What is the Full Form of NABL?

The full form of NABL is the National Accreditation Board for Testing and Calibration Laboratories.

It is an autonomous body under the Quality Council of India (QCI) and acts as a national accreditation authority for laboratories. It ensures laboratories meet international requirements for competence to perform testing, calibration and to communicate the results of tests and calibrations. This is essential for pathology and radiology laboratories and diagnostic centres.

Why is it Important for Labs?

When a lab gets NABL accreditation, it enhances the credibility and accuracy of lab test reports. It also builds trust and helps in the lab’s association with hospitals, government schemes and insurance companies. In simple terms, it helps the lab grow and also ensures accurate and trustworthy results for patients.

Want to Learn More About NABL and ISO 15189:2022?

Join our 4-day Online course on 'Quality Management & ISO 15189:2022' to learn the NABL process, documentation and audits.

The course is suitable for pathologists, lab technicians, owners, quality managers, etc.

Need NABL Accreditation for Your Lab?

We at Qualityveda provide end-to-end support in getting NABL accreditation for labs across India.

• Documentation
• Auditing
• Implementation of quality in real time

Contact us at +91 888 250 9194 for free consultation.

Purpose of Obtaining NABL Accreditation

It provides formal recognition to a laboratory's technical competence. It assures that the laboratory can perform certain testing/calibration functions.

Accreditation helps to establish and maintain a robust QMS within the laboratory.

It helps identify and fix errors in lab testing, enhances lab test processes, and aids in providing consistent testing results.

NABL medical labs must adhere to the requirements set out in ISO 15189:2022 to ensure their labs meet standards for quality and technical competence.

Accreditation is awarded based on an independent assessment of their competence. (NABL official website)

Which Laboratories are Eligible for NABL Accreditation?

NABL accreditation is extended to various types of laboratories based on the standards and scope of tests conducted by them.

These include:

• Medical laboratories, e.g., pathology and diagnostic laboratories.
• Testing laboratories.
• Calibration laboratories.

Accreditation is offered for individual disciplines in medical laboratories such as clinical biochemistry, clinical microbiology, clinical haematology, clinical pathology and histopathology.

Any laboratory can apply for accreditation.

ISO 15189:2022

An international standard that defines how medical laboratories should operate in order to be of high quality and technically competent.

The standard provides requirements for laboratory management systems, processes, personnel competence and patient safety.

It provides the key requirements for the laboratory including:

• Sample collection and handling.
• Equipment maintenance and calibration.
• Internal quality control.
• External quality assessment schemes.

It also provides information on laboratory processes including personnel training/competence, record keeping and documentation, internal audits and management reviews.

This helps improve the quality management system and testing processes within the laboratory.

How to Gain NABL Accreditation for Medical Laboratories

According to NABL there are a series of steps needed to gain NABL accreditation for your medical laboratory. The first step is to understand the requirements set by NABL.

1. Understand NABL Requirements

Medical laboratory should have an understanding of ISO 15189:2022 and identify which requirements apply to your testing.

2. Create Required Documentation

The laboratory will need to create a series of documents, this includes quality manuals, standard operating procedures, policies, forms and records.

3. Implementation of Quality Management Practices

The laboratory must implement quality management and Assurance practices.

4. Carrying out Internal Audits

Internal audits must be conducted to assess compliance of the laboratory processes and identify nonconformities.

5. Application for NABL Accreditation

The scope of accreditation and associated fees must be paid by the medical laboratory prior to the assessment.

6. Completing NABL Assessment

The NABL assessors evaluate the competence of the management system of the laboratory as well as the IMS (implementation of the requirements) of the laboratory.

The medical laboratory must address all the nonconformities to ensure the accreditation of the IMS.

For more information, check Qualityveda's NABL accreditation process.

What Documents Are Required for NABL Accreditation?

The quality management system of a laboratory is incomplete without proper documentation.

Some of the key documents and records for a laboratory quality management system include, but are not limited to, the following:

• Quality Manual: Describes the laboratory's quality management system.
• Standard Operating Procedures (SOPs): Outline the processes performed in the laboratory.
• Equipment Records: Contain information regarding calibration and maintenance of equipment.
• Quality Control Records: Document the results of In-house Control and Participation in an external quality assurance scheme.
• Training Records: Contain information regarding training imparted to staff.
• Internal Audit Records
• Audit Findings
• Corrective Actions

Although it is not a regulatory requirement, good documentation will help laboratories to keep track of what they have done and provide evidence that they have implemented during assessments and inspections.

Challenges Faced by Laboratories During NABL Accreditation Process

Applicant laboratories often experience issues when applying for accreditation for the first time.

First-time applicant laboratories often face challenges during accreditation.

Documentation

Many issues are due to the absence or inadequacy of records, e.g., staff training, calibration, and inspection records.

QM Requirements

Staff may have training in laboratory testing, but may not be knowledgeable about QM System requirements, which constitutes a challenge during preparation for accreditation.

Implementation Gaps

It is common for a laboratory to prepare documents before actually implementing the required processes and procedures. This can result in nonconformities.

Inadequate Internal Audits

Many laboratories experience challenges related to inadequate preparation for accreditation and/or assessment. This challenge can be mitigated if laboratories adequately implement quality management requirements and consistently plan and document their activities.

Frequently Asked Questions (FAQs)

Q1. Is NABL Accreditation a Mandatory Requirement for Pathology Labs?

Ans. It is generally voluntary however may be required in certain contracts, schemes or legislation.

Q2. What is the Difference Between NABL and ISO 15189?

Ans. NABL is the accreditation body which assesses the laboratory and acknowledges its competency while ISO 15189 is an international standard which defines the quality & technical requirements that must be met by medical laboratories.

Q3. What is the Time Frame for NABL Accreditation?

Ans. It depends on the state of readiness of the laboratory, the quality and completeness of the documentation and the findings of the assessment.

Q4. Can a Small Diagnostic Lab Get NABL Accredited?

Ans. Yes. Small diagnostic labs are eligible for accreditation.

Final Thoughts

Obtaining NABL accreditation will improve the quality of services offered by diagnostic laboratories. It will also give confidence to the client.

By putting the correct systems in place to ensure quality documents, quality controls, staff training and correct technical procedures are in place, labs will improve their quality management systems and gain confidence from patients and healthcare professionals.