Key NABL Standards Every Lab Must Follow [2026]

To ensure all testing laboratories in India ensure the highest quality of practices, the National Accreditation Board for Testing and Calibration Laboratories (NABL) set a code of conduct for them. That is what NABL standards for labs could mean. All labs are expected to follow the standards in the safety of their operations, clients and stakeholders. Many of them are in accordance with the international standard of ISO 17025. They range from operational, legal, and technical standards to ethical practices to uphold the integrity of laboratory operations. Let’s learn about them in this article.

What Are NABL Standards?

NABL standards refer to the guidelines and criteria set by the National Accreditation Board for Testing and Calibration Laboratories (NABL) to ensure quality, technical competence, and reliability in testing and calibration laboratories in India.
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NABL Requirements for Testing Laboratories

Comprehensive Listing of Products/Services

Laboratories should prepare and maintain a detailed list of all the products and services they’re offering, for example the types of diagnostic tests in case of pathology labs. It ensures that clients and stakeholders have a clear picture of the laboratory’s testing capabilities, adhering to NABL standards for clarity and transparency.

Accreditation for All Products and Applicable Tests

All the laboratories are encouraged to obtain NABL accreditation for every product they test and for all relevant tests associated with each product. A comprehensive accreditation is mandatory for clients to receive thorough and reliable testing services from recognised, accredited laboratories, aligning with NABL guidelines and government principles.

Cooperation with NABL

During NABL assessments, labs must fully cooperate with various procedures and representatives. It involves providing unrestricted access to facilities, documentation, and personnel. By facilitating thorough evaluations and audits, labs demonstrate commitment to high-quality testing services and transparency. It also helps identify areas of improvements with respect to NABL standards.

Accurate Claim of NABL Accreditation

Every laboratory must represent their NABL accreditation status transparently and accurately. When accreditation is applicable for only specific tests and scopes, it should be mentioned clearly. Any misleading claims about the scope of accreditation are discouraged and clear guidelines are given to communicate your accreditation status in compliance with NABL standards.

Transparent Accreditation Status

Lab report results have immense weight in legal and healthcare services. Such reports must clearly indicate whether each test parameter listed is accredited by NABL. The NABL symbol and QR code should be displayed prominently as NABL standards to ensure transparency and authenticity.

Digitization and Automation of Processes

In response to growing digitalisation and patient care safety, every laboratory must pursue complete digitisation and automation of their processes to reduce manual intervention and increase accuracy. It includes IT-enabled systems for receipt, testing status updates, result reporting, and dispatch. For example, getting LIS software, employing EHR integrations, etc. It improves efficiency, accuracy, and the overall efficiency of laboratory operations in line with NABL standards.

Reference Materials

Testing laboratories must possess all necessary reference materials pertinent to their applied scope, along with valid certificates of calibration or verification. They are essential for ensuring the accuracy and reliability of test results. Proper documentation and certification of these materials underpin the laboratory's adherence to NABL standards, providing confidence to clients and regulatory bodies.

Integration with NABL’s Blockchain Portal

Laboratories must integrate with NABL’s blockchain portal and upload all test reports onto the platform. It is mainly to ensure authenticity and confidentiality of reports, which are crucial for diagnostic testing labs. The integration in turn proves trustworthiness of labs according to clients, staying in accordance with NABL guidelines.

Fee Payment Clearance

During accreditation process and at the time categorisation, laboratories have to pay various fees to help timely evaluation. They support various assessments, audits and administrative functions. Prompt payment ensures timely completion of processes involved and reflects the commitment of labs for quality services.

Following Ethical Practices

NABL standards for labs are not mere a bunch of instructions. They are constructed for the safety of both labs and their stakeholders. Hence, every laboratory must adhere to ethical practices and NABL guidelines. Engaging in practices intended to influence accreditation decisions can lead to adverse categorisation of a lab’s status, impacting its credibility in the long-term.

Encourage Collaboration

Calibration labs are encouraged to support testing labs in obtained accreditation for parameters not available in their country. It helps expand the range of testing services available domestically, following NABL standards. All testing labs must pursue the same for increasing their credibility and impact.

Participation PT Programs

Laboratories are required to participate in Proficiency Testing (PT) programs continuously throughout the recognition period, with a minimum of one PT program per year covering the entire scope of their accreditation. It is a critical component of maintaining NABL standards, as it helps labs benchmark their performance against industry standards, identify potential issues, and implement corrective actions.

Control on Resource Sharing

All labs must ensure strict control over resource sharing, including equipment, personnel, and certified reference materials (CRM). Any unauthorised sharing of these resources is against NABL standards and treated severely to uphold the integrity and independence of laboratory operations.

Prompt Reporting and Communication with NABL

Regular staffing changes, and visitations by pertinent regulatory bodies might happen in laboratories. In that case, they must ensure to report the occurrence of the same to NABL within the stipulated time period– 15 days for staff changes and immediate reporting for regulators and their outcomes.

Continuous Compliance

NABL standards for labs mandate that labs must respond promptly to any changes initiated by NABL in its criteria and procedures. They must stay up-to-date with the latest updates and modifications to NABL guidelines and integrate these changes into their operations without delay. It ensures healthy maintenance of accreditation status, and amassing credibility overtime.

NABL Guidelines for Chemical Testing Laboratories

Chemical testing laboratories must follow the below guidelines to comply with NABL standards.

1. Obtain ISO 17025 accreditation to demonstrate competence and credibility.
2. Nominate a responsible person as Quality Manager to coordinate accreditation activities.
3. Train technical officers on Quality Management System ISO 17025, Internal audit, Measurement Uncertainty, and Inter Laboratory Comparison.
4. Prepare a Quality Manual as per NABL document No-160.
5. Develop Quality System Procedures (QSP), Standard Operating Procedures (SOP), and Work Instructions.
6. Ensure proper environmental conditions in the laboratory (temperature, humidity, storage, housekeeping).
7. Calibrate equipment and glassware from an accredited institute and maintain traceability records.
8. Purchase certified reference materials and maintain their traceability records.
9. Calculate measurement uncertainty for every procedure/equipment.
10. Implement and evaluate all aspects documented in the Quality Manual.
11. Participate in inter-laboratory comparisons with accredited laboratories.
12. Conduct internal audits for Quality Management and Technical Aspects.
13. Maintain records of Internal audits and training documents.
14. Apply for accreditation through NABL's website and submit required documents.
15. Undergo pre-assessment and final assessment by NABL assessors.
16. Take corrective actions based on assessment findings.
17. Apply for desktop surveillance audit annually after accreditation.
18. Apply for renewal of accreditation six months before expiry.
19. Follow NABL's policies on calibration, traceability, proficiency testing, and measurement uncertainty.
20. Adhere to NABL's terms and conditions for obtaining and maintaining accreditation.

Conclusion

Adhering to NABL standards ensures that laboratories in India maintain high-quality practices, fostering trust and reliability in their operations. By committing to these guidelines, labs can enhance their reputation and ensure safety. It also helps them deliver accurate, and dependable results, ultimately contributing to the overall improvement of the scientific and medical testing landscape.