application form for for testing labs iso17025

NABLNATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

NABL 151

APPLICATION FORM for TESTING LABORATORIES

ISSUE NO : 12 AMENDMENT NO : 03ISSUE DATE: 27.06.2012 AMENDMENT DATE: 23.04.2013

AMENDMENT SHEET

Sl no

Page No.

Clause No.

Date of Amendment

Amendment made

Reasons Signature QO

Signature Director

1 6/11

7/11

13

1.1

22.08.2012 Laboratory locations Internal audit findings

2 9/11 3.4.1 16.10.2012 Quality manager shall have 4 days training

Laboratory operating shifts shall identify the staff working in shift

APLAC finding

3 3-5/11 4.0 23.04.2013 Change in fee/

assessment

charges structure

GB Decision

4

5

6

7

8

9

10

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: 03 Amend Date: 23.04.2013 Page No: 1/11

CONTENTS

Sl. No Title Page

1 Information & Instructions for completing an Application Form 3

2 Application Form 7


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:

F i n a n c i a l Y e a r

Application Fee (non-refundable, 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.)

2013-14(Rs)

2014-15(Rs)

17,000 20,000

For each additional product group in each discipline of testing

8,500 10,000

Forensic Laboratories (covering all sub-discipline):

34,000 40,000

Enhancement of Scope (apart from the scheduled re-assessment)

Testing LaboratoriesAny extension in the existing accredited scope per group per discipline (except forensic laboratory)

4,000/ group 5,000/ group

For each additional product group in each discipline of testing

8,500 10,000

For any change in scope of forensic laboratory 17,000 20,000

Addition of Testing Discipline

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

17,000 20,000

b. For each additional product group in each discipline of testing

8,500 10,000


c. Forensic Laboratories (covering all sub- discipline)

Forensic LaboratoriesAny extension in the existing accredited scope

4,000 5,000

Change in Name of Laboratory or Premises

Any change in the name of the laboratory or address leading to issue of new accreditation certificate with scope

4,000 / discipline 5,000 / discipline

Any Change in Authorized signatory

Any addition of authorized signatory(s) apart from the scheduled assessment

4,000 / request 5,000/ request

Overhead ChargesFor each assessment (including Desktop surveillance) irrespective of number of disciplines

8,500 10, 000

Annual Accreditation Fee

Testing Laboratories (per discipline):

17,000 20,000

(per year from the date of accreditation)

Forensic Laboratories (covering all sub- discipline):

34,000 40,000

Assessment Charges (payable after the completion of assessment visit to the laboratory)

Comprising of ---

Travel, Boarding, Lodging Honorarium for NABL AssessorsOverhead Charges

Travel, Boarding and Lodging expenditure

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 Rs. 1,500

Pre-Assessment - by Lead Assessor Rs. 3,000/day- by Technical Assessor/ Expert Rs. 2,500/day


Assessment, Surveillance, Verification, Special Visit- by Lead Assessor Rs. 3,000/day- by Technical Assessor/ Expert Rs. 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. group of products, materials or items testedb. specific tests or types of tests performed c. specification, standard (method) or technique used with year of publicationd. range of testing/ limit of detection for each test (as applicable)


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.

* * *


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 Details1.1 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 __________________________________________________________________________

_________________________________________________________________________________


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

Sl no

Group of products, materials or items tested

Specific tests or types of tests performed

Specification, standard (method) or technique used

Range of testing/ 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 level4. 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 & Designation of

Signatory

Qualification with

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 LaboratoriesDoc. No: NABL 151 Application Form for Testing Laboratories Issue No: 13 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 ___________________________________________________


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)

l.

o.

Product/ Material

Details of Test(s)

Date of Testing

Nodal Laboratory/ PT Provider

(Accreditation Body/ Country)

Performance in terms of Z

score

Corrective Action Taken (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 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 ________________________________________________________________

Date & Place ______________________________________________________________________

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

9. Application Form - Check List

l.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 feesa) 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 of application form.

Signature of Laboratory Head/Director -----------------------------------------------------------------------------------------

Name & Designation ____________________________________________________________________

Date & Place __________________________________________________________________________

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

National Accreditation Board for Testing and Calibration LaboratoriesNABL House

Plot No. 45, Sector- 44, Gurgaon – 122002, Haryana

Tel.: +91-124 4679700Fax: +91-124 4679799

Website: www.nabl-india.org

http://www.nabl-india.org/

application form for for testing labs iso17025

Documents

testing laboratories

addition of testing

application form3

incomplete application

rejection of application

separate application

testing activities

forensic laboratories