The Importance of NABL Accreditation

In India, there are thousands of diagnostic labs. How do we determine which lab gives the right results? Here is where NABL accreditation comes into the picture.

National Accreditation Board for Testing and Calibration Laboratories (NABL) is one the boards under the Quality Council of India. It assesses laboratories against the international standard ISO/IEC 17025:2017 and similar standards.

It ensures quality in laboratories and can be used to prove technical proficiency to the client/patients/doctors/healthcare organizations.

What Is NABL Accreditation?

It is the recognition given by a third-party accreditation body, to a laboratory for its capability to perform a certain test or calibration activity.

In case of medical laboratories, accreditation is based on the requirements given in ISO 15189:2022.

Prior to accreditation, a laboratory must show that its procedures, equipment, and personnel are competent to perform the tests.

Accreditation applies to the tests and activities included in the laboratory's approved scope.

Why Is NABL Accreditation Important?

There are multiple advantages of NABL accreditation to diagnostic laboratories and the clients they serve.

1. Earn the Trust of Patients

When a laboratory is accredited by NABL, it means the laboratory has the competence to perform tests in accordance with internationally established standards and brings trust to the laboratory system.

A laboratory is expected to follow standard operating procedures and perform tests in a way to attain NABL accreditation, which in turn gives patients the confidence to trust the test results.

Wrong test results affect patient treatment and diagnosis.

2. Give Doctors Confidence

Accurate laboratory tests help in providing the right treatment to patients. A laboratory accredited by NABL builds the confidence of doctors to fully rely on test results.

NABL Labs earn trust of the medical fraternity for providing reliable reports.

Laboratory results are vital for diagnosing, assessing and treating patients.

Reports contain the result of the tests done on the patient and interpretation of the result to assess the patient condition and/or identify the disease. The report should be reliable.

3. Government and Legal Recognition

NABL Accreditation is recognized by Government and Legal agencies.

Some Government tenders, embplement schemes and insurance companies only consider a laboratory which is NABL accredited.

Lack of such accreditation will result in loss of opportunities for the laboratory.

Certain government schemes, hospitals and other healthcare organizations require labs to be accredited to participate in their schemes and programs.

NABL accreditation is voluntary unless a regulatory requirement or scheme makes it mandatory.

4. Operational Excellence

Continuous improvement of operations of the laboratory and reducing errors is the key focus of NABL. This is accomplished by proper documentation and regular calibration, quality checks and staff training.

5. Competitive Advantage

Accreditation provides a competitive edge over local labs.

NABL accreditation provides reassurance to the hospitals and other healthcare organizations for the laboratory which they outsource their diagnostic requirements.

How does ISO 15189:2022 help NABL Accreditation?

ISO 15189:2022 is the latest international standard for quality and competence of medical laboratories.

It encompasses management and technical activities.

The essential elements include:

• Quality Management System: Maintenance of policies, procedures and records
• Internal Quality Control (IQC): Monitoring of performance of laboratory testing
• External Quality Assessment (EQA): Evaluation of performance of testing by means of external comparison
• Calibration of Equipment: Maintenance of the equipment and its suitability for testing
• Training of Staff: and evaluation of staff’s ability to perform the activities for which they are responsible.
• Method Validation and Verification: Validation and verification that testing methods are suitable for their intended use
• Internal Audits: Review of laboratory activities and identification of nonconformities
• Management Review:

Review of how well the quality management system is working.

By ensuring that they comply with these elements laboratories can be assured that they will carry out the tests using a set procedure.

For official information, visit the NABL Medical Laboratory Accreditation page.

Is NABL Accreditation Compulsory for Every Laboratory?

NABL accreditation for medical and diagnostic laboratories in India is voluntary.

Accreditation is, however, necessary for certain schemes, e.g. insurance and government sponsored schemes, as well as for institutional partnerships and hospital linkages.

Laboratories have to ensure they understand the conditions for the scheme or partnership before they start with the application process.

Small or large laboratories can apply to become NABL accredited if they meet the required criteria.

How Can a Laboratory Become NABL Accredited?

There are a number of important activities involved in achieving NABL accreditation.

1. Understanding the Requirements of NABL

The laboratory determines which NABL requirements apply to them and defines the scope of the accreditation.

2. Documentation

The laboratory prepares Quality Manuals, Standard Operating Procedures (SOPs), policies and related documents.

3. Implementation of Quality Management System

SOPs are implemented and related documentation is maintained.

Step 4: Train Laboratory Staff

Employees are trained to gain understanding on methods of testing, quality control and equipment operation and laboratory procedures.

Step 5: Conduct Internal Audits

Nonconformities and improvement opportunities are identified during internal audits.

Management review helps assess the effectiveness of the quality management system.

Step 6: Submit NABL Application

The laboratory submits its application to NABL through the official NABL website with the proposed scope and supporting documents.

7. NABL Assessment

The NABL assessors will review your laboratory documentation, technical capability, procedures and equipment.

8. Corrective Actions & NABL Accreditation decision

The laboratory will put corrective actions in place for any non conformities found. Evidence will be provided to NABL.

NABL review the assessment report and takes a decision on accreditation.

How Qualityveda Helps You Get NABL Accreditation Easily

At Qualityveda, we have the experience of working with 100+ labs in India and understand the pain of getting quality management systems evaluated and accredited.

Our aim is to bring quality in laboratories so that each patient of India gets the right test reports.

We achieve this goal by providing a Quality Specialist who works like an extension of your team.

We support labs with staff training, documentation, quality control and internal audits, and prepare the labs for assessments.

We guide labs to adopt quality management systems which are critical for continuous improvement.

For more information, read NABL Consultants – Who They Are and How They Help.

Frequently Asked Questions (FAQs)

Q1. What is the significance of NABL accreditation for laboratories?

NABL accreditation is a process to define, assess, affirm and showcase the technical competence of labs. It helps labs to instill reliability in testing and build confidence of the patient and the healthcare community.

Q2. Is NABL accreditation mandatory for all labs?

NABL accreditation is generally voluntary. However, compliance to certain government schemes, contracts and regulations may mandate NABL accreditation.

Q3. What is the applicable standard for medical labs?

Standard for quality and competence in medical laboratories is ISO 15189:2022.

Q4. Can small diagnostic labs also go for NABL accreditation?

Yes, small diagnostic labs can also go for NABL accreditation, if they meet the requisite criteria for eligibility and accreditation.

Q5. Is NABL accreditation a guarantee for accurate test results?

NABL accreditation affirms that the laboratory has been assessed against the applicable quality and competence requirements. It, however, does not guarantee error free test results.

Q6. Can NABL consultants issue accreditation certificates?

NABL consultants help labs prepare for accreditation. Only NABL has the authority to take the final decision and issue the accreditation certificates.

Final thoughts

Overall, having NABL accreditation will show that the lab has technical competency and will make them more reliable and give them confidence within the health care fraternity.

Lab documentation, training staff, quality control, internal audits and following standard operating procedures will help the lab become more ready for accreditation.