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MAKMAL KESIHATAN AWAM KOTA BHARU
Document Number : MKAKB/BP/QP-17
QUALITY PROCEDURE
Issue Number : 01
METHOD SELECTION, VALIDATION & Issue Date : 07.06.2018
VERIFICATION Page Number : 3 of 7
6.0 PROCEDURE
NO PROCEDURE RESPONSIBILITY
6.1.0 METHOD SELECTION
6.1.1 Whenever possible, choose the standard method to be TM
used in the laboratory.
6.1.2 Select non-standard methods in case where standard TM
method does not exist.
6.1.3 Perform method verification or validation on the selected TM
method according to the following:
Activity Selected Method
Method A standard method / examination
Verification procedure from a method developer /
manufacturer.
Method 1. A non-standard method
Validation 2. A laboratory designed or developed
examination procedure (in-house)
3. A validated examination procedure
from a method developer /
manufacturer that has been modified
or is used outside its intended scope.
6.2 METHOD VERIFICATION AND VALIDATION FOR
QUALITATIVE AND QUANTITATIVE TEST
6.2.1 Identify the performance specification established for the TM
selected method.
6.2.2 Prepare the reagents/kit, instruments and consumables TM
needed.
Disease Sector Quality Procedure
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