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NABLNATIONAL ACCREDITATIONBOARD FOR TESTING ANDCALIBRATION LABORATORIES
NABL 151
APPLICATION FORM
forTESTING LABORATORIES
ISSUE NO : 12 AMENDMENT NO : 02ISSUE DATE: 27.06.2012 AMENDMENT DATE: 16.10. 2012
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 02 Amend Date: 16.10.2012 Page No: 1/11
AMENDMENT SHEET
Slno
PageNo.
ClauseNo.
Date ofAmendment
Amendmentmade
Reasons SignatureQO
SignatureDirector
1 6/11
7/11
13
1.1
22.08.2012 Laboratory locations Internal auditfindings
2 9/11 3.4.1 16.10.2012 Quality manager shallhave 4 days training
Laboratory operatingshifts shall identifythe staff working inshift
APLAC finding
3
4
5
6
7
8
9
10
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 00 Amend Date: -- Page No: 2/11
CONTENTS
Sl. No Title Page
1 Information & Instructions for completing an Application Form 3
2 Application Form 7
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 00 Amend Date: -- Page No: 3/11
Information & Instructions for completing an Application Form
1. Application shall be made in the prescribed form NABL 151 only. Separate application form shall besubmitted for each discipline of testing. The application shall consist of the following:
Three copies of completed application form
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 ofapplication. In case the space provided is insufficient, please use additional pages clearly indicating towhich section they relate to.
2. The applicant laboratory shall undertake to carry out its testing activities in such a way as to meet therequirement of ISO/IEC 17025: 2005, 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 availablewith them.
4. The application fee and other necessary charges related to accreditation process will be applicable asper the details given below:
F i n a n c i a l Y e a r
Application Fee (non-refundable, to be paidalong with the application)
Testing Laboratories (other than Forensiclaboratories):Upto 2 product groups per discipline oftesting (eg. Metals & alloys, Food &agricultural products, Drugs &pharmaceuticals, Textiles etc.)
2011-12(Rs)
2012-13(Rs)
14,000 15,000
For each additional product group in eachdiscipline of testing
7,000 7,500
Forensic Laboratories (covering all sub-discipline):
28,000 30,000
Enhancement of Scope(apart from renewalassessment)
Testing LaboratoriesAny extension in the existing accreditedscope per discipline of testing
2,800 / group 3,000 / group
For each additional product group in each
discipline of testing (same as initialassessment)
7,000 7,500
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 00 Amend Date: -- Page No: 4/11
Annual AccreditationFee
Testing Laboratories(per discipline):
14,000 15,000
(per year from the date ofaccreditation)
Forensic Laboratories(covering all sub-discipline):
28,000 30,000
Assessment Charges(payable after thecompletion of assessmentvisit to the laboratory)
Comprising of -
-
-
Travel, Boarding, Lodging
Honorarium for NABL Assessors
Overhead Charges
Travel, Boarding andLodging expenditure
Travel to be made by Air in economy class (Apex fare) or by train in 2nd AC Class or byAC Bus.
The laboratory shall provide the tickets as per above entitlement. If the laboratory is notable to provide the tickets, NABL will reimburse the expenses incurred by the assessorsas per above entitlement, on production of ticket/ receipt/ boarding pass. If the journey ismade 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 Assessmentteam. A single occupancy AC accommodation may be provided for each Assessor/Observer in a reasonably good hotel/ guesthouse and arrangement for localtransportation from temporary residence to the laboratory site and airport/ railway station/bus stand.
Honorarium for NABLAssessors
Adequacy Audit of Quality Manual by Lead Assessor Rs. 1,000
Pre-Assessment - by Lead Assessor Rs. 2,500
- by Technical Assessor/ Expert Rs. 2,000
Assessment, Surveillance, Verification, Special Visit
- by Lead Assessor Rs. 2,500per day
- by Technical Assessor/ Expert Rs. 2,000per day
For additional discipline of testing
a.Testing laboratories except ForensicLaboratories
b.Forensic Laboratories (covering all sub-discipline)
14,000
28,000
15,000
30,000
Forensic LaboratoriesAny extension in the existing accreditedscope
2,800 3,000
Change in Name ofLaboratory or premises
Any change in the name of the laboratory oraddress leading to issue of newaccreditation certificate with scope
2,800 / discipline 3,000 / discipline
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 00 Amend Date: -- Page No: 5/11
2011-12(Rs)
2012-13(Rs)
Overhead Charges For each assessment (including Desktop surveillance)irrespective of number of disciplines
7000 7500
Note: 1. Payments shall be made in demand draft/ at par cheques in favor of NABL payable at New Delhi.
2. In addition to the above mentioned fee, service tax @ 12.36 % (Existing / as applicable) to be paid along with the charges /fees5. 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 forObtaining and Maintaining Accreditation before filling up this form.
