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Full NABL Accreditation / Consulting

NABL accreditation is recognized and valid throughout the world’s major economies, as well as by all Indian regulators.

Benefits of NABL :

  • NABL accredited Laboratory demonstrates superior testing competence with respect to their quality of work as well as reporting
  • NABL Accredited laboratories are highly benefited when they get empanelled by various corporate companies, government health schemes, etc.
  • There is a scope for potential revenue growth for the laboratory as a result of increased patient satisfaction as well as community confidence
  • Having undergone the process of NABL accreditation helps in reduction of re-testing of samples which in turn saves enormous time as well as money.
  • Patients & laboratory clients are also highly benefitted as they are assured of best quality of care and accurate test reports compared to Non- NABL accredited laboratories.
  • NABL ensures that qualified and trained staff are involved in testing the samples and thus the patients and referring clinicians trust the accredited laboratories more.
  • Laboratory staff including technicians, phlebotomists, pathologists are very confident and they get safe and secure working environment
  • The laboratories infrastructure, facilities and maintenance are certified and reliable to be accessed along with the level of care and safety

What is Full NABL Accreditation :

The National Certification Board for Testing and Calibration Laboratories (NABL) is an autonomous agency under the supervision of the Department of Science and Technology, Government of India, whose mission is to offer accreditation for clinical laboratory testing and calibration throughout the nation.
It is the only certification agency recognized by the Indian government to conduct a third-party review of lab quality and technical ability. NABL is also affiliated with the Asia Pacific Laboratory Accreditation Cooperation and the International Laboratory Accreditation Cooperation (ILAC).
NABL accreditation is recognized and valid throughout the world’s major economies, as well as by all Indian regulators.

 

What are the Full NABL Accreditation standards:

NABL standards are a set of evaluation criterias for the laboratories. They provide a comprehensive framework for quality of care and improvement in the Laboratorys as well as patient safety. NABL divides the category of laboratories. NABL standards are divided into following categories as per ISO 15189:2012 :

 

  • Micro Laboratories: Upto 25 patients per day
  • Mini Laboratories: 26 – 50 patients per day
  • Small Laboratories: 51 – 100 patients per day per location
  • Medium Laboratories: 101 – 400 patients per day per location
  • Large Laboratories: 401 – 1000 patients per day per location
  • Very large laboratories: More than 1000 patients per day per location

Management requirements:

  • Organization and management responsibility
  • Service agreements
  • Examination by referral laboratories
  • Advisory services
  • Control of records
  • Evaluation and audits

General Technical Requirements For full nabl accreditation :

  • Personnel
  • Accommodation and environmental conditions
  • Laboratory equipment, reagents, and consumables
  • Pre-examination processes
  • Examination processes
  • Ensuring quality of examination results
  • Post-examination processes
  • Reporting of results
  • Release of results
  • Laboratory information management

Discipline wise Technical Requirements For full nabl accreditation :

  • Clinical Biochemistry
  • Haematology
  • Clinical Pathology
  • Microbiology & Infectious disease serology
  • Histopathology
  • Cytopathology
  • Flow Cytometry
  • Cytogenetics
  • Molecular Testing

Who can apply for full NABL Accreditation :

NABL can be applied by any laboratory that specializes in Clinical Biochemistry, Hematology, Clinical Pathology, Microbiology and Infectious Disease Serology, Histopathology, Cytopathology, Flow Cytometry, Cytogenetics, or Molecular Testing.

 

What is the duration of Full NABL accreditation :

Various phases guide the NABL accreditation process. From preparing the Laboratory to achieve accreditation, there are various steps involved that need to be accomplished.

 

Conducting Internal Audit & filling the full NABL application form :

The laboratory should prepare for NABL and implement the standards for at least 3 months before applying for NABL accreditation.

Pre-Assessment Visit
If there are no issues with the application, a lead assessor will be assigned to conduct a pre-assessment visit to the CAB. The evaluation is carried out to see whether there are any anomalies in the CAB’s quality control procedures. Along with this, the assessor will determine if the NABL is necessary to conduct any more assessments.

Final Assessment
When the CAB has completed all corrective actions, the NABL will assemble a team composed of the lead assessor, technical experts, and other persons with experience in relevant sectors and disciplines. The team investigates and determines whether or not compliance is reached in line with the relevant standards. If any inconsistencies are discovered in the CAB, a report will be prepared and sent to the Secretariat. Remedies to remedy the disparities would also be included in the report. A copy of this will be sent to the appropriate CAB.

