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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.
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