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 The National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued terms and conditions to testing labs or Conformity Assessment Bodies (CAB) for obtaining and maintaining NABL Accreditation.
CAB includes Testing Laboratory/Calibration Laboratory/Medical Testing Laboratory/Proficiency Testing Provider (PTP)/ Reference Material Producer (RMP)/ Biobank.
The terms and conditions specified are considered as accreditation agreement between NABL and CAB. By accepting these terms and conditions, it is implied that a CAB as an applicant and after obtaining accreditation agrees to comply at all times with all the terms and conditions for maintaining NABL Accreditation.
Any violation of any one or more of these terms and conditions (accreditation agreement) shall result in adverse decision as per NABL 216 ‘Procedures for Dealing with Adverse Decisions’, including legal action.
The CAB that are applicant or accredited by NABL shall be required to fulfil the terms and conditions mentioned below.
The CAB shall carry out its testing, calibration, medical, PTP, RMP and Biobank activities in such a way as to meet the requirements of relevant standard (eg. ISO/IEC 17025 or ISO 15189 or ISO/IEC 17043 or ISO 17034 or ISO 20387, whichever is applicable), appropriate NABL specific criteria/application documents (wherever applicable) and other policies of NABL, as relevant to the accredited scope at all times. CAB shall ensure that the latest versions of NABL documents are available with it and are effectively implemented. CAB shall familiarize itself with all relevant standards, NABL documents etc. applicable for particular accreditation scheme. The CAB shall have a valid legal entity status.
CAB shall provide all necessary information about its antecedents as required by NABL which shall include but not limited to its background information i.e. history, establishment, ownership, and organizational structure, Key Personnel, Previous Experience, Legal Compliance, Disputes and Complaints if any, Quality Management System, Financial Information if required, Conflict of Interest, Accreditations and Certifications from any other body or Any other information, deemed necessary by NABL to analyse and evaluate the CAB's eligibility for accreditation.
By submitting the application for accreditation, the CAB expressly consents to the collection, use, and disclosure to NABL of the provided information for the purpose of evaluating the accreditation application and ensuring compliance with accreditation standards. NABL reserves the right to verify the accuracy and authenticity of the provided information. Failure to provide accurate and complete information or any attempt to withhold relevant details shall result in the rejection of the accreditation application.
It is the responsibility of CAB to abide by the National/Regional/State/Local regulatory requirements/ Acts/Rules/Legal orders/Court decisions/Orders issued by Government/Statutory Bodies as applicable and effective from time to time.
The CAB shall identify and define various activities which they are involved in, and ensure that it does not lead to any potential conflict of interest. The CAB shall have available qualified and trained personnel for applied and/or accredited scope including sampling (wherever applicable).
Wherever applicable, the CAB shall follow the test methods as mentioned in the current National or International standards and/or as stipulated by regulatory bodies. Where such methods do not exist, other validated methods may be followed. In case CAB uses in-house validated methods, the validation data should be submitted along with the application.
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