As part of applying to NABL accreditation, knowing the exact application process is crucial. Anomalies in the application process, or lack of data can delay NABL accreditation process significantly. The NABL application is completely online on the NABL web portal.
It is based on ISO 15189 standard, while the application form is based on NABL 153. You will have to fill details, upload various documents, and complete the form by paying applicable fees. Let’s look at the sample application procedure for NABL labs step-by-step.
Step-by-Step Application Process
Go to the NABL official website– nabl-india.org.
Find the Apply for Medical labs option on the home page, and click on “APPLY online NOW”. You will be redirected to the registration or NABL login page.
)Here, select login/registration for Medical Labs.
If you’re a new lab going for first-time accreditation, select registration. If you’re an old lab for any other purpose like renewal, then login.
Registration for NABL Accreditation
On the registration page, fill all laboratory details like the type of lab, name, address, contact person name, number, and email. Login credentials are sent to the mobile number and email.
You will get OTP on your mobile number and email id. You have to validate your mobile number and email id using OTP.
After successful registration, username and password are sent to your email ID. Ensure to give an active email ID.
Login for NABL Accreditation
- Open the URL at– http://nablwp.qci.org.in/Account/Login, to directly visit the login page.
- Enter the credentials sent to you via email.
- When you’re logging in for the first time, you will be redirected to the password change page after entering credentials.
- It is mandatory to change the password for the first time.
- After login, you have to agree to a “Zero tolerance towards corruption” declaration.
Application Filling
After agreeing to the declaration, the requirements and instructions as per NABL 153 form for medical laboratories will open up.
Read the “Information & Instructions…” and accept the T&Cs.
You have to fill the application starting with laboratory details
The first page requires filling of details–Name of laboratory, address, mobile number, email ID, GST/PAN, whether your lab used consultant service, if any adverse action taken by NABL against the lab in the past, and parent organisation details (if applicable).
On the next page, you have to enter the legal entity details (Name and Type of Legal entity) and upload the legal entity document in PDF or JPG format.
Entering to the third page of application filling, you have to provide details of lab services like Open to Others/Partly Open to Others/An In-house Activity.
Specify if it is Sample Collection Centre(s)/ Facility(ies).
Update the status of Internal Audit (IA) conducted and management review (MRM) conducted along with dates.
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Next, you have to upload the organisation chart (mandatory) and parent organisation chart (if applicable) in PDF or JPG format.
In the next section, you have to fill in the employee details, including senior management and the person proposed to report, review and authorise the test results.
This section activates after the lab fills in the scope details under the Discipline Details section, as shown later in this document.
When it comes to employee details, you have to follow the below:
- Fill in the Head of the Laboratory details, Management System Responsible Person, and Technical Operations Responsible Person details.
- If one person takes up all three roles, enter their details under each relevant category from the dropdown.
- These persons can also be proposed to report, review, and authorise test results.
- Mention and upload the signature (in jpg format) of the person(s) proposed to report, review, and authorise test results for each scope group.
- Upload the management system document (Quality Manual) as per the ISO 15189: 2012 in PDF format.
Application Filling (Discipline Details)
- After laboratory details, you have to start filling discipline details, where you have to select the disciplines or groups (refer to NABL 135).
- After selecting the disciplines/groups, a table will appear to fill in the following details: Scope, Equipment, Reference Material, List of Phantoms, List of Reference Materials and Test Kits/Radioisotopes, PT/ILC details.
- Use the "+" button to enter one detail at a time.
- Use the "↑" upward arrow for bulk uploads via Excel.
- Use the "i" button to view the entered details.
- Once the details are filled, the red cross (X) changes to a green tick (✓).
Application Filling (Scope of Accreditation)
- Select the discipline from the dropdown.
- Enter the materials or products tested.
- Enter the specific test performed, component, parameter, or characteristic tested.
- Enter the test method specification, including the publication year, range (lower and upper limits with SI units), and techniques/equipment used.
- For non-quantitative parameters, select Qualitative or Others, and enter remarks (e.g., Absent/Present or Positive/Negative).
