Nabl 155

NABL 155
National Accreditation Board for Testing

and Calibration Laboratories (NABL)
Application Form and Checklist

for
Quality Assurance Scheme for Basic Composite Medical
Laboratories (Entry Level)
ISSUE NO. : 01 AMENDMENT NO. : 00

ISSUE DATE : 04- Feb-2019 AMENDMENT DATE : --
AMENDMENT SHEET
Sl Page Clause No. Date of Amendment Reasons Signature Signature

no No. Amendment QM CEO
1
10
National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 155 Application Form and Checklist for Quality Assurance Scheme for Basic Composite Medical Laboratories
(Entry Level)
Issue No: 01 Issue Date: 04-Feb-2019 Amend No: 00 Amend Date: -- Page 1 of 18
CONTENTS
Sl. Title Page
1 Information & Instructions for completing Application Form 3
2. Information & Instructions for Filling Checklist by the Applicant Lab 4
3. Instruction for NABL Assessor for Filling Checklist 5
4. Application Form for QAS-BC 6
5. Checklist 9
6. Test Witnessing (Format A) 17
7. Assessment Summary (Format B) 18

(Entry Level)
Information & Instructions for completing Application Form
1. Application shall be made in the prescribed application form NABL 155 only. All applied disciplines of medical
testing should be covered in the same application form. The application shall consist of the following:
 Two Copies of completed application form

 Prescribed application fees
Incomplete application submitted may lead to closure/rejection of application. In case the space provided is
insufficient, please use additional pages clearly indicating to which section they relate to.
2. The applicant laboratory shall undertake to carry out its testing activities in such a way as to meet the
requirements mentioned in checklist, other relevant requirements of NABL and the regulatory authorities, as
applicable at all times.
3. Applicant laboratories are advised to ensure that the latest versions of NABL documents are available with
them.
4. The applicant laboratory shall provide photocopy of appropriate document(s) in support of the legal status
claimed (eg. Registration Certificate under Indian companies Act, Limited Liability Act, Partnership Act,
Registration of Business as Sole Proprietor, Indian trust Act, Societies Registration Act, Registration under
CEA, Any Government notification in support of establishment of institution/ laboratory or any approval from
local or regulatory bodies etc.) The name of the organization / laboratory shall not be different from the name
given in the proof of legal identity certificate. If it is different, valid reasons for the same shall be furnished.
5. The applicant laboratory shall intimate NABL about any change in the information provided in this application
such as scope applied, personnel, and location etc. within 15 days from the date of changes.
6. NABL expects applicant laboratories to follow the test methods as mentioned in the current National or
International standards and as stipulated by regulatory bodies. Where such methods do not exist, other
validated methods are acceptable. In case laboratory uses in-house validated methods the validation data
should be submitted along with the application.
7. The applicant laboratory must participate satisfactorily in the Proficiency Testing program / EQAS conducted
by national or international PT provider/ Interlaboratrory Comparison (ILC)
8. The laboratory shall also inform NABL in advance about any reservation regarding appointment of Assessor
for the assessment.
9. The applicant laboratory shall be given due notice of any intended changes relating to criteria/requirements
mentioned in checklist and will also be given such time, as in the opinion of NABL is reasonable to carry out
the necessary adjustments to its procedure(s). The laboratory shall inform NABL when such adjustments have
been completed.
10. The application must be filled up carefully to provide required information in such a manner that further
correspondence for seeking clarifications are not required. Particularly the scope applied (para 2.1) shall be
complete to indicate unambiguously:
a. materials or items tested
b. specific tests or types of tests performed
(Entry Level)
c. specification, standard (method) or technique used
d. range of testing/ limit of detection for each test (desirable)
e. %CV for quantitive tests(desirable)
11. The list of tests those are performed at site should be clearly identified in the applied scope (para 2.1).
Note: The lab is allowed to add few basic tests in the list of scope (upto 10% of total number of tests).which
may be T3, T4, TSH, Gram’s staining, Sputum for AFB, PS for MP, Peripheral Blood Smear (Refer Checklist
for details)
12. The laboratory shall submit declaration duly signed by the Technical Head/Laboratory Director to NABL
Secretariat along with this application form. By signing this declaration the laboratory agrees to comply at all
times with Terms and Conditions of NABL (as specified in Procedure -NABL 128).
13. The laboratory shall offer NABL or its representative cooperation in:
a. undertaking any check to verify testing capability of the laboratory.
b. the laboratory shall unambiguously provide names of all authorized signatories who are responsible for
authenticity and issue of test certificates and reports.
c. offering access to relevant areas of the laboratory for witnessing the activity being performed.
d. examination of all relevant documentation and records.
e. interaction with all relevant personnel.
14. The laboratory shall discharge all non-conformities raised during the assessment within the stipulated time.
The same shall be verified to the satisfaction of NABL. The final decision on Quality Assurance Scheme for
Basic Composite Medical Laboratories (Entry Level) shall rest with NABL.
15. The application shall be kept confidential by NABL and information obtained during the processing of
application, assessment visit and grant shall be safeguarded and dealt with impartiality until required by Law.
Information & Instructions for Filling Checklist by the Applicant Lab
The checklist is based on the requirements enlisted in Gazette notification dated 18th May, 2018 by MOHFW to
amend Clinical Establishments (Central Government) Rules, 2012.
Components of assessment of technical competence have been added to the criteria checklist to
ensure quality of test results given by the laboratory and facilitate achieving ISO 15189 accreditation
over a period of time.
The applicant labs are required to fill the checklist in column provided as “Yes or No” for submission along with the
application form.

