NABL certification procedure for Laboratories

NABL certification procedure involves a systematic process of application, documentation, evaluation, and compliance with the accreditation requirements.

NABL National Accreditation Board for Testing and Calibration Laboratory
SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID:
Rakesh Dahiya

Last Updated on January 5, 2024 by The Health Master

NABL certification

Obtaining NABL certification involves a systematic process of application, documentation, evaluation, and compliance with the accreditation requirements.

Simple steps to obtain NABL accreditation

Here are the simple steps a laboratory needs to follow to achieve NABL certification:

1. Pre-Assessment and Readiness Review:

The laboratory should conduct an internal assessment to ensure it meets the requirements of NABL accreditation.

Review the NABL accreditation criteria and relevant international standards (ISO/IEC 17025 for testing laboratories and ISO/IEC 17025 for calibration laboratories).

Identify any gaps in the laboratory’s quality management system, infrastructure, equipment, and technical competence.

Lab Laboratory
Picture: Pixabay

2. Application Submission:

  • Submit the formal application for NABL accreditation to the NABL office.
  • The application form can typically be downloaded from the NABL website.
  • Pay the application fee that has been specified by NABL.

3. Document Preparation:

  • Prepare all the required documents and records, including quality manuals, standard operating procedures (SOPs), policies, and laboratory-specific documents related to testing or calibration procedures.
  • Ensure that the documents comply with the requirements of ISO/IEC 17025 standards.

4. On-Site Assessment:

  • Once the application is accepted, NABL will schedule an on-site assessment of the laboratory.
  • A team of qualified assessors will visit the laboratory to evaluate its technical competence, quality management system, facilities, equipment, and personnel qualifications.
  • The assessors will review the laboratory’s documents, conduct interviews, and witness the laboratory’s testing/calibration activities.

5. Corrective Actions:

  • After the on-site assessment, the laboratory will receive a report highlighting any non-compliances or areas for improvement.
  • The laboratory is expected to address these findings by implementing corrective actions within a specified timeframe.

6. Proficiency Testing:

  • NABL may require the laboratory to participate in proficiency testing (also known as inter-laboratory comparisons) to assess its ability to produce accurate and reliable results.

7. Accreditation Decision:

  • The assessment team will submit their findings to the NABL accreditation committee for review and decision.
  • If the laboratory meets all the requirements, NABL will grant accreditation.

8. Surveillance Assessments:

  • After obtaining accreditation, the laboratory will be subject to periodic surveillance assessments to ensure ongoing compliance with NABL standards and continuous improvement.

9. NABL Certificate:

  • Upon successful completion of the accreditation process, the laboratory will receive an official NABL certificate stating the scope of accreditation and the validity period.

It’s essential for laboratories seeking NABL certification to be well-prepared and committed to meeting the stringent requirements for technical competence, quality management, and adherence to international standards.

The accreditation process is thorough and may take some time, but it offers significant benefits, including enhanced credibility, global recognition, and improved quality assurance for the laboratory’s testing or calibration services.

FAQs about NABL certification:

Q1. What is NABL certification, and why does it matter?

NABL certification signifies a lab’s competence in testing and calibration. It’s vital for credibility, reliability, and meeting international standards.

Q2. What are the steps for NABL certification?

  • Apply with documents.
  • Assessment of the lab’s processes.
  • Address any issues.
  • Final assessment and decision.

Q3. Is NABL accreditation recognized globally?

Yes, NABL follows international standards, making its accreditation recognized and respected internationally. This is valuable for collaboration and trust on a global scale.

Q4. How long does NABL certification take?

The duration varies, but it usually takes a few months due to assessments, corrections, and final review.

Q5. What are the benefits of NABL certification for labs?

NABL boosts quality, trust, and competitiveness through international recognition and adherence to standards.

Q6. Is NABL certification a one-time thing?

No, labs must maintain standards by participating in testing, upholding quality systems, and undergoing periodic reviews for reaccreditation.

Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana

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