Why NABL Accreditation is Required?

Importance of NABL Accreditation

NABL is mandatory because it helps set a quality bar for labs. A lab's only job is to give test reports. Labs send test reports to doctors, who in turn make decisions that determine patients’ treatment and care. So, test reports determine a patient’s treatment and care. If reports are wrong, undue harm can come to patients.

NABL ensures labs implement the procedures and functions described in ISO 15189:2022, maintain documentation, perform internal quality audits and strictly implement quality control, so that all the reports are trustworthy and reproducible.

NABL Accreditation is mandatory for many government schemes and insurance company tie-ups, as well as hospital collaborations.

At Qualityveda, we assist labs in getting NABL accreditation in the least possible time and at minimum cost. We provide complete services, including training, documentation, and audits.

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) that provides accreditation to testing/calibration laboratories based on the evaluation of their technical competence and the quality management system.

What is the significance of NABL Accreditation?

NABL accreditation certifies that the laboratory’s methods, equipment, staff and quality management systems have been assessed and found to be appropriate for testing.

It also encourages laboratories to maintain reliable testing practices and to demonstrate technical competence.

Test results that have not been handled correctly can affect the decisions and actions of health care staff and adversely affect patient care.

Laboratories accredited by NABL are required to have documented procedures and monitor performance of testing. This facilitates identification of errors and improves the trustworthiness and reliability of laboratory test results.

2. Patient Trust and Confidence

The results of any medical test play a significant role in the management of patients’ health.

If the laboratory processes, instruments and personnel are accredited, patients and healthcare personnel are assured of the quality of laboratory tests and the report, and their confidence is improved.

3. Doctor’s Confidence

Doctors rely on the laboratory reports for assessment of patients’ health conditions and make decisions on appropriate treatment.

If laboratory processes and personnel are accredited, it helps provide assurance to doctors that the laboratory reports are dependable and can be relied upon.

4. Govt. and Hospital Requirements

Many government-sponsored schemes, hospitals, and health insurance and care organizations require laboratory services to be accredited by NABL for participation in their programs.

NABL accreditation is voluntary unless it is required as per a specific mandate.

5. Better Quality Management

Accreditation is a strong enabler for improving the quality management system of laboratories.

Proper implementation helps laboratories improve their processes and other practices, and strengthen their confidence in sustained operations.

6. Continuous Improvement

For continued improvement of quality, the performance of the laboratory must be reviewed at regular intervals, and gaps, if any, must be identified.

Prof. Dr. Sanjay Raikar, (CMD) Apex Institute of Life Sciences (India)

Benefits of using ISO 15189:2022 for NABL Accreditation

ISO 15189:2022 is the latest edition of the International Standard pertaining to Medical Laboratories. It is applicable to both management and technical activities of a medical laboratory.

This International Standard specifies requirements for the quality and competence of medical laboratories. It provides guidance on the establishment, maintenance, and development of a quality management system, including the competence of medical laboratories.

The requirements of ISO 15189:2022 cover the following activities of medical laboratories:

• Collection and handling of samples
• Maintenance of laboratory equipment
• Calibration of laboratory equipment
• Internal quality control
• External quality assessment
• Validation and verification of methods
• Training of laboratory personnel
• Information Management in the Laboratory
• Internal audits and management reviews

Compliance with ISO 15189:2022 helps medical laboratories establish standardized testing processes.

Medical laboratories have to comply with additional requirements stipulated by NABL.

For more information, visit NABL Medical Laboratory Accreditation.

Is NABL Accreditation Compulsory for All Laboratories?

For medical laboratories in India, NABL accreditation is voluntary. However, this accreditation is mandatory for some government schemes, hospitals and institutional contracts.

NABL accreditation is compulsory for medical laboratories if it is mentioned in the conditions of a specific scheme or contract. It is the responsibility of the medical laboratories to verify the conditions of the scheme or contract before applying for NABL accreditation.

Which Laboratories can be Accredited by NABL?

NABL accredits laboratories for a variety of testing and calibration activities. Thus, both small and large medical laboratories can be NABL accredited if they meet the stated requirements.

What is the Process for Getting NABL Accreditation?

There are several steps involved in the NABL accreditation process. They are:

1. Understanding the requirements of NABL

The laboratory should know the accreditation standard they need to comply with. They also need to know the scope of testing.

2. Document Preparation

The laboratory prepares all the documents, including the quality manual, SOPs, policies and other supporting documents.

3. Implementation of Quality Management System

Documented procedures are implemented, and records are maintained as evidence.

4. Training of Employees

Staff are trained on various aspects of testing, quality control, etc.

5. Internal Audit

An internal audit is carried out to identify non-conformances and areas for improvement.

Management reviews are carried out to evaluate the quality management system.

Step 6: Submit NABL Application

The laboratory submits an application via the NABL online portal, outlining the scope of its service and supporting evidence.

Step 7: NABL Assessment

NABL-appointed assessors evaluate the laboratory’s documentation, process control and the competence of its personnel and their ability to perform tests.

Step 8: Corrective Actions and Accreditation Decision

The laboratory takes corrective actions to address the noted nonconformities and provides evidence for the same.

NABL makes a decision on accreditation after evaluating the assessment.

Challenges During NABL Accreditation

While preparing for NABL accreditation, a laboratory may face a host of challenges.

• Incomplete Documentation: Lack of up-to-date records pertaining to processes and tests carried out.
• Quality Control: Failure to control the performance of the testing process.
• Staff Training: Employees require additional training on the subject of quality control.
• Equipment Records: Inadequate or out-of-date equipment calibration records.
• Internal Audits: Nonconformities requiring corrective action.

To address these challenges, proper planning, adequate training and regular supervision are essential for laboratories.

How Qualityveda Helps with NABL Accreditation

At Qualityveda, we assist laboratories seeking NABL accreditation through consultancy and onsite support for practical implementation.

Our services include:

• Guidance on NABL: Help with understanding the requirements of ISO 15189:2022.
• Documentation: Develop quality manuals, SOPs and related documents.
• Support Quality Control: Help with the use of IQC and EQA techniques.
• Staff Training: Training in laboratory quality management.
• Internal Audits: Help in the identification of gaps and corrective actions.
• Assessment Preparation: Help in preparing for NABL assessments.

Our goal is to help laboratories develop systems which ensure the continued maintenance of quality in the laboratory beyond the first assessment.

You can read NABL Consultants - Who They Are and How They Help.

FAQs

Q1. Why should you get NABL accreditation?

It shows your customers and stakeholders that you have an efficient Quality Management System.

Q2. Is NABL accreditation mandatory?

No, it is generally optional; however, there can be certain conditions, such as Government schemes and contracts, where accreditation will be mandatory.

Q3. What standard do medical labs follow?

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

Q4. Can small laboratories get NABL accreditation?

Yes, if they meet the requirements, they can.

Q5. Will I get error-free results?

No, NABL accreditation means that the medical laboratory is competent to perform certain tests to the required standards. Error-free results can never be guaranteed.

Q6. Can a consultant give you NABL accreditation?

No, whilst NABL consultants can advise and support medical labs to prepare for accreditation, it is ultimately up to NABL to decide.

Final Thoughts

NABL accreditation helps medical laboratories put in place and maintain reliable testing processes. They also show that they are competent.

By carrying out self-assessments, having sufficient documentation and staff training, quality control measures, regular internal audits and many more initiatives, laboratories can become accredited.

If you need any help with NABL accreditation, please get in touch with us at Qualityveda.