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Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
ON SITE ASSESSMENT REPORT
ISO 15189:2012 - Medical Laboratories –
Requirement for quality and competence
SUPPLEMENTARY CHECKLIST - EXTENDED MICROBIOLOGY
INSPECTION CHECKLIST
Part-I: GENERAL INFORMATION
ACCAB Reference No.:
Assessment Type:
Pre – Assessment
Re - Assessment
Short Notice Visit
Date(s) of Assessment:
Initial Assessment
Extension of Scope
On-site Clearance
Surveillance Visit
Re-Instatement Visit
Assessment Team:
Assessor / Technical
Expert(s)::
Persons Interviewed:
Laboratory Details:
Laboratory’s Name:
Address:
Country:
Telephone No.
Email address:
Principal Contact Name:
Postcode:
Fax. No.
Web Site:
Designation:
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Tel/Fax: 91-22-28794410, 28794411, 28794412
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PART - II
CLAUSE
NO.
1.0
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.9.1
1.9.2
1.9.3
1.9.4
1.10
1.11
1.12
1.13
DETAILED CHECKLIST: EXTENDED MICROBIOLOGY INSPECTION
CHECKLIST
(Doc.
ASSESSMENT
Ref. /
COMPLIANCE
REQUIREMENT
Clause Y/N/NA
NOTES
No.)
QUALITY CONTROL
Are controls run and documented on each day
of use?
For qualitative tests that use a cut-off value to
distinguish positive from negative; is the cut-off
value established initially?
Are control specimens tested in the same
manner and by the same personnel as patient
samples?
Is quality control data reviewed at least monthly
by the laboratory director or designate and is
this review documented?
Are the day of use control results verified for
acceptability before reporting patient results?
Are tolerance limits established for the controls
run on each day of use?
Are criteria for referral of “out of control”
results to the supervisor and/or senior staff
identified?
Is there evidence of documented corrective
action taken when controls on day of use exceed
defined tolerance limits?
Does the documentation include:
What was out of control?
Why the analysis was out of control?
Corrective action taken?
Signature/initials of individual responsible
Is lot number change of quality control material
documented on the quality control record?
Are quality control records retained for at least
two years?
Is each new lot number and shipment of
reagents used in bacteria identification systems
tested with a positive and a negative organism?
For direct antigen tests on patient specimens
that DO include internal controls, are positive
and negative external controls tested and
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
1.14
1.15
2.0
2.1
2.2
2.3
2.3.1
2.3.2
2.3.3
2.3.4
2.3.5
2.3.6
2.3.7
2.3.8
2.3.9
2.4
2.5
2.6
2.7
2.8
2.9
2.10
2.11
documented with each new kit lot number or
separate shipments of a given lot number?
For direct antigen tests on patient specimens
that do NOT include internal controls, are
positive and negative controls tested and
documented each day of patient testing?
Are positive and negative controls tested and
results recorded for each new batch, lot number
and shipment of anti-sera when prepared or
opened and once every 6 months thereafter?
PROCEDURE MANUAL
Is a current procedure manual available for
laboratory staff?
Is the procedure manual maintained as oer the
documented procedure ?
Are the following included for each procedure:
(if applicable)
Purpose
Specimens (type, source, amount, storage)
Equipment and Materials required
Preparation and storage of reagents, standards
and controls
Procedure – including Step by step instructions
Clinical Significance
Critical values
Reporting results (units, stats, critical values)
Safety
Is there documentation of annual review of the
procedure manual by the laboratory director or
designate?
Is there documentation of annual review of the
procedure manual by the laboratory staff?
Are all changes in methodology signed and
dated by whoever made the changes?
Are all new procedures reviewed by the
medical director or designate?
Are discontinued procedures retained for two
years after the procedure is taken out of
service?
Is there a current file on manufacturer’s
inserts/updates?
Are there adequate and up to date reference text
books available to laboratory staff?
