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NABL 153

NATIONAL ACCREDITATION
NABL BOARD FOR TESTING AND
CALIBRATION LABORATORIES

APPLICATION FORM
for MEDICAL TESTING
LABORATORIES

ISSUE NO : 03 AMENDMENT NO : 01
ISSUE DATE: 27.06.2012 AMENDMENT DATE: 22.08.2012
AMENDMENT SHEET

Sl Page Clause No. Date of Amendment Reasons Signature Signature


no No. Amendment made QO Director
1 5/11 13 22.08.2012 Laboratory Internal audit
locations
findings
6/11 1.1

10

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 01 Amend Date:22.08.2012 Page No: 1 / 11
CONTENTS

Sl. Title Page

1 Information & Instructions for completing an Application Form 3


2 Application Form 6

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 00 Amend Date:-- Page No: 2 / 11
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 15189:2007, 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:

Financial Year
2011-12 2012-13
(Rs) (Rs)
Application Fee Small Laboratories (upto100 patients/ day) 12,000 13,000
(covering all fields) Medium Laboratories (101-400 patients/ day) 28,000 30,000
(non-refundable, to be paid
along with the application) Large Laboratories (above 400 patients/ day) 70,000 75,000

Charges Number of Collection centers NA


For Collection up to 10 2,000
Centers >10-50 5,000
> 50- 100 10,000
More than 100 20,000

Enhancement of Any extension in the existing accredited scope 2,800 3,000


Scope

Change in Name/ Any change in the name and or premises of 2,800 3,000
premises of the laboratory leading to issue of new
Laboratory accreditation certificate with scope

Accreditation Fee Small Laboratories (upto 100 patients/ day) 12,000 13,000
(covering all fields)
(per year from the date of
Medium Laboratories (101-400 patients/ day) 28,000 30,000
accreditation) Large Laboratories (above 400 patients/ day) 70,000 75,000

Accreditation Fee Number of Collection Centers NA


for Collection up to 10 2,000
Centers > 10-50 5,000
> 50- 100 10,000
More than 100 20,000

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 00 Amend Date:-- Page No: 3 / 11
Assessment Comprising of - Travel, Boarding, Lodging
Charges Honorarium for NABL Assessors
(payable after the Overhead Charges
completion of
assessment visit to the
laboratory)

Travel, Boarding and Travel to be made by Air in economy class (Apex fare) or by train in 2nd AC Class or by AC
Lodging expenditure Bus.

The laboratory will 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. If the journey is made by own car,
the re-imbursement will be restricted to 2nd AC class fare by train.

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 Adequacy Audit of Quality Manual by Lead Assessor Rs. 1,000
Assessors**
Pre-Assessment - by Lead Assessor Rs. 2,500
per day
- by Technical Assessor/ Expert Rs 2,000
per day
Assessment, Surveillance, Verification, Special Visit
- by Lead Assessor Rs. 2,500
per day
- by Technical Assessor/ Expert Rs. 2,000
per day

Overhead Charges For each assessment (including desktop surveillance) irrespective of Rs. 7,500
number of Disciplines
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’,
NABL 216 ‘Procedures for Dealing with Adverse Decisions’ and NABL 131 ‘Terms and Conditions for
Obtaining & Maintaining Accreditation’, which are supplementary to this form, 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 Companies Act, approval from local or regulatory
bodies, etc.)
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.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 00 Amend Date:-- Page No: 4 / 11
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 may apply for NABL accreditation as a single
laboratory. 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 be applied separately for accreditation.
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 take all necessary actions and 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 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 01 Amend Date:22.08.2012 Page No: 5 / 11
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. Name/ Identification of the Laboratory
1 _______________________________________________
(Permanent Facility)
Locations and Address(s)__________________________________________________________
Telephone No. _____________________ Fax No. __________________E-mail ________________
Note: refer cl 13 for details on laboratory locations

1. Does the laboratory operate from different locations having Yes No


2 same 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,
3.1.5, 3.2.2, 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 details

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 Size of laboratory (inclusive of all centres/locations for which accreditation is being sought)
Small laboratory Medium laboratory Large laboratory

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 01 Amend Date:22.08.2012 Page No: 6 / 11
1.8 Number of collection centers
Upto 10 >10- 50 >50- 100 More than 100

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 01 Amend Date:22.08.2012 Page No: 7 / 11
1.9 Details of primary sample collection facilities at sites other than the permanent facility
(provide list of all facilities with complete contact details)

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 Materials or items Specific tests/ Specification, standard Range of testing/ %CV / MU


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

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 Calibration Laboratories


Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 00 Amend Date:-- Page No: 7 / 11
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 Laboratory/ Name & Qualification Experience in Relevant Authorised for Specimen


no Department/ Designation of with years related to Training which specific Signature
Section Signatory Specialisation present work area of testing

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 (please clearly indicate staff responsible for site testing)
Sl Name Designation Academic and Professional Experience related to
no Qualifications* present work (in years)

* Please clearly indicate the field of specialisation

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

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 00 Amend Date:-- Page No: 8 / 11
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
** 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 ISO15189:2007 covering all activities of laboratory have been
audited at least once in last one year 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. 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

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.

8. Declaration by the laboratory

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 153 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 00 Amend Date:-- Page No: 9 / 11
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 ISO15189:2007 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.
8.3 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.
8.4 We satisfy all national, regional and local regulatory requirements for operating a laboratory.
8.5 __________________________________________________________________________ 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)
8.6 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: 03 Issue Date: 27.06.2012 Amend No: 00 Amend Date:-- Page No: 10 / 11
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 : 2007

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

c) Demand Draft in favour of 'NABL'

6. Copy of Legal Identity (Registration Details of the Laboratory)

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

8. Details of Senior Management with Designation and Contact Details

9. List of Staff and proposed Authorized Signatories

10. Organization Chart enclosed

11. List of Equipments / Reference Material used with details of Traceability

12. Details of PT/EQAS / ILC participation

13. Dates of Internal Audit and Management Review

14. Declaration about the Consultant (if any)

15. 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 Application Form for Medical Testing Laboratories
Issue No: 03 Issue Date: 27.06.2012 Amend No: 00 Amend Date:-- Page No: 11 / 11
National Accreditation Board for Testing and Calibration Laboratories
3rd Floor, NISCAIR
14, Satsang Vihar Marg
New Mehrauli Road
New Delhi – 110 067
Tel.: + 91-11 46499999
Fax: + 91-11 26529716
Website: www.nabl-india.org

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