(Entry Level)
Instruction for NABL Assessor for Filling Checklist
The details filled in by the laboratory are to be verified by the NABL assessor during assessment(initial/on-site
surveillance) and the remarks to be entered in the column provided for the same in the checklist.The
representative number of tests (at least 10% of the applied tests) are to be witnessed. Observations and
comments on overall competence of the laboratory are to be recorded in Format A (whether tests are performed
according to SOPs & other requirements of QAS).
Where non-compliance is observed by the assessor, the statement of non-conformity will be recorded in the
Format B (Assessment Summary). Format B is to be signed jointly by Assessor and Representative of the
Laboratory.

(Entry Level)
Application Form for Quality Assurance Scheme for Basic Composite Medical
Laboratories (Entry Level)
We apply for Quality Assurance Scheme for Basic Composite Medical Laboratories (Entry Level)
for our Basic Composite Testing Medical laboratory as per details given below:
1. Laboratory Details
1. Name of the Laboratory _______________________________________________
1
Location and Address__________________________________________________________
District__________________ Pin Code_______________
State_________________________________________
Telephone No. _____________________ Fax No. __________________E-mail ________________
1.2 Legal identity of the laboratory and date of establishment ______________________________

(Please give Registration No. and name of authority who granted the registration. Copy of the certificate shall be enclosed)
_________________________________________________________________________________________________
1.3 Goods and Service Tax (GST) Number along with PAN/TAN Number
____________________________
1.4 Indicate exactly how the name of the laboratory is going to appear on the certificate
In English _________________________________________________________________________
_________________________________________________________________________________
2. Indicate whether all tests performed in the laboratory have been included in applied scope.
If No, Specify _________________________
Note: All tests performed in the laboratory in compliance with the requirements of checklist have
to be included in the applied scope
2.1 Scope Applied
Sl Type of Samples Specific tests/ Standard (method), Principle /Methodology or technique

no examined/tested examination used
performed
Note 1. Laboratories applying for Point of Care testing shall clearly identify the specific tests/examination performed.

(Entry Level)
3. Organization
3.1 Senior Management (Name, Designation, Telephone, Fax, E-mail)
3.1.1 Name of person in-charge with Qualification and registration number (Technical Head/Lab Director)
_________________________________________________________________________________
3.1.2 Contact person for NABL _______________________________________________________
3.2 Employees
3.2.1 Details of staff including Lab Technicians and support staff
Sl Name Designation Academic and Professional Experience related to
no Qualifications present work (in years)
4. Equipment
List of major test equipment available for use
Sl Name of Model/ type/ Receipt date & Date of last Calibration Calibrated by
no equipment year of make date placed in calibration due on
service
5. Proficiency Testing
Participation in PT / /EQAS/ any other Inter Laboratory Comparison
Sl. Product/ Details of Date of Organizing body Performance in Corrective action
no. Material Test(s)/ Testing/ terms of z taken (if
examination examination score or any required)
other criteria
6. Application Fees
7.1 Application fees (Rs).____________________________________________________________

