Why is NABL Required for Labs in India?
Published 22 Apr 2025

Why is NABL Required for Labs?
With the increasing importance of lab reports in making healthcare decisions, errors made can lead to a major misdiagnosis. Ensuring your labs have a high standard of quality and accuracy is very important.
This is where enable accreditation comes in.
What is NABL and Why is it Required?
NABL stands for National Accreditation Board for Testing and Calibration Laboratories. It is an autonomous body under the Quality Council Of India (QCI). It provides accreditation to labs that follow International standards such as ISO 15189 : 2022.
Reasons why NABL is Required:
1. Build Patient Confidence
Labs that have NABL accreditation follow strict quality assurance procedures to ensure accurate and reliable results. Patients will have confidence knowing their life is following a standardised protocol.
2. Meets Hospital and Government Requirements
Many hospitals, corporates and government bodies will only work with NABL accredited labs. This means if you are applying for empanelment, tenders, aur insurance NABL accreditation will give you more opportunities.
3. Minimise Errors
Accredited labs will perform frequent internal audits, quality control and EQA to ensure they are following best practice. This reduces errors from both people and machines.
4. Gain an Advantage Over Your Competitors
Patients nowadays search everything on Google. Having NABL accreditation will give you the advantage as patients are more likely to choose a lab with NABL accreditation. It shows that you are serious about providing quality service.
How to Obtain NABL Accreditation?
Obtaining NABL accreditation is a structured process but can be achieved with the correct support.
This is where Qualityveda can help!
We specialise in helping labs across India achieve NABL, NABH and CAP accreditation at 50% less than traditional consultants. We provide everything from SOP creation, internal auditing, training and audit representation.
Whether you are starting up a new lab or looking to upgrade your existing lab, Qualityveda can help.
Do you want to gain NABL accreditation?
Give us a call on 888 250 9194 or visit our website www.qualityveda.co to book a free consultation.
The Importance Of NABL Accreditation For Medical Laboratories
NABL accreditation helps improve the quality and reliability of medical laboratory services.
It provides an official recognition that a laboratory is technically competent.
Medical laboratories are accredited according to ISO 15189:2022, a standard which sets quality and competence requirements.
Benefits of NABL accreditation include;
- Reliable Results – Helps to ensure consistent testing.
- Improved Lab Practices – Ensures proper documentation.
- Increase Patient Confidence – Increases confidence for patients and doctors.
- Quality Management – Ensures processes are continuously monitored and improved.
- Recognises Professionalism – Shows that the lab has been assessed independently.
Find out more about accreditation using our NABL accreditation guide.
Is NABL Accreditation Mandatory For All Laboratories In India?
NABL accreditation is generally voluntary for medical laboratories in India.
However some hospitals, government schemes, tenders and healthcare organisations may require labs to have NABL accreditation.
This will depend on the contract, scheme or regulations.
Whilst it may not be mandatory it will show that the lab has technical competence.
Role Of ISO 15189:2022 In NABL Accreditation
ISO 15189:2022 is an international standard specifically for medical laboratories.
It sets the requirements for quality and technical competence.
Some key areas covered include;
- Sample collection, handling and processing.
- Equipment calibration and maintenance.
- Internal Quality Control (IQC).
- External Quality Assessment (EQA).
- Staff training and competency.
- Documentation.
- Internal audit and management.
This ensures labs can identify any potential errors within their testing.
Find out more information regarding the requirements of accreditation from NABL medical laboratories.
Which Laboratories Can Apply For NABL Accreditation?
There are many different laboratories who can apply for NABL accreditation.
Medical laboratories can apply for accreditation in disciplines such as;
- Clinical Biochemistry
- Clinical Pathology
- Haematology
- Microbiology
- Histopathology
- Cytopathology
- Molecular Diagnostics
Small and large laboratories can apply for NABL accreditation. As long as they meet the requirements.
Find out more information about accreditation on the official NABL website.
Documents Required For NABL Accreditation
Having the correct documentation in place is an important part of quality management.
Some common documents and records include;
- Quality Manual – Provides information on the labs quality management system.
- Standard Operating Procedures (SOPs) – Provides information on testing and operations.
- Equipment Records – Equipment maintenance, calibration and verification records.
- Quality Control Records – IQC and EQA records.
- Training Records – Training undertaken by employees.
- Internal Audit Records – Evidence of auditing.
Common Issues When Applying For NABL Accreditation
Many labs struggle to apply for accreditation.
- Poor documentation – Lack of records or records that are out of date can cause issues.
- Lack Of Knowledge – Employees may need further training to understand quality management.
- Not Implemented – Without implementing processes the documents can result in non-conformances.
- Poor Quality Control – Labs may not consistently monitor quality control.
- Not Enough Internal Auditing – Labs may not have found non-conformances.
These issues can be reduced by having proper planning, training and monitoring.
FAQ
Q1. Why would a lab want NABL accreditation?
This gives assurance to the lab that they are technically competent and has systems in place that can be trusted.
Q2. Is it mandatory to get NABL accreditation as a pathology lab?
Generally it is voluntary however some contracts/schemes may require you to have accreditation.
Q3. Can small diagnostic labs get NABL accreditation?
Yes as long as they meet the criteria.
Q4. What is the difference between NABL and ISO 15189?
NABL is an accreditation body who assess labs. ISO 15189 is an international standard for quality and technical competence in medical laboratories.
Q5. How long does NABL accreditation take?
This depends on how prepared your lab is, documentation, quality management systems and results of assessment.
Final Thoughts
Obtaining NABL accreditation can help diagnostic labs improve quality management systems, have trustworthy systems and improve confidence from patients and healthcare professionals.
If you have the appropriate documentation, training, quality control and improvement in place you will be assured your lab is of a good quality.
If you understand what is required and have quality management systems in place it can help labs wanting to apply for accreditation have a more structured process.