NABL

NABL

National Accreditation Board for Testing and Calibration Laboratories (NABL) is a Constituent Board of Quality Council of India. NABL has been established with the objective to provide Government, Industry Associations and Industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories.

In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with ISO/IEC 17025:2005 and ISO 15189:2012 for medical laboratories. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence.

NABL accreditation system complies with ISO/IEC 17011:2004 and Asia Pacific Accreditation Cooperation (APAC) MR001. Based on evaluation of NABL operations by APAC in 2000, NABL has been granted signatory member status by APAC and International Laboratory Accreditation Cooperation (ILAC) under their Mutual Recognition Arrangements (MRAs). Under these MRAs, the reports issued by NABL accredited laboratories are considered to be equivalent to reports issued by laboratories accredited by (currently) 76 accreditation bodies in 64 economies. NABL has undergone re-evaluation by four-member APAC evaluation team in July 2008. APAC/ILAC has recommended NABL’s Mutual Recognition Arrangement (MRA) status for further four years with extension of scope for Medical Testing laboratory as per new international standard ISO 15189:2012.

Recently, NABL also added a new dimension in the area of accreditation as a new program on “Accreditation of PT Providers” based on international standard ISO/IEC 17043-Conformity Assessment- General Requirements of Proficiency Testing and strive to obtain ILAC / APAC Mutual Recognition Arrangement (MRA) Signatory Status for international acceptability also.

ELIGIBILITY CRITERIA FOR NABL

To satisfy the requirement of the NABL, the institution (CAB) has to satisfy the following eligibility criteria:

• First and foremost, the institution must be a CAB carrying out relevant activities such as laboratory testing, calibration, food processing, research, and development.
• A CAB institution must either appoint a representative to start the formalities for the NABL approval process.
• The appointed representative must be aware of the existing quality processes followed by the CAB.
• The institution (CAB) must have developed a manual that indicates the quality standards. Such quality standards must satisfy the requirements of :

1. ISO/ IEC 17025: 2005; or
2. ISO 15189: 2012; or
3. ISO/IEC 17043/2010.

• The CAB must have an appointed manager who has relevant training up to 4 days on internal audit and management policies, which are followed.
• The quality document which is prepared by the CAB must be implemented immediately. The CAB must also satisfy the criteria as required, according to NABL 130- which provides the criteria for Site testing and Site Calibration Laboratories.
• Any applicant must participate in the Proficiency Training Program, which is conducted by the NABL or an international institution. If there is no form of training available, the institution can carry out an inter-lab comparison when it comes to quality assessment. If a lab wants to participate in the above event, then the minimum standard must be one parameter or one test.
• The CAB must carry out at least one internal audit and management review before applying for the NABL approval.

BENEFITS OF NABL FOR HEALTHCARE PROVIDERS

• Superior competence in the process of calibration
• Potential increase in business due to customer confidence and satisfaction
• Recognition and greater reach of products in domestic & international markets
• Saving of time and money from  reduced retesting of products
• Better control of laboratory operations and feedback

BENEFITS OF NABL FOR THE PEOPLE

• Assurance of genuine reports from accurately calibrated testing
• Confidence in personnel performing tests
• Elimination of the need for re-testing thereby saving money & time
• Satisfaction from the services provided

PROCEDURE FOR NABL

• Step 1- Make an Application

In this step, the institution must make an application to the NABL. Along with the application, respective documents must be submitted to the NABL. An application must be made in triplicate (3 copies). Two copies must describe the quality manual of the management system. This must be in accordance with the requirement of the ISO/ IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016.

• Step 2- Payment of Fees

The applicant has to pay the respective fee, which is present under NABL 100. If an applicant does not want to make any form of information disclosures, then the same reasons must be provided to the authority.

• Step 3- Receipt of Application

When the application is received by the NABL Secretariat (along with the requisite fee), a unique identification number (UIN) will be issued. The applicant must quote this number in all correspondences with the NABL.

• Step 4- Pre-Assessment Visit

If there are no discrepancies in the application, then a lead assessor will be appointed to carry out a pre-assessment visit to the CAB. The assessment is carried out to understand if there are no discrepancies in the quality control adopted by the CAB. Along with this, the assessor will find out if there is any other assessment required to be carried out by the NABL.

• Step 5- Submission of Report

After the evaluation is carried out by the lead assessor; a report is submitted to the Secretariat of the NABL. A copy is submitted to the Secretariat, and all the records are stored in the document management system of the Secretariat.

• Step 6- Assessment Team

When the CAB has taken all the measures to correct the issues, the NABL will form a team constituted by the lead assessor, technical experts, and other individuals who are experienced in relevant fields and disciplines. The team analyses and finds out if compliance is met in accordance with the required standards. If there are any forms of discrepancies found in the CAB, then a report will be made and submitted to the Secretariat. In the report, remedies would also be included to address the discrepancies. A copy of this will be submitted to the respective CAB.

• Step 7- Follow-up Action

When the NABL secretariat reviews the report, the CAB must take follow-up action. This action must be taken within 60 days of the Report of the Assessment Team. In action, the CAB must mention the corrective action it has taken to mitigate difficulties.

• Step 8- Recommendations

After the follow-up action is taken by the CAB; the Accreditation Committee will make recommendations to the NABL Chairman. The Chairman's decision is not binding, and it can be appealed to the director of the NABL.

• Step 9- Grant of Certificate

When the accreditation is allowed, the NABL will send the following to the applicant:

a) Unique Identification Number;

b) Certificate of NABL Approval;

c) Hologram having the NABL signs;

d) Date of Validity of the Certificate; and

e) Discipline.

• Step 10- Outstanding Amount

If the applicant has any outstanding amount to pay the NABL; the same must be made before the certificate is granted to the NABL.

• Step 11- Compliance

The Applicant must ensure that compliance has to be maintained. The following compliances have to be maintained by the applicant.

a) ISO/ IEC 17025: 2005; or

b) ISO 15189: 2012; or

c) ISO/IEC 17043:2010 or ISO 17034:2016.

d) Apart from this, the applicant also has to comply with the terms and conditions of the NABL 131.

FAQ