1. What are the aims and objectives of NABL...?

National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government, Industry and Society in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for 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 NABL criteria based on internationally accepted standard for laboratory accreditation ISO/IEC 17025. 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 has established its Accreditation System in accordance with ISO/IEC 17011:2004, which is followed internationally. NABL also compiles to the requirement of APLAC MR001 for the fulfillment of APLAC MRA and ILAC Arrangements.

NABL Secretariat
NABL Secretariat is functioning from its office situated at 3rd Floor, NISCAIR, 14, Satsang Vihar Marg, New Mehrauli Road – New Delhi 110067. NABL Secretariat administers and co-ordinates all activities of NABL including accreditation related activities for Testing and Calibration laboratories.

Registered Office
Registered Office of NABL is located in Department of Science & Technology, Technology Bhavan, New Mehrauli Road, New Delhi – 110016.

The working days of NABL are from Monday to Friday. The office timings are from 9-00 a.m. to 5-30 p.m.

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.

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. Society also needs to know the technically competent laboratory in fields such as Medical, Forensic, Food Testing etc.

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.

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

ISO 9000 Certification is on Quality System Management only whereas the NABL Accreditation provides formal recognition of technical competence of the laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands as well as the Quality system. Accreditation is a higher level activity than system certification.

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.
  

Accreditation to a laboratory is given on the basis of its capability to perform test(s) / calibration(s) and provide accurate and reliable results. A laboratory may apply for accreditation from as little as one to as many tests / calibrations provided it is performing these in accordance with NABL criteria.

NABL is the sole accreditation body in India that provides third party assessment and has been authorized by Government of India.

Laboratory accreditation provides a means of evaluating the competence of laboratories to perform specific types of testing, measurement ad calibration. It also provides feedback to laboratories as to whether they are performing their work in accordance with international criteria for technical competence. Manufacturing organizations may also use laboratory accreditation to enhance the testing of their products by their own in-house laboratories.

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.

NABL accreditation is not a one-time phenomenon. Once the laboratory gets accredited for some specific tests or calibration parameters, accreditation to a laboratory shall be valid for a period of 2 years and NABL shall conduct periodical surveillance of the laboratory on annual basis. Laboratory shall apply for renewal of accreditation to NABL at least 6 months before the expiry of the validity of accreditation.

Applicant laboratories are required to successfully participate in atleast one Proficiency Testing program provided by NABL or other reputed institutions before grant of accreditation. Accredited laboratories are required to participate in Proficiency Testing programs covering all major areas in their scope of accreditation in a span of 4 years. The accredited medical laboratories are required to participate atleast once in a year, in the Proficiency Testing / External Quality Assurance Scheme, as appropriate.

Stage I

• 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.
• 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.
• 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.
• 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.
• 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

• NABL Secretariat shall organise the Pre-Assessment audit, which shall normally be carried by Lead Assessor at the laboratory sites.
• 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.
• A copy of Pre-Assessment Report will be provided to Laboratory for taking necessary corrective action on the concerns raised during audit, if any.
• 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

• 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.
• 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.
• 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.
• 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

• 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.
• 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.
• Laboratory shall have to take corrective action on any concerns raised by the Accreditation Committee.
• Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to NABL Secretariat.
• Laboratories are free to appeal against the findings of assessment or decision on accreditation by writing to the Director, NABL.
• 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

• 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.
• Laboratory shall apply for Renewal of accreditation to it at least 6 months before the expiry of the validity of accreditation.
  

Enquiries for accreditation may be addressed to Director NABL or mail at info@nabl-india.org

• Laboratory management should first decide about getting accreditation for its laboratory from NABL.
• It is important for a laboratory to make a definite plan of action for obtaining accreditation and nominate a responsible person to coordinate all activities related to seeking accreditation. The person nominated should be familiar with laboratory's existing Quality System. S/he should be formally designated as the Quality Manager.
• Procure all relevant NABL documents from NABL Secretariat and get fully acquainted with each of these.
• Laboratory needs to ascertain the status of its existing Quality System and Technical Competence with regards to requirements for NABL Accreditation. Is the system documented and effective or does it need modification. Does it need to build the Quality System of the laboratory from scratch?
• It must be remembered that Quality Manual is a policy document, which has to be supplemented by a set of other documents like Procedural Manuals, Work Instructions etc. to align the Quality System in accordance with NABL Criteria. The laboratory must ensure that the procedures described in the Quality Manual and other documents are being implemented. For preparing Quality Manual or verifying its contents, the laboratory may take help of " Guide for Preparing Quality Manual" (NABL 160). The laboratory may also get its personnel trained in NABL's training programme on Laboratory Quality System, Management and Internal Audit.
• Relevant requirements for NABL accreditation should be discussed amongst concerned staff of the laboratory. This will enable them to understand their weaknesses and strengths.
• Quality Manager must conduct an Internal Audit and take corrective actions before applying for accreditation.
  

