NABL provides laboratory accreditation to ensure competence and compliance with ISO/IEC 17025 standards. Accreditation certifies laboratories' technical ability to perform specific testing and calibration tasks. It enhances customer confidence by providing formal recognition of competent laboratories. NABL is the sole accreditation body for laboratories in India, and its accreditation system complies with international guidelines. Accredited laboratories must participate in proficiency testing and are subject to surveillance to maintain accreditation.
NABL provides laboratory accreditation to ensure competence and compliance with ISO/IEC 17025 standards. Accreditation certifies laboratories' technical ability to perform specific testing and calibration tasks. It enhances customer confidence by providing formal recognition of competent laboratories. NABL is the sole accreditation body for laboratories in India, and its accreditation system complies with international guidelines. Accredited laboratories must participate in proficiency testing and are subject to surveillance to maintain accreditation.
NABL provides laboratory accreditation to ensure competence and compliance with ISO/IEC 17025 standards. Accreditation certifies laboratories' technical ability to perform specific testing and calibration tasks. It enhances customer confidence by providing formal recognition of competent laboratories. NABL is the sole accreditation body for laboratories in India, and its accreditation system complies with international guidelines. Accredited laboratories must participate in proficiency testing and are subject to surveillance to maintain accreditation.
NABL provides laboratory accreditation to ensure competence and compliance with ISO/IEC 17025 standards. Accreditation certifies laboratories' technical ability to perform specific testing and calibration tasks. It enhances customer confidence by providing formal recognition of competent laboratories. NABL is the sole accreditation body for laboratories in India, and its accreditation system complies with international guidelines. Accredited laboratories must participate in proficiency testing and are subject to surveillance to maintain accreditation.
This to provide a means for third-party services to laboratories that are certification of the competence of performing tests and calibrations in laboratories to perform specific type(s) of accordance with ISO/ IEC 17025: 1999 testing and calibration. (General requirements for the competence of Testing and Calibration Laboratories). Laboratory Accreditation provides formal recognition of competent laboratories, thus NABL has established its accreditation providing a ready means for customers to system in accordance with ISO IEC Guide find reliable testing and calibration 58, which is followed internationally. services in order to meet their demands. NABL is signatory to APLAC (Asia Laboratory Accreditation enhances Pacific Laboratory Accreditation customer confidence in accepting testing / Cooperation) & ILAC (International calibration reports issued by accredited Laboratory Accreditation Cooperation) laboratories. Mutual Recognition Arrangement (MRA) National Accreditation Board for Testing since October 2000 & November 2000 and Calibration Laboratories (NABL) respectively. Current APLAC and ILAC MRAs is valid till October 2012. NABL accreditation is a formal recognition of the technical competence of MRA is essential for mutual acceptance of a testing, calibration or medical laboratory test results and measurement data amongst for a specific task. 52 accreditation bodies representing 45 countries. NABL accredited laboratories This is to check the compliance of the have therefore emerged as a member of laboratory to ISO/IEC 17025:2005, ISO global family of accredited laboratories. 15189:2007 Standards. WTO recognizes non-acceptance of test Based on mutual evaluation and results and measurement data as Technical acceptance of other country’s laboratory Barrier to Trade (TBT). accreditation systems, international agreements called Mutual Recognition Accreditation is considered to be the first Arrangements (MRA) have been essential step towards removing such established for realizing the ideal of technical barriers. having products “tested once and accepted NABL everywhere”. National Accreditation Board for Testing Such agreements are crucial in enabling and Calibration Laboratories (NABL) has test data by an accredited laboratory to be been established with the objective to accepted in overseas markets and facilitate provide Government, Industry trade. Associations and Industry in general with a scheme for third-party assessment of the NABL has also extended its services to quality and technical competence of Clinical and Food testing laboratories testing and calibration laboratories. having strong relevance to the society. NABL is an autonomous body under the NABL provides an efficient and aegis of Department of Science & transparent mechanism to the laboratories Technology, Government of India, and is and their users. registered under the Societies Act. Accredited laboratories have the Government of India has authorized responsibility of satisfying the criteria of NABL as the sole Accreditation body for laboratory accreditation at all times, which Testing and Calibration laboratories in are verified during Surveillance and Re- India. assessment visits by NABL.