Follow-up Action
When the NABL secretariat reads the report, the CAB must take appropriate action. This step must be performed within 30 days of receiving the Assessment Team’s report. In action, the CAB must disclose the corrective action it has taken to alleviate issues.

 

 

WHAT IS THE PROCESS OF Full NABL ACCREDITATION ?​​

Once the Laboratory has decided to pursue NABL certification, Medigence will accompany you through every stage of the process, from preparing the Laboratory to receiving accreditation confirmation.

Preparing the Laboratory for NABL accreditation
Before submitting an application to NABL, the Laboratory must first adopt the NABL certification requirements for at least three months. The professionals at Medigence will assist your laboratory in understanding the requirements and practical methods for adopting them.


Preparing your Laboratory shall involve the following activities :

• Conducting a gap assessment of the Laboratory for infrastructure changes, equipment changes, licences and regulatory requirements, and human resources
• Sensitization of staff to all NABL standards in relation to ISO 15189:2012
• Advisory support for the overall NABL Accreditation Process • Documentation of all required policies and procedures
• Guidelines and tools for policy and procedure implementation
• Guidelines for training programs

Filling up the NABL Application form
Once the Laboratory is ready, our NABL professionals will assist you in completing the whole NABL application process. After completing the application form, the Laboratory will be requested to submit the application costs to NABL. After successfully paying the application costs, the Laboratory will get the NABL reference number, which will serve as your permanent reference number.


Internal Assessment & Mock Assessment
While the NABL authorities review your application and schedule the pre-assessment dates, our NABL experts will assist your Laboratory with different implementation procedures, training programs, mock drills, and so on. Our NABL specialists will perform a simulation assessment in terms of Internal Audit shortly before the pre-assessment to ensure that the Laboratory is ready to face the actual audit.
Mock assessments/Internal audits allow workers to practice and understand what to expect during the actual evaluation. The experts will raise the non-compliance report in the same manner as the NABL assessors. Staff will also be instructed on how to deal with non-compliances.

Pre-assessment
NABL Pre-assessment is a high-level overview of the Laboratory’s preparation to meet NABL requirements. As a result, depending on the size of the Laboratory, it takes either 2 or 4 man-days. Once your application form has been accepted by NABL, dates for pre-assessment will be mutually agreed upon. Our NABL specialists will provide back-end assistance during pre-assessment. At the end of the evaluation, daily briefings will be conducted, and the observations will be addressed. If any observation may be met, our professionals will assist you in closing it at that time. Following the pre-assessment, we will assist you in developing a report of corrective and preventive action in response to the assessor/s’ non-compliances. The same shall be submitted to NABL within the timeframe provided by the evaluators.


Final Assessment
The NABL final assessment is a thorough examination of the Laboratory to verify that it is adhering to and executing the NABL standards to the best of its ability. Again, depending on the size of the Laboratory, the evaluation might take 2 to 4 man-days. NABL will also require the Laboratory to pay the yearly fees before arranging the final assessment.
Our NABL professionals will provide constant help from the backend during the final evaluation days. Daily observations will be reviewed at daily briefing meetings at the end of each assessment day, so that if there is any query that may be satisfied, we will assist you with it. Following the final assessment, our NABL experts will assist you in developing a corrective and preventive action report in response to non-compliances flagged by the assessors during the assessment days. The same must be submitted to NABL within the timeframe specified by the assessors.
NABL Accreditation Committee Review & receiving Accreditation


The Laboratory application will be sent to the NABL accreditation committee for assessment if the provided closure report is accepted. Within the next month. Following a review of the application, the committee may request specific details. Medigence will assist you during this final stage of your procedure and in submitting your enquiry response. The committee’s final recommendations will be notified to the Laboratory, after which accreditation will be granted. The accreditation once received is valid for a period of 2 years.

Surveillance
Maintaining certification is always challenging. Throughout the accreditation period, NABL fosters continual quality improvement at all levels. As a result, a surveillance evaluation is scheduled every 12 months following certification to check that the Laboratory is maintaining the standards and applying them to the best of its ability.


Renewal of accreditation
In order to ensure the continuation of the accreditation, the Laboratory must request for renewal at least 6 months before it expires. Applying before 6 months allows NABL to schedule the assessment correctly, and the Laboratory will have enough time to deal with any non-compliances found during the examination before the accreditation expires.

 

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