NABL 153

NABL

NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBRATION LABORATORIES

APPLICATION FORM
for MEDICAL TESTING LABORATORIES

ISSUE NO : 04
ISSUE DATE: 01.10.2013

AMENDMENT NO : 00
AMENDMENT DATE: --

AMENDMENT SHEET
Sl
no

Page
No.

Clause No.

Date of
Amendment

Amendment
made

Reasons

Signature
QO

Signature
Director

1
2
3

10

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No:-00

Amend Date:--

Page No: 1 / 12

CONTENTS
Sl.

Title

Page

Information & Instructions for completing an Application Form

Application Form

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 2 / 12

Information & Instructions for completing an Application Form

1. Application shall be made in the prescribed form NABL 153 only. All applied fields of medical testing
should be covered in the same application form. The application shall consist of the following:
Three copies of completed application forms
Two copies of laboratory Quality Manual
Prescribed application fees
Copy of NABL-131 duly signed
Incomplete application and insufficient number of copies submitted may lead to 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
requirement of ISO 15189:2012, additional 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 application fee and other necessary charges related to accreditation process will be applicable as
per the details given below:

Application Fee

(covering all fields)

(non-refundable, to be paid
along with the application)

Small Laboratory (upto100 patients/ day/

location)
Medium Laboratory (101-400 patients/ day/
location)
Large Laboratory (401-1000 patients/ day/
location)
Very Large Laboratory ( more than 1000
patients/ day/ location)
Multiple Locations Laboratory (more than one
locations in the same city)

Financial Year
2013-14
2014-15
(Rs)
(Rs)
15,000

17,000

34,000

40,000

85,000

1000,00

1,50,000

2,000,00

1,50,000

2,000,00

NA
2,500
6,000
12,000
24,000

3,000
7,000
14,000
28,000

Charges
for Collection
Centers

Number of Collection centers

up to 10
>10-50
> 50- 100
More than 100

Enhancement of
Scope

Any extension in the existing accredited scope

in the same size of the laboratory i.e. small/
medium/ large /very large

4,000

5,000

Change in Name/
premises of
Laboratory

Any change in the name and or premises of

the laboratory leading to issue of new
accreditation certificate with scope

4,000

5,000

Change in
Authorized
Signatory

Any addition of authorized signatory(s) apart

from the scheduled assessment

4,000/request

5,000/request

Accreditation Fee

Small Laboratory

15,000

17,000

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 3 / 12

(covering all fields)

(per year from the date of
accreditation)

Medium Laboratory

Accreditation Fee
for Collection
Centers

Number of Collection Centers

up to 10
> 10-50
> 50- 100
More than 100

Overhead Charges

For each assessment (including desktop

surveillance) irrespective of number of
Disciplines

Assessment
Charges

Large Laboratory
Very Large Laboratory
Multiple Location Laboratory

Comprising of

(payable after the

completion of assessment
visit to the laboratory)

Travel, Boarding and

Lodging expenditure

34,000

40,000

85,000
1,50,000
1,50,000

1,00,000
2,00,000
2,00,000

2,500
6,000
12,000
24,000

3,000
7,000
14,000
28,000

8,500

10,000

Travel, Boarding, Lodging

Honorarium for NABL Assessors
Overhead Charges

a) Travel to be made by Air in economy class (Apex fare) or by train in 2nd AC

Class or by AC Bus.
b) The laboratory shall provide the tickets as per above entitlement. If the
laboratory is not able to provide the tickets, NABL will reimburse the expenses
incurred by the assessors as per above entitlement, on production of ticket/
receipt/ boarding pass and consecutively the incurred expenses (on actuals)
shall be paid by the laboratory to NABL based on the invoice. If the journey is
made by own car, the re-imbursement will be restricted to 2nd AC class fare
by train
c) The laboratory shall also make arrangements for boarding & lodging for the

Assessment team. A single occupancy AC accommodation may be provided

for each Assessor/ Observer in a reasonably good hotel/ guesthouse and
arrangement for local transportation from temporary residence to the
laboratory site and airport/ railway station/ bus stand.

