Beruflich Dokumente
Kultur Dokumente
Issue Number: 3
April 2016
APPROVAL SHEET
Reviewed by ~'
Quality Manager of National Accreditation Committee
of Indonesia (KAN)
Approved by : ~'
Director of National Accreditation Committee
of Indonesia (KAN)
LIST OF AMENDMENT
Part
Part Number
No. Date Brief Description of Changes Revision
Revised
Number
SR.LM.KAN 002 was revised as a whole
1 January 2008 All 1
(except introduction)
Identification
document Identification document changed to KAN-
2 7 April 2016 2
KAN-R-LM TN-LM 02
02
Insert the term "safety" including "biosafety
3 7 April 2016 Clause 1 1
and biosecurity"
4 7 April 2016 All Replace "Analyst" into "Technician" 3
- Add " ... certificates of training .."
- Delete " ... health analysis vocation .."
- Add "d v Appropriate numbers of
laboratory technician (1 laboratory
5 7 April 2016 Clause 2 1
technician handles for 1 - 15
specimens)"
- Restructure e until j into e by adding
"biosafety and biosecuritv"
6 7 April 2016 Clause 3 a iii Replace " .. . resistant.. " into " ... clean, dry .. " 1
- Restructure 3 a iv and 3 a v into "3 a iv
Design laboratory is complied with a
regulation on Health Minister Decree
(KMK No. 1244/Xll/1994)."
7 7 April 2016 Clause 3 1
- Add b
- Restructure 3 c and 3 d into 3 c and
replace the term "chamber'' into
"bioloQical safety cabinet"
8 7 April 2016 Clause 5 d Add " ....and calibrated routinely." 1
9 7 April 2016 Clause 5 k ii Delete " ... .when aooropriate. " 1
Replace "Clinical microbiology, standards
and reference materials and cultures ... "
10 7 April 2016 Clause 61 1
into "Reference cultures (stock cultures,
lyophilized) ... "
Delete "Clinical microbiology .." and " .. . of
1
11 7 April 2016 Clause 6 m clean media."
Replace "areas" into "room " 2
ii
1 INTRODUCTION
2 PERSONNEL
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a The test method are based on the valid method or reference method and
adequately documented, including :
title and method number,
ii scope and field of application,
iii number of revision,
iv page numbering, total number of pages,
v references,
vi principles and definitions,
vii reagents and materials,
viii apparatus,
ix analytical methodology,
x expression of results,
xi performance criteria,
xii storage and shelf-life,
xi ii procedures for media preparation ,
xiv procedures for maintenance of stock cultures,
xv procedures of safety for media handling,
xvi quality control ,
xvii colony counting,
xviii reporting criteria,
xix issuing authority.
b The microbiological test method number and title used in the laboratory
shall the same as the scope of testing whe n carry out assessment for
accreditation.
c The validation of microbiological test methods should reflect actual test
conditions. This may be achieved by using naturally contaminated products
or products spiked with a predeterm ined level of contaminating organisms.
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m Media preparation and sterilization room are separated from work room to
prevent contamination.
n Laboratories shall ensure that all reagents including stock solutions, media,
diluents, and other suspending flu ids are adequately labeled to indicate, as
appropriate, identity, concentration , storage conditions, preparation date,
and validated expiry date and I or recommended storage periods.
o Reference cultures and reference material are requ ired for establishing
acceptable performance of media including test kits, for validating methods
and for assessing I evaluating on-going performance.
Traceability is necessary, when establishing media performance for
test kit and method validations.
ii To demonstrate traceability, laboratories must use reference strains
of microorganisms obtained directly from a recognized national or
international collection , where these exist.
iii Commercial derivatives of reference strains for which all relevant
properties have been shown by the laboratory to be equivalent at the
point of use may be used as alternatively.
iv Reference strains may be sub-cultured once to provide reference
stocks. Purity and biochemical checks should be made in parallel as
appropriate.
v It is recommended to store reference stocks in aliquots either deep-
frozen or lyoph ilized.
vi Working cultures for routine use should be primary subcultures from
the reference stock. If reference stocks have been thawed, they must
not be re-frozen and re-used.
vii Working stocks should not be sub-cultured unless it is required and
defined by a standard method or laboratories can provide
documentary evidence that there has been no change in any relevant
property.
viii Working stocks shall not be sub-cultu red to replace reference stocks.
Commercial derivatives of reference strains may only be used as
working cu ltures.
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BIBLIOGRAPHY
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