7.2 DD / At par Cheque*
number___________________________________________________________
(Please refer NABL 100 for fee structure))
*All payments made through Cheques or Demand Draft shall be made in favor of ‘Quality Council of India' payable at Gurgaon.
Note: Kindly make all kind of payments preferably through the ‘Payment Gateway’ available on NABL website (www.nabl-
ndia.org)
(Entry Level)
7. Declaration by the laboratory
We declare that
7.1 We agree to comply with procedure of this scheme, pay charges for assessment irrespective of the
result.
7.2 We agree to co-operate with the assessment team appointed by NABL for examination of all relevant
documents by them and their visits to those parts of the laboratory that are part of the applied scope.
7.3 We satisfy all national, regional and local regulatory requirements for operating a laboratory.
7.4 We agree to comply with the terms & conditions mentioned in NABL 128 (Procedure for Quality
Assurance Scheme for Basic Composite Medical Laboratories (Entry Level)
7.5 All information provided in this application is true.
Signature of Technical Head/ Laboratory Director _________________________________________
Name & Designation ________________________________________________________________
Date & Place ______________________________________________________________________

(Entry Level)
Checklist for Quality Assurance Scheme for Basic Composite Medical Laboratories
(Entry Level)
To be filled in To be filled Remarks by
by the in by NABL Assessor
Applicant Assessor
Laboratory
S.No. Yes/No Yes/No# # In case of Non-
(Specify as Conformity (NC),
statement to be
applicable) written by
assessor in
Format B
I *SCOPE OF LABORATORY *Remarks on
a) Biochemistry competence are
Routine Biochemistry tests – to be provided
by Assessor in
the Format A
 Glucose -Specify
FBS, PPS, GCT, OGTT Specify the tests
 Renal Function Tests witnessed &
whether tests
Urea, Creatinine, Albumin, are performed
Total Protein according to
 Liver Function Tests SOPs & other
T. Bil, D. Bil, ALT, AST, ALP requirements of
QAS-BC
 Amylase
 Lipase
 Lipid Profile
Cholesterol , Triglyceride
 Cerebro-spinal Fluid(CSF)-
Glucose & Protein
 Other Biological Fluids-
Glucose & Protein
 Electrolytes
 Calcium/ Inorganic
Phosphorus
 HbA1c
 Rapid test (Biochemistry
based), Specify
b) Hematology
 Haemogram
CBC
Hb, TLC, DLC, Platelet count,
RBC Count, HCT, MCV, MCH,
MCHC

(Entry Level)
(Entry Level)
Applicant Assessor
Laboratory
statement to be
assessor in
Format B
ESR
 Bleeding Time
 Clotting Time
 Prothrombin Time
 Activated Partial
Thromboplastin Time
 Blood Group
c) Medical Microbiology &

Immunology-
 Rapid test(Point of care tests)
for infection, Specify
 Urine Routine examination
and microscopy
 Hanging drop for Vibrio
cholera
 Stool for ova, cyst
All HIV positive on screening need to

be confirmed as per NACO
guidelines.
Note: The lab is allowed to add few basic

tests in the list of scope (upto 10% of total
number of tests).provided above which may
be T3, T4, TSH, Gram’s staining, Sputum
for AFB, PS for MP, Peripheral Blood Smear
at the time of application when the lab is
adding tests from this list, it shall meet the
requirements of local regulations
w.r.t.authorised signatories for signing the
test reports and produce evidence of the
same during assessment.