Honorarium for NABL

Assessors

Adequacy Audit of Quality Manual by Lead Assessor

Rs. 1,500

Pre-Assessment

Rs. 3,000 /day

Rs. 2,500/ day

- by Lead Assessor
- by Technical Assessor/ Expert
Assessment, Surveillance, Verification, Special Visit
- by Lead Assessor
- by Technical Assessor/ Expert

Rs. 3,000 / day

Rs. 2,500 / day

Note: 1. All payments shall be made by demand draft payable in favour of NABL at New Delhi.
2. In addition to the above mentioned fee, service tax @ 12.36 % (Existing) (or) as applicable to be paid along with said charges /
fees

5. Laboratories are advised to familiarize themselves with NABL 100 General Information Brochure,
NABL112 Specific Criteria for Accreditation of Medical Laboratories and NABL 131 Terms and
Conditions for Obtaining & Maintaining Accreditation before filling up this form.
National Accreditation Board for Testing and Calibration Laboratories
Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 4 / 12

6. 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, 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.
7. The applicant laboratory shall intimate NABL about any change in the information provided in this
application such as scope applied for accreditation, personnel, and location etc. within 15 days from the
date of changes.
8. NABL expects applicant laboratories that are to be accredited 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.
9. The applicant laboratory must participate satisfactorily in the Proficiency Testing program / EQAS
conducted by NABL / APLAC or any other national or international accredited/ recognized PT provider.
The minimum stipulated participation is one type of test per discipline prior to grant of accreditation.
The satisfactory performance shall be defined in term of Z score or any other criteria depending upon
the program design. For unsatisfactory performance, the laboratory shall take corrective action and
inform NABL.
10. The laboratory shall also inform NABL in advance about any reservation regarding appointment of
Lead Assessor/ Assessor for the assessment.
11. The applicant laboratory shall be given due notice of any intended changes relating to NABL
accreditation criteria 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.
12. 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 of accreditation (para
2.2) shall be complete to indicate unambiguously:
a. materials or items tested
b. specific tests or types of tests performed
c. specification, standard (method) or technique used
d. range of testing/ limit of detection for each test (as applicable)
e. % CV (or) uncertainty of measurement (MU) for each test (wherever applicable) at a confidence
probability of 95%.
13. The laboratory locations, tests, which the laboratory intends to cover, vide NABL accreditation must be
listed clearly. The tests those are performed at site should be clearly identified in the scope of
accreditation (para 2.2).
Note: Laboratory operates from different locations in the same city can apply for NABL accreditation as a single
laboratory. The details of each location shall be explicitly mentioned in 1.1 of application form. NABL will issue a
single certificate to the laboratory with main lab address on the accreditation certificate and details of all
locations in the annexure (ie. scope of accreditation). In events where the laboratory operates from different city/
state, each laboratory shall be applied separately for accreditation.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 5 / 12

14. The laboratory shall submit NABL 131 duly signed by the Chief Executive or his/her Authorized
Representative to NABL Secretariat along with this application form. By signing NABL 131 the
laboratory agrees to comply at all times with Terms and Conditions of NABL.
15. The laboratory shall offer the 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 authorised signatories who are
responsible for authenticity and issue of test certificates and reports.
c. offering access to relevant areas of the laboratory including primary sample collection centers for
witnessing the activity being performed.
d. examination of all relevant documentation and records.
e. interaction with all relevant personnel.
16. The laboratory shall discharge all non-conformities raised during the assessment within a
maximum time of two months. The same shall be verified to the satisfaction of NABL. The final
decision on accreditation shall rest with NABL.
17. The application shall be kept confidential by NABL and information obtained during the processing of
application, assessment visit and grant of accreditation shall be safeguarded and dealt with impartiality.
The procedure for processing of application for accreditation is given in NABL 100.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 6 / 12

Application Form for Laboratory Accreditation

We apply for NABL accreditation of our medical testing laboratory as per details given below:
First Accreditation

Renewal of Accreditation

1. Laboratory Details
1.1 Name/ Identification of the Laboratory _______________________________________________
(Permanent Facility)

Locations and Address(s)__________________________________________________________

Telephone No. _____________________ Fax No. __________________E-mail ________________
Note: refer cl 13 for details on laboratory locations

1.2 Does the laboratory operate from different locations having

same legal identity within the city?

Yes

No

a.

