What is NABL Accreditation in India?
National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the Quality Council of India that provides formal recognition to laboratories for their technical competence and quality management systems.
In simple terms, NABL accreditation certifies that a testing, calibration, or medical laboratory is competent, reliable, and operates as per international standards.
Objective of NABL Accreditation
The primary objectives of NABL are to:
- Ensure accuracy and reliability of test and calibration results
- Promote international acceptance of Indian laboratory reports
- Improve laboratory quality management systems
- Enhance confidence among customers, regulators, and courts
Who Can Apply for NABL Accreditation?
NABL accreditation is applicable to:
- Testing laboratories
- Calibration laboratories
- Medical laboratories
- Diagnostic and pathology labs
- Research and industrial laboratories
Both government and private laboratories are eligible.
Standards Covered Under NABL Accreditation
NABL grants accreditation as per international standards such as:
- ISO/IEC 17025 – Testing & Calibration Laboratories
- ISO 15189 – Medical Laboratories
- ISO/IEC 17020 – Inspection Bodies
Why NABL Accreditation is Important in India
NABL accreditation is often mandatory or strongly recommended for labs involved in:
- Regulatory testing
- Government tenders
- Legal and forensic evidence
- Healthcare diagnostics
It ensures global credibility and technical trustworthiness.
Step-by-Step Process for NABL Accreditation in India
Step 1: Gap Analysis & Preparation
Conduct an internal gap analysis to understand compliance requirements under the applicable ISO standard.
Step 2: Documentation & Quality Manual
Prepare:
- Quality Manual
- Standard Operating Procedures (SOPs)
- Technical and calibration records
Step 3: Application to NABL
Submit the online application to NABL along with scope of accreditation and required fees.
Step 4: Pre-Assessment (Optional)
NABL may conduct a pre-assessment to identify non-conformities and readiness gaps.
Step 5: Final Assessment
A team of NABL assessors conducts an on-site assessment to verify:
- Technical competence
- Equipment calibration
- Staff qualifications
- Quality system implementation
Step 6: Closure of Non-Conformities
The laboratory must submit corrective actions for non-conformities within the stipulated timeline.
Step 7: Grant of NABL Accreditation
Upon successful compliance, NABL grants accreditation and issues the certificate with approved scope.
Documents Required for NABL Accreditation
- Quality Manual and SOPs
- Equipment calibration records
- Staff qualification and training details
- Internal audit and management review records
- Legal identity of laboratory
Validity & Renewal of NABL Accreditation
- NABL accreditation is generally valid for 2 years
- Surveillance assessments are conducted periodically
- Renewal is required before expiry
Benefits of NABL Accreditation
- Technical Credibility: Trusted test and calibration results
- Global Acceptance: International recognition of reports
- Regulatory Compliance: Accepted by authorities and courts
- Business Growth: Eligibility for government and PSU tenders
- Quality Improvement: Strong laboratory management systems
Common Mistakes to Avoid
- Incomplete documentation
- Poor calibration traceability
- Untrained technical staff
- Delay in corrective action submission
NABL vs NABH Accreditation
| Aspect | NABL | NABH |
|---|---|---|
| Applicable To | Laboratories | Hospitals & Healthcare |
| Focus | Technical competence | Patient safety & care |
| Standard | ISO/IEC 17025, 15189 | Healthcare standards |
| Authority | Quality Council of India | Quality Council of India |
Conclusion
NABL Accreditation in India is a vital quality benchmark for laboratories seeking accuracy, credibility, and global recognition. By following a structured step-by-step process and maintaining strict compliance, laboratories can enhance trust, expand opportunities, and deliver reliable services across industries.
Disclaimer
This article is published for general informational purposes only and does not constitute legal, technical, or professional advice. NABL standards, procedures, fees, and timelines are subject to change. Readers are advised to refer to official NABL guidelines or consult qualified professionals before applying for accreditation.