What is the Quality Specialist Program?

In the field of diagnostics, lab quality is of utmost importance. However, consistent lab quality is easier said than done. For smaller to medium-sized labs, hiring a full-time quality manager or paying NABL consultancy fees can be very difficult. This is where Qualityveda's Quality Specialist Program comes into the picture.

What is the Quality Specialist Program?

At Qualityveda, we’ve created a unique consulting model for medical labs with our Quality Specialist Program. We place a Quality Specialist with your lab to assist you in meeting the requirements for NABL accreditation as well as ISO 15189:2022.

Our Quality Specialist assists your lab staff to enhance their documentation, quality control, and internal audits.

The Program offers ongoing support and, in the absence of frequent consultancy visits, helps the lab prepare for assessments.

Why This Program Matters

Lab quality needs to be monitored constantly. This can also mean staff training and documentation, and most importantly, a continuous drive for improvement in the lab. In a smaller lab, it can be very challenging to manage all of these in addition to performing tests.

Our mission is to help as many labs as we can, affordably and easily navigate through the process of attaining NABL accreditation.

We hope that one day, every medical lab in India will be able to issue timely, accurate and trustworthy reports to patients.

The Quality Specialist Program encourages laboratories to maintain practices consistently throughout the year instead of only documenting processes leading up to an assessment.

The purpose of this component is to enable our partner laboratories to identify and eliminate weaknesses, improve their processes and strengthen their quality management systems.

What We Do in the Quality Specialist Program

1. Monitoring through Quality Control

Daily Quality Control (QC) helps laboratories monitor their testing activities and performance, take corrective actions, and identify the cause of adverse or unexpected results. Our specialists review Quality Control (QC) activities through video calls and our software, and provide support in analyzing results. This helps identify potential trends and patterns that may require corrective action.

2. Quality Management Oversight

On-site visits are carried out every week to help the laboratory put quality management into place. Quality specialists will assess and update systems and look for areas of shortcomings and lack of documentation. Suggestions and implementation of improvements can be made. Support can also be provided to overcome any issues that may occur with the system during everyday use. Unlike other programs, this one is very hands-on.

3. Staff Training

Staff training provides laboratory staff with the KSA and competence to understand what needs to be done within the NABL Accreditation Manual, Transition Chapter and ISO 15189:2022. It allows staff to learn about quality, get to know it and implement quality management practices.

4. Quality Indicators (Monthly)

Quality indicators can help a laboratory measure and evaluate its performance.

Our specialists hold monthly meetings to measure and evaluate laboratory performance indicators, and provide suggestions for improvement to processes.

These may include appraisal of sample rejection rate, turnaround times, critical value reporting and other indicators.

Through regular appraisal, the laboratory is able to assess which of its activities are performing to expectations, as well as to identify areas for improvement.

The information obtained may be useful in planning corrective action.

5. Internal Audits

Internal audits are performed to assess whether the procedures of the laboratory are in accordance with their requirements.

We help you carry out your internal audits and identify non-conformities in the lab.

By auditing your lab paperwork, processes and corrective actions, we can help find issues.

Regular internal audits can help you identify potential issues prior to external assessments.

For formal conditions, the laboratories can refer to the NABL documents.

6. MRM (Management Review Meetings)

Through Management Review Meetings, the effectiveness and improvement of the quality management system of the laboratory is assessed.

Our Program supports the meeting process and the assessments for a period of one year.

The discussions cover quality indicators, the findings of management audits and corrective actions, if any, resource requirements, and opportunities for improvement.

The meetings ensure that the needs of the laboratory are assessed and that quality objectives are met.

7. Risk Assessment and Process Control

There are various risks in the laboratory related to the equipment, documentation, procedures, sample handling and reporting.

Assessing risks enables identification of vulnerable areas in the laboratory which may impact laboratory operations, and more importantly, patient care.

Our Quality Specialists assist the laboratories in risk assessment and review the process controls in place, and if necessary, suggest improvements.

These activities allow laboratory teams to take preventive actions and enhance their operational processes.

How the Quality Specialist Program Helps with NABL Accreditation

For laboratories to obtain and retain NABL accreditation, they are required to demonstrate evidence of the application of quality management principles and practices.

Preparing for accreditation also involves documentation, staff training, quality controls, internal audits and management reviews.

The Quality Specialist Program provides valuable support during this process through review and practical guidance.

Post-accreditation, laboratories are also required to perform similar activities and demonstrate implementation of various requirements. This Program provides continued support.

Who can benefit from the Quality Specialist Program?

The Quality Specialist Program is designed to address the quality management needs of laboratories looking for sustained and continuous support.

This may include small and mid-sized diagnostic laboratories; laboratories preparing for NABL accreditation; accredited laboratories looking for sustained quality system support; laboratories needing documentation and audit support; and laboratories in need of continuous training, monitoring of quality and adherence to required practices.

The Program can be tailored to suit the activities, needs and existing quality management processes of a laboratory.

Our Promise

"Leave your lab's quality management to us and focus on growing your business"

With our specialists handling documentation and compliance, your laboratory can keep quality management records up to date in a more organized way and focus on other core activities of the business.

Frequently Asked Questions (FAQs)

Q1. What is the Quality Specialist Program?

The Quality Specialist Program is a service provided by Qualityveda in which a team of consultants dedicated to a medical laboratory provides support for documentation, quality control, training and audit activities and helps with NABL accreditation.

Q2. Is the Quality Specialist Program suitable for small laboratories?

Yes, the Program helps small and mid-size medical laboratories in developing and sustaining quality management systems.

Q3. Does the Program include on-site visits?

Yes, the Program includes on-site visits conducted once a week to review the activities of the laboratory and provide guidance to the staff for improvement.

Q4. Does Qualityveda conduct staff training?

Yes, monthly staff training is held to familiarize the laboratory staff with the requirements of ISO 15189:2022 and NABL.

Q5. Will the program help in retaining NABL accreditation?

Yes, the Program helps with various quality management activities, documentation and performance evaluation. It is to be noted that NABL is the accrediting body and will make a decision based on its assessment.