- Download the sample file and then populate it with data according to the Excel column headers
- Select the discipline, where the test is performed, complete the Excel file and click on “Upload”.
- Similarly, fill details of Equipment, Reference Material (If applicable), List of Phantoms (For Medical Imaging laboratories), Reference materials and test kits/Radioisotopes, and PT/ILC.
- Read, understand, and accept NABL 131.
- Submit a “Declaration Form” and update it within 15 days if changes occur.
- You can preview the application at this stage.
- Pay and submit the application form. You can pay applicable fees through Debit Card, Credit Card, Net Banking, or UPI.
Fees for NABL Accreditation (Medical Labs Only)
There are various fees associated with NABL accreditation and post-accreditation procedures. We have given fees for medical labs below. Further information can be found at the official website of NABL India.
NABL Fees in India
| Purpose | Latest Fees |
|---|---|
| Application Fee - Micro Laboratories | ₹6,000+₹200 per SCF |
| Application Fee - Mini Laboratories | ₹10,000+₹200 per SCF |
| Application Fee - Small Laboratories | ₹18,700+₹200 per SCF |
| Application Fee - Medium Laboratories | ₹44,000+₹200 per SCF |
| Application Fee - Large Laboratories | ₹1,10,000+₹200 per SCF |
| Application Fee - Very Large Laboratories | ₹2,20,000+₹200 per SCF |
| Medical Imaging-Conformity Assessment Bodies (MI-CAB) | ₹11,000 |
| Enhancement of Scope - Medical Laboratories & Associated Sample Collection Centre/Facility (SCF) | ₹5,500 |
| Enhancement of Scope - Any addition in Sample Collection Centre/Facility (SCF) | ₹200 per SCF |
| Enhancement of Scope - Medical Imaging-Conformity Assessment Body (MI-CAB) | ₹5,500 |
| Enhancement of Scope - Any extension of new group/modality in the existing accredited scope of MI-CAB | ₹11,000 |
| Change in Person responsible to authorise the results | ₹5,500 / request |
| Change of Certificate - Medical Laboratories | ₹5,500 |
| Change of Certificate - MI-CAB | ₹5,500 |
| Annual Accreditation Fee (per year from the date of accreditation) - Micro Laboratories | ₹6,000+₹1,000 per SCF |
| Annual Accreditation Fee (per year from the date of accreditation) - Mini Laboratories | ₹10,000+₹1,000 per SCF |
| Annual Accreditation Fee (per year from the date of accreditation) - Small Laboratories | ₹20,000+₹1,000 per SCF |
| Annual Accreditation Fee (per year from the date of accreditation) - Medium Laboratories | ₹48,000+₹1,000 per SCF |
| Annual Accreditation Fee (per year from the date of accreditation) - Large Laboratories | ₹1,20,000+₹1,000 per SCF |
| Annual Accreditation Fee (per year from the date of accreditation) - Very Large Laboratories | ₹2,40,000+₹1,000 per SCF |
| MI-CAB | ₹24,000 |
| Overhead Charges | ₹11,000 |
| Assessment Charges - Micro Laboratories | ₹20,000 per SCF |
| Assessment Charges - Mini Laboratories | ₹25,000 per SCF |
| Assessment Charges - Sample Collection Centre/Facility (SCF) | ₹5,000 per SCF |
Source: NABL-India.org
Note:
Micro Laboratories: Up to 25 patients/day
Mini Laboratories: 26 - 50 patients/day
Small Laboratories: 51 - 100 patients/day/location
Medium Laboratories: 101-400 patients/day/location
Large Laboratories: 401-1000 patients/day/location
Very Large Laboratories: above 1000 patients/day/location
Also check - List of NABL Accredited Labs in India
Conclusion
Ensuring accuracy and completeness in your NABL accreditation application is vital for timely approval. Follow the detailed online steps, upload necessary documents, and pay the applicable fees to streamline the process. Compliance with ISO 15189 and NABL 153 standards is essential for successful accreditation.
Suggested read: NABL Accreditation Procedure
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