General Information Brochure NABL 100 is published by NABL to guide you about NABL accreditation and its procedure.

Many countries around the world have a formally recognized organization responsible for the accreditation of their laboratories. Most of these accreditation bodies are presently following ISO/IEC 17025 as the basis for accrediting their country's testing and calibration laboratories.

NABL publishes Newsletter on quarterly basis. NABL regularly sends the newsletter to all the empanelled assessors and accredited as well as the applicant laboratories.

All NABL accredited testing and calibration laboratories are required to participate in Proficiency Testing Programmes conducted by NABL or the nodal organizations appointed by NABL. Accredited and applicant laboratories are required to approach NABL Co-ordinator for Proficiency Testing programs or the nodal laboratories appointed by NABL whenever a PT programme for a specific testing / calibration is organized by NABL. For calibration laboratories, NPL, Delhi is the main nodal laboratory.

NABL conducts following training courses regularly:

• All NABL accredited laboratories are expected to use NABL symbol on their letterhead, test / calibration reports and any other relevant documents. NABL symbol shall be used for the purpose of identifying correctly and unambiguously the test / calibration services accredited by NABL.
• While using the symbol it shall be ensured by the laboratory that design and its manifestations are not distorted, It can be reproduced in any single color (preferably black) and any size.
• It shall be responsibility of the accredited laboratory that the use of symbol does not misrepresent the scope of accredited testing / calibration services. In case where the accreditation sought and granted do not cover all the activities of the laboratory's services care should be exercised to restrict the use of symbol only to those accredited activities. The letterheads and publicity materials, brochures, test / calibration reports of the accredited laboratory bearing the NABL symbol shall cover only the test results under accredited category. For non-accredited category the laboratory shall use a letterhead without NABL symbol or specially identify those tests/ measurements which are not covered by accreditation..
• Accredited laboratories shall not authorize the use of symbol for tests / calibration services sub-contracted to other laboratories, which are not accredited by NABL.
• In case of complaints in this regard from users and other laboratories, NABL shall get the same examined by a committee and take appropriate action.
  

Government bodies and Regulators are constantly called upon to make decisions related to:

• Protecting health and welfare of consumers and the public at large.
• Protecting the environment.
• Developing new regulations and requirements.
• Measuring compliance with regulatory and legal requirements.
• Allocating resources, both technical & financial.

• Increasing confidence in data that are used to establish baselines for key analysis and decisions.
• Reducing uncertainties associated with decisions that effect the protection of human health and the environment.
• Increasing public confidence, because accreditation is recognizable mark of approval.
• Eliminating redundant reviews and improving the efficiency of the assessment process, which may reduce costs.
  

Accredited laboratories are required to include NABL symbol on their test or calibration reports. Indicating their accreditation. You should check with the laboratory as to what specific tests or calibrations they are accredited for, and for what ranges or uncertainties. You should request a list of test and / or calibration for which the laboratory is accredited. This is specified in a laboratory’s Scope of Accreditation issued by NABL along with Accreditation Certificate.

• Minimum risk.
• Avoid expensive re-testing.
• Enhance your customer’s confidence.
• Reduce costs and improve acceptance of your goods overseas.
  

The number of assessors that will be assigned to conduct laboratory’s assessment will depend upon applied / accredited scope of accreditation in various field(s) of testing and / or calibration. To conduct an assessment NABL sends sufficient number of Technical Assessors accompanied by Lead Assessor so as to cover all the tests, types of tests or calibrations in laboratory’s scope of accreditation.

The peer evaluation is the internationally accepted mechanism used to formally evaluate and recognize laboratory accreditation bodies.

The key factor in determining the time will take is the laboratory’s readiness. Laboratories that have taken the time to prepare well for the on-site assessment and can respond quickly to assessment deficiencies can complete the process in a timely manner.

The list of specific tests, types of tests or calibrations for which a laboratory is found competent is listed in scope of accreditation along with details like test methods, ranges, uncertainties etc. The final content of the scope is recommended by the assessors and approved by NABL. It is very important to note that scope don’t always include all the laboratory’s capabilities. This is due either to the laboratory’s request to limit the scope, or because the assessors have not been able to affirm the laboratory’s competency in all areas for which the laboratory was seeking accreditation. Capabilities that are not listed on the scope of accreditation are not covered by the laboratory’s NABL accreditation.