NABL 151NABL 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 04.04. Clause No.2013 Change in fee/ GB Decision assessment charges structure 4 5 6 7 8 9 10 National Accreditation Board for Testing and Calibration Laboratories Doc.0 23. Date of Amendment Amendment made 1 6/11 13 22.08.06.4.1 2 9/11 3. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.2013 Page No: 1/11 .2012 Laboratory locations 7/11 1.AMENDMENT SHEET Sl no Page No.2012 Amend No: 03 Amend Date: 23.2012 Reasons Signature QO Signature Director Internal audit findings Quality manager shall APLAC finding have 4 days training Laboratory operating shifts shall identify the staff working in shift 3 3-5/11 4.1 16.10. 06. No Title Page 1 Information & Instructions for completing an Application Form 3 2 Application Form 7 National Accreditation Board for Testing and Calibration Laboratories Doc.04.CONTENTS Sl.2012 Amend No: 03 Amend Date: 23.2013 Page No: 2/11 . No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27. 000 Forensic Laboratories (covering all subdiscipline): 34. Incomplete application and insufficient number of copies submitted may lead to rejection of application. Food & agricultural products. 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. Applicant laboratories are advised to ensure that the latest versions of NABL documents are available with them.500 10.2012 Amend No: 03 Amend Date: 23.2013 Page No: 3/11 .) Testing Laboratories Any extension in the existing accredited scope per group per discipline (except forensic laboratory) a.000 4.000 20.000 For any change in scope of forensic laboratory 17. Drugs & pharmaceuticals. The application fee and other necessary charges related to accreditation process will be applicable as per the details given below: Financial Year Application Fee (nonrefundable. to be paid along with the application) Enhancement of Scope (apart from the scheduled reassessment) Addition of Testing Discipline 2013-14 (Rs) 2014-15 (Rs) 17. 3.000 20. additional requirements of NABL and the regulatory authorities. Application shall be made in the prescribed form NABL 151 only.000 For each additional product group in each discipline of testing 8.Information & Instructions for completing an Application Form 1. 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. 4. In case the space provided is insufficient. Separate application form shall be submitted for each discipline of testing. 2.04.000 Testing Laboratories (other than Forensic laboratories): Upto 2 product groups per discipline of testing (eg.000 17. Testing laboratories except Forensic Laboratories ( Upto 2 product groups per discipline of testing) National Accreditation Board for Testing and Calibration Laboratories Doc.500 10.06. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27. please use additional pages clearly indicating to which section they relate to.000/ group For each additional product group in each discipline of testing 8. Metals & alloys. Textiles etc.000/ group 5. as applicable at all times.000 20.000 40. Boarding.000 / discipline 5.000 40.by Technical Assessor/ Expert National Accreditation Board for Testing and Calibration Laboratories Doc. 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. For each additional product group in each discipline of testing c.000 Overhead Charges Annual Accreditation Fee (per year from the date of accreditation) Forensic Laboratories (covering all sub. Honorarium for NABL Assessors Adequacy Audit of Quality Manual by Lead Assessor Rs. 1. 3. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27. Lodging Honorarium for NABL Assessors Overhead Charges Assessment Charges (payable after the completion of assessment visit to the laboratory) Comprising of Travel. If the journey is made by own car.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.discipline): - Travel. 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.000 20.000/day 2.2013 Page No: 4/11 . If the laboratory is not able to provide the tickets.2012 Amend No: 03 Amend Date: 23. Forensic Laboratories (covering all subdiscipline) Forensic Laboratories Any extension in the existing accredited scope 8.500/day .000 34. The laboratory shall also make arrangements for boarding & lodging for the Assessment team.b.by Lead Assessor . NABL will reimburse the expenses incurred by the assessors as per above entitlement. 000 17. The laboratory shall provide the tickets as per above entitlement.06. the re-imbursement will be restricted to 2nd AC class fare by train.000 4.000 / request 5.000 5. Rs.04.000/ request For each assessment (including Desktop surveillance) irrespective of number of disciplines Testing Laboratories (per discipline): 8.000 / discipline Any Change in Authorized signatory Any addition of authorized signatory(s) apart from the scheduled assessment 4.500 10.500 Pre-Assessment Rs.500 10. 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. other validated methods are acceptable. 12. 11. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27. Special Visit . Laboratories are advised to familiarize themselves with NABL 100 ‘General Information Brochure’. 3. service tax @ 12. The laboratory shall also inform NABL in advance about any reservation with valid reason regarding appointment of Lead Assessor/ Assessor for the assessment.04. 9. In case laboratory uses in-house validated methods the validation data should be submitted along with the application.36 % (Existing / as applicable) to be paid along with the charges / fees 5. b. Particularly the scope of accreditation (para 2. The applicant laboratory shall provide photocopies of appropriate document in support of the legal identity claimed (eg. For unsatisfactory performance. within 15 days from the date of changes. In addition to the above mentioned fee. c. as in the opinion of NABL is reasonable to carry out the necessary changes to its policies/practices & procedure(s).2013 Page No: 5/11 . 