National Accreditation Board for Testing and Calibration Laboratories

(A Constituent Board of Quality Council of India)

NABL Medical Entry Level Testing M(EL)T Labs Program

Terms & Conditions
The applicant and recognized entry level laboratories under NABL M(EL)T Labs Program shall be required to fulfill the following terms & conditions:
  1. The entry level lab shall meet the requirements of Clinical Establishment Act , Regulators (Local/Regional/State /National regulations), etc.
  2. The entry level scheme will not be covered under ILAC/APAC MRA.
  3. It is desired that the entry level laboratories achieve accreditation as per ISO 15189 within 3 years.
  4. The entry level lab shall offer cooperation to NABL or its representative in undergoing assessments whenever NABL considered it as required:
    • Access to all entry level lab area of operations
    • Undertaking any check / inspection to verify the capability of the entry level lab for the applied scope.
    • Witnessing the activities being performed relevant to this entry level scheme.
    • Assessing the competence of the staff during assessment.
    • Access to all relevant information and documentation.
    • Access to those documents that provide insight into the level of independence and impartiality to the entry level lab from its related bodies, if applicable.
    • Access to all records pertaining to relevant personnel.
    • Providing names of all personnel(s) who are responsible for authenticity and for review, evaluation & release of results (medical testing), as applicable.
    • Investigating any complaints against the entry level lab.
  5. The entry level lab shall not involve in any kind of activity(ies) which may bring NABL into disrepute
  6. The recognized entry level laboratories under NABL M(EL)T Labs Program, can relinquish through a written notice to NABL by surrendering the certificates.
  7. The entry level lab shall respond promptly to the changes initiated by NABL in its criteria, policies and procedures. The entry level lab shall inform NABL when such alterations under the agreed time frame have been completed.
  8. NABL absolves itself of any legal or financial liability arising out of activities of any of its entry level lab covered under this entry level scheme involving any accidental or consequential damages to personnel / equipment / products at any time. Any violation of this terms and conditions shall result in denial of certificate under NABL M(EL)T Labs Program. 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.