NABL 151

NABL

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

APPLICATION FORM

for TESTING LABORATORIES

ISSUE NO : 12 ISSUE DATE: 27.06.2012

AMENDMENT NO : 03 AMENDMENT DATE: 23.04.2013

AMENDMENT SHEET
Sl no Page No.
6/11 7/11

Clause No.
13 1.1 3.4.1

Date of Amendment
22.08.2012

Amendment made
Laboratory locations

Reasons
Internal audit findings

Signature QO

Signature Director

9/11

16.10.2012

Quality manager shall APLAC finding have 4 days training Laboratory operating shifts shall identify the staff working in shift

3-5/11

4.0

23.04.2013

Change in fee/ assessment charges structure

GB Decision

10

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 03 Amend Date: 23.04.2013 Page No: 1/11

CONTENTS
Sl. No
1 2

Title
Information & Instructions for completing an Application Form Application Form

Page
3 7

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 03 Amend Date: 23.04.2013 Page No: 2/11

Information & Instructions for completing an Application Form

1. Application shall be made in the prescribed form NABL 151 only. Separate application form shall be submitted 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 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/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 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 2013-14 (Rs) 2014-15 (Rs)

Application Fee (nonrefundable, to be paid along with the application)

Testing Laboratories (other than Forensic laboratories): Upto 2 product groups per discipline of testing (eg. Metals & alloys, Food & agricultural products, Drugs & pharmaceuticals, Textiles etc.) For each additional product group in each discipline of testing Forensic Laboratories (covering all subdiscipline):

17,000

20,000

8,500 34,000

10,000 40,000

Enhancement of Scope (apart from the scheduled reassessment)

Testing Laboratories Any extension in the existing accredited scope per group per discipline (except forensic laboratory) For each additional product group in each discipline of testing For any change in scope of forensic laboratory

4,000/ group

5,000/ group

8,500 17,000 17,000

10,000 20,000 20,000

Addition of Testing Discipline

a. Testing laboratories except Forensic Laboratories ( Upto 2 product groups per discipline of testing)

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 03 Amend Date: 23.04.2013 Page No: 3/11

b. For each additional product group in each discipline of testing c. Forensic Laboratories (covering all subdiscipline) Forensic Laboratories Any extension in the existing accredited scope

8,500

10,000

4,000 4,000 / discipline

5,000 5,000 / discipline

Change in Name of Laboratory or Premises Any Change in Authorized signatory Overhead Charges Annual Accreditation Fee (per year from the date of accreditation)

Any change in the name of the laboratory or address leading to issue of new accreditation certificate with scope Any addition of authorized signatory(s) apart from the scheduled assessment For each assessment (including Desktop surveillance) irrespective of number of disciplines Testing Laboratories (per discipline): Forensic Laboratories (covering all sub- discipline): Comprising of -

4,000 / request 8,500 17,000

5,000/ request 10, 000 20,000

34,000

40,000

Assessment Charges (payable after the completion of assessment visit to the laboratory) Travel, Boarding and Lodging expenditure

Travel, Boarding, Lodging Honorarium for NABL Assessors Overhead Charges

Travel to be made by Air in economy class (Apex fare) or by train in 2nd AC Class or by AC Bus. 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. 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 Pre-Assessment - by Lead Assessor - by Technical Assessor/ Expert

Rs. Rs. Rs.

1,500 3,000/day 2,500/day

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 03 Amend Date: 23.04.2013 Page No: 4/11

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

Rs. Rs.