6. The applicant laboratory shall provide photocopies of appropriate document in support of thelegal identity claimed (eg. Registration Certificate under Companies Act, approval from local orregulatory 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, location etc. within 15 days from thedate of changes.
8. NABL expects applicant laboratories that are to be accredited to follow the test methods as mentionedin the current National or International standards and as stipulated by regulatory bodies. Where suchmethods do not exist, other validated methods are acceptable. In case laboratory uses in-housevalidated methods the validation data should be submitted along with the application.
9. The applicant laboratories must participate satisfactorily in the Proficiency Testing program conductedby NABL/ APLAC or any other national or international accredited/ recognized PT provider. In cases,where formal accredited /recognized PT programmes are not available, the laboratory will either initiateInter laboratory comparison or participate in Appropriate ILC programme conducted by accredited
/reputed laboratory. The minimum stipulated participation is one type of test per discipline prior to grantof accreditation. The satisfactory performance shall be defined in term of z score. For unsatisfactoryperformance, the laboratory shall take corrective action and inform NABL.
10.The laboratory shall also inform NABL in advance about any reservation with valid reason regardingappointment of Lead Assessor/ Assessor for the assessment.
11.The applicant laboratory shall be given due notice of any intended changes relating to NABLaccreditation criteria and will also be given such time, as in the opinion of NABL is reasonable to carryout the necessary changes to its policies/practices & procedure(s). The laboratory shall inform NABLwhen such changes have been completed.
12.The application must be filled up carefully to provide required information in such a manner that furthercorrespondence for seeking clarifications are not required. Particularly the scope of accreditation (para2.2) shall be complete to indicate unambiguously:
a. group of products, materials or items testedb. specific tests or types of tests performedc. specification, standard (method) or technique used with year of publicationd. range of testing/ limit of detection for each test (as applicable)
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 01 Amend Date: 22.08.2012 Page No: 6/11
e. uncertainty of measurement (MU) for each test (wherever applicable) at a confidence probability of95%
13.The details of laboratory locations and the tests which the laboratory intends to cover vide NABLaccreditation must be listed clearly. The tests those are performed at site should be clearlyidentified in the scope of accreditation.
Note: Laboratory operates from different locations in the same city may apply for NABL accreditation as a singlelaboratory. The details of each location shall be explicitly mentioned in 1.1 of application form. In events wherethe 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 AuthorizedRepresentative to NABL Secretariat along with this application form. By signing NABL 131 thelaboratory 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 for witnessing the test 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 raisedduring the assessment within a maximum time of two months. The same shall be verified to thesatisfaction 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 ofapplication, 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.
* * *
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 01 Amend Date: 22.08.2012 Page No: 7/11
Application Form for Laboratory Accreditation
We apply for NABL accreditation of ourtesting laboratory as per details given below:
First Accreditation Renewal of Accreditation
1. Laboratory Details
1.1 Name of the Testing Laboratory_____________________________________________________Locations and Address(s)_________________________________________________
Telephone No. _____________________ Fax No. __________________ E-mail ________________
Note: refer cl. 13 for details on laboratory locations
1.2 Category of Facility(s) applied under the scope of Accreditation
(Please clearly indicate in the scope of accreditation, para 2.2, the test conducted)
a. Permanent Facility Yes No
b. Site Facility Yes No
c. Mobile facility Yes No
Note: for details please refer NABL-130
1.3 Name of Parent Organization ________________________________________________________(if part of an organization)
Telephone No. _____________________ Fax No. __________________ e-mail ________________
1.4 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)
_________________________________________________________________________________________________
1.5 Type of laboratory by service
open to others partly open to others an in-house activity
1.6 Other accreditations _______________________________________________________________
1.7 Indicate exactly how the name and address of the laboratory are to appear on the certificate (the current bi-lingual system calls for this information)
In English _________________________________________________________________________
_________________________________________________________________________________
In Hindi __________________________________________________________________________
_________________________________________________________________________________
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 00 Amend Date: --- Page No: 8/11
2. Accreditation Details
2.1 Discipline of Testing for which accreditation is sought
Biological Mechanical
Chemical Non-Destructive
Electrical Optical/ Photometry Electronic Radiological
Fluid-Flow Thermal
Forensic Science
2.2 Scope of Accreditation
Slno
Group of products,materials or itemstested
Specific tests or typesof tests performed
Specification, standard(method) or technique used
Range of testing/Limit of detection
MeasurementUncertainty
( )
Note 1. Laboratories performing site testing shall clearly identify the specific tests on product(s)/ material performed at siteseparately.
