nabl 131 by neeraj upadhyay

NABL 131

NABL

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

TERMS & CONDITIONS for MAINTAINING NABL ACCREDITATION

ISSUE NO : 05 ISSUE DATE: 02.11.2005

AMENDMENT NO : 04 AMENDMENT DATE: 01.03.2008

AMENDMENT SHEET Sl no

Page No.

Clause No.

Date of Amendment

1/ 4

4 (b)

30.03.2006

3/ 4

14 (h)

2/ 4

08.02.2007

1/ 4

3/ 4

12 a.

Amendment made

Signature QM

Signature Director

Correction

Sd/-

Word ‘satisfactory’ replaced by ‘unsatisfactory’

Correction

Sd/-

01.03.2008

‘ISO 15189’ changed to ‘ISO 15189:2007’

Implementation of new standard

Sd/-

01.03.2008

NABL 214 changed to NABL 100

NABL 214 is withdrawn & contents covered in NABL 100

Sd/-

Word ‘logo’ changed to ‘symbol’

Reasons

Word ‘logo’ changed to ‘NABL symbol’

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 131 Issue No: 05

Terms & Conditions for Maintaining NABL Accreditation Issue Date: 02.11.2005 Last Amend No: 04 Amend Date: 01.03.2008

Page No: i

Terms & Conditions for Maintaining NABL Accreditation (To be submitted to NABL along with the application form)

The Testing/ Calibration laboratories that have been granted NABL accreditation shall be required to fulfill the following terms and conditions: 1. The laboratory shall carry out its testing/ calibration activities in such a way as to meet the requirements of ISO/ IEC 17025: 2005 or ISO 15189:2007 which ever is applicable and relevant NABL specific criteria. 2. The accreditation shall be initially granted for a period of two years and shall be subject to an on-site surveillance within one year of grant of accreditation in the first cycle of accreditation and a re-assessment before the end of two years, for which the laboratory shall apply six months before the expiry of accreditation. Thereafter NABL shall conduct re-assessment every two years and shall be subjected to other surveillance activities. 3. The laboratory shall offer to NABL or its representative cooperation in: a. Access to all testing and calibration areas. b. Undertaking any check to verify testing/calibration capability of the laboratory. c. Witnessing the testing/calibration being performed relevant to accreditation. d. Access of all relevant information and documentation. e. Access to those documents that provide insight into the level of independence and impartiality to the laboratory from its related bodies, if applicable. f. Access to all records and relevant personnel. g. Providing names of all authorised signatories who are responsible for authenticity and issue of test/ calibration certificates/ reports. 4. On grant of accreditation, the laboratory shall: a. Claim accreditation in only those premises, fields/ facility, disciplines, tests/ calibrations for which it has been accredited (as stated in Accreditation Certificate). b. Use NABL symbol on its letterheads, test/ calibration reports and any other relevant documents. Symbol shall be used for the purpose of identifying correctly and unambiguously its test/ calibration services accredited by NABL. The laboratory shall abide by the guidelines for use of NABL symbol (refer NABL 133). c. Not use test/ calibration reports nor any part thereof in a misleading manner. d. Not state its accreditation in a manner as to be considered misleading or unauthorised and bring NABL to disrepute. e. Ensure that no part of its test/ calibration report is used by its clients, or be authorised by its clients for use, for promotional or publicity purposes in any way that NABL may consider to be misleading.

Signature of Chief Executive or his Authorised Representative __________________________

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 131 Issue No: 05

Terms & Conditions for Maintaining NABL Accreditation Issue Date: 02.11.2005 Amend No: 03 Amend Date: 01.03.2008

Page No: 1/ 4

Make it clear in all its contracts with clients that a satisfactory test/ calibration report in no way implies that the product so tested or equipment calibrated is approved by NABL. g. Ensure that its clients are made clear that accreditation of test/ calibration facility in no way implies that its process system or person is approved by NABL. 5. The accredited laboratory shall pay application fees for re-accreditation; expenses towards travel, boarding & lodging for assessment, surveillance, re-assessment and annual accreditation fees as shall be from time to time determined by NABL. 6. The laboratory shall inform NABL within 15 days of significant changes affecting the laboratories activities and operations relevant to accreditation, such as: a. its legal, commercial, ownership or organisational status b. the organisation, top management and key personnel including authorised signatories c. main policies d. resources and premises e. scope of accreditation and f. other such matter that may affect the ability of the laboratory to fulfill ISO/ IEC 17025 or ISO 15189 which ever is applicable. 7. The laboratory shall continuously keep in touch with NABL to keep itself updated with the latest versions of NABL documents and national and international standards. However, NABL shall publish such information in its quarterly newsletter and website. 8. The laboratory shall unambiguously declare the name of any individual or organisation that has provided consultancy for preparing towards NABL accreditation. 9. The accredited laboratory shall itself normally perform the test/ calibration which is covered under scope of accreditation. Where a laboratory subcontracts a substantial or critical part of the test/ calibration, this work shall be placed with another accredited laboratory only. The laboratory shall record and retain details of its investigation of the competence and compliance of its subcontractor and maintain a register of all subcontracting. The laboratory shall advise its clients at the time of contract review about the intended sub-contracting. 10. The accredited laboratory shall regularly and satisfactorily participate in the Proficiency Testing programmes being conducted by NABL, APLAC, EA or any other international body covering its scope of accreditation. Whenever possible, NABL will inform the laboratories of the available programmes. The minimum stipulated participation is one parameter/ type of test per discipline prior to gaining accreditation and all parameters/ types of tests included in the accredited scope of each discipline at least once every four years. The unsatisfactory performance shall be determined in terms of │Z│≥ 3 or │En│>1 or any other criteria depending on the programme design. The laboratory shall carry out investigation for unsatisfactory performance in proficiency testing and inform NABL of the necessary corrective action taken. The laboratory shall part with all available information related to proficiency testing to the assessors at the time of surveillance and re-assessment.