If yes, whether application for accreditation covers all

locations

Yes

No

b.

If yes, whether complete details have been provided for

each location with respect to 1.1, 2.1, 2.2, 3.1.2, 3.1.3, 3.3,
4, 6 of the application form.

Yes

No

1.3 Do you conduct Testing in the following Category

(if yes, please clearly indicate in the scope of accreditation, sl. no. 2.2, the test conducted)

a.

Site Facility (when undertaking testing at site of the customer)

Yes

No

b.

Permanent Facility

Yes

No

c.

Mobile Laboratory

Yes

No

Note: Please refer NABL-130 for requirements on site /mobile facilities

1.4 Name of Parent Organisation ________________________________________________________

(if part of an organisation)

Telephone No. _____________________ Fax No. __________________ E-mail _______________

1.5 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)
_________________________________________________________________________________________________

1.6 Type of laboratory by service

(please tick in appropriate box)

open to others

partly open to others

an in-house activity

1.7 Category for which accreditation is being sought

Small Laboratory

Very Large Laboratory

Medium Laboratory

Multiple Location Laboratory

Large Laboratory
Note: refer section 4 for details on category
National Accreditation Board for Testing and Calibration Laboratories
Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 7 / 12

1.8 Number of collection centers

Upto 10

>10- 50

>50- 100

More than 100

1.9 Details of primary sample collection facilities other than the permanent facility
(Provide list of all facilities with complete contact details. List of facilities shall segregated in terms of ownership, management,
Franchisee as referred in NABL- 112)

1.10 Other accreditations ______________________________________________________

1.11 Indicate exactly how the name of the laboratory and the centres (if any) are to appear on the
certificate (the current bi-lingual system calls for this information)
In English _________________________________________________________________________
_________________________________________________________________________________
In Hindi __________________________________________________________________________
_________________________________________________________________________________

2. Accreditation Details
2.1 Disciplines for which accreditation is sought
(please tick the appropriate box, separate application to be filled for each discipline, refer to NABL 112 for details on scope)

Clinical Biochemistry

Clinical Pathology

Haematology and Immunohaematology

Microbiology and Serology

Histopathology

Cytopathology

Genetics

Nuclear medicine (in-vitro tests only)

2.2 Scope of Accreditation

Sl
no

Type of Samples
examined/tested

Specific tests/
examination
performed

Standard (method),
Principle /Methodology or
technique used

Range of testing/
Limit of detection

%CV / MU
( )

Note 1. Laboratories performing site testing shall clearly identify the specific tests/examination performed at site.
Note 2. Laboratories are encouraged to provide estimates of Measurement of Uncertainty (MU) / % CV. MU should be calculated
at a confidence probability of 95%.

National Accreditation Board for Testing and C alibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 8 / 12

3. Organisation
3.1 Senior Management (Name, Designation, Telephone, Fax, E-mail)
3.1.1 Chief Executive of the laboratory _________________________________________________
3.1.2 Person responsible for the management system _____________________________________
3.1.3 Person responsible for technical operations ________________________________________
3.1.4 Contact person for NABL _______________________________________________________
3.2 Authorised Signatories
3.2.1 Authorised Signatories for approval of test reports
(Please refer to NABL 112 for qualification and experience details))
Sl
no

Laboratory/
Name &
Qualification Experience in Relevant Part time / Full Authorised for
Department/ Designation of
with
years related to Training time (timings if which specific
Section
Signatory
Specialisation present work
part time)
area of testing

Specimen
Signature

3.3 Organisation Chart

3.3.1. Indicate in an organisation chart the operating departments of the Medical testing laboratory for
which accreditation is being sought (please append)
3.3.2 Indicate how the testing laboratory is related to external organisations or to its own parent
organisation (where applicable)
3.4 Employees
3.4.1 Details of staff
Sl
no

Name

Designation+

Academic and Professional

Qualifications*

Experience related to
present work (in years)

* Please clearly indicate the field of specialisation

+ Quality

Manager shall have 4 days training course on laboratory management system from a reputed institute
Note: Laboratory operating in shifts shall clearly identify the staff working in shifts

4. Equipment and Reference Materials

List of major test equipment available for use
Sl
no

Name of
equipment

Model/ type/ Receipt date &

year of make date placed in
service

Range and
accuracy

Date of last
calibration

Calibration Calibrated by**

due on *

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 9 / 12

List of reference materials available for use

Sl.
no.

