NABL Consultants – Who They Are and How They Help

You need the right consultant if you want to get your lab NABL-accredited.

NABL consultants specialize in ensuring pathology and diagnostic labs adhere to the ISO 15189:2022 standards to be accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).

Amongst other things, they help you with:

• Documentation and SOP preparation
• Setting up internal audits and quality control systems
• Staff training
• Preparing for the final NABL audit

Why You Need a NABL Consultant

Lab staff sometimes find it overwhelming to comprehend the requirements of the NABL process. There is more to it than just preparing for audits.

A consultant guides you through the process.

A consultant can also assist with identifying missing records, improving laboratory procedures and helping staff understand their responsibilities. This allows laboratories to prepare for assessments in a more organized manner.

What a NABL Consultant Does

Accreditation is often a lengthy and expensive process for laboratories. NABL consultants ensure your Laboratory is equipped for accreditation by guiding you with the following and more.

1. Documentation and SOP Preparation

1. Quality Manual
2. Standard Operating Procedures (SOPs)
3. Equipment maintenance and calibration records
4. Quality control records
5. Staff training records
6. Internal Audit reports
7. Corrective action records

Proper documentation helps laboratories maintain consistent procedures and demonstrate that quality management activities are being followed.

2. Internal Audits and Quality Control

Consultants also help laboratory staff with setting up and organizing internal audits to identify non-conformities and implement corrective actions.

They also support the implementation of Internal Quality Control (IQC) and External Quality Assessment (EQA) procedures. These activities help laboratories monitor and report their testing performance in addition to providing confidence to users that testing results are reliable.

3. Staff Training and Competency

Laboratory employees must be trained on the requirements that apply to their job functions. NABL consultants provide training on various activities, including operation of laboratory equipment, quality control, laboratory safety, sample collection and handling, record keeping, internal auditing, and other procedures and activities relevant to the functioning of the quality system.

4. Assessment preparation

Laboratories should review the documents, quality control procedures and laboratory equipment to ensure readiness for the official NABL assessment.

Consultants may also perform mock audits to help identify gaps and assist in addressing them. The Laboratory is required to demonstrate its compliance with the relevant standards during an assessment.

What Is the NABL Accreditation Process?

The NABL accreditation process involves several activities that laboratories must undertake.

Step 1: Gap Analysis

Laboratories review their current situation vis-à-vis the applicable requirements of the NABL accreditation. This helps them identify gaps in documents, inadequate records and other areas that need improvement.

Step 2: Documentation

Laboratories draft their quality manual, standard operating procedures (SOPs), policies and supporting records.

Step 3: Quality Management System Implementation

Laboratories put in place their procedures and systems and maintain records to demonstrate the effectiveness of their quality management system.

Step 4: Staff Training

Employees are trained on their laboratory procedures to ensure uniformity.

Step 5: Internal Audits and Management Review

Laboratories carry out internal audits to review the quality management system and perform management reviews to evaluate the adequacy and effectiveness of the quality management system.

Step 6: NABL Application

The Laboratory submits an application to NABL through the NABL portal for the scope of accreditation sought, along with supporting information.

Step 7: NABL Assessment

NABL appoints assessors to evaluate the Laboratory for compliance with applicable requirements.

Step 8: Corrective Actions and Accreditation Decision

The Laboratory corrects the nonconformities and provides evidence.

NABL reviews the assessment findings and makes an accreditation decision.

For official requirements, consult the NABL medical laboratory accreditation guidelines.

What Are the Advantages of Using a NABL Consultant?

NABL consultants help laboratories organize the accreditation process in the following ways:

• Documentation: Preparation and maintenance of required records.
• Awareness: Employee training on accreditation requirements.
• Preparation: Follow a planned approach instead of last-minute preparation.
• Identify Shortcomings: Anticipate corrective actions.

Consultants also help develop quality management systems.

• Assessment readiness: Mimic evaluations.

Simplification of preparation does not guarantee accreditation. NABL accreditation is only awarded if the Laboratory meets all the requirements.

Which Medical Laboratories Need a NABL Consultant?

NABL consultancy services are useful to medical laboratories providing testing services in the following areas:

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

Large and small medical laboratories are eligible for accreditation if they meet the eligibility, technical and other requirements set by NABL.

Read What is NABL Accreditation? for more details on accreditation requirements.

Choosing the Right NABL Consultant

Every Laboratory should review the consultant’s experience, services and approach towards NABL accreditation.

Some important aspects to consider:

1. Understanding of ISO 15189:2022

The consultants should be well aware of the quality and competency requirements of medical laboratories.

2. Documentation Support

Do they assist in developing Quality Manuals, Standard Operating Procedures (SOPs) and other related records?

3. Training Services

Do they provide training to the staff and assist in developing their competencies?

4. Internal Audit Support

Do they identify the nonconformities in the Laboratory and help in improving the Laboratory’s readiness for audit?

5. Transparency

What services do they provide, and what will they charge for?

We at Qualityveda offer end-to-end services and reduce your cost by 50%, with a success rate of getting 99% of our clients accredited!

Frequently Asked Questions

Q1. Who are NABL consultants?

These consultants understand the NABL requirements and aid medical laboratories in meeting NABL requirements.

Q2. Are NABL consultants mandatory?

Laboratories can apply for NABL accreditation on their own. However, hiring a consultant may help in preparing for the documentation, training and assessment requirements.

Q3. Which standard is applicable for medical laboratories?

Requirements for quality and competence in medical laboratories are specified in ISO 15189:2022.

Q4. Can small diagnostic laboratories apply for NABL accreditation?

Small diagnostic laboratories can apply for accreditation as long as they are eligible and fulfill the accreditation requirements.

Q5. Does hiring a NABL consultant guarantee accreditation?

No. Laboratories must be compliant with the requirements, and NABL makes the final decision after its assessment.

Final Thoughts

NABL accreditation validates laboratories’ ability to carry out testing services in a competent manner, thereby reassuring confidence to the users of their services.

Preparing for NABL accreditation requires a systematic approach towards the documentation of systems, quality control, staff competency, internal audits and other improvements.

A NABL consultant can assist laboratories through this process by interpreting the requirements and assisting the laboratories in the various systems and preparing for the NABL assessment.