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The accredited laboratories should prove In case of repeated failure or gross failure their technical competence by satisfactory indicated by Z factor, En ratio etc. scope participation in recognized Proficiency of accreditation is reduced by NABL. Testing programmes. Annual Surveillance are carried out to The accredited laboratories can be ensure that the accredited laboratories are suspended or its scope of accreditation can continuing to comply the accreditation be reduced or even withdrawn in cases of criteria. negligence and gross non-compliance of NABL conducts One-day Awareness ISO/IEC 17025:2005, ISO 15189:2007 Programmes on key issues such as standard detected during routine or Uncertainty in Measurement, Proficiency surprise Surveillance or Re-assessment. Testing, Validation etc., at different parts NABL provides laboratory accreditation of India so that applicant and accredited services to laboratories that are performing laboratories can take the appropriate tests / calibrations in accordance with action. ISO/IEC 17025:2005 and ISO 15189:2007 Information regarding NABL accredited for medical laboratories. laboratories (status and their scope of These services are offered in a non- accreditation) is available in the NABL discriminatory manner and are accessible website (www.nabl-india.org) to all testing and calibration laboratories in The list of laboratories which are either India and abroad, regardless of their suspended or their scope of accreditation ownership, legal status, size and degree of is partially or fully withdrawn is also independence. available. NABL has established its Accreditation Mutual Recognition Arrangement (MRA) System in accordance with ISO/IEC 17011:2004, which is followed Many countries around the world have a internationally. formally recognized organization responsible for the accreditation of their NABL has to also comply with the laboratories. Most of these accreditation requirements of APLAC MR001, which bodies are presently following ISO/IEC requires the applicant and the accredited 17025 as the basis for accrediting their laboratories to take part in recognized country's testing and calibration Proficiency Testing Programmes in laboratories. accordance with ISO/IEC Guide 43. Adoption of international standards has An applicant laboratory has to helped countries employ a uniform satisfactorily participate in at least one approach to determine laboratory Proficiency Testing programme. competence. It has also encouraged The accredited laboratories are expected to laboratories to adopt internationally cover the major scopes of accreditation in accepted testing and measurement a cycle time of four years. practices. NABL has been conducting Proficiency This uniform approach allows Testing with the help of selected accreditation bodies to establish accredited laboratories as nodal arrangements between themselves through laboratories in different fields. APLAC and ILAC (International The performance remains confidential Laboratory Accreditation Cooperation), between NABL and each participating based on mutual evaluation and laboratory by using laboratory code acceptance of each other's laboratory numbers. accreditation systems. Such international arrangements, called Mutual Recognition In case of unsatisfactory performance, Arrangement, are crucial in enabling test laboratory is expected to investigate and data to be accepted between countries. take the necessary corrective actions.
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Advantages of laboratory accreditation Savings in terms of time and money due to Provides formal recognition to competent reduction or elimination of the need for re- laboratories and ensures that they perform testing of products. their work in accordance with Better control of laboratory operations and international criteria. feedback to laboratories as to whether they Minimises the risk of unreliable results have sound Quality Assurance System and which, in turn, reduces the risk for are technically competent. manufacturers or suppliers to produce or Increase of confidence in Testing / supply a faulty product. Calibration data and personnel performing Minimises the chances of retesting and work. hence reduces chances of additional Customers can search and identify the financial burden and time delays. laboratories accredited by NABL for their Enhances Customer confidence and specific requirements from the Directory Satisfaction. of Accredited Laboratories. International acceptability of test results. Users of accredited laboratories will enjoy greater access for their products, in both Laboratory Accreditation provides formal domestic and international markets, when recognition of competent laboratories, thus tested by accredited laboratories. providing a ready means for customers to find reliable testing and calibration What types of laboratories can seek services in order to meet their demands. accreditation...? Laboratory Accreditation enhances The laboratories should be legally identifiable customer confidence in accepting testing / & appropriately registered. calibration reports issued by accredited They can be a part of a big organization or an laboratories. independent entity. NABL can provide The globalisation and the liberalisation accreditation to: policies initiated by the Government in Laboratories undertaking any sort of reducing trade barriers and providing testing or calibration in the specified greater thrust to exports makes it fields. imperative for Accredited Laboratories to Private or government laboratories. be at international level of competence. Small operations to large multi-field Potential increase in business due to laboratories. enhanced customer confidence and satisfaction. Site facilities, temporary field operations and mobile laboratories.
