The Science & Technology Ministry of Indian Government supervises the independent body of National Accreditation Board for Testing & Calibration Laboratories (NABL). It provides testing and calibration facilities. The process of NABL approval encompasses an in-depth evaluation of the laboratory’s capabilities, adherence to international regulations, and the process of management of quality.

What is NABL Approval?

NABL is a separate entity that is a member of the Indian Quality Council. The NABL performs the evaluation of the quality requirements for organizations, government agencies, and elementary schools. Proficiency testing, lab testing, medical testing, and testing for medical producers are the tests that will be carried out in order to get NABL approval. 

Therefore, all medical research, bioengineering, pharmaceutical, food processing, or R&D departments has to apply for NABL approval or accreditation.

Need for NABL Approval

• NABL recognition helps in evaluating objectively the quality of the goods available in the market. The Conformity Assessment Body (CAB) attains NABL approval in order to show that the different products manufactured by it are of high quality.
• All the CABs need to get clearance from NABL for maintaining quality standards. 
• Therefore, for a product produced in a CAB would be provided by NABL approval. This would be necessary for both domestic and exported goods and devices from India which is significant for domestic products. 

• A third-party evaluation of quality standards is carried out as part of the approval process. The requirements should be aligned with these quality standards.
• Therefore, NABL approval is a quality evaluation that grants approval for products made by CABs.

Goals of NABL Approval

• The CAB would receive a license to operate in domestic markets.
• When CABs adhere to the NABL’s criteria, regular compliance will be maintained.
• The NABL’s accreditation would increase the CAB goods’ quality, especially in forensic testing, culinary tasting, and medical testing. This will raise the products quality that is produced and made in India.
• Memorandums of Understanding (MOUs) have been inked by NABL with several foreign institutions to intensify R&D access and training. Any CAB with NABL clearance would have access to international training.
• The acceptance of the NABL will increase output and confidence in calibration and medical laboratories.
• The responsibility for supplying quality standards would fall to NABL.
• This approval will result in the CAB’s long-term performance. 

Eligibility for NABL Approval

In order to meet the eligibility requirements of the NABL, the CAB needs to meet the following requirements:

• It needs to firstly be a CAB engaged in food processing, research and development, laboratory testing, and calibration.
• One of the two options available to CAB institutions is to designate a representative to initiate the NABL approval process.
• The designated representative should know about the current quality processes that the CAB uses.
• An appointed manager with up to four days of relevant training on internal auditing and following the management policies under the CAB.
• The CAB’s high-quality document needs to be put into effect right away. The NABL 130 outlines the requirements for site testing and site calibration laboratories mentions that the CAB must meet the necessary requirements.
• The Proficiency Training Program, run by the NABL is a pre-requisite for all applicants. If no training program is conducted, the NABL can compare labs to evaluate quality. A lab must meet the requirement of one parameter or test in order to take part in the aforementioned program.
• Before asking for NABL approval, the CAB must complete at least one internal audit and one management review.

Documents Required for NABL Approval

• NABL 112 pertains to standards for medical laboratories 

• NABL 126 pertains to specific Requirements for Medical Device Calibration 
• NABL 151 pertains to testing labs.
• NABL 152 pertains to calibration laboratories
• NABL 153 pertains to medical laboratory
• NABL 155 pertains to medical application form and check list
• NABL 160 pertains to details about the maintenance of the quality system handbook 
• NABL 180 NABL pertains to for PTP 
• NABL 190 pertains to RMP 
• NABL 100 pertains to overview of NABL Information
• NABL 219 pertains to checklist and assessment forms for NABL (ISO/IEC 17025:2017).

Process Followed for the NABL Approval

• Submit an application: The institution needs to apply to the NABL in this step. The appropriate Documents must be sent to the NABL with the application. The application needs to be submitted in three copies. Two copies must describe quality guide for the management system.

• Fee Payment: The fee has to be paid by the applicant under NABL 100. If the applicant chooses not to disclose anything, the same should be explained to the authorities.
• Obtaining the Application: A unique identifying number (UIN) is given when the application and the fee have been received by the NABL Secretariat. This UIN needs to get mentioned by the applicant in all communications done with the NABL.
• Pre-assessment Meeting: If there are no errors found in the application, a lead assessor shall be appointed to carry out a pre- assessment meeting to the CAB. The aim of the evaluation is to establish to check the quality control adopted for the CAB. In addition, the assessor will make sure of the required activities to be performed by NABL.
• Report Submission: Following the evaluation conducted by the lead assessor, a report is delivered to the NABL Secretariat. A copy is delivered to the Secretariat, and every record is kept in the Secretariat’s document management system.
• Evaluation Team: The lead assessor and other people with relevant experience will form a team that will be gathered by the NABL after the CAB has completed all necessary steps to address the issues. The group examines and determines compliance that is to be achieved in line with the necessary requirements. A report will be prepared and sent to the Secretariat if any issues are found within the CAB. The evaluation will have recommendations for correcting the discrepancies.  This will be copied and sent to the appropriate CAB.
• Subsequent Measures: The CAB has to take action after the report is reviewed by the NABL secretariat. This is to be carried out within 60 days of receiving the Assessment Team Report. The corrective action the CAB has taken to lessen obstacles must be mentioned in action.
• Recommendations: The NABL Chairman will receive recommendations from the Accreditation Committee following the CAB’s follow-up action. The decision rendered by the Chairman is not final and can be challenged in front of the director of NABL.
• Grant of Certificate: The certificates that be sent to the applicant by the NABL upon approval or accreditation are as follows:

• Individual Number of Identification;
• The NABL Approval Certificate;
• Hologram with the NABL indicators;
• The Certificate’s Validity Date; and
• Order.

• Outstanding Amount: Before the certificate is given to the NABL, the applicant must pay any outstanding amounts owed.
• Compliance: The applicant is responsible for making sure that compliance is maintained. The applicant must continue to maintain the following compliances.

• ISO/ IEC 17025: 2005; or
• ISO 15189: 2012; or
• ISO/IEC 17043:2010 or ISO 17034:2016.
• Following the terms & conditions of NABL 131.

Conclusion

The approval from NABL is a very important step since it establishes the assessment framework for the quality and the competence of the testing and calibration labs. It encourages the labs and the clients by providing self-assurance, reliability, and standing worldwide.