Name of reference material/

strain/ culture

Source

Date of
expiry/ validity

Traceability

* the laboratory to decide the calibration interval based on NABL-112 & ISO 10012
** Please mention name of calibration agency. In case the equipment is calibrated in-house, same needs to be clearly indicated
under this column.

5. Internal Audit and Management Review

5.1 Date /schedule of last Internal Audit _________________________________________________
5.1.1
5.1.2
5.1.3

Whether all requirements of ISO15189:2012 covering all activities of laboratory have been
audited at least once in last one year
YES/NO
Whether various locations (including collection centers) were covered in the audit: YES /NO
Whether pre and post examination activities were included in the audit schedule: YES/NO

5.2 Date of last Management Review ___________________________________________________

6. Proficiency Testing
Participation in NABL/ APLAC/ any other Inter Laboratory Comparison/EQAS
(for details and requirements please refer to ISO/ IEC 17043, NABL 162 & NABL 163)

Sl.
no.

Product/
Material

Details of
Test(s)/
examination

Date of
Testing/
examination

Organizing body

Performance in
terms of z
score or any
other criteria

Corrective
action taken (if
required)

7. Application Fees
7.1 Application fees (Rs).____________________________________________________________
7.2 DD / Cheque** number___________________________________________________________
*while estimating total fees laboratory shall consider the number of collection centers along with the size of the
laboratory.
**NABL will accept at par cheques also. All payments shall be made in favor of 'NABL' payable at New Delhi.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 10 / 12

8. Declaration by the laboratory

We declare that
8.1 We are familiar with the terms and conditions of maintaining accreditation (NABL 131), which is
enclosed and will abide by them.
8.2 We agree to comply fully with ISO15189:2012 for the accreditation of testing laboratory.
8.3 We agree to comply with accreditation procedures, pay all costs for pre-assessment,
assessment, verification visit (if any), surveillance and reassessment irrespective of the result.
8.4 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
scope of accreditation.
8.5 We satisfy all national, regional and local regulatory requirements for operating a laboratory.
8.6 __________________________________________________________________________ has
provided consultancy for preparing towards NABL accreditation. (Information regarding any
individual or organization who provided consultancy (if any) for NABL accreditation shall be
declared)
8.7 All information provided in this application is true.
Signature of Laboratory Head/ Laboratory Director _________________________________________
Name & Designation ________________________________________________________________
Date & Place ______________________________________________________________________

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 11 / 12

9. Application Form - Check List

Sl.

Information / details provided as part of application

1.

Three copies of Application Forms

2.

Two copies of Quality Manual (latest issue) according to ISO 15189 : 2012

3.

Application fees
a) Information on size of the laboratory & number of Collection Centres
applied for accreditation
b) Estimated applicable fees as per NABL 153

Availability

c) Demand Draft in favour of 'NABL'

4.

Copy of Legal Identity (Registration Details of the Laboratory)

5.

Scope of Accreditation with Test Methods, Range of Testing and MU/ % CV

6.

Details of Senior Management with Designation and Contact Details

7.

List of Staff and proposed Authorized Signatories

8.

Organization Chart enclosed

9.

List of Equipments / Reference Material used with details of Traceability

10.

Details of PT/EQAS / ILC participation

11.

Dates of Internal Audit and Management Review

12.

Declaration about the Consultant (if any)

13.

Signed copy of NABL 131 ( latest issue)

Verified the above details and confirmed the availability of all required documents/ details as part of
application form.
Signature of Laboratory Head / Director ----------------------------------------------------------------------------------------Name & Designation ____________________________________________________________________
Date & Place __________________________________________________________________________

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153
Issue No: 04

Application Form for Medical Testing Laboratories

Issue Date: 01.10.2013
Amend No: 00

Amend Date:--

Page No: 12 / 12

National Accreditation Board for Testing and Calibration Laboratories

NABL House
Plot No. 45, Sector- 44,
Gurgaon 122002, Haryana
Tel.: +91-124 4679700
Fax: +91-124 4679799
Website: www.nabl-india.org