Does the laboratory staff have access to current
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Tel/Fax: 91-22-28794410, 28794411, 28794412
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CLSI guidelines?
3.0
3.0
3.1
3.1.1
3.1.2
3.1.3
3.1.4
3.1.5
3.1.6
3.1.7
4.0
4.1
4.2
4.3
4.4
4.4.1
4.4.2
4.4.3
4.4.4
4.5
4.6
4.7
SPECIMEN COLLECTION MANUAL
Is a specimen collection manual available at all
collection sites?
Are there instructions for microbiology
specimen collection and handling that include
all of the following:
Method for proper collection of culture
specimens from different sources
Proper labelling of culture specimens
Use of transport media when necessary
Procedures for safe handling of specimens
(tightly sealed containers, no external spillage)
Need for prompt delivery of specimens to
ensure minimum delay and processing
Method for preservation of specimens if
processing is delayed
Are there written criteria for specimen rejection
REAGENTS/SUPPLIES
Are all reagents/supplies used within their
expiry date?
Are outdated reagents discarded?
Are all reagents/supplies used according to
manufacturer’s instructions?
Are all reagents/supplies labelled with:
Date of receipt
Date prepared or opened
Expiry date
Content and concentration
Are all reagents/supplies stored according to
manufacturer’s instructions?
If there are multiple components of a reagent
kit, does the laboratory use components of
reagent kits only within the same kit lot, unless
otherwise specified by the manufacturer?
Prior to use, are new reagent lots checked
against old reagent lot?
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
5.0
5.1
5.2
5.3
5.3.1
5.3.2
5.4
5.4.1
5.4.2
5.4.3
MEDIA
Are there instructions to indicate the number
and types of media and method of inoculation
required?
Does the laboratory have documentation that its
media supplier carries out the quality assurance
guidelines?
Does the laboratory have documentation that
the purchased media that are not listed in
standard/guidelines as exempt from testing is
checked for each of the following:
Ability to support growth by means of stock
cultures or by parallel testing with previous
batches
Biochemical reactivity (where appropriate)
For media prepared in-house, is there
documentation that it is checked for each of the
following:
Sterility (following introduction of additives
after sterilization)
Ability to support growth by means of stock
cultures or by parallel testing with previous
batches
Biochemical reactivity (where appropriate)
6.0
REFERENCE CULTURES
6.1
Are ATCC reference cultures maintained?
Are appropriate cultures used to check media,
stains, reagents, identification kits and
susceptibility testing?
Is there documented receipt of pathogens
imported for control purposes?
Do the records indicate where the pathogen was
used/stored and the date of disposal?
6.2
6.3
6.4
7.0
SURGICAL PATHOLOGY CULTURES
7.1
Are specimens obtained by surgical procedures
treated as high priority specimens?
8.0
INSTRUMENTS AND EQUIPMENT
8.1
Is there a procedure for maintenance of all
instruments and equipment?
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
8.2
8.3
8.4
8.5
8.6
8.7
8.8
8.9
8.10
8.11
8.12
8.13
8.13.1
8.13.2
8.13.3
8.13.4
8.14
8.15
8.16
8.17
8.17.1
8.17.2
Are the maintenance records reviewed by a
supervisor?
Is this review documented?
Are there instructions for troubleshooting?
Are service records maintained for the life of
the instrument, plus two years?
Is there emergency power for instruments and
equipment?
Are instruments equipped with surge
protection? (this also includes computers)
If the laboratory uses more than one
instrument/method to test for a given analyte,
are the instruments/methods checked against
each other at least twice a year for correlation
of results?
Are there defined tolerance limits for result
agreement of inter-instrument assays?
Does the laboratory have a procedure for
evaluating automatic pipette systems for
carryover?
Are pipettors, microtiter or automatic
dispensers checked at least annually for
accuracy and reproducibility, and results
recorded?
Is the temperature of water baths and/or heat
blocks checked on days of use?