(Entry Level)
(Entry Level)
Applicant Assessor
Laboratory
statement to be
assessor in
Format B
II INFRASTRUCTURE
Signage
a. Basic Signage-A signage
within or outside the facility
should be made available
containing the following
information.
b. Name of the person-in-charge
with qualification and
registration number
c. Broad services provided i.e.
Biochemistry, Haematology,
Clinical Pathology – whichever
is applicable.
d. Timings of different
consultants (Desirable)
e. Internet facility or telephone
and mobile number for
appointment
(Desirable)
f. Fee structure: To be displayed
separately including type of
investigation and charges for
all routine tests.
Hygiene and Safety (wherever
applicable)
a. General cleanliness
 Dust free
 Good house keeping
b. Universal standard
precautions for safety

(Entry Level)
(Entry Level)
Applicant Assessor
Laboratory
statement to be
assessor in
Format B
c. Safety hazard and caution
signs - Biomedical waste
segregated in colored bins
and bags as per
Biomedical Waste
Management Rules, 2016
including radioactive
materials, toxic chemicals,
microbial agents, infected
biological material
d. Appropriate Fire exit
signage- Minimum one fire
extinguisher
(Desirable)
Space requirement
a. Registration, waiting room,

public utilities, safe drinking
water etc
b. Sample collection area
c. Laboratory with adequate

diffuse and spot lighting
d. Reporting and billing area
e. Washing area
f. Preservation of the
specimen and slides
g. Electrical facilities
h. Temperature control for

specialized equipment etc.

(Entry Level)
(Entry Level)
Applicant Assessor
Laboratory
statement to be
assessor in
Format B
i. Counselling room for HIV
(If HIV test is done)
Furniture and fixtures

Communication system:
(Desirable)
Telephone and Mobile no. for
appointment
Wash Basins
III HUMAN RESOURCE
a. Minimum Qualification of
Technical Head of
Laboratory or Specialist or
*Authorized Signatories.
Desirable: MBBS from a

recognized university
institution preferably with
medical laboratory
experience
*The authorized signatory

will be liable for authenticity
of the laboratory test report.
(**Where ever interpretation
of lab results or opinion
thereon, are required,
registered Bachelor of
Medicine and Bachelor of
Surgery (MBBS) medical
practitioner is essential.)

(Entry Level)
(Entry Level)
Applicant Assessor
Laboratory
statement to be
assessor in
Format B
b.
No. of Lab technicians with
DMLT or BSc, MLT or M.Sc
Biochemistry or
Microbiology qualification
from a recognized
university or institution-
Essential No.-1
c. Support staff (Laboratory
Assistant or Laboratory
Attendant), roster of salary
of staff, periodic health
check-ups and vaccination
of staff
Essential No.-1
IV EQUIPMENT
a.
List of minimum medical
diagnostics laboratory
equipment/instrument with
quantity(essential as per
scope)
b. Sterilization such as hot air
oven or autoclave
c. List of reagents and
consumables
required
d. Annual maintenance
contract or comprehensive
maintenance contract and
records for equipment (Log
books) (Desirable)
V LEGAL OR STATUTORY
REQUIREMENTS AS APPLICABLE

(Entry Level)
(Entry Level)
Applicant Assessor
Laboratory
statement to be
assessor in
Format B
a.
Registration under the
provisions of Biomedical
Waste Management Rules,
2016 with State or Union
territories’ Or
b. Pollution Control Board with
registration number and date
of expiry, site, space, location
and environmental
requirements to be as per
local bye- laws
VI RECORD MAINTANENCE AND
REPORTING:
a. Reports of all patients date
a wise as per regulatory
requirement or till next audit,
whichever is later.
b. Medico legal records, if
b applicable (as per relevant
law).
c. Record keeping of
c technicians working in
laboratory indicating their
details of qualification training
and others
d. Availability of reference
d library including books or
periodicals or e-journals
(Desirable)
e. Duration of preservation of
record (as applicable from
time to time)
VII STANDARDS ON BASIC
PROCESSES:

(Entry Level)
(Entry Level)
Applicant Assessor
Laboratory
statement to be
assessor in
Format B
a. Infection Control practices -
a as per Bio Medical Waste
Management Rules, 2016
b. Safety considerations- use of
b disposable needles etc
c. Patient Information and

c Education
d. Process of calibration of
d equipment and reagents
e. Booklet of Standard
e operating procedures of all
procedures available(kit
inserts may be used as
SOPs)
f. Grievance registration and
f disposal mechanism
g. Quality Control in the form of

g Internal Quality Control
(atleast one level to be run
on the day of testing
samples) and inter-laboratory
comparison in the form of
external quality assurance
scheme

