Two laboratories that perform medical tests are within walking distance of each other. Both laboratories obtain samples of patients' blood, provide clear reports of the test findings, and charge approximately the same amount for the testing services. When a patient compares these two laboratories, he/she will be unable to determine how often quality control testing is performed on the test equipment, how the sample tubes are identified, or if the laboratory results have been compared with another laboratory's results. Typically the only indication that an external organization has evaluated these factors is the presence of the National Accreditation Board for Testing and Calibration Laboratories (NABL) logo displayed on the wall.
For laboratory owners the problem is in reverse: how can you provide a doctor/patient with a basis for confidence in your laboratory data without having them rely on your "word"? The purpose of this guide is to explain what NABL accreditation is, what is covered by the scope of NABL accreditation, what is excluded from the scope of NABL accreditation, how much effort is required to achieve NABL accreditation, and what role software plays in achieving NABL accreditation. Information regarding NABL was obtained from their website and other available literature.
What Is a NABL-Accredited Laboratory?
A laboratory with NABL accreditation has had its technical capability verified by an independent review process conducted by the National Accreditation Board for Testing and Calibration Laboratories (NABL). Medical laboratories are evaluated against the ISO 15189 standard. Accreditation only applies to the specific tests, areas of practice and locations identified in the laboratory's scope of work. According to NABL, accreditation is a voluntary program.
Key takeaways
- Third-party certification of competency to perform within a given scope is what accreditation is. It is not an overall government approval.
- NABL states that they are a voluntary accreditation body and do not possess regulatory authority. Regardless, labs are required to comply with all relevant regulations.
- NABL is an organization that accredits laboratories. The standard that is used by NABL to accredit medical laboratories is ISO 15189:2022.
- A test method or location that is not in the scope is not covered.
- While software may be used to document and control it cannot provide or guarantee accreditation.
What Is NABL?
NABL, which stands for National Accreditation Board for Testing and Calibration Laboratories is a component of the Quality Council of India (QCI). The nodal agency of QCI is the Department for Promotion of Industry and Internal Trade, Ministry of Commerce and Industry. NABL operates under the guidelines of ISO/IEC 17011, the international standard that governs accreditation bodies. NABL provides accreditation on a voluntary basis to testing, calibration, and medical laboratories, along with proficiency testing organizations, reference material manufacturers, and biological specimen repositories.
NABL provides accreditation for medical labs in several areas including clinical biochemistry, clinical pathology, hematology, microbiology and infectious disease serology, histopathology, cytopathology, flow cytometry, cytogenetics and molecular diagnostics.
What a NABL-Accredited Laboratory Means in Practice
NABL describes accreditation as an independent verification (third-party) that an organization performing conformity assessments in this case a laboratory has proven its ability to perform certain tasks. The word "certain" makes a big difference. According to NABL's guidelines capabilities not included on the scope of accreditation will not be recognized.
A laboratory can be accredited at its primary location for both clinical biochemistry and hematology. If a laboratory runs a thyroid panel using an accredited method at its primary location then it is considered to be within the scope of accreditation. However if a biopsy is reviewed at a different branch of the laboratory or if the laboratory performs a new test that they have not yet requested to be added to their scope of accreditation, then those tests would not fall under the scope of accreditation even though the report may contain the same logo as reports issued from the accredited location. This is why NABL advises users to verify the test parameters, methods, locations, and expiration dates of certificates.
NABL Accreditation vs ISO Certification: What Is the Difference?
| NABL accreditation | ISO certification (for example ISO 9001) | |
|---|---|---|
| What is assessed | Technical competence for specific tests, plus the quality system | Conformity of a management system to a standard |
| Who grants it | An accreditation body, NABL | A certification body |
| What it covers | A defined scope: tests, disciplines, locations | The organisation's management system |
| Standard used for medical labs | ISO 15189 | ISO 9001 or another management-system standard |
The FAQ for NABL also emphasizes that the ISO 9000 type certification will address the laboratory's quality management system however ISO 17025 accreditation will provide a review of the laboratory's technical competency. In addition to these types of certifications, there are other types of permits, such as registration and licensing. These types of permits are granted by the government or other appropriate body and NABL states that each laboratory is ultimately accountable for complying with both national and state laws that govern its activities.