3. Measurement uncertainty shall be expressed as expanded uncertainty with 95% confidence level
4. Test methods and standards shall be mentioned along with the year of publication of the standard
5. In case of enhancement of scope; it shall be specifically mentioned and clearly identified in the scope of accreditation
3. Organization
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 Authorized Signatories
3.2.1 Authorized signatories for approval of test reports(Please refer relevant specific criteria for qualification and experience details)
Slno
Laboratory/Department/
Section
Name &Designation of
Signatory
Qualificationwith
Specialization
Experience inyears related to
present work
RelevantTraining
Authorized forwhich specificarea of testing
SpecimenSignature
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 02 Amend Date: 16.10.2012 Page No: 9/11
3.3 Organization Chart
3.3.1. Indicate in an organization chart the operating departments of the testing laboratory for whichaccreditation is being sought (please append)
3.3.2 Indicate how the testing laboratory is related to external organizations or to its own parentorganization (where applicable)
3.4 Employees
3.4.1 Details of staff
Slno
Name Designation+ Academic and ProfessionalQualifications*
Experience related topresent work (in years)
RelevantTraining
Note: Laboratory shall clearly indicate staff responsible for site testingLaboratory operating in shifts shall clearly identify the staff working in shifts
* Please clearly indicate the area of specialization+
Quality Manager shall have 4 days training course on laboratory management system from a reputed institute
4. Equipment and Reference Materials/ Reference standards
4.1 List of equipment available
Slno
Name ofequipment
Model/ type/year of make
Range andaccuracy
Date of lastcalibration
Calibration due on * Calibrated by**
4.2 List of reference materials/ reference standards available+
Sl.no.
Name of reference material/strain/ culture/ standard
Source Date of expiry/Calibration validity
Traceability
* The laboratory to decide the calibration interval based on ISO 10012 or ILAC-G24
** Please mention name of calibration agency. In case the equipment is calibrated in-house, same needs to be clearly indicatedunder this column.
+ information should be provided for reference standards only and not for all testing and measuring equipment.\
5. Internal Audit and Management Review
5.1 Date /schedule of last Internal Audit_________________________________________________
5.1.1 Whether all requirements of ISO/IEC 17025: 2005 covering all activities of laboratory havebeen audited at least once in last one year YES/NO
5.2 Date of last Management review___________________________________________________
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 00 Amend Date: -- Page No: 10/11
6. Proficiency Testing
Participation in NABL/ APLAC/ any other Inter Laboratory Comparison(for details and requirements please refer to ISO/IEC 17043, NABL 162 , NABL 163)
Sl.no.
Product/Material
Details ofTest(s)
Date ofTesting
Nodal Laboratory/PT Provider
(Accreditation Body/Country)
Performance interms of Z
score
Corrective ActionTaken (if any)
7. Application Fees
7.1 Number of groups* applied for accreditation__________________________________________
7.2 Application fees (Rs. )___________________________________________________________
7.3 DD / Cheque** number __________________________________________________________*information regarding the groups applied for accreditation in each discipline. Refer relevant specific criteria for moredetails on groups.
**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
We declare that
8.1 We are familiar with the terms and conditions of maintaining accreditation (NABL 131), which isenclosed and will abide by them.
8.2 We agree to comply fully with ISO/IEC 17025: 2005 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 allrelevant documents by them and their visits to those parts of the laboratory that are part of thescope of accreditation.
8.4 We satisfy all national, regional and local regulatory requirements for operating a laboratory.
8.5 __________________________________________________________________________ hasprovided consultancy for preparing towards NABL accreditation. (Information regarding any
individual or organization who provided consultancy (if any) for NABL accreditation shall bedeclared)
8.6 All information provided in this application is true.
Signature of laboratory head/ Laboratory director __________________________________________
Name & Designation ________________________________________________________________
Date & Place ______________________________________________________________________
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National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories
Issue No: 12 Issue Date: 27.06.2012 Amend No: 00 Amend Date: -- Page No: 11/11
9. Application Form - Check List
Sl. Information / details provided as part of application Availability
1. Three copies of application in each discipline (eg. Mechanical/Chemical/Electrical etc)
2. Two copies of Quality Manual (latest issue) according to ISO/IEC 17025: 2005
3. Application fees
a) Information on total groups applied for accreditation
b) Estimated applicable fees as per NABL 151
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
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/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 ofapplication form.
Signature of Laboratory Head/Director -----------------------------------------------------------------------------------------
Name & Designation ____________________________________________________________________
Date & Place __________________________________________________________________________
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National Accreditation Board for Testing and Calibration Laboratories3rd Floor, NISCAIR
14, Satsang Vihar MargNew Mehrauli RoadNew Delhi 110 067
Tel.: +91-11 46499999Fax: +91-11 26529716
Website:www.nabl-india.org
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