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Issue Number : 3
April 2016
APPROVAL SHEET
Reviewed by :
Quality Manager
Approved by :
Director for Accreditation of Laboratory and Inspection Body
LIST OF AMANDMENT
Part Part
No. Date number Brief description of changes revision
revised number
1. January 2008 All Change of identification 2
Adding
Point 4a.
xvii. colony counting (if applicable)
Adding
Point 5 ix. Laminar air flow
x. Sterilising ovens
Divided into 2 Point : 3
2. April 2016
6. Reagent and Culture Media
Adding the information that should be
Point 6
available from producer.
7. Reference Material and Reference
culture
1. INTRODUCTION
a. This Specific requirements are an interpretation of the general requirements of
ISO/IEC 17025-2005.
2. PERSONNEL
a. The Laboratory analyst has been working in relevant test areas of a microbiology
laboratory for at least two years.
e. Laboratory shall establish and define an internal training program and ensure the
competency of laboratory personnel.
f. Laboratory shall have training procedure that used to ensure that training has
taken place with each employee for procedures and methods that the employee
performs. The procedure applies to on-the-job training, in-house training and new-
hire training.
g. The training procedure is applicable to new employees, for the introduction of new
procedures and methods, for retraining of employees, and for re-verification of
employee performance.
h. The laboratory shall maintain an up-to-date record of the training that each
member of staff has received.
iii. Floors in the laboratories are constructed from a material that is resistant to
easily disinfected.
iv. Floors in the laboratories are clean, dry, and in sound condition so there are
no tripping hazards.
v. Environment suitable for the tasks carried out microbiology testing.
b. The microbiological test method number and title used in the laboratory shall the
same as the scope of testing when 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 predetermined level of contaminating organisms.
e. The methods performance characteristics are based on the intended use of the
method. Method that used for qualitative microbiological test analysis there does
no need validate the methods linearity over the full dynamic range of the
equipment.
iii. Prepare and analyze positive and negative culture controls. Negatives control
is a typically negative or no growth and the positive control is positive or shows
microbial growth.
iv. Spike positive culture control is prepared and analyzed. This assesses the
matrix effects as well as the sensitivity of the method. It is recommended that
a 25 gram sample be spiked with inoculums of 30 cells or less.
v. Evaluate interferences. This assesses the selectivity and specificity of the
method.
ii. Work instructions for disinfection / sterilization and disposal of bio hazardous
material
iii. Work instructions for glassware cleaning
iv. Work instructions for equipment instruction manuals
v. Work instructions for computer software related data entry and approval.
iii. Laboratory shall have operating instructions for each instrument, including
starting and shutting down the instrument.
iv. pH meter at least available two buffer to cover the range of pH needed in the
tests methods for determination of pH standards, buffers available within their
expiry dates.
vi. Safety cabinet shall have documented protocol and record of decontamination.
vii. Program established to check regularly the rate of airflow and particle count in
the Biohazard hoods or laminar flow cabinets.
e. Are there regular checks to ensure that the equipment is performing within the
specifications.
g. Equipment that is not operating properly is clearly marked to show that it is out
of service.
j. All instruments required for the routine test in microbiology field are available:
i. Bunsen burners or other flame source functioning properly,
ii. Colony counter for pour plate and spread plate method functioning properly,
m. Verification should not be necessary for glassware which has been certified to a
specific tolerance.
n. Equipment should be checked for the accuracy of the delivered volume against
the set volume (for several different settings in the case of variable volume
instruments) and the precision of the repeat deliveries should be measured.
d. All containers, especially those for dehydrated media, should be sealed tightly.
e. Dehydrated media that are caked or cracked or show a color change should not
be used.
f. Shelf life of prepared media under defined storage conditions shall be determined
and verified.
g. Stored reagents, reference materials and supplies shall be under the appropriate
conditions and in a secure manner to ensure the separation of incompatible
materials.
h. Solutions of reagent, standard and any other such as mobile phase properly
labeled with solution name, concentration, date of preparation, expiration date, and
identity of person who prepared.
l. Microbiology media preparation and sterilization areas are separated from work
areas to prevent contamination of clean media.
m. Laboratories shall ensure that all reagents including stock solutions, media,
diluents, and other suspending fluids are adequately labeled to indicate, as
appropriate, identity, concentration, storage conditions, preparation date, and
validated expiry date and / or recommended storage periods.
b. Approach of quality control is the principal recourse available for ensuring that only
quality data is released.
c. The Principe of the laboratory quality control program is its internal quality control
to monitoring of analytical performance, and its external quality control based on
the laboratorys performance in proficiency testing programs.
Bibliography:
1. Eurochem Guide 2013. Accreditation for Microbiological Laboratories
2. ISO 7218; 2007, Microbiology of food and animal feeding stuffs - General rules for
microbiological examinations.
3. ISO 11133; 2014, Microbiology of food and animal fedd and water Preparation,
production, storage and performance testing of culture media