What is the Meaning of NABL Accreditation?

NABL Accreditation means that a laboratory is technically competent to perform specific tests as per the requirements of international standards.

NABL stands for National Accreditation Board for Testing and Calibration Laboratories. It is a constituent board of the Quality Council of India (QCI). It is focused on improving the quality and reliability of medical testing and calibration laboratories in India.

NABL accreditation ensures that laboratories meet the stipulated requirements of quality, reliability, competency and integrity in their testing services and earn the confidence of the patients, doctors and the healthcare industry.

Why is NABL Accreditation Important?

NABL accreditation has a positive impact on the overall quality of laboratories and the diagnostic services provided.

1. Accuracy of Test Reports

In order to produce reliable results and to ensure that tests meet the established technical requirements, NABL-accredited laboratories are required to implement quality control and Quality Assurance Practices.

Laboratory reports are a vital part of medical diagnoses and treatments. If incorrect, this can cause problems with medical decisions and clinical decisions and can result in poor care for the patient.

Quality control procedures are used to maintain quality in laboratory testing. This includes regular quality analysis and assessment of tests.

2. Compliance with Global Standards

The latest edition of ISO 15189 outlines what the medical laboratory should do in order to meet quality and competency requirements.

It includes requirements for laboratory management, staffing and equipment, plus documentation, technical requirements and processes.

For other calibration and testing laboratories, compliance with ISO/IEC 17025 is a requisite.

Following these standards, within the scope of the accreditation, ensures that laboratories are competent to perform the tasks they are accredited to do.

3. Trust Among Doctors and Patients

Laboratories with NABL accreditation are generally deemed to be more credible, which in turn helps build trust among patients and increases clinical confidence.

Patients are informed of the status of their health by reports generated by laboratories. Doctors, in turn, use these reports to assist them in making important clinical decisions.

Laboratory accreditation helps demonstrate that a laboratory has undergone an independent assessment of its technical competence and the quality management practices of its personnel.

This is intended to build confidence among stakeholders such as patients, doctors, hospitals, and other healthcare establishments.

4. Eligibility for Empanelments and Tie-ups

For certain government schemes, insurance panels and partnering hospitals, NABL accreditation is mandatory.

Preference is generally given to NABL-accredited laboratories by healthcare organizations for entering into diagnostic service agreements.

NABL accreditation can enhance opportunities for collaborations by laboratories.

However, it should be noted that NABL accreditation is generally voluntary.

5. Better Laboratory Management

NABL accreditation ensures that laboratories are equipped with a system to organize their documentation, equipment, staff, quality control systems, and other activities. This in turn enables laboratory management to regularly monitor and assess various activities in the laboratory for improvement.

What Types of Laboratories Can Apply for NABL Accreditation?

NABL offers accreditation services to a wide range of laboratories. These include:

• Medical laboratories including clinical pathology, clinical chemistry and clinical microbiology.
• Testing laboratories, including chemical, biological, mechanical, and other types of laboratories.
• Calibration laboratories.

We welcome applications from both small and large laboratories that meet relevant criteria and technical requirements.

Accreditation will be awarded for specific tests, measurement and/or calibration activities (scope) within your application.

What does the NABL accreditation process consist of?

NABL accreditation process requires laboratories to prepare and make available a number of important documents and records.

1. Preparation of Documentation and Standard Operating Procedures (SOPs)

SOPs explain the various activities performed in the laboratory. These documents are essential to monitor and control the activities carried out in a laboratory.

2. Conducting internal audits and quality control

In addition, internal quality control helps assess testing performance. Laboratories review corrective actions and maintain quality records.

3. Staff training and assessment

To be competent to perform their job functions, laboratory staff must receive adequate training and assessment.

4. Equipment calibration and validation

Performance records and reports are maintained. Verification and validation of testing methods are also performed.

5. Participate in external quality assessment (EQA) and proficiency testing (PT) programs

Laboratories participate in competency-based EQA/PT schemes to help them determine the level of performance achieved by the laboratory compared to other laboratories.

For the official requirements, visit the NABL Medical Laboratory Accreditation webpage.

How to gain NABL accreditation:

Labs should be aware of requirements and have a plan for their scope.

In general, the following steps are taken to apply for accreditation:

1. Identify the applicable NABL standard and proposed scope of testing.
2. Develop and implement procedures and documentation.
3. Maintain records of quality control, equipment and staff competency.
4. Conduct internal audits and management reviews.
5. Fill out the online application on the official NABL website.
6. Go through an assessment process conducted by NABL assessors.
7. Eliminate nonconformities identified and provide evidence of corrective actions.
8. Wait for NABL’s decision on accreditation.

It is important for laboratories to implement the requirements in their routine activities, and not just prepare the documentation prior to the assessment.

Refer to the Complete Step-by-Step NABL Accreditation Process for further information.

How Qualityveda Supports NABL Accreditation

Qualityveda simplifies, speeds up, and reduces costs of NABL accreditation.

We have successfully supported over 100 labs in India with NABL accreditation through the following:

• End-to-end Consulting: Guiding labs through the NABL accreditation process.
• Quality Specialist: Supporting labs in managing their quality in routine activities.
• Documentation & SOPs: Supporting labs in preparing and maintaining documents.
• Practical Implementation: Guiding labs in the quality management system and its practical aspects.
• Quality Control: Supporting labs in IQC and performance monitoring.
• Training: Training lab personnel on NABL and ISO 15189:2012.
• Audit Preparation: Supporting labs with internal audits and readiness for assessment.

Besides providing support to laboratories for their first assessment, we are focused on assisting laboratories to maintain and improve their quality management system.

For more details on our services, please visit NABL Consultants – Who They Are and How They Help.

FAQs

Q1. What is NABL Accreditation?

Accreditation by NABL is granted to laboratories for their capability to undertake testing and/or calibration services as outlined within the relevant Standard.

Q2. Is NABL accreditation a requirement for all laboratories?

Generally, it is optional; however, some government schemes, contracts or legislation may require it.

Q3. What is the Standard relating to medical laboratories?

ISO 15189:2022 outlines the requirements for quality and competence of medical laboratories.

Q4. Can small diagnostic laboratories apply for NABL accreditation?

Yes, small Diagnostic laboratories can also apply for accreditation by NABL; however, they must meet certain criteria.

Q5. Will NABL accreditation ensure error-free test results?

No. NABL accreditation will give confidence to the laboratory that it has the technical competence for performing the tests against the given requirements. Still, it may not ensure completely error-free tests.

Q6. Will NABL consultants assess and issue accreditation certificates?

No. Only the NABL assessors and assessment committee can make the decision and issue the accreditation certificate.

Final thoughts

NABL accreditation gives assurance of laboratory competence, improves laboratory quality and gives confidence to the doctors, healthcare personnel, patients and healthcare organizations.