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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 : 1 of 7
1.0 PURPOSE
The purpose of this procedure is to establish the guideline for method selection and
the procedures for verification of standard method performance, as well as the
validation of non-standard methods.
2.0 SCOPE
This procedure is applicable for all new method (tests/methods/analyzers) introduced
in Disease Division.
3.0 REFERENCE
3.1 Malaysian Standard MS ISO 15189:2014: Medical Laboratories-Particular
Requirements for Quality and Competence
3.2 SAMM POLICY 5 (SP5) – Policy On Measurement Uncertainty Requirements
For SAMM Testing Laboratories
3.3 SC2 – Specific Criteria For Accreditation in the Field of Medical Testing
3.4 STR 2.3 – Specific Technical requirement for Accreditation of Chemical
Pathology Laboratories
3.5 EURACHEM GUIDE : “Guide To Quality in Analytical Chemistry”
3.6 EURACHEM GUIDE : “The Fitness For Purpose of Analytical Methods”
3.7 EURACHEM: “Quantifying Uncertainty in Analytical Measurement”
3.8 APLAC : Interpretation and Guidance On The Estimation of Uncertainty of
Measurement In Testing
3.9 NATA Technical Note 17 : Guideline For The Validation and Verification of
Quantitative and Qualitative Test Method
4.0 DEFINITION
4.1 Standard : Validated / published method by known organization and
Method proven to be fit for purpose as define in the scope of the
method
4.2 Method : The process of defining an analytical requirement, and
Validation confirming that the method under consideration has
capabilities consistent with what the application requires.
4.3 Method : A confirmation, through provision of objective evidence, that
Verification specified requirements have been fulfilled.
4.4 Accuracy Closeness of agreement between a quantity value obtained
by measurement and the true value of the measurand (VIM)
Closeness of the agreement between the result of a
measurement and a true value of the measurand (IUPAC)
Disease Sector Quality Procedure
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