Why NABL is Important?

The significance of NABL lies in the credibility it gives to the test reports generated by your lab. By obtaining NABL accreditation, your lab gets assured by the concerned authorities that the lab functions according to international standards (like ISO 15189:2022) and gives assurance to patients and doctors that the lab is credible.

NABL accreditation enhances the lab’s credibility, improves the confidence level of doctors, patients and the lab’s reputation in the market. It helps the lab gain government partnerships, health insurance panels and institutional referrals.

The NABL journey can be daunting for an individual lab. At Qualityveda, we walk the NABL journey with you and simplify the process by giving you expert guidance and documentation and implementing processes to get your lab accredited and set for the future.

To know more about us or to get started, call us at 8882509194 or visit us at qualityveda.co

What is NABL Accreditation?

NABL is a constituent board of the Quality Council of India (QCI) and is the national accreditation body for testing and calibration laboratories.

NABL accreditation is a validation of a laboratory’s capability to perform specific tests, calibrations, and measurements.

For medical laboratories, NABL has the requirement of ISO 15189:2022, which provides requirements for quality and competence in medical laboratories.

What are the advantages of NABL accreditation?

NABL accreditation helps medical laboratories, diagnostic centers and healthcare organizations to-

• Achieve accuracy and reliability in their test results
• Increase the level of confidence of doctors
• Build credibility of the lab in the market

These practices assist laboratories in error detection, performance monitoring and improvement of the reliability of test results.

2. Patient Trust and Confidence

Laboratory reports are the means for patients to gain knowledge about their health condition.

NABL accreditation is recognition of a laboratory’s performance against various quality and technical requirements.

This fosters trust and confidence among patients using diagnostic laboratory services.

3. Doctor Confidence

Laboratory results form the basis of clinical decisions.

Depending upon the reports, healthcare professionals take necessary clinical decisions to manage a patient’s health condition and administer appropriate treatment.

NABL accreditation validates competence of laboratory’s testing processes.

4. Government and Hospital Opportunities

Various government schemes, hospitals, corporate health care programs and health insurance companies have provisions to provide diagnostic services only through NABL accredited laboratories.

NABL accreditation provides opportunity to eligible laboratories to extend their diagnostic services to the above mentioned categories of clients.

However, eligibility criteria would vary based on the government scheme, hospital, corporate health care program or insurance company.

5. Improvement of Laboratory Management

NABL accreditation facilitates laboratories to refine their management systems, procedures and practices for calibration and maintenance of instruments, documentation, staff training, internal audits, management reviews, quality control and assurance.

Practicing these helps in improvement of laboratory services and decrease unnecessary errors.

6. Continuous Improvement

NABL accredited laboratories are obligated to continuously benchmark their performance and identify improvement opportunities.

In addition, internal audits, quality indicators and corrective actions help laboratories to identify problems and improve their processes and systems.

Continuous improvement forms the foundation of quality management in laboratories.

The role of ISO 15189:2022 in NABL Accreditation

ISO 15189:2022 specifies requirements of quality and competency for medical laboratory services.

It encompasses both managerial and technical aspects.

Important components include:

• Collection, handling, and processing of samples
• Maintenance and calibration of equipment
• Internal Quality Control (IQC)
• External Quality Assessment (EQA)
• Staff training and proficiency
• Method validation and verification
• Laboratory information management
• Internal audits and management reviews

Incorporating these components allows the laboratories to build and institutionalize practices to ensure consistency in their testing activities.

NABL expects medical laboratories seeking accreditation to adhere to the criteria specific to them.

More information is available at the NABL Medical Laboratory Accreditation page.

Which laboratories can apply for NABL Accreditation?

NABL offers accreditation services to a range of laboratories.

Medical laboratories are offered accreditation to domains such as:

• Clinical Chemistry
• Clinical Pathology
• Hematology
• Microbiology
• Histopathology
• Cytopathology
• Molecular Diagnostics

Large and small laboratories have the opportunity to apply for accreditation, as long as they meet the requirements.

The laboratory selects the tests and activities for which accreditation is desired.

How do I attain NABL accreditation?

The accreditation process is made up of a number of important processes.

First, the laboratory determines the applicable standards and accreditation scope.

Then, the laboratory prepares the quality manual and other procedures and documentation.

Next, the laboratory implements the documented procedures and quality management systems.

The laboratory conducts training on quality management systems and audit procedures for staff.

The staff audits the laboratory to assess adherence to quality management systems and procedures and identify opportunities for improvement.

Managements reviews assist us in examining the effectiveness of the laboratories quality management system.

Step 6: Submit NABL Application

The laboratory applies for accreditation through NABL’s online portal, and provides the proposed scope of their services, along with supporting documents.

Step 7: NABL Assessment

Appointed assessors of NABL perform a comprehensive review of the laboratory’s documentation, technical and staff competence and the process of laboratory testing.

Step 8: Corrective Actions and Accreditation Decision

Should findings of the assessors indicate nonconformities in the laboratory’s management system, the laboratory is required to provide evidence of corrective actions taken.

NABL assessors review the findings of the assessment, and make a decision on accreditation.

Common Issues During NABL Assessment

Challenges are often faced by a laboratory in preparation for accreditation.

• Inadequate Documentation: Outdated, or completely missing records and documents.
• Poor Quality Control: Tests are performed without prior monitoring of the laboratory’s performance.
• Staff Training: Employees may not be fully aware of the requirements applied to the services.
• Calibration and Maintenance: Records may be completely missing.
• Nonconformities: Identified during an internal audit, and require corrective action.

Continuous planning, staff training and monitoring by the laboratory helps to address most of these challenges.

How Qualityveda Helps Laboratories with NABL Accreditation

At Qualityveda we offer practical onsite and consultancy support for laboratories to prepare for accreditation.

Our support includes

• Understanding NABL Requirements: Explanation of requirements of NABL and ISO 15189:2022.
• Documentation: Drafting quality manuals, standard operating procedures and other laboratory records.
• Quality Control: Implementation of IQC and EQA.
• Staff Training: Training on quality management practices.
• Internal Audits: Identifying nonconformities, and formulating corrective actions.
• Preparation for Assessment: Support in preparation for NABL assessment.

Our aim is to help laboratories develop a quality management system, that ensures quality and improvements are sustained beyond the first accreditation assessment.

You can read NABL Consultants - Who They Are and What They Do

Frequently Asked Questions (FAQs)

Q1. Importance of NABL accreditation to laboratories

Labs accredited by NABL are able to showcase to the public and healthcare fraternity their commitment towards demonstrating competence and reliability in testing.

Q2. Is it mandatory for laboratories to get NABL accreditation?

It is not mandatory for laboratories to get NABL accreditation, however, several contracts and regulatory requirements may mandate it.

Q3. What is the standard pertaining to Medical laboratories?

ISO 15189:2022 is the latest standard which deals with medical laboratories and other similar services.

Q4. Can small diagnostic laboratories apply for NABL accreditation?

Yes. Small diagnostic laboratories can also apply for NABL accreditation.

Q5. Does NABL accreditation mean a laboratory will not give erroneous test results?

NABL accreditation does not mean that a laboratory will not give erroneous test results. Errors may happen due to several reasons which are beyond the laboratory's control.

Q6. Can a consultant grant NABL accreditation to a laboratory?

A consultant can help a laboratory in preparing for NABL accreditation and the final decision about accreditation lies with NABL.

Final Thoughts

Laboratories, with the help of staff training, proper documentation, quality control and regular internal audits, can enhance their readiness for NABL accreditation.

Contact Qualityveda for such accreditation related services.