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MAKMAL KESIHATAN AWAM KOTA BHARU
Document Number : MKAKB/BP/QP-19
QUALITY PROCEDURE
Issue Number : 01
MANAGEMENT OF LABORATORY Issue Date : 03.04.2016
INFORMATION SYSTEM Page Number : ii of iv
AMENDMENT RECORD
PAGE / DESCRIPTION OF
NO. DATE SECTION / AMENDMENT APPROVED BY
PARAGRAPH
1. 07.06.2018 Page 4, Para 6.0, Delete ‘using alternative
No. 6.6.4(c) method.’
2. 20.12.2018 Page 2, Para 6.0, Add ‘Refer Appendix 1 for Level
No. 6.2.2 of Authority and Responsibility’
Add ‘for iLab Refer SOP
Page 3, Para 6.0, BIOKIMIA,
No 6.3.1 MKAKB/BP/BCM/SOP-21’
Add no 6.7.1 to no 6.7.2
Page 5, Para 6.0,
No. 6.7.0
3. 16.11.2021 Page 3, Para 6.0, Add 6.5: Test LIS for
No. 6.6 reproducibility performance at
least 3 times a year.
a) Fill up LIS Data Transfer
Validation / Report
Reproducibility
Performance form
(MKAKB/BP/BR-30). 10
samples for each
performance are
selected randomly.
b) Verify that the test
conforms to original
report by stamped with
tally. If test report was
not concordant, inform
HOU/ AITO
c) Investigate the cause of
problem and take
corrective action. Fill up
Corrective Action form
(MKAKB/BP/BR-12)
Page 6. Para 8.0 Add Quality record no 3 and
and 9.0 appendix no 3.
Disease Sector Quality Procedure
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