National Accreditation Board for Testing and Calibration Laboratories (NABL), is an autonomous body under the aegis of Department of Science & Technology, Government of India

Government of India

The Government of India, officially known as the Union Government, and also known as the Central Government, was established by the Constitution of India, and is the governing authority of the union of 28 states and seven union territories, collectively called the Republic of India...

, and is registered under the Societies Act.

About NABL

NABL accredit recognition of the technical competence of a testing, calibration or medical laboratory for a specific task following ISO/IEC 17025:2005, ISO 15189:2007 Standards. It is associated with Asia Pacific Laboratory Accreditation Corporation (APLAC), Mutual Recognition Arrangement (MRA), International Laboratory Accreditation Cooperation (ILAC).

Objectives

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. Government of India has authorised NABL as the sole accreditation body for Testing and Calibration laboratories.

Laboratory Accreditation

The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration.

Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands.

Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence.

For Accreditation, the laboratories should be legally identifiable & appropriately registered. They can be a part of a big organization or an independent entity. NABL can provide accreditation to:

• Laboratories undertaking any sort of testing or calibration in the specified fields.
• Private or government laboratories.
• Small operations to large multi-field laboratories.
• Site facilities, temporary field operations and mobile laboratories.

Process for Accreditation at NABL

The procedure for getting accreditation is detailed in general information brochure published as NABL 100.

Stage I

1. Prepare your laboratory's application for NABL accreditation, giving all desired information and enlisting the test(s) / calibration(s) along with range and measurement uncertainty for which the laboratory has the competence to perform. Laboratory can apply either for all or part of their testing / calibration facilities. Formats NABL 151, NABL 152 & NABL 153 are to be used by Testing, Calibration and Medical Laboratories respectively for applying to NABL for accreditation.
2. Laboratory has to take special care in filling the scope of accreditation for which the laboratory wishes to apply. In case, the laboratory finds any clause (in part or full) not applicable to the laboratory, it shall furnish the reasons.
3. Laboratories are required to submit three sets of duly filled in application forms for each field of testing / calibration along with two sets of Quality Manual and Application Fees.
4. NABL Secretariat on receipt of application will issue acknowledgement to the laboratory. After scrutiny of application for it being complete in all respects, a unique Customer Registration Number will be allocated to laboratory for further processing of application.
5. NABL Secretariat shall then nominate a Lead Assessor for giving Adequacy Report on the Quality Manual / Application submitted by the laboratory. A copy of Adequacy Report by Lead Assessor will be provided to Laboratory for taking necessary corrective action, if any. The laboratory shall submit Corrective Action Report.

After satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory will be organised by NABL. Laboratories must ensure their preparedness by carrying out its internal audit before Pre-Assessment.

Stage II

1. NABL Secretariat shall organise the Pre-Assessment audit, which shall normally be carried by Lead Assessor at the laboratory sites.
2. The pre-assessment helps the laboratory to be better prepared for the Final Assessment. It also helps the Lead Assessor to assess the preparedness of the laboratory to undergo Final Assessment apart from Technical Assessor(s) and Total Assessment Man-days required vis-à-vis the scope of accreditation as per application submitted by the laboratory.
3. A copy of Pre-Assessment Report will be provided to Laboratory for taking necessary corrective action on the concerns raised during audit, if any.
4. The laboratory shall submit Corrective Action Report to NABL Secretariat.

After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory shall be organised by NABL.

Stage III

1. NABL Secretariat shall organise the Final Assessment at the laboratory site(s) for its compliance to NABL Criteria and for that purpose appoint an assessment team.
2. The Assessment Team shall comprise of a Lead Assessor and other Technical Assessor(s) in the relevant fields depending upon the scope to be assessed.
3. Assessors shall raise the Non-Conformance(s), if any, and provide it to the laboratory in prescribed format so that it gets the opportunity to close as many Non-Conformance(s) as they can before closing meeting of the Assessment.
4. The Lead Assessor will provide a copy of consolidated report of the assessment to the laboratory and send the original copy to NABL Secretariat.

Laboratory shall take necessary corrective action on the remaining Non-Conformance(s) / other concerns and shall submit a report to NABL within a maximum period of 2 months.

Stage IV

1. After satisfactory corrective action by the laboratory, the Accreditation Committee examines the findings of the Assessment Team and recommend additional corrective action, if any, by the laboratory.
2. Accreditation Committee determines whether the recommendations in the assessment report is consistent with NABL requirements as well as commensurate with the claims made by the laboratory in its application.
3. Laboratory shall have to take corrective action on any concerns raised by the Accreditation Committee.
4. Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to NABL Secretariat.
5. Laboratories are free to appeal against the findings of assessment or decision on accreditation by writing to the Director, NABL.
6. Whenever possible NABL will depute its own technical personnel to be present at the time of assessment as Coordinator and NABL Observer. Sometimes, NABL may at its own cost depute a newly trained Technical Assessor as "Observer" subject to convenience of the laboratory to be accessed.

Stage V

1. Accreditation to a laboratory shall be valid for a period of 2 years and NABL shall conduct periodical Surveillance of the laboratory at intervals of one year.
2. Laboratory shall apply for Renewal of accreditation to it at least 6 months before the expiry of the validity of accreditation.

Benefits of Accreditation

NABL is a signatory to ILAC Arrangements as well as APLAC Mutual Recognition Arrangements (MRA), based on mutual evaluation and acceptance of other MRA Partner laboratory accreditation systems. Such international arrangements facilitate acceptance of test / calibration results between countries to which MRA partners represent.

This developing system of international mutual recognition agreements between accreditation bodies has enabled accredited laboratories to achieve a form of international recognition, and allowed test data accompanying exported goods to be readily accepted on overseas markets amongst the countries which have already qualified as significant to ILAC Arrangements. This effectively reduces costs for both the exporters and the importers, as it reduces or eliminates the need for products to be re-tested in another country.

Following are the benefits one can accrue with accreditation:-

1. Potential increase in business.
2. Increase Confidence and satisfaction.
3. Time and money saving due to reduction or elimination of the need for re-testing of products.
4. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
5. Increase of confidence in Testing / Calibration data and personnel performing work.
6. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the Directory of Accredited Laboratories.
7. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.

Proficiency Testing

It is about assessing and determining the reliability of data that they are producing against their testing. The tool of Inter-Laboratory comparison is used to determine the proficiency of testing. All Accredited Laboratories have to successfully participate in at least one inter-laboratory comparison.

All the accredited laboratory have to follow ISO/IEC 17025 to maintain quality management system in testing and calibration.

Measurement audits are also undertaken. NABL also undertake proficiency testing programme for its accredited as well as applicant laboratories.

Training Courses

NABL undertakes following courses:-

1. ISO/IEC 17025 Assessor's Training Course
2. ISO 15189 Assessor's Training Course

Scope of Accreditation

Its scope for accreditation extends to:-

Testing Laboraotires:
Biological, Chemical, Electrical, Electronics,
Fluid-Flow,Mechanical,Non-Destructive,Photometry, Radiological,
Thermal

Calibration Labroatories:
Electro-Technical, Mechanical, Fluid Flow, Thermal & Optical, Radiological,

Medical Labroatories:
Clinical Biochemistry, Clinical Pathology, Haematology and Immuno-haematology, Microbiology and Serology, Histopathology, Cytopathology, Genetics, Nuclear Medicine (in-vitro tests only)