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.500/day Note: 1. The minimum stipulated participation is one type of test per discipline prior to grant of accreditation. 6. The applicant laboratory shall intimate NABL about any change in the information provided in this application such as scope applied for accreditation. personnel. Rs.by Lead Assessor .2) shall be complete to indicate unambiguously: a. where formal accredited /recognized PT programmes are not available. materials or items tested specific tests or types of tests performed specification. location etc.Assessment.) 7. The satisfactory performance shall be defined in term of z score. the laboratory shall take corrective action and inform NABL. 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. Where such methods do not exist. Registration Certificate under Companies Act. NABL 216 ‘Procedures for Dealing with Adverse Decisions’ and NABL 131 ‘Terms and Conditions for Obtaining and Maintaining Accreditation’ before filling up this form. In cases. The laboratory shall inform NABL when such changes have been completed. the laboratory will either initiate Inter laboratory comparison or participate in Appropriate ILC programme conducted by accredited /reputed laboratory. 10. The applicant laboratory shall be given due notice of any intended changes relating to NABL accreditation criteria and will also be given such time.2012 Amend No: 03 Amend Date: 23.by Technical Assessor/ Expert Rs. 8. Surveillance. group of products. d.000/day 2. The application must be filled up carefully to provide required information in such a manner that further correspondence for seeking clarifications are not required. 2. 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. Payments shall be made in demand draft/ at par cheques in favor of NABL payable at New Delhi. Verification.06. approval from local or regulatory bodies. etc. 2012 Amend No: 01 Amend Date: 22. 14. c. By signing NABL 131 the laboratory agrees to comply at all times with Terms and Conditions of NABL. 16. In events where the laboratory operates from different city/ state. 17. 15. b. The details of laboratory locations and the tests which the laboratory intends to cover vide NABL accreditation must be listed clearly. examination of all relevant documentation and records. The procedure for processing of application for accreditation is given in NABL 100. The details of each location shall be explicitly mentioned in 1. offering access to relevant areas of the laboratory for witnessing the test being performed. the laboratory shall unambiguously provide names of all authorized signatories who are responsible for authenticity and issue of test certificates and reports. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27. e. The laboratory shall offer the NABL or its representative cooperation in: a. assessment visit and grant of accreditation shall be safeguarded and dealt with impartiality. The tests those are performed at site should be clearly identified in the scope of accreditation. The laboratory shall take all necessary actions and discharge all non.06.e.1 of application form.2012 Page No: 6/11 . The same shall be verified to the satisfaction of NABL. The application shall be kept confidential by NABL and information obtained during the processing of application.08. 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. interaction with all relevant personnel. Note: Laboratory operates from different locations in the same city may apply for NABL accreditation as a single laboratory. each laboratory shall be applied separately for accreditation. The final decision on accreditation shall rest with NABL. undertaking any check to verify testing capability of the laboratory. *** National Accreditation Board for Testing and Calibration Laboratories Doc.conformities raised during the assessment within a maximum time of two months. d. uncertainty of measurement (MU) for each test (wherever applicable) at a confidence probability of 95% 13. Permanent Facility Yes No b.6 Other accreditations _______________________________________________________________ 1. Mobile facility Yes No Note: for details please refer NABL-130 1.08. the test conducted) a.2012 Amend No: 01 Amend Date: 22.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. para 2. and name of authority who granted the registration.06. Laboratory Details 1.2012 Page No: 7/11 .5 Type of laboratory by service open to others partly open to others an in-house activity 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.2 Category of Facility(s) applied under the scope of Accreditation (Please clearly indicate in the scope of accreditation. __________________ e-mail ________________ 1. 13 for details on laboratory locations 1. _____________________ Fax No. __________________ E-mail ________________ Note: refer cl.4 Legal identity of the laboratory and date of establishment _______________________________ (Please give Registration No.1 Name of the Testing Laboratory _____________________________________________________ Locations and Address(s)_________________________________________________ Telephone No. _____________________ Fax No.2. Site Facility Yes No c. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.3 Name of Parent Organization ________________________________________________________ (if part of an organization) Telephone No. Copy of the certificate shall be enclosed) _________________________________________________________________________________________________ 1. 2.1 Senior Management (Name. Laboratories performing site testing shall clearly identify the specific tests on product(s)/ material performed at site separately.1. Measurement uncertainty shall be expressed as expanded uncertainty with 95% confidence level 4. 