NABL 153

National Accreditation Board for Testing

and Calibration Laboratories (NABL)

Application Form for Medical

Testing Laboratories

ISSUE NO. : 06 AMENDMENT NO. : 02

ISSUE DATE : 22-Jan-2018 AMENDMENT DATE : 20-June-2018
 AMENDMENT SHEET

Sl Page Clause No. Date of Amendment Reasons Signature Signature

no No. Amendment QM CEO
1 9& 7&9 22.03.2018 Change in Development -Sd- -Sd-
Payment option of NABL
12 payment
gateway/
Cheque/ DD
2 6 1.9 20.06.2018 a to d from a to c typographical -Sd- -Sd-
error
3 11 Annexure-A 20.06.2018 Changes as Start of -Sd- -Sd-
highlighted Recognition of
SCF
4

10

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 1 of 12
 CONTENTS

Sl. Title Page

1 Information & Instructions for completing an Application Form 3

2 Application Form 5

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 2 of 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:

 Copy of completed application form

 Copy of laboratory Quality Manual
 Prescribed application fees
 Duly signed NABL-131
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, NABL specific criteria, 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 application fee and other necessary charges related to accreditation process is given in NABL document
NABL 100 ‘General Information Brochure’ under NABL Finance and NABL Fee Structure’. NABL 100 is
available on NABL website.

5. Laboratories are advised to familiarize themselves with NABL 100 ‘General Information Brochure’, NABL 201
‘Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operations’, NABL 216
‘Procedures for Dealing with Adverse Decisions’ and NABL 131 ‘Terms and Conditions for Obtaining and
Maintaining Accreditation’ before filling up this form.
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 APLAC or NABL any other national or international accredited/ recognized PT provider. For participation in
PT, refer NABL document NABL 163. .
10. The laboratory shall also inform NABL in advance about any reservation regarding appointment of Lead
Assessor/ Assessor for the assessment.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 3 of 12
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: Multilocation laboratory: A laboratory with more than one location in the same city with same legal identity and
with overlapping scopes in different locations. The details of each location shall be explicitly mentioned in 1.1 of
application form. In events where the laboratory operates from different city/ state, each laboratory shall apply
separately for accreditation except those cases where safety or regulatory requirements are there for operation of the
laboratory. In such cases, the laboratory shall provide the proper justification.
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 authorized 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 centres 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 the stipulated time.
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 until
required by Law. 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 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 4 of 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

Extension of Scope (Apart from the scheduled assessment)

(If accredited by NABL, Please provide accreditation certificate no. & validity (if applicable) & CAB ID:
____________________________________________________________________________________________

1. Laboratory Details
1. Name/ Identification of the Laboratory _______________________________________________
1
(Permanent Facility)
Locations and Address(s)__________________________________________________________
Telephone No. _____________________ Fax No. __________________E-mail ________________
Note: Refer cl 13 of NABL 153 & cl 3 & 4 of NABL 112 for details on laboratory locations

1.2 Does the laboratory operate from different locations having same Yes No
legal identity within the city?

a. If yes, whether application for accreditation covers all Yes No

locations
b. If yes, whether complete details have been provided for Yes No
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.

1. Do you conduct Testing in the following Category

3
(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 Organization _________________________________________________ _______

(if part of an organization)
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 Goods and Service Tax (GST) Number along with PAN/TAN Number
______________________________________________________________________________________

1.7 Type of laboratory by service

(please tick in appropriate box)
National Accreditation Board for Testing and Calibration Laboratories
Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 5 of 12
 open to others partly open to others an in-house activity
1.8 Category for which accreditation is being sought
 Small Laboratory  Very Large Laboratory

 Medium Laboratory  Large Laboratory

Note: Refer section 4 for details on category

1.9 Does laboratory gets samples from Sample Collection Centres/ Facilities Yes No
(If yes, please furnish details of Sample Collection Centres/ Facilities (Refer Annexure-A Attached with Application. List of collection
centres / facilities shall be segregated as defined in clause 6 (a to d) of NABL- 112.

1.10 Details of other source(s) of sample collection other than the medical testing laboratory or sample collection
centre/ facility
(Provide list of all facilities with complete contact details with address)

1.11 Other accreditations ______________________________________________________

1.12 Indicate exactly how the name of the laboratory and the centres (if any) are to appear on the certificate
In English _________________________________________________________________________
_________________________________________________________________________________
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 Serelogy

 Histopathology

 Cytopathology

 Genetics

 Nuclear Medicine (in-vitro tests only)

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 6 of 12
2.2 Scope of Accreditation

Sl Type of Samples Specific tests/ Standard (method), Range of testing/ %CV / MU

no examined/tested examination Principle /Methodology or Limit of detection ( )
performed technique used

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

3. Organization

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

3.1.1 Chief Executive of the laboratory _________________________________________________

3.1.2 Laboratory Director _________________________________________________

3.1.3 Person responsible for the management system _____________________________________

3.1.4 Person responsible for technical operations ________________________________________

3.1.5 Contact person for NABL _______________________________________________________

3.2 Authorized Signatories

3.2.1 Authorized Signatories for approval of test reports

(Please refer to NABL 112 for qualification and experience details))

Sl Laboratory/ Name & Qualification Experience in Relevant Part time / Full Authorised for Specimen
no Department/ Designation of with years related to Training time (timings if which specific Signature
Section Signatory Specialization present work part time) area of testing

