NABL Accreditation

NABL accreditation is required by laboratories across various sectors to ensure quality, accuracy, and compliance. It is commonly sought by pharmaceutical QC labs, food testing labs, calibration laboratories, pathology and diagnostic centers, environmental labs, construction testing labs, electrical and electronics labs, textile laboratories, and forensic or defence testing facilities. It helps improve credibility and ensures wider acceptance of test results.

The documents required for a NABL Accreditation Certificate generally include regulatory approvals and quality management records. These may include the hospital registration certificate, drug license, biomedical waste authorization, fire safety NOC, PCB and AERB approvals, blood bank and equipment-related licenses, along with quality manuals, SOPs, clinical protocols, infection control manuals, HR and training records, audit reports, CAPA records, and patient feedback documentation.

The process of obtaining an NABL accreditation certificate involves conducting a gap analysis and defining the scope as per ISO/IEC 17025 or ISO 15189 standards. Laboratories must prepare QMS documents, ensure equipment calibration and qualification, complete method validation with PT/ILC participation, and conduct internal audits. After this, the NABL application is filed online, followed by pre-assessment and final assessment by NABL. Once all observations are resolved and approvals are obtained, the NABL accreditation certificate is granted.

Some of the list of NABL accreditation Programme and scope are it provides accreditation for Testing and Calibration Laboratories (ISO/IEC 17025), Medical Testing Labs (ISO 15189), Proficiency Testing Providers (ISO/IEC 17043), Reference Material Producers (ISO 17034), and Inspection Bodies (ISO/IEC 17020), covering testing, calibration, diagnostics, proficiency testing, reference material production, and inspection activities.

The eligibility criteria for obtaining a NABL certificate include that the laboratory must be a legally registered entity, such as a company, LLP, trust, society, or government body, and should have at least 6 months of operational experience with proper testing or calibration records.
It must have a documented Quality Management System (QMS) as per ISO/IEC 17025:2017 or ISO 15189:2022, along with qualified staff, calibrated and traceable equipment, and validated test methods. The lab should also participate in proficiency testing, conduct internal audits, hold management review meetings, and maintain adequate infrastructure with a controlled laboratory environment.

Post-NABL calibration certificate compliance includes periodic surveillance audits conducted by NABL within 12–18 months of accreditation to ensure continued adherence to standards.
Laboratories must pay the annual accreditation fee and participate in mandatory Proficiency Testing (PT) for all applicable disciplines each year. Re-accreditation applications should be submitted at least 6 months before the certificate expiry, typically following a 2-year cycle under ISO 17025/15189. Additionally, any scope changes, such as adding or removing tests, parameters, or laboratory locations, require NABL approval through a supplementary assessment.

An accreditation is a public recognition certificate that a healthcare facility or organization meets the required standards or quality, confirmed through an independent external review of its performance.

It stands for National Accreditation Board for Testing and Calibration Laboratories (NABL), an autonomous body that assesses and accredits testing and calibration laboratories based on international standards, while ensuring their competence and reliability in producing accurate results.

The list of expenses included for NABL accreditation is application and accreditation fees, assessment and surveillance charges, equipment calibration costs, laboratory infrastructure upgrades, implementation of quality management system and staff training programmes.