FQS ISO 15189 Accreditation
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Medical laboratories can be accredited to ISO 15189, Medical
laboratories - Particular requirements for quality and competence,
to demonstrate the quality and reliability of their services. ISO
15189, which was developed with the participation of the medical,
scientific, and clinical community, contains requirements for
diagnostic labs to demonstrate competence to deliver reliable
timely, accurate, and reliable results.
Based on ISO/IEC 17025, General requirements for the competence
of testing and calibration laboratories, and ISO 9001, Quality
management systems - Requirements, ISO 15189 includes five
additional criteria for medical laboratories:
- Providing advice on the type of sample and testing that may be
- Interacting with clinical staff with the laboratory responsible
for the quality of service to clinicians referring patient samples
- Providing opinions on results of testing relative to diagnosis
and patient care.
- Collecting samples or providing information on collection
procedures, sample containers, and sample volumes.
- Ethical practice.
ISO 15189 accreditation involves an independent assessment of
the medical laboratory that includes an examination of personnel
qualifications and competence, equipment, reagents and supplies,
quality assurance, and analytical, pre-analytical, and
post-analytical factors. Qualified assessors conduct a thorough
evaluation of all factors affecting the production of test data
To ensure continued compliance, accredited medical laboratories
are regularly re-assessed to ensure they maintain their technical
expertise. They are also required to participate in proficiency
testing programs (EQAs).
This diagram outlines the FQS accreditation process:
To learn more about FQS medical laboratory accreditation to ISO
15189, send e-mail or call toll free
877-344-3044, ext. 202.
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