Is the temperature of refrigerators and other
temperature dependent equipment documented
daily:
Room temperature
Freezer
Refrigerator
Incubators
Is there evidence of active review of results of
temperature?
Are these reviews documented?
Is there a procedure available if acceptable
temperature ranges are exceeded?
Biological Safety Cabinets
Is a biological safety cabinet used for handling
all specimens or organisms considered to be
contagious by airborne routes?
Does the biological safety cabinet meet
minimum requirements for the work performed
in it, as described in the Health Canada
Laboratory Biosafety Guidelines?
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Page 6 of 14
ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
8.17.3
8.17.3.1
8.17.3.2
8.17.3.3
8.17.4
8.17.5
8.17.6
8.17.7
8.17.8
9.0
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
Type of biological safety cabinet used:
Class I – protect operator
Class II – protect operator plus specimen
Class III – protect operator plus specimen,
airtight
Is the biological safety cabinet certified
annually (and documented)?
Is the cabinet appropriately situated to
avoid/minimize air turbulence?
Is the cabinet uncluttered so as not to
compromise its effectiveness?
Does the cabinet have a mechanism to signal
when it is inoperative?
Is the air flow monitored and recorded prior to
starting work each day?
ANTIMICROBIAL SUSCEPTIBILITY
TESTING
Are susceptibility tests performed only on pure
cultures?
Is each new lot of susceptibility disks checked
for activity before use?
For antimicrobial susceptibility testing of either
disk or dilution type, are control organisms
tested with each new lot or batch of
antimicrobials or media, and each day the test is
performed?
For antimicrobial susceptibility testing systems,
are there documented criteria for interpretation
of the endpoint or zone size?
Is the inoculum used for antimicrobial
susceptibility testing (ie. inoculum size)
controlled using a turbidity standard or other
acceptable method?
Are guidelines established for the number and
type of antibiotics reported for organisms
isolated from different sites of infection?
For hospital based microbiology laboratories,
are cumulative antimicrobial susceptibility test
data maintained and reported to the medical
staff at least yearly?
Does the procedure manual address unusual or
inconsistent antimicrobial testing results?
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Page 7 of 14
ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
10.0
INFECTIOUS DISEASE SEROLOGY
10.1
Quality Control
Are positive and negative controls run each day
of analysis with each batch of specimens for all
tests?
For EIA or IFA, are substrate, conjugate and
buffers prepared according to manufacturer’s
instructions?
Is EIA plate reader quality control done for
linearity, accuracy, precision and diode check
as well as mechanical alignment every six
months?
Is EIA washer quality control done according to
manufacturer’s instructions?
Syphilis Serology
Are the recommendations of the manufacturer
for proper use of reagents and controls
followed?
Is the delivery of antigen dispensing needles
used in syphilis serology testing checked on
each day of use to determine volume delivery?
Do all equipment glass for reagent, control and
techniques conform to those recommended in
the current manual of test for syphilis?
Are weakly reactive controls used with each
batch of tests?
Are non-reactive controls used with each batch
of tests?
Do records reflect the results of all control
procedures?
10.1.1
10.1.2
10.1.3
10.1.4
10.2
10.2.1
10.2.2
10.2.3
10.2.4
10.2.5
10.2.6
11.0
VIROLOGY
11.1
Specimen Collection and Handling
Are specimens for viral culture collected
appropriately and transported to the laboratory
promptly?
Quality Control
Does the laboratory have documentation that
each shipment of commercial cell culture tubes,
flasks, shell vials or cluster trays is examined
for breakage?
Does the laboratory have procedures for the
acceptance and rejection of cell culture tubes,
flasks, shell vials or cluster trays used for virus
11.1.1
11.2
11.2.1
11.2.2
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
11.2.3
11.2.4
11.2.5
11.3
11.4
11.5
11.6
11.7
11.8
11.9
11.10
11.11
11.12
11.12.1
11.12.2
11.12.3
isolation?
