The National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued an updated set of Terms & Conditions governing the accreditation and continued compliance of Conformity Assessment Bodies (CABs) across India. The revised guidelines—documented as NABL 131, Issue 08, Amendment 03—lay down requirements that testing laboratories, calibration laboratories, medical laboratories, proficiency testing providers, reference material producers, and biobanks must fulfill to secure and maintain NABL accreditation.
The updated document, which functions as a binding accreditation agreement between NABL and each CAB, emphasizes strict adherence to international standards such as ISO/IEC 17025, ISO 15189, ISO/IEC 17043, ISO 17034, and ISO 20387, alongside NABL-specific criteria and policies. Acceptance of these terms is mandatory at the time of submitting an accreditation application.
Clear Expectations for Competence, Impartiality, and Compliance
The revised conditions place significant focus on maintaining technical competence, impartiality, and regulatory compliance. CABs are required to:
- Operate in full alignment with applicable international standards and NABL documents.
- Maintain up-to-date versions of all NABL criteria and demonstrate effective implementation.
- Ensure adequate staffing, validated methods, appropriate equipment, and overall capability for each accredited scope.
- Avoid conflicts of interest and safeguard impartiality in all conformity assessment activities.
The document reiterates that providing misleading information, concealing facts, or claiming NABL accreditation prematurely will result in immediate rejection of the application or possible legal action.
Mandatory Assessments and Information Transparency
CABs must fully cooperate with assessments, including unannounced visits and risk-based audits. The terms grant NABL assessors unrestricted access to facilities, staff, records, and operational sites—including subcontractor and mobile facilities—relevant to the accredited scope.
Any changes in ownership, personnel, premises, resources, scope, or legal status must be communicated to NABL within 15 days. CABs are also required to maintain complete transparency about consultants involved in their accreditation preparation.
Proficiency Testing and Continual Monitoring
Applicant CABs must demonstrate competence through successful participation in Proficiency Testing (PT) programs, as specified in NABL 163. Renewal applications must be submitted well before the expiry of accreditation, and assessment cycles must not exceed 24 months.
NABL stresses that accredited CABs may claim accreditation only for the premises and scope listed on their certificate. Use of the NABL symbol or the ILAC MRA mark is strictly regulated under NABL 133, and any misuse may lead to suspension or legal consequences.
Strict Enforcement, Confidentiality, and Legal Provisions
The revised terms underscore NABL’s authority to enforce compliance, including:
- Suspension or withdrawal of accreditation in cases of fraud, non-conformity, non-payment, or violations affecting NABL’s integrity.
- Severing ties and halting activities for all CABs linked to a legal entity involved in litigation against NABL.
- Prohibiting inducements, gifts, or undue favours to assessment personnel.
- Ensuring confidentiality of all sensitive information accessed during the accreditation process.
CABs must also indemnify NABL against third-party claims arising from their accredited activities and maintain adequate insurance to mitigate potential liabilities.
Appeal Rights and Jurisdiction
The terms state that after exhausting all internal remedies provided by NABL, CABs may approach courts only in New Delhi, with all matters governed by Indian law. CABs retain the right to appeal suspension or withdrawal decisions through the NABL appeals process.