3,000/day 2,500/day

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 / 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 and Maintaining Accreditation before filling up this form. 6. The applicant laboratory shall provide photocopies of appropriate document in support of the legal identity 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, 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 laboratories must participate satisfactorily in the Proficiency Testing program conducted by 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 initiate Inter 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 grant of accreditation. The satisfactory performance shall be defined in term of z score. For unsatisfactory performance, the laboratory shall take corrective action and inform NABL. 10. The laboratory shall also inform NABL in advance about any reservation with valid reason 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 changes to its policies/practices & procedure(s). The laboratory shall inform NABL when such changes 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. b. c. d. group of products, materials or items tested specific tests or types of tests performed specification, standard (method) or technique used with year of publication range of testing/ limit of detection for each test (as applicable)

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 03 Amend Date: 23.04.2013 Page No: 5/11

e. uncertainty of measurement (MU) for each test (wherever applicable) at a confidence probability of 95% 13. The details of laboratory locations and the 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.
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 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 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 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 01 Amend Date: 22.08.2012 Page No: 6/11

Application Form for Laboratory Accreditation

We apply for NABL accreditation of our testing 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. b. c.

Permanent Facility Site Facility Mobile facility

Yes Yes Yes

No No 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 __________________________________________________________________________ _________________________________________________________________________________

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 01 Amend Date: 22.08.2012 Page No: 7/11

2. Accreditation Details
2.1 Discipline of Testing for which accreditation is sought Biological Chemical Electrical Electronic Fluid-Flow Forensic Science Mechanical Non-Destructive Optical/ Photometry Radiological Thermal

2.2 Scope of Accreditation

Sl no Group of products, materials or items tested Specific tests or types of tests performed Specification, standard Range of testing/ (method) or technique used Limit of detection Measurement Uncertainty ( )

Note 1. Laboratories performing site testing shall clearly identify the specific tests on product(s)/ material performed at site separately. 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)

Sl no

Laboratory/ Department/ Section

Name & Qualification Designation of with Signatory Specialization

Experience in years related to present work

Relevant Training

Authorized for which specific area of testing

Specimen Signature

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 151 Issue No: 13 Application Form for Testing Laboratories Issue Date: Amend No: 00 Amend Date: --Page No: 8/11

3.3 Organization Chart 3.3.1. Indicate in an organization chart the operating departments of the 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) 3.4 Employees 3.4.1 Details of staff
Sl no Name Designation+ Academic and Professional Qualifications* Experience related to present work (in years) Relevant Training

Note: Laboratory shall clearly indicate staff responsible for site testing Laboratory 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
Sl no Name of equipment Model/ type/ year of make Range and accuracy Date of last calibration 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 indicated under 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 have been audited at least once in last one year YES/NO 5.2 Date of last Management review ___________________________________________________
National Accreditation Board for Testing and Calibration Laboratories
Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 02 Amend Date: 16.10.2012 Page No: 9/11

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 of Test(s)

Date of Testing

Nodal Laboratory/ Performance in PT Provider terms of Z (Accreditation Body/ score Country)

Corrective Action Taken (if any)

7. Application Fees
7.1 Number of groups* applied for accreditation__________________________________________ 7.2 7.3 Application fees (Rs. )___________________________________________________________ DD / Cheque** number __________________________________________________________
*information regarding the groups applied for accreditation in each discipline. Refer relevant specific criteria for more details 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 is enclosed 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 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 ________________________________________________________________
National Accreditation Board for Testing and Calibration Laboratories
Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 00 Amend Date: -Page No: 10/11

Date & Place ______________________________________________________________________

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 00 Amend Date: -Page No: 11/11

9. Application Form - Check List

Sl.
1. 2. 3.

Information / details provided as part of application

Three copies of application in each discipline (eg. Mechanical/Chemical/Electrical etc) Two copies of Quality Manual (latest issue) according to ISO/IEC 17025: 2005 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'

Availability

4. 5. 6. 7. 8. 9.

Copy of Legal Identity (Registration Details of the Laboratory) Scope of Accreditation with Test Methods, Range of Testing and MU Details of Senior Management with Designation and Contact Details List of staff and proposed Authorized Signatories Organization Chart enclosed 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 of application form. Signature of Laboratory Head/Director ----------------------------------------------------------------------------------------Name & Designation ____________________________________________________________________ Date & Place __________________________________________________________________________

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.06.2012 Amend No: 00 Amend Date: -Page No: 12/11

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