ISO
15189 pens down the requirements for quality and competence in medical
laboratories. This international standard is used by medical laboratories in
developing their quality management systems and assessing their own competence.
This
standard is essential for the company’s goodwill as it is used for confirming
or recognizing the competence of medical laboratories by laboratory customers,
regulating authorities and other accreditation bodies.
ISO 15189 Check List:
Based on ISO 17025 and ISO 9001 few
additional requirements are laid down in ISO 15189. Such as-
• Providing advice on the type of sample and
testing that are required.
• Having an interaction with clinical staff
responsible for the quality of service to clinicians.
• Providing opinions on the results of
testing.
• Collecting samples or suggesting
information on collection procedures, sample containers, and sample volumes.
• To check whether they are working as per
ethics.
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
auditors conduct a thorough evaluation of all factors affecting the production
of test data. To ensures the quality regular checkups are conducted.
Accreditation
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