3.3 Person responsible for technical operations _________________________________________ 3. Fax.2.1. it shall be specifically mentioned and clearly identified in the scope of accreditation 3.1 Discipline of Testing for which accreditation is sought Biological Mechanical Chemical Non-Destructive Electrical Optical/ Photometry Electronic Radiological Fluid-Flow Thermal Forensic Science 2.1.1 Chief Executive of the laboratory _________________________________________________ 3.1.2 Scope of Accreditation Sl no Group of products.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. Designation. telephone. standard Range of testing/ (method) or technique used Limit of detection Measurement Uncertainty ( ) Note 1. materials or items tested Specific tests or types of tests performed Specification. e-mail) 3. Accreditation Details 2. No: NABL 151 Issue No: 13 Application Form for Testing Laboratories Issue Date: Amend No: 00 Amend Date: --- Page No: 8/11 .4 Contact person for NABL _______________________________________________________ 3.2 Authorized Signatories 3. Organization 3. Test methods and standards shall be mentioned along with the year of publication of the standard 5. In case of enhancement of scope.2 Person responsible for the management system _____________________________________ 3. 2 Indicate how the testing laboratory is related to external organizations or to its own parent organization (where applicable) 3.1 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. In case the equipment is calibrated in-house. Indicate in an organization chart the operating departments of the testing laboratory for which accreditation is being sought (please append) 3. + information should be provided for reference standards only and not for all testing and measuring equipment. 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. Equipment and Reference Materials/ Reference standards 4.1 Date /schedule of last Internal Audit _________________________________________________ 5.3.1.2 Date of last Management review ___________________________________________________ National Accreditation Board for Testing and Calibration Laboratories Doc. Internal Audit and Management Review 5.1 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 4.06.2012 Amend No: 02 Amend Date: 16.3 Organization Chart 3.1.10.4.1 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. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27. same needs to be clearly indicated under this column.3. \ 5.3.2 List of reference materials/ reference standards available+ Sl. no.4 Employees 3.2012 Page No: 9/11 . 8. All payments shall be made in favor of 'NABL' payable at New Delhi. Declaration by the laboratory We declare that 8. pay all costs for pre-assessment. (Information regarding any individual or organization who provided consultancy (if any) for NABL accreditation shall be declared) 8. assessment.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. no. 8. surveillance and reassessment irrespective of the result. 8. 8. verification visit (if any).3 We agree to comply with accreditation procedures.1 Number of groups* applied for accreditation__________________________________________ 7.4 We satisfy all national. regional and local regulatory requirements for operating a laboratory.6 All information provided in this application is true. **NABL will accept at par cheques also. NABL 162 .2012 Amend No: 00 Amend Date: -- Page No: 10/11 . Proficiency Testing Participation in NABL/ APLAC/ any other Inter Laboratory Comparison (for details and requirements please refer to ISO/IEC 17043. 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: 27.1 We are familiar with the terms and conditions of maintaining accreditation (NABL 131). which is enclosed and will abide by them. 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. )___________________________________________________________ 7. Refer relevant specific criteria for more details on groups.06.6. 8.5 __________________________________________________________________________ has provided consultancy for preparing towards NABL accreditation. NABL 163) Sl. 8. Application Fees 7.2 Application fees (Rs.3 DD / Cheque** number __________________________________________________________ *information regarding the groups applied for accreditation in each discipline.2 We agree to comply fully with ISO/IEC 17025: 2005 for the accreditation of testing laboratory. Date & Place ______________________________________________________________________ National Accreditation Board for Testing and Calibration Laboratories Doc.06.2012 Amend No: 00 Amend Date: -- Page No: 11/11 . No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27. List of staff and proposed Authorized Signatories 8. Mechanical/Chemical/Electrical etc) 2. List of Equipments / Reference Material used with details of Traceability 10. Three copies of application in each discipline (eg.2012 Amend No: 00 Amend Date: -- Page No: 12/11 .Check List Sl. Copy of Legal Identity (Registration Details of the Laboratory) 5. Information / details provided as part of application Availability 1.06. Organization Chart enclosed 9. Scope of Accreditation with Test Methods. Details of PT/ILC participation 11. Signature of Laboratory Head/Director ----------------------------------------------------------------------------------------Name & Designation ____________________________________________________________________ Date & Place __________________________________________________________________________ National Accreditation Board for Testing and Calibration Laboratories Doc. Range of Testing and MU 6. Application Form . Details of Senior Management with Designation and Contact Details 7. Dates of Internal Audit and Management Review 12. No: NABL 151 Issue No: 12 Application Form for Testing Laboratories Issue Date: 27.9. 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. Declaration about the Consultant (if any) 13. 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. : +91-124 4679700 Fax: +91-124 4679799 Website: www.org . Sector.National Accreditation Board for Testing and Calibration Laboratories NABL House Plot No. Gurgaon – 122002.nabl-india.44. 45. Haryana Tel.