Accreditation from NABL as per ISO/IEC 17025

NABL (National Accreditation Board for Testing and Calibration Laboratories) is a constituent board of the Quality Council of India (QCI) that provides formal recognition to testing, calibration, and medical laboratories demonstrating technical competence as per ISO/IEC 17025:2017 standards.

Why NABL Accreditation Matters:

• Global Recognition: NABL is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA), ensuring your test reports are accepted in over 100 countries worldwide.
• Mandatory Compliance: Many regulatory bodies (BIS, Ministry of Commerce, Export Promotion Councils, etc.) require NABL-accredited test reports for product certification, export licenses, and quality compliance.
• Enhanced Credibility: NABL accreditation demonstrates your laboratory's technical competence, impartiality, and consistent delivery of accurate results, building trust with clients and stakeholders.
• Market Access: Many government tenders, private contracts, and international buyers mandate NABL-accredited laboratories, giving you a competitive edge.
• Operational Excellence: The accreditation process strengthens your internal quality management systems, improves traceability, and reduces errors.

Omega QMS has successfully guided numerous laboratories across diverse sectors to achieve NABL accreditation, ensuring they meet international standards and gain access to lucrative markets.

The NABL accreditation process typically takes 6 to 12 months from initial preparation to final accreditation, depending on your laboratory's readiness and the complexity of the scope of accreditation.

Typical Timeline Breakdown:

• Gap Analysis and Preparation (1-3 months): Assessment of current laboratory practices, documentation development, staff training, equipment calibration, and internal audits.
• Application Submission and Review (1-2 months): Submission of formal application to NABL, document review by NABL, and scheduling of assessment.
• On-Site Assessment (1 week): NABL assessors conduct a comprehensive evaluation of your laboratory's technical competence, quality systems, and compliance with ISO/IEC 17025.
• Non-Conformity Resolution (1-3 months): Address any findings or non-conformities identified during the assessment, implement corrective actions, and submit evidence to NABL.
• Accreditation Decision and Certificate Issuance (1-2 months): NABL's technical committee reviews the assessment report and issues the accreditation certificate.

With Omega QMS's expert guidance, many laboratories achieve accreditation on the shorter end of this timeline, as we streamline documentation, ensure first-time assessment success, and minimize non-conformities.

Our proven methodology focuses on rapid readiness, reducing unnecessary delays and getting your laboratory accredited faster.

The total cost of NABL accreditation depends on the scope of accreditation, laboratory size, number of test methods, and the extent of preparation required. Key cost components include:

NABL Fees (Payable to NABL):

• Application Fee: Ranges from INR 10,000 to INR 30,000 depending on the scope and type of laboratory (testing, calibration, medical).
• Assessment Fee: Based on the number of assessor-days required, typically ranging from INR 50,000 to INR 2,00,000 or more for complex laboratories with multiple scopes.
• Annual Accreditation Fee: Payable after accreditation is granted, ranging from INR 25,000 to INR 1,00,000 depending on scope.
• Surveillance and Re-assessment Fees: Charged for periodic surveillance visits and re-assessments every 2-4 years.

Internal Investment and Consultancy Costs:

• Infrastructure and Equipment: Investment in calibrated equipment, controlled environment (temperature, humidity controls), and traceability standards.
• Documentation and Quality Systems: Development of quality manuals, standard operating procedures (SOPs), test methods, calibration procedures, and record-keeping systems.
• Staff Training: Training personnel on ISO/IEC 17025 requirements, measurement uncertainty, internal audits, and method validation.
• Professional Consultancy (Omega QMS): Expert guidance for gap analysis, documentation, pre-assessment audits, corrective action support, and assessment readiness. Consultancy fees vary based on laboratory complexity but provide significant ROI by ensuring first-time success and avoiding costly re-assessments.

Omega QMS offers transparent, customized pricing based on your laboratory's unique needs. We provide upfront cost estimates and work within your budget to maximize value and minimize delays.

For a detailed cost breakdown and confidential consultation, contact us at info@globalomega.com or call +91-9810047474.

To achieve NABL accreditation, your laboratory must demonstrate full compliance with ISO/IEC 17025:2017 standards, which cover both management and technical requirements. Key requirements include:

1. Organizational and Management Requirements:

• Legal Entity: The laboratory must be a legally recognized entity (private company, partnership, government lab, etc.).
• Impartiality and Confidentiality: Documented policies to ensure unbiased testing/calibration and protection of client data.
• Quality Management System (QMS): A comprehensive QMS covering all laboratory operations, documented in a quality manual and supporting procedures.
• Document Control: Systems to manage and control documents, records, and data integrity.