The fourth version of the international standard "Medical laboratories — Requirements for quality and competence" was released by ISO in December 2022 and is designated as ISO 15189:2022. It replaced the 2012 version of the standard and also replaced ISO 22870, which was previously a separate standard for point-of-care testing. The current version of the standard is applicable to both point-of-care testing and other laboratory services. Professional organizations in the United Kingdom consider the standard to be risk-based and patient-centric, and state that most established quality systems continue to be compliant with the requirements of the standard. Although ISO produces the standard, they do not accredit laboratories. Pre-assessment guidelines for NABL (NABL 208A) have been updated to reflect the 2022 version of the standard.
Why Does NABL Accreditation Matter in India in 2026?
That's why a referring doctor can use the information from the outside source to verify that the lab is properly calibrated. They may not be able to review your calibration logs, however, they can confirm that the outside source has reviewed those logs.
- Assessors assess the technical knowledge required for designated examinations as well as reviewing documentation.
- Consistency: Laboratories will produce consistent (repeatable) results through documenting their methods and controls, as well as participating in either proficiency testing or an external quality assessment program.
- Trust in your patient: certificates that have a defined scope and valid dates are much easier to trust than just claims.
- Provider confidence: According to NABL, results from accredited labs are used extensively by many different types of users and that having accreditation will help providers compete in requests for proposals (RFPs) that require testing done by an independent lab.
- Risk Management & Improvement: Internal Audit, Corrective Actions and Management Review are all parts of the cycle.
Error-free results are not guaranteed by accreditation however, accreditation indicates a lab has an organized method for identifying and correcting errors.
Major Benefits of NABL Accreditation
- For patients. You will find ways to determine if the lab where you are going to get your blood drawn is competent. You will also be able to verify that the lab has a certificate showing that it is certified to perform the exact type of test you require.
- For pathology and laboratory personnel. clearly defined processes, defined roles and responsibilities and documentation of competency assessments will allow for a more defensible decision making process, as well as providing a way to assess if the quality management system is working.
- For laboratory owners. Better operational control, increased customer confidence and the ability to participate in tenders that require accreditation. NABL indicates that there is a potential for business growth due to increased customer confidence; however, this should be considered a possible result rather than a guarantee.
- For hospitals and other health care organizations. a criteria to select either a laboratory that is reference based or one that provides services outside of your organization (outsourced), as results obtained through an accredited laboratory will be provided by a laboratory that has been evaluated against an international standard.
NABL Accreditation Requirements for Pathology Laboratories
NABL assesses medical laboratories based on ISO 15189, as well as on its specific criteria in NABL 112A, with additional guidance in NABL 112B. The table provides an easy-to-read summary of major categories. This table does not replace the above mentioned documents and items listed under "Good Practices" are simply examples and not clauses.
| Area | What it covers | Good practice example |
|---|---|---|
| Quality management system | Documented policies, procedures and responsibilities | A controlled quality manual with named owners |
| Personnel | Qualified, competent staff authorised for tasks | A training and competency matrix per person |
| Equipment | Management, calibration and maintenance | A register with due dates and service records |
| Internal quality control | Monitoring each run's performance | Daily QC review signed by a supervisor |
| External quality assessment | Comparing results with other labs | Enrolment per discipline and review of each round |
| Sample handling | Collection, identification and traceability | Barcode labelling from registration to storage |
| Methods | Verification or validation as applicable | A file per method showing performance checks |
| Document and record control | Current versions, retained records | One master list of SOPs with revision history |
| Risk management | Identifying and reducing risks to results | A reviewed risk register for key processes |
| Internal audits | Planned checks of the system | A yearly audit plan covering every area |
| Management review | Leadership review of performance | Minuted reviews with actions and owners |
| Nonconformities | Investigation and corrective action | A log with root cause, owner and closure date |
| Reporting | Report content, approval, critical results | A written critical-result call and record process |
| Continual improvement | Acting on audits, complaints and data | Monthly review of rejection and delay trends |
Per its FAQ, NABL requires that prior to accreditation in each discipline being sought after applicants have participated in at least one proficiency testing/EQA program and conducted at least one internal audit and one management review prior to submitting their application.
NABL Accreditation Process in India: Step-by-Step Guide
The following steps are based on NABL’s published process. To verify which is the most recent version, refer to NABL 100B, available from the NABL website under "Documents."
- Determine if the lab is eligible based on the requirements. The lab must be a legal entity with the proper registration. Both private and government labs are eligible to apply regardless of size (small or large) as well as both stationary and mobile labs.
