NABL Certificates – What They Are and Why They Matter

What Is a NABL Certificate?

It is a recognition awarded to laboratories by NABL for attaining a particular level of quality in their operations. Medical laboratories are assessed against the requirements of ISO 15189:2022.

What Does This Certificate Mean?

It attests that the activities included in the scope of accreditation have been assessed and found to be competent.

What Do Laboratories with This Certification Do?

• Follow testing protocols strictly and maintain quality control and internal audits
• Use test equipment that is properly calibrated and maintained
• Produce reliable test reports

NABL certificates assist medical laboratories in gaining recognition and building trust, which in turn facilitates entering into contracts and/or referral relationships with hospitals, as well as working with government and insurance company programs.

What is a NABL Certificate and why is it important?

Issuance of this certificate is dependent on the successful completion of the relevant accreditation process.

In the case of medical laboratories, the applicable standard is ISO 15189:2022.

Having NABL accreditation provides confidence to healthcare professionals and patients who depend on the results of medical tests.

For further details, read What is NABL Accreditation?

Benefits of a NABL Certificate for Laboratories

For diagnostic and medical laboratories, the main advantages of a NABL certificate are improved credibility and an ability to compete in the marketplace.

This instills confidence in patients, doctors and healthcare organizations.

2. Dependable Test Results

Laboratories accredited by NABL follow systems and procedures for testing, quality control and performance monitoring.

This helps ensure the consistency and reliability of test results.

3. Effective Quality Management

NABL accreditation encourages laboratory management to maintain adequate quality management system documentation, records and procedures.

4. Advantages Related to Hospitals and Government

Some hospitals and government schemes and healthcare organizations require NABL accreditation for their laboratory empanelment or participation.

5. Continuous Improvement

Laboratories are required to monitor and review their performance and identify non-conformities.

What is the Process to Get a NABL Certificate?

To obtain a NABL certificate, adequate documentation, training, internal audits, and compliance with the applicable requirements are mandatory.

Process of NABL Accreditation

The process of NABL accreditation consists of several important steps.

The First Step: Understand NABL Standards and Requirements

The medical laboratories need to identify the applicable standard and determine the scope of testing for which accreditation is sought.

The medical laboratories follow the standard ISO 15189:2022 along with the applicable NABL requirements.

These include:

• Internal Quality Control (IQC)
• External Quality Assessment (EQA)
• Calibration of Equipment
• Verification or Validation of Methods, as appropriate
• Staff Competency Assessment

Step 5: Conduct Internal Audit and Management Review

The laboratory performs internal audits and management reviews as part of its accreditation exercise.

These activities help in identifying issues and evaluating the effectiveness of the quality management system.

Step 6: Submit the NABL Application

The laboratory applies for accreditation to NABL via the official NABL portal, mentioning the proposed scope and submitting supporting information, if any.

For more details, refer to How to Fill NABL Application Online?

Step 7: NABL Assessment

Assessors appointed by NABL evaluate the laboratory’s technical competence and quality management system, as well as review the laboratory’s processes and documentation associated with testing.

Step 8: Corrective Actions and Accreditation Decision

Following the assessment, should there be any nonconformities, the laboratory is required to take appropriate corrective actions and submit them to NABL for consideration.

Once the nonconformities are determined to be satisfactory, NABL issues the laboratory’s accreditation.

The laboratory is presented with its certificate and the approved scope of accreditation.

Documents Required for a NABL Certificate

Accreditation helps laboratories gain and retain confidence in the services they provide.

Demonstrating compliance with the accreditation requirements, to a large extent, is dependent on effective documentation.

Some of the important documents and records are as follows:

• Quality Manual and Policies
• Standard Operating Procedures
• Staff qualifications
• Staff Competency
• Calibration of Equipment
• IQC and EQA
• Internal Audits
• Management Reviews
• Corrective Actions
• Method Validation
• Proposed Scope of Accreditation

Laboratories should ensure these documents are effective and appropriately implemented.

Which Laboratories Can Apply for a NABL Certificate?

There are several testing and calibration laboratories that NABL accredits.

Medical laboratories can apply for accreditation in areas such as

• Clinical Biochemistry
• Clinical Pathology
• Haematology
• Microbiology
• Histopathology
• Cytopathology
• Molecular Diagnostics

NABL accredits both big and small laboratories if they qualify for the eligibility and accreditation requirements.

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

What Is the Validity of a NABL Certificate?

In general, NABL accreditation is valid for a period of four years, subject to continued compliance with the applicable requirements of surveillance and assessment.

During this period, the laboratory has to maintain its quality management system and its technical competence.

The laboratory must carry out the required surveillance activities and assessment to maintain accreditation.

Laboratories must check the validity date mentioned on their accreditation certificate and follow the latest NABL policies.

How to Verify a NABL Certificate Online?

Patients and hospitals can check if a laboratory is accredited on the official NABL website.

The verification includes

1. Search for the accredited laboratory either by name or certificate number.
2. Check if the laboratory is accredited and the validity of the accreditation.
3. Check the scope of accreditation.
4. Check if the laboratory test is included in the scope of accreditation.

Verification is necessary because a laboratory’s accreditation applies to the activities listed in its approved scope of accreditation.

Need Help Getting a NABL Certificate? Contact Qualityveda

We offer:

• Consulting Expertise
• Ready-to-Use Documents
• Training and Audit Preparation
• Quality Specialist Support

NABL consultants are legal practitioners and would love to help you understand NABL and offer advice based on their experience.

For more information regarding consultancy services, check out NABL Consultants - Who They Are and How They Help.

To achieve NABL accreditation

Call us at 8882509194 or visit our website qualityveda.co

Common Questions (FAQs)

Q1. What is a NABL certificate?

A NABL certificate is a legal document issued by NABL to a laboratory which has been found competent by NABL assessors for conducting tests or calibration activities included in the laboratory’s accredited scope.

Q2. Which standard is applicable for medical laboratory accreditation?

Medical laboratories are assessed against the requirements of ISO 15189: 2022, where applicable.

Q3. Is a NABL certificate mandatory for all laboratories?

In most cases, NABL accreditation is voluntary. However, certain government schemes, contracts, or regulatory requirements may mandate accreditation.

Q4. Can small diagnostic laboratories apply for a NABL certificate?

Yes, small diagnostic laboratories are also eligible to apply for accreditation if they meet the requirements.

Q5. What is the validity of a NABL certificate?

In the absence of nonconformities, NABL accreditation is valid for a period of four years.

Q6. Can a consultant issue a NABL certificate?

No, NABL consultants are only legal practitioners. Only NABL makes the final decision on accreditation and issues the certificate.

Q7. What is the process to verify if a lab is NABL accredited?

The official NABL website allows users to search accredited lab names or certificate numbers to access accreditation information, status and validity and the approved scope of accreditation.

Final Thoughts

NABL accreditation helps in demonstrating the competence of the laboratory, in maintaining good quality management practices and helps in gaining the confidence of patients, healthcare professionals and others concerned about quality.

Preparing for accreditation requires various strategies and staff training to ensure quality, perform internal audits, and develop and submit required documents.

For NABL accreditation, various standards and requirements are applied to laboratories that do testing. Compliance with those requirements also helps maintain those standards.

For assistance regarding NABL accreditation, contact Qualityveda.

Tel: 8882509194

Web: www.qualityveda.co