2. Technical Competence Requirements:

• Personnel Competence: Qualified, trained, and authorized staff with documented competency for specific test methods. Educational qualifications, training records, and competency assessments must be maintained.
• Infrastructure and Environment: Adequate facilities, controlled environmental conditions (temperature, humidity, lighting), and segregated areas to prevent cross-contamination.
• Calibrated Equipment: All testing and measuring equipment must be calibrated and traceable to national or international standards. Calibration records and uncertainty budgets must be maintained.
• Validated Test Methods: Use of standard test methods (IS, ISO, ASTM, etc.) or validated in-house methods. Method validation must demonstrate accuracy, precision, and repeatability.
• Measurement Uncertainty: Calculation and reporting of measurement uncertainty for all test results.
• Proficiency Testing: Participation in relevant proficiency testing schemes or inter-laboratory comparisons to validate competence.

3. Operational Requirements:

• Sample Handling: Proper identification, receipt, storage, and disposal of samples.
• Internal Audits and Management Review: Regular internal audits of the QMS and periodic management reviews to ensure continual improvement.
• Corrective and Preventive Actions: Systems to identify, document, and resolve non-conformities and prevent recurrence.
• Test Reporting: Accurate, clear, and comprehensive test reports with all required information as per ISO/IEC 17025.

Omega QMS provides end-to-end support to help laboratories meet all NABL requirements, from infrastructure setup and documentation to staff training and pre-assessment audits. We ensure your laboratory is fully prepared for a successful NABL assessment.

Yes, absolutely. NABL accreditation is not restricted by laboratory size. Small laboratories, startups, and even single-person laboratories can achieve NABL accreditation as long as they meet the technical competence and quality management requirements of ISO/IEC 17025:2017.

Key Considerations for Small Laboratories:

• Limited Scope: Small laboratories can apply for accreditation for a limited number of test methods or parameters, reducing complexity and cost. You can expand the scope later as your business grows.
• Flexible Approach: NABL recognizes that small laboratories may have resource constraints and allows flexibility in documentation and systems, provided technical competence is demonstrated.
• Cost-Effective Solutions: With expert guidance, small laboratories can achieve accreditation efficiently without over-investing in unnecessary infrastructure or documentation.
• Competent Personnel: Small laboratories must demonstrate that their personnel are adequately trained and competent for the accredited scope, even if the same person performs multiple roles.
• Market Advantage: For small laboratories, NABL accreditation is a powerful differentiator that opens doors to government contracts, regulatory approvals, and export opportunities that would otherwise be inaccessible.

Omega QMS specializes in helping small and medium-sized laboratories achieve NABL accreditation with practical, cost-effective strategies. We tailor our approach to your specific needs, ensuring compliance without unnecessary burden.

Many of our clients are small laboratories that have successfully achieved accreditation and grown their business significantly as a result.

NABL accreditation is not a one-time achievement — it requires ongoing compliance and periodic renewal to maintain validity. The accreditation cycle includes surveillance visits, re-assessments, and continuous quality management.

Maintenance Requirements:

• Continuous Compliance: Your laboratory must continue to operate in accordance with ISO/IEC 17025 standards at all times. This includes maintaining calibration schedules, conducting internal audits, participating in proficiency testing, and addressing non-conformities promptly.
• Surveillance Visits: NABL conducts periodic surveillance assessments (typically every 12-18 months) to verify ongoing compliance. These are shorter assessments focused on specific aspects of your QMS and technical operations.
• Annual Accreditation Fee: You must pay an annual fee to NABL to keep your accreditation active.
• Notification of Changes: Any significant changes to your laboratory (change of address, scope modification, new equipment, key personnel changes) must be reported to NABL and may trigger a special assessment.

Renewal and Re-assessment:

• Re-assessment Cycle: NABL accreditation must be renewed every 4 years through a comprehensive re-assessment, similar to the initial assessment.
• Application for Renewal: You must submit a renewal application 6 months before your accreditation expiry date.
• Re-assessment Process: A full on-site assessment is conducted to verify continued compliance with ISO/IEC 17025 and NABL criteria.
• Certificate Renewal: Upon successful re-assessment, a new accreditation certificate is issued for another 4-year cycle.

Scope Extension or Reduction:

• If you wish to add new test methods or parameters to your accreditation scope, you must apply for scope extension and undergo an assessment for the new methods.
• Similarly, if certain tests are no longer relevant, you can request scope reduction.

Omega QMS provides ongoing support to accredited laboratories, including surveillance preparation, internal audit services, corrective action assistance, and re-assessment support. We help ensure your accreditation remains valid and your laboratory operates at peak performance.

Our post-accreditation support packages are designed to keep you compliant with minimal effort, allowing you to focus on growing your business.