILC) protocols where the lab is benchmarked against reputable laboratories. The personnel are also evaluated for their qualifications and competence. Inspection of equipment, reagents, and supplies, the quality assurance processes followed, and analytical, pre-analytical, and post-analytical factors are also examined as part of the accreditation process. Qualified assessors evaluate the factors impacting test data production.

Continued compliance of the accredited medical laboratories and the retaining of their technical expertise is ensured through regular reassessment. They are also expected to be part of proficiency testing programs such as EQAs.

Laboratories are becoming complex. The need to keep costs low, improve outcomes, and deliver in a timely manner without compromising on quality and patient safety. With ISO 15189 compliance, businesses can overcome some of these challenges.

Experts say the process of getting ISO 15189 is almost akin to getting the Deming TQM recognition and requires the involvement of the entire organization.

In this whitepaper, we talk about:

  • Why do laboratories need ISO 15189
  • The benefits of ISO 15189 accreditation
  • The ISO 15189 accreditation process: 5-steps
  • And more

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