Dear All,
We are preparing for the accreditation using a new ISO15189: 2012 standard which requires reagent lot to lot and shipment to shipment verification. Please could you share with me your SOPs covering this aspect? I am especially interested what percentage cut offs are used for the accepting of the difference between lots and shipments.
Kind Regards
Magdalena
Dr M Turzyniecka
HOD, Chemical Pathology
NHLS, IALCH, Durban, SA
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