Signature of Chief Executive or his Authorised Representative __________________________ National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 131 Issue No: 05

Terms & Conditions for Maintaining NABL Accreditation Issue Date: 02.11.2005 Amend No: 02 Amend Date:08.02.07

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11. The accredited laboratory shall respond promptly to the changes initiated by NABL in its accreditation criteria, policies and procedures. The laboratory shall be given sufficient notice and time, as in the opinion of NABL is found reasonable, to carry out adjustments in its system. The laboratory shall inform NABL when such adjustments have been completed. 12. NABL may occasionally give provisional extension of accreditation beyond the normal cycle of three years where: a. Re-assessment has been completed, but the recommendation of the accreditation committee (refer NABL 100) and approval from Chairman is pending. b. There is delay in conducting re-assessment for reasons beyond control of NABL. c. A subsequent verification visit has become necessary leading to delay in decision. 13. NABL may at subsequent stage decide to reduce the scope of accreditation, granted initially as per NABL 216, if: a. Major non-compliance is observed during surveillance or re-assessment in the quality system or technical competence, which is likely to adversely influence the test/calibration results. b. Laboratory is unable to complete corrective actions within agreed/ stipulated time of the surveillance/ re-assessment related to specific tests/ calibration.

c. The performance in a proficiency testing programme conducted by NABL/ APLAC/ EA/ ILAC or

equivalent organisation recognised programme is unsatisfactory or is declared an outlier or in terms of │Z│≥ 3 or │En│>1 or any other criteria depending on the programme design and laboratory could not take appropriate corrective actions within two months.

14. NABL may suspend or withdraw accreditation of an accredited laboratory, as per NABL 216, on one or more of the following grounds: a. After undergoing a surveillance or re-assessment laboratory has not taken any corrective action after getting sufficient time and notice from NABL. b. Non-payment of accreditation expenses like assessment or surveillance or re-assessment charges and annual accreditation fees. c. Not applied six months before the expiry of accreditation and NABL has not been able to take a decision for renewal of accreditation. d. Non-cooperation with NABL. e. Refusal to allow examination of documents and records by NABL & its assessors. f. Denial of access to NABL & its assessor to its testing and calibration areas. g. Wrong representation of scope of accreditation. h. Misuse of NABL symbol or its use after expiry of accreditation. i. Misleading reporting of facts. j. Activity bringing disrepute to NABL. k. Result of complaint analysis or any other information which indicates that the laboratory no longer complies with requirements of NABL. Signature of Chief Executive or his Authorised Representative __________________________

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 131 Issue No: 05

Terms & Conditions for Maintaining NABL Accreditation Issue Date: 02.11.2005 Amend No: 04 Amend Date: 01.03.2008

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15. The accredited laboratory upon suspension or withdrawal of its accreditation (however determined) or expiry of validity of accreditation shall forthwith discontinue its use of all advertising matter that contain any reference to the accreditation status and return the certificates of accreditation to NABL. 16. The accredited laboratory can relinquish accreditation by giving three months notice in writing to NABL. 17. The laboratory is required to inform the NABL Secretariat, if any of the proposed assessor(s) happens to be their Consultant or associated with the laboratory in any other capacity, since NABL cannot appoint these Consultants as assessors. 18. NABL absolves itself of any legal or financial liability arising out of any item/ product calibrated/tested in any of its accredited laboratory involving any accidental or consequential damages to personnel/equipment/products at any time. 19. All disputes, if any, arising out of NABL decisions that remain unresolved through mechanism provided by NABL are subject to the exclusive jurisdiction of the Courts at New Delhi and none other. By signing this document, it is implied that a laboratory as an applicant and after accreditation agrees to comply at all times with all Terms and Conditions for Maintaining NABL Accreditation.

Signature of Chief Executive or his Authorised Representative __________________________ Name, Designation & Laboratory ______________________________________________ Date & Place _____________________________________________________________________ Signature of NABL official & Date of Receipt ____________________________________________

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 131 Issue No: 05

Terms & Conditions for Maintaining NABL Accreditation Issue Date: 02.11.2005 Amend No: 00 Amend Date: -

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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 26529718 – 20, 26526864 Fax: 91-11 26529716 Website: www.nabl-india.org