Are culture media tested for sterility if additives
are introduced after sterilizing?
Are continuous cell lines checked for
mycoplasma contamination?
Are continuous cell lines checked for
endogenous viral contamination?
Does the laboratory have the cell line(s)
available for all types of specimens tested and
for all viruses reported by the laboratory?
Are tube monolayer cultures incubated for a
sufficient time to recover the viruses?
Are inoculated cultures checked for cytopathic
effect in a manner that optimizes the time to
detection of viral pathogens?
Is a negative (uninoculated) control set up each
day of patient testing?
Are there procedures for the handling of cell
cultures with unusual cytopathic effect?
Are media and diluents checked for sterility and
pH?
Are reactive and non-reactive controls
processed in serologic reactions for detection of
antibodies or antigens?
Is each new lot and shipment of
immunofluorescent reagents that detect multiple
viruses validated for each individual virus
component prior to patient testing?
Is each new lot and shipment of reagents that
are used for the enzymatic detection of viruses
validated for each individual virus component
prior to patient testing?
Testing
For viral screening tests by direct antigen
detection (direct immunofluorescence or EIA),
do rapid cell culture or molecular methods,
reports and test order information indicate the
specific viruses sought/detected by the assay?
Does the laboratory have procedures for the
isolation of viruses based upon such criteria as
specimen source, diagnosis, suspected virus(es)
and season?
Does the laboratory have policies for the
acceptance and rejection of samples for CMV
antigenemia testing?
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
12.0
PARASITOLOGY
12.1
Specimen Collection & Handling
Are specimens transported in SAF
preservative?
Instruments and Equipment
Is an ocular micrometer available for
determining the size of eggs, larvae, cysts or
trophozoites?
Has the ocular micrometer been calibrated for
the microscope in which it is used and
recalibrated whenever eyepieces or objective
lenses are changed?
Reagent Quality Control
If zinc sulphate is used, is the solution checked
for specific gravity?
Is the zinc sulphate flotation solution stored in
tightly stoppered bottles?
Are permanent stains checked with control
specimens at least monthly?
Are stains that are used to detect specific
parasites checked with appropriate control
organisms each time the stain is used?
Testing
Does the examination of stool include:
direct mount of a fresh specimen
concentration procedure
permanent stained preparations
If the procedure uses Formalin, is there a record
of formaldehyde vapour monitoring?
If the procedure uses ether, is the diethylether
stored on open shelves in a well-ventilated
room using the smallest can manufacturered?
12.1.1
12.2
12.2.1
12.2.2
12.3
12.3.1
12.3.2
12.3.3
12.3.4
12.4
12.4.1
12.4.1.1
12.4.1.2
12.4.1.3
12.4.2
12.4.3
13.0
MYCOLOGY
13.1
Specimen Collection and Handling
If culture media for mycology is used in petri
dishes, are appropriate safety precautions taken
to prevent accidental opening of plates?
Is the use of slide cultures prohibited in
working with highly infectious dimorphic
fungi?
When preparing teased preparations or scotch
tape preparations, are mycelia always
submerged in a liquid medium such as
13.1.1
13.1.2
13.1.3
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
13.1.4
13.1.5
13.2
13.2.1
13.2.2
13.2.3
13.3
13.3.1
13.3.2
13.3.3
13.3.4
13.3.5
13.3.6
13.4
13.4.1
13.4.2
13.4.3
13.4.4
13.4.5
13.4.6
Lactophenol cotton blue?
Are all specimens for fungal culture collected
and/or received in sealed leak-proof containers?
Are sealed screw- capped tubes enclosed in
sealed safety centrifuge carriers used to
minimize aerosol hazards?
Quality Control
Are positive and negative controls tested each
day of use if nucleic acid probes or exo-antigen
tests are used for identification of fungi?
Are stains (eg. acid fast, PAS, Giemsa,
Gomori’smethenamine silver, India ink)
checked with positive and negative controls on
each day of patient sample testing?