(Entry Level)
Format A
TEST(S) WITNESSED BY THE ASSESSOR

(To be filled in by Assessor)
Laboratory: Date(s) of Visit:

Assessor: Discipline:
Ref. to Test(s) witnessed Test Method Remarks
Obs. in
Checklist
Signature of Assessor

(Entry Level)
Format B
Assessment Summary
(To be filled by Assessor during Initial/on-site surveillance assessment)
Details of Non-Conformities(NCs) raised w.r.t S.No. of checklist
1.
2.
Date by which the non-conformities are to be discharged by the lab (within 30 days of
assessment) __________
Final Recommendations by the Assessor: Tick mark appropriate option
Recommended as per QAS for Basic Composite Medical Laboratories subject to closure
of NCs
Not recommended as per QAS for Basic Composite Medical Laboratories subject to
closure of NCs
Signature of representative of Lab Signature of Assessor

(Entry Level)
National Accreditation Board for Testing and Calibration Laboratories (NABL)
NABL House,
Plot No. 45, Sector- 44,
Gurugram– 122002, Haryana
Tel.: +91-124 4679700
Fax: +91-124 4679799
Website: www.nabl-india.org

Nabl 155

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NABL 155

National Accreditation Board for Testing

Application Form and Checklist

ISSUE NO. : 01 AMENDMENT NO. : 00

Sl Page Clause No. Date of Amendment Reasons Signature Signature

National Accreditation Board for Testing and Calibration Laboratories

Sl. Title Page

1 Information & Instructions for completing Application Form 3

2. Information & Instructions for Filling Checklist by the Applicant Lab 4

3. Instruction for NABL Assessor for Filling Checklist 5

4. Application Form for QAS-BC 6

6. Test Witnessing (Format A) 17

7. Assessment Summary (Format B) 18

National Accreditation Board for Testing and Calibration Laboratories

 Two Copies of completed application form

Information & Instructions for Filling Checklist by the Applicant Lab

National Accreditation Board for Testing and Calibration Laboratories

National Accreditation Board for Testing and Calibration Laboratories

1.2 Legal identity of the laboratory and date of establishment ______________________________

2.1 Scope Applied

Sl Type of Samples Specific tests/ Standard (method), Principle /Methodology or technique

National Accreditation Board for Testing and Calibration Laboratories

3.1 Senior Management (Name, Designation, Telephone, Fax, E-mail)

3.1.2 Contact person for NABL _______________________________________________________

7.1 Application fees (Rs).____________________________________________________________

7.5 All information provided in this application is true.

Signature of Technical Head/ Laboratory Director _________________________________________

Name & Designation ________________________________________________________________

Date & Place ______________________________________________________________________

National Accreditation Board for Testing and Calibration Laboratories

National Accreditation Board for Testing and Calibration Laboratories

c) Medical Microbiology &

All HIV positive on screening need to

Note: The lab is allowed to add few basic

National Accreditation Board for Testing and Calibration Laboratories

National Accreditation Board for Testing and Calibration Laboratories

a. Registration, waiting room,

c. Laboratory with adequate

h. Temperature control for

National Accreditation Board for Testing and Calibration Laboratories

Furniture and fixtures

Desirable: MBBS from a

*The authorized signatory

National Accreditation Board for Testing and Calibration Laboratories

National Accreditation Board for Testing and Calibration Laboratories

National Accreditation Board for Testing and Calibration Laboratories

c. Patient Information and

g. Quality Control in the form of

National Accreditation Board for Testing and Calibration Laboratories

TEST(S) WITNESSED BY THE ASSESSOR

Laboratory: Date(s) of Visit:

National Accreditation Board for Testing and Calibration Laboratories

(To be filled by Assessor during Initial/on-site surveillance assessment)

Details of Non-Conformities(NCs) raised w.r.t S.No. of checklist

Final Recommendations by the Assessor: Tick mark appropriate option

Signature of representative of Lab Signature of Assessor

National Accreditation Board for Testing and Calibration Laboratories

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