How to Apply for NABL Accreditation: A Comprehensive Guide for Medical Laboratories in 2024

Making an application to be accredited by NABL (National Accreditation Body for Testing and calibration Laboratories) accreditation is an important step for medical laboratories that want to gain international recognition and guarantee high quality test and calibration. This step-by-step guide to apply for NABL Accreditation

Step 1: Pre-Application for NABL Login

Before you apply, become familiar in prior to applying for a job, you should be aware of NABL standard (ISO/IEC 17025 as well as ISO 15189). Check that your lab is compliant with the standards by implementing quality management procedures and technical specifications. Conduct internal audits as well as staff instruction to help prepare accreditation.

Step 2: Apply for NABL Accreditation Application Submission

Go to the NABL portal and sign up for accounts if do not already have one. Complete the NABL application form and provide the required information regarding your laboratory. Complete the application online via NABL’s portal. NABL portal.

Step 3: Document Review

After your application has been submitted, NABL will review your documents to determine if they meet the required criteria. This might include reviewing your quality guideline procedures, records, and reports from internal audits.

Step 4: Pre-Assessment Visit

NABL performs a pre-assessment audit of your laboratory to ensure the processes and systems meet the guidelines. This inspection helps to identify areas that need to be improved prior to an assessment in the form of a formal report.

Step 5: Assessment

A formal evaluation will be carried out by NABL assessors, who will determine your laboratory’s conformance to the guidelines. It involves a thorough analysis of your equipment, procedures and personnel’s skills.

Step 6: Decision and Accreditation

Following the evaluation, NABL will make a determination based on its findings. If your lab meets NABL requirements then you’ll be granted accreditation. You will be issued an accreditation certificate and will be able to utilize your NABL logo on your promotional material.

Step 7: Continuous Surveillance

To keep you accreditation lab will be subjected to periodic inspections conducted by NABL to ensure continuous conformity to the standards. This will ensure that your laboratory continues be in compliance with the standards of excellence that are set by NABL.

NABL Accreditation through NABL Portal Login

To manage your application and accreditation you’ll need to sign into your account on the NABL portal. Here’s how:

1. Go to on the NABL website to login.

2. 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 login page.

3.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.

Now , How to Register for NABL Accreditation

On the registration page, fill all your laboratory information like the type of lab, name, address, contact person name, number, and email . Nabl 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

Navigate to the ( NABL Login ) login page by opening the URL: http://nablwp.qci.org.in/Account/Login.

Enter the credentials provided in the email you received.

On your first login, you will be redirected to a password change page after entering your credentials.

It is mandatory to change your password during this initial login.

After logging in, you must agree to the “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.

• On that third section of your application you’ll be required to provide information about your lab’s services, including if they are available to Others and Partly open to Others or an in-house Activity.
• Then, indicate if it is Sample Collection Centre(s) or Facility(ies).
• Check on the progress of Internal Audit (IA) as well as the Management Review Meeting (MRM) held, as well as their dates.
• Then, upload the organizational chart (mandatory) and where appropriate the parent chart in either PDF or JPG format.

• In the next section, you have to filled up 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.

For employee details, please follow these steps:

1. Please provide the information of the Director of the Laboratory, The Management System Responsible Person, and the Responsible for Technical Operations.
2. If a single person fulfills the three roles, then enter their information under each category using the menu dropdown.
3. They can also be assigned to report the results, examine them, and sign off on the results of tests.
4. Upload your signature (in JPG format) of the person(s) responsible for reporting, reviewing, and approving testing results for each test scope.

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 for NABL)

• 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 NABL 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)

Now you can see, There are various fees to be paid for getting or continuing to maintain NABL accreditation. The following are the charges specifically for medical laboratories. For more details you can visit the official website NABL India.

NABL Fees in India

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

Conclusion

Achieving NABL accreditation requires a precise and thorough application process. Follow the detailed online steps, ensure all necessary documents are uploaded, and pay the required fees to streamline the procedure. Adherence to ISO 15189 and NABL 153 standards is crucial for successful accreditation.