Are fluorescent stains (calcofluor white)
checked with positive and negative controls
each day of use?
Testing
Are preliminary screening procedures such as
direct wet mount preparations and stains
performed when indicated?
Are selective media used for the growth and
isolation of dermatophytes and/or systemic
fungi?
Are media with antimicrobial agents used to
suppress the growth of contaminants?
Are incubation temperatures for the growth and
isolation of dermatophytes and systemic fungi
defined and followed under culture conditions?
If cultures are incubated at room temperature, is
the actual temperature checked daily to
determine if proper growth conditions are being
maintained?
Are procedures for the differentiation and
identification of fungi adequate for the
laboratory’s needs?
Do differential procedures include:
Chlamydospore formation on corn meal
rice agar
temperature growth requirements
biochemical tests such as urease, carbohydrate
assimilation, and/or fermentation
slide cultures
germ tube test
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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E-Mail: info@accab.org Website: www.accab.org
14.0
MYCOBACTERIOLOGY
14.1
Specimen Collection and Handling
Are specimens for mycobacteriology collected
appropriately and transported to the testing
laboratory without delay?
Are all specimens for mycobacterial culture
collected and/or received in sealed leak-proof
containers?
Are sealed screw-capped tubes enclosed in
sealed safety centrifuge carries used to
minimize aerosol hazards?
Are certain specimens (eg. sputum)
concentrated before AFB smear examination
and culture?
Quality Control
Is fluorochrome staining performed on
mycobacterial smears prepared from primary
specimens, either in the laboratory or by the
reference laboratory?
Are AFB and fluorescent stains checked with
positive and negative controls each day of use
and results documented?
If nucleic acid probes are used for identification
of mycobacteria grown in culture, are
appropriate positive and negative controls tested
on each day of use?
Are the differential biochemical tests
appropriate for the extent and manner of
mycobacterial identification?
If the laboratory performs susceptibility testing
of M. tuberculosis, is a control stain sensitive
to all anti-mycobacterial agents run:
each week of patient testing
with each new batch/lot number of media
with each new batch/lot number of antimycobacterial agents
Are biochemical tests checked each day of use
with a positive and negative control and
documentation?
Reporting of Results
Are results of acid-fast stains reported within a
timely manner of specimen receipt by the
testing laboratory?
Are susceptibility test results for M.
tuberculosis available in a timely manner?
14.1.1
14.1.2
14.1.3
14.1.4
14.2
14.2.1
14.2.2
14.2.3
14.2.4
14.2.5
14.2.5.1
14.2.5.2
14.2.5.3
14.2.6
14.3
14.3.1
14.3.2
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
15.0
15.1
15.2
15.3
15.4
15.5
15.6
BIOSAFETY
Are there documented policies and procedures
for the safe handling and processing of
specimens?
Have policies and procedures been developed to
minimize the occupational risk of exposure to
infectious agents handled in the microbiology
laboratory, in accordance with current
recommendations regarding the bio-safety
levels for working with different organisms?
Are there documented policies for handling
spills of contaminated materials?
Are bench tops decontaminated daily?
Are engineering and work practice controls
appropriate to the bio-safety level of the
laboratory defined and implemented?
Does the microbiology laboratory have policies
and procedures for the recognition of isolates
that may be used as agents of bioterrorism?
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Tel/Fax: 91-22-28794410, 28794411, 28794412
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Bibliography:
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expressed a prior general interest in receiving similar information for research and
educational purposes. In the event that any content of this checklist causes harm/unlawful
use/loss/unhappiness to anyone , the same should be brought to the notice of Accreditation
Commission For Conformity Assessment Bodies Private Limited, Mumbai India
info@accab.org
1. College of Physicians & Surgeons of Saskatchewan
2. College of Physicians & Surgeons of Alberta
3. Various other internet sources.
CRA-F-05-15189-S-03-EMIC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
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