3.3 Organization Chart

3.3.1. Indicate in an organization 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 organizations or to its own parent organization
(where applicable)

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 7 of 12
3.4 Employees
3.4.1 Details of staff
Sl Name Designation+ Academic and Professional Experience related to
no Qualifications* present work (in years)

* Please clearly indicate the field of specialization

+
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 Name of Model/ type/ Receipt date & Range and Date of last Calibration Calibrated by**
no equipment year of make date placed in accuracy calibration due on *
service

List of reference materials available for use

Sl. Name of reference material/ Source Date of Traceability
no. strain/ culture expiry/ validity

* the laboratory to decide the calibration interval based on NABL-112 & ISO 10012 or ILAC-G24
** 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 Whether all requirements of ISO15189:2012 covering all activities of laboratory have been audited at
least once in last one year YES/NO
5.1.2 Whether various locations (including collection centres) were covered in the audit: YES /NO
5.1.3 Whether pre and post examination activities were included in the audit schedule : YES/NO

5.2 Date of last Management Review ___________________________________________________

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 8 of 12
6. Proficiency Testing

Participation in PT / any other Inter Laboratory Comparison/EQAS

(for details and requirements please refer to ISO/ IEC 17043, & NABL 163, NABL 112)

Sl. Product/ Details of Date of Organizing body Performance in Corrective

no. Material Test(s)/ Testing/ terms of z action taken (if
examination examination score or any required)
other criteria

7. Application Fees

7.1 Application fees (Rs).____________________________________________________________

7.2 DD / At par Cheque* number___________________________________________________________

(Please refer Specific Criteria for Medical Testing Laboratories; NABL 112)

*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)

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 9 of 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 have conducted internal audit of our Sample Collection Centre/ facility (ies) at least once during the
last one year.
8.3 We agree to comply fully with ISO15189:2012 and relevant specific criteria for the accreditation of
testing laboratory and associated Sample Collection Centre/ Facility (ies) .
8.4 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.
8.5 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.
8.6 We satisfy all national, regional and local regulatory requirements for operating a laboratory.
8.7 __________________________________________________________________ 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)
8.8 No adverse action has been initiated / taken against the laboratory in the past. (If yes, please provide
the details with present status ………………………………………………………..)

8.9 Self declaration shall be submitted by the laboratory on the basis of the internal audit conducted by them,
to confirm to NABL that their collection centres / facilities are complying with NABL norms and relevant
clauses of ISO 15189.

8.10 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 Application Form for Medical Testing Laboratories
Issue No: 06 Issue Date: 22-Jan-2018 Amend No: 02 Amend Date: 20-Jun-2018
Page 10 of 12
 Lab ID Lab ID

Name of Collection Lab Name

Centre/Facility

Type of Collection (M-/MC-)Certificate No.

centre/facility (Refer clause
6 (a to c) of NABL- 112

Owner/Contact Person yyyy)Issue Date (dd.mm.

Email yyyy)Valid Date (dd.mm.

Phone entreNo. of Sample Collection

Mobile Number State

dd/mm/yyyyLast Internal Audit Date City

Av. No. Patient/ Day PIN

(in Sqm)Areas of SCF Location of Lab

(in Km)Distance from Laboratory

Complete Lab Address

Type of Transport Receipt) Mode of Payment (Drop

Annexure - A

(Rail/Road/Air) Down - DD/ Cheque/ UTR/

Give Details of Sample Collection Centre/ Facility (Add rows for more SCFs)

Logistics arrangement Name of Bank

Does centre/ facility DD/Cheque/ UTR/ Receipt

complies with latest No
Biomedical waste
management rules - Y/N

(Fortnight 1/2)Tentative assessment Date (dd/mm/yyyy)

Month for the assessment Amount

First Name
State
Sample Collection Centre/ Facility (SCF) (To be submitted by lab declaring SCFs)

City
PIN

Location Last Name

Email
Landmark
Address
9. Application Form - Check List

Sl. Information / details provided as part of application Availability

1. Three copies of Application Forms

2. Two copies of Quality Manual (latest issue) according to ISO 15189 : 2012
3. Application fees
 Information on size of the laboratory & number of Collection Centres
applied for accreditation
 Estimated applicable fees as per NABL 100
 Demand Draft / At Par Cheque in favor of Quality Council of India’ &
details of payment made through Payment Gateway of NABL
6. Copy of Legal Identity (Registration Details of the Laboratory)
7. Goods and Service Tax (GST) Number along with PAN/TAN Number
8. Details of Sample Collection Centre/ Facility as per Annexure-A (if applicable)
9. Scope of Accreditation with Test Methods, Range of Testing and MU/ % CV
10. Details of Senior Management with Designation and Contact Details
11. List of Staff and proposed Authorized Signatories
12. Organization Chart enclosed
13. List of Equipments / Reference Material used with details of Traceability
14. Details of PT/EQAS / ILC participation
15. Dates of Internal Audit and Management Review
16. Self declaration to confirm that laboratory’s collection centres/ facilities are
complying with NABL norms and relevant clauses of ISO 15189 on the basis of
the internal audit conducted by laboratory.
17. Declaration about the Consultant (if any)
18. 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 (NABL)

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