What is NABL and NABL Accreditation in India: Explore Meaning, Process, and Benefits

NABL accreditation is a quality certification awarded to laboratories that meet international standards for testing and calibration. It is granted by the National Accreditation Board for Testing and Calibration Laboratories, an autonomous body operating under the Department of Science and Technology.

The purpose of NABL accreditation is to ensure that laboratories provide accurate, reliable, and internationally accepted test results.

During the accreditation process, laboratories are assessed on several parameters:

• Laboratory infrastructure and facilities
• Accuracy and calibration of testing equipment
• Competence of laboratory personnel
• Quality management systems
• Participation in proficiency testing programmes

Once accredited, a laboratory receives formal recognition of its technical competence and reliability.

Business loans can facilitate the process of obtaining NABL accreditation by providing financial support for the expenses involved in meeting the accreditation requirements. This may include investing in infrastructure upgrades, purchasing specialised equipment, hiring skilled personnel, and covering other associated costs. With the help of a business loan, laboratories and testing facilities can ensure they have the necessary resources to meet the stringent standards set by NABL, thereby enhancing their credibility and competitiveness in the market.

The National Accreditation Board for Testing and Calibration Laboratories provides accreditation to various types of laboratories based on the nature of their services.

Major types of NABL accreditation:

Each category follows specific evaluation standards aligned with international laboratory quality requirements.

The eligibility requirements depend on the type of conformity assessment body and the scope you want accredited. NABL currently accredits testing and calibration laboratories under ISO/IEC 17025, medical laboratories under ISO 15189, proficiency testing providers under ISO/IEC 17043, reference material producers under ISO 17034, and biobanks under ISO 20387.

Key eligibility requirements

For a typical testing or calibration laboratory seeking NABL accreditation:

• Applicable standard: The laboratory must comply with ISO/IEC 17025:2017 and the relevant NABL specific criteria. 
• Quality management system: The laboratory should have a documented quality system, including a suitable quality manual, procedures and work instructions, and these must be implemented effectively. 
• Technical competence: The laboratory must have competent technical personnel, appropriate facilities and equipment to perform the tests or calibrations included in its proposed scope. NABL assesses technical competence as part of the accreditation process. 
• Proficiency testing: Where applicable, the laboratory must satisfactorily participate in proficiency testing or an appropriate inter-laboratory comparison before accreditation. 
• Internal audit and management review: The laboratory should have completed at least one internal audit and one management review before submitting its application. 
• Application: The applicant submits the prescribed NABL application, relevant management-system documentation, proposed scope of accreditation and applicable fees through the NABL portal. 
• Assessment and corrective action: NABL assessors review the documentation and technical competence, identify any non-conformities and assess the laboratory's corrective actions before recommending accreditation. 

Important: NABL accreditation is voluntary, and the exact requirements can vary according to the laboratory type, technical discipline and accreditation scope.

Advantages of NABL for healthcare professionals

• Enhanced expertise in calibration processes
• Potential for business growth driven by increased customer trust and satisfaction
• Recognition and broader market reach both domestically and internationally
• Reduced product retesting leads to savings in both time and costs
• Improved control over laboratory operations and more effective feedback

Advantages of NABL for individuals

• Confidence in receiving accurate reports from properly calibrated tests
• Trust in the expertise of the testing personnel
• Savings in time and money by avoiding unnecessary re-testing
• Satisfaction with the quality of services received

Here are the key principles of NABL accreditation:

• Reach out to the NABL secretariat to obtain the necessary documents related to the accreditation process. 
• Familiarise yourself with all pertinent documents, the accreditation procedure, and the steps required for submitting an application.
• Nominate a staff member for training on quality management systems and internal audits by enrolling them in NABL's 4-day residential training programme.
• Develop a quality manual in compliance with ISO 15189 standards.
• Create a detailed standard operating procedure (SOP) for every laboratory investigation, ensuring proper environmental controls like temperature, humidity, and storage are maintained.
• Labs aiming for NABL accreditation must calibrate all instruments and equipment. Calibration must be performed exclusively by NABL-accredited calibration laboratories.
• Provide training to staff on documentation procedures, covering proper formatting, authorisation, issuance and withdrawal processes, as well as document review and change protocols. Each document should include an ID number, controlling authority's name, retention period, etc.
• It's important to remember that the quality manual serves as a policy document, which must be supported by additional procedural documents that also require proper preparation.
• Ensure that all processes outlined in the quality manual are thoroughly implemented.
• Document the internal quality control (IQC) measures used during patient testing, including uncertainties in measurements using tools such as Levy Jennings charts.
• Participate in External Quality Assessment Schemes (EQAS) and inter-laboratory comparisons for analytes not covered by available schemes.
• Record corrective actions taken in response to deviations in IQC/EQA results.
• Conduct internal audits and management reviews.

Submit your application for NABL accreditation and pay the necessary fees.

Process of NABL accreditation

The NABL accreditation process ensures that laboratories consistently meet international quality standards.

The process involves the following stages:

• Submission of the application by the laboratory
• Evaluation of documents by NABL assessors
• Pre-assessment visit to review readiness
• Detailed on-site laboratory assessment
• Accreditation decision by the committee
• Ongoing surveillance audits

Each stage verifies the laboratory’s technical competence and operational reliability.