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.
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.
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.
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.