- Define the scope. Determine what disciplines, tests, methods and locations will be included. A multi-disciplinary laboratory can be applied to every discipline that applies to the scope.
- Prepare the quality system. Develop a quality manual and procedures which conform to both ISO 15189 and NABL 112A. NABL suggests that labs develop their own materials and all external consultants must be identified to NABL.
- Implement and test. Use the procedures, participate in proficiency testing/external quality assessment (EQA) perform an internal audit and conduct a management review.
- Apply. Send the completed application form (NABL 153) quality manual and payment based on the fees stated in NABL 100A. The application fee varies depending upon the size of the lab and there is an additional charge per collection center. All other fees can be found in NABL 100A.
- The application is reviewed by NABL and a pre-assessment can be scheduled to find out what needs to be improved prior to the final assessment.
- Assessment and Corrective Action. An assessment team evaluates the system and technical capabilities of the lab at its location. Any deficiencies found by the team during the evaluation must be corrected by the lab within the specified timeframe.
- The accreditation process at NABL involves the following steps. decision certificate and surveillance. The outcome of the decision process is reviewed by NABL's Accreditation Committee. After that, a certificate is issued with a specific scope and validity period. According to NABL's FAQ page, accreditation is granted for four years, during which time there are annual surveillances and one mid-cycle assessment. In addition to these scheduled assessments, NABL has the right to conduct unscheduled assessments. NABL also reserves the right to suspend or revoke accreditation.
NABL does not offer a specific time frame for when you will be able to begin testing your samples, therefore you should use discretion regarding how long it may take.
Common Challenges Faced by Pathology Labs
- Manual documentation: paper registers that are filled in later or not at all.
- Inconsistent Identification of Samples - Different practices at different centers and hand-written labels.
- Missing records: a calibration done but nothing to show it.
- Equipment maintenance tracking: service dates held in someone's memory.
- QC documentation: results reviewed informally with no sign-off.
- Staff competency records: training happens but is not recorded.
- Multiple branches: each site drifts into its own habits.
- Audit preparation: a last-minute scramble to assemble evidence.
Most of these problems occur as habits before they occur as technological issues. Therefore it is easier to resolve when records are created during the time that work occurs.
How LIMS Software Supports NABL-Ready Laboratory Operations
A Laboratory Information Management System (LIMS) which is sometimes used as a synonym for an LIS in diagnostic labs may be useful to help organize the evidence upon which a Quality System relies:
- Pathology Lab sample tracking with Barcodes From Sample Registration through to reporting. See our guide to Barcode based Sample Tracking in Pathology Labs.
- Test and report workflows with defined review and approval steps.
- QC records kept per run with review and sign-off.
- Audit trails showing who created changed or approved a record.
- Integrate analyzers to ensure that data is associated with the correct sample without manual input of the same information.
- Digital documentation for SOPs and corrective actions.
- Operational tracking (e.g., turnaround times, rejection patterns) and multi-site workflows. The operational aspects of managing laboratories are discussed in our overview of common issues faced by laboratory managers.
A LIMS provides both operational controls and documentation. A LIMS does not automatically lead to NABL accreditation or compliance therefore an assessor will continue to evaluate personnel, procedures, and competency.
How MargLabz Supports Modern Diagnostic Laboratories
MargLabz is an artificial intelligence-based laboratory operating system used by diagnostic laboratories.
On its site it says it has 40+ different modules for example from the time the patient registers until the report is issued, for barcoding samples to track them throughout the process, for two-way interfaces with analyzers so data can flow in both directions, for automated validation and delta checking to find when there is a problem that requires human intervention, for quality control and external quality assessment using Westgard rules, for standard operating procedures (SOP), corrective action preventive action (CAPA) and calibration records, for keeping track of all actions taken during the testing process (audit trails) and for measuring how long it takes to complete tests (turnaround-time monitoring). MargLabz claims that its processes are NABL ready, which means they are created to meet the documentation requirements of the National Accreditation Board for Testing and Calibration Laboratories (NABL).
MargLabz offers an enterprise plan that allows users to operate multiple locations, and also offers an "AI Smart Report" feature that adds plain language descriptions next to the pathologist-signed reports.
MargLabz will not provide accreditation to a lab or cause a lab to become compliant on its own. Ask each vendor (including MargLabz) to demonstrate the traceability trail and QC review within their demonstration of the product using your lab's workflow. To schedule a Free Demo with MargLabz please click here.