Getting a NABL Certificate

A NABL accreditation for your diagnostic or pathology lab would bolster credibility. Here, we explain the process of obtaining a NABL accreditation, step by step.

What is NABL?

NABL stands for National Accreditation Board for Testing and Calibration Laboratories, a constituent board of the Quality Council of India (QCI). NABL evaluates laboratories against the applicable quality and technical requirements.

A laboratory is awarded NABL accreditation when it has been assessed and has been found to be technically competent to perform the tests specified in its approved scope.

For medical laboratories, accreditation is based on ISO 15189:2022.

Process to Obtain NABL Certificate

Obtaining NABL accreditation requires proper documentation and implementation of quality procedures, staff training and preparation for assessment.

1. Understand Requirements

There are certain standards that your laboratory needs to comply with, as determined by NABL.

NABL accreditation can be obtained using the ISO 15189:2022 standard. Before applying you will need to know which tests and parameters you are looking to gain accreditation for.

You will also need to look at what NABL requirements apply to your lab, this will include looking at staffing requirements, equipment requirements, quality control requirements and documentation requirements.

Your approved scope should be limited to those tests that the laboratory can perform competently.

For additional details, visit What NABL Accreditation is?.

2. Prepare Documents

A major part of NABL accreditation is document preparation.

You need to show that your system complies with the processes and procedures described in the standard.

Description of equipment, appropriate staff training, quality control and quality assurance should also be documented.

You also need to demonstrate that the staff is competent to perform the tests that your laboratory seeks accreditation for.

After the documents have been prepared, you should submit an application to NABL for assessment.

For more details, visit What NABL Accreditation is?.

This includes:

• Standard Operating Procedures (SOPs)
• Quality manuals and policies
• Equipment calibration and maintenance records
• Training and competency records
• Internal audit reports
• Management review records
• Quality control records
• Corrective action reports

These documents help laboratories sustain procedures and provide evidence of implementing quality requirements.

Documentation should reflect the actual activities performed in the laboratory.

This can seem like a daunting task, but Qualityveda provides documentation support to laboratories to assist them in preparation and maintenance of the above-mentioned records.

3. Implement the Quality System

It is not enough to just document processes; the laboratory must actually implement quality procedures, processes and protocols.

Some of these important processes are:

• Daily Internal Quality Control (IQC)
• External Quality Assessment (EQA)
• Equipment calibration and maintenance
• Staff training and competency assessment
• Method verification and validation

To demonstrate continuous improvements and the effectiveness of the quality management system, a lab should maintain records on the performance of these activities.

A quality management system should be implemented during routine operations rather than just before an assessment.

4. Conduct Internal Audit and MRM

Prior to applying for NABL, a laboratory should perform an internal audit and hold a Management Review Meeting (MRM).

An internal audit assists in identifying gaps between existing laboratory processes and the requirements of the accreditation.

During an audit, the laboratory reviews documentation, quality control records, equipment records, testing procedures and other processes.

Ensure corrective actions are carried out for any points of non-conformance.

Management reviews allow quality teams to review quality metrics and audit results and also identify areas for improvement.

This helps evaluate how prepared the laboratory is for the NABL assessment.

5. Apply on NABL Portal

Your laboratory would have implemented the required Quality Management activities. You are now ready to complete your application online through the NABL website.

The application process requires you to:

1. Register on the NABL application portal.
2. Choose the appropriate accreditation programme.
3. Enter the details of the laboratory and personnel.
4. Propose the scope of accreditation.
5. Upload the required documents.
6. Make payment for accreditation.

Medical testing laboratories can submit their applications through NABL 153.

Upon receiving the application, NABL will review it and may request additional information or clarification.

For additional information, see How to Fill NABL Application Online?.

6. Pre-assessment and Final Assessment

After reviewing the completed application, NABL will determine the assessment activities that are applicable to your laboratory.

Pre-assessment

Pre-assessment is usually not done for medical testing laboratories.

Should pre-assessment be done, this will help the assessment team to check the laboratory’s readiness, identify potential nonconformities and review the quality management system.

Initial Assessment

NABL’s assessment team examines the laboratory’s documentation and checks the competence of the personnel as well as the technical and support resources of the laboratory.

The team carries out assessments by checking:

• Laboratory procedures and records
• Equipment calibration and maintenance
• Staff competency
• IQC and EQA participation
• Participation in method validation and internal audits
• Management review

The assessment team identifies potential nonconformities and provides corrective actions where required.

7. Submit Corrective Actions

If nonconformities are identified during the assessment, the laboratory should take corrective actions within the stipulated time.

Corrective actions should be taken for the causes identified for problems.

The laboratory should provide relevant evidence showing that the issues have been resolved.

NABL reviews the evidence and can also ask for more information.

Not taking proper corrective actions can result in nonconformities being recorded as unresolved and can affect the accreditation decision.

8. Get Your NABL Certificate

Upon satisfactory assessment, closure of nonconformities and completion of the accreditation process, NABL may grant accreditation.

The laboratory receives its NABL accreditation certificate and scope of accreditation.

NABL's general accreditation cycle requires the certificate to be valid for four years. Surveillance and reassessment requirements may apply.

Laboratories are required to maintain quality management practices for the duration of the accreditation.

Documents Required for NABL Accreditation

Laboratories should maintain the following records before submitting their application.

Quality Manual, SOPs, employee records, training, competency, calibration, IQC/EQA, methods, audits, management reviews, risks, corrections, proposed scope of accreditation, etc.

The exact requirements depend on the activities of the laboratory and the NABL requirements.

Laboratories can check with official NABL documentation for requirements.

Why Labs Choose Qualityveda for NABL Accreditation

We have helped 100+ Labs in India with NABL accreditation and implementation of Quality Management Systems.

We strive to bring affordability, ease and practicality in quality management for Labs.

Quality Specialist Program

Through our Quality Specialist Program, we provide:

• Comprehensive documentation and implementation of systems
• QC monitoring through video calls
• Weekly onsite visits
• Monthly training of staff
• Monitoring of quality indicators
• Conducting Internal Audits and Preparation for Management Review
• Preparing for Full Assessment

Experts will work with you to prepare quality processes and procedures within the laboratory. This ensures that your lab is prepared for assessment without requiring last minute help from consultants.

Find out more about NABL Consultants here.

FAQs

Q1: How do I obtain a NABL certificate?

You will need to ensure your lab meets NABL requirements. You will need to put a quality management system in place, apply for assessment, address any non conformances.

Q2: Which standard will I need to meet for a Medical Lab?

Medical labs will need to be assessed against the ISO 15189:2022 and any other relevant NABL requirements.

Q3: Is NABL accreditation mandatory?

Generally NABL accreditation is optional. Some government sponsored schemes, contracts and regulations will require you to be accredited.

Q4: How long does a NABL certificate last?

Generally you will be accredited for 4 years.

Q5: Can I apply for accreditation if I have a small pathology lab?

Yes! Small pathology/diagnostic labs can apply for accreditation.

Q6: Can a Consultant issue a NABL certificate?

No. Whilst we can help you prepare for accreditation, only NABL can issue the accreditation.

Conclusion

The process to obtain a NABL certificate can be quite involved. Labs will need to put in place quality management systems, improve documentation, training of staff and show technical competence.

By preparing your lab, having regular quality controls and internal audits you can increase your readiness for NABL accreditation.

At Qualityveda, we provide laboratories with support in documentation, training, QC and assessment preparation.

Wish to get NABL certified?

We will make the process easy for you.

Call: 8882509194

Website: qualityveda.co