NABL Accreditation given to
Testing laboratories Calibration laboratories Medical laboratories Biological Electro-Technical Clinical Biochemistry Chemical Mechanical Clinical Pathology Electrical Fluid Flow Haematology and Electronics Thermal & Optical Immunohaematology Fluid-Flow Radiological Microbiology and Mechanical Serology Non-Destructive Histopathology Photometry Cytopathology Radiological Genetics Thermal Nuclear Medicine (in-vitro tests only)
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Accreditation to a laboratory All applications for accreditation shall have to be in accordance with ISO/IEC Accreditation is given on the basis of its 17025 or ISO 15189 Standard. capability to perform test(s) / calibration(s) and provide accurate and Evaluating the competence of a laboratory reliable results. Methods used by Accreditation Body for A laboratory may apply for accreditation evaluating the competence of a laboratory from as little as one to as many tests / On the spot assessment of the laboratory calibrations provided it is performing by the experts for its technical these in accordance with NABL criteria. competence and its adherence to quality system practices. The accreditation granted to a laboratory is valid for a period of 2 years subject to By analysing the test data of a particular satisfactory periodical (annual) test/measurement as a result of its surveillance. participation in a proficiency testing programme. Laboratory also has an option to widen the scope of accreditation in terms of Management requirements of ISO/IEC 17025 specific tests and calibrations. Organization Documentation NABL has established policies and procedures for granting, suspending and Review of requests and sub-contracting withdrawal of accreditation of Purchasing services accreditation in accordance with ISO/IEC 17011:2004. Service to the client & Complaints Control of non-conforming work The laboratories seeking accreditation are assessed in accordance with ISO/IEC Corrective & preventive action 17025:2005 for testing and calibration Records laboratories and ISO 15189:2007 for medical laboratories. Internal audit & Management review etc.
A laboratory wishing to be accredited by Technical requirements of ISO/IEC 17025
NABL must have a Quality Manual on Knowledge of the laboratory personnel its Quality System satisfying the requirements. Technical validity of the methods Adequacy and calibration of equipment Quality System documentation and its implementation by the laboratories shall Sampling and handling of test items be verified by the Assessors for its Environmental factors compliance with standard. Traceability of measurements The laboratory management shall Uncertainty in measurement demonstrate to the NABL Assessment Assuring the quality of tests Team that all requirements as laid down (participation in proficiency testing in the standard, Specific Criteria and programmes, use of certified reference other Guidelines / Requirements of materials, retesting etc) NABL are being followed.
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Pre-requisites for laboratories seeking Procure all relevant NABL documents NABL accreditation from NABL Secretariat and get fully acquainted with each of these. Laboratory or the organisation of which it is part shall be legally registered so Laboratory needs to ascertain the status that it can be held responsible for the of its existing Quality System and testing and / or calibration activities it Technical Competence with regards to carries out. requirements for NABL Accreditation. (like - Is the system documented and Laboratory should have adequate effective or does it need modification? facilities and technically competent Does it need to build the Quality qualified staff to carry out the testing and System of the laboratory from scratch?) / or calibration for which it wishes to seek accreditation. Prepare a Quality Manual: This is a policy document, which has to be Laboratory must comply with all the supplemented by a set of other requirements as laid down in the documents like Procedural Manuals, Standard ISO/IEC 17025, relevant Work Instructions etc., to align the Specific Criteria and other NABL Quality System in accordance with documents. NABL Criteria. The laboratory must Laboratory to ensure that all test ensure that the procedures described in equipment in the laboratory are properly the Quality Manual and other calibrated and have traceability to documents are being implemented. National / International standards. For preparing Quality Manual or Laboratory must have completed one verifying its contents, the laboratory Internal Audit covering all clauses of may take help of “Guide for Preparing ISO/IEC 17025 and a Management Quality Manual" (NABL 160). The Review. laboratory may also get its personnel trained in NABL's training programme Laboratory must have satisfactorily on Laboratory Quality System, participated in at least one Proficiency Management and Internal Audit. Testing Program conducted by NABL or Relevant requirements for NABL other reputed national or international accreditation should be discussed organizations in accordance with the amongst concerned staff of the international standard ISO/IEC Guide laboratory. This will enable them to 43. understand their weaknesses and Preparations before applying for strengths. accreditation Quality Manager must conduct an Internal Audit and take corrective Laboratory management should first actions before applying for decide about getting accreditation for its accreditation. laboratory from NABL. Process of accreditation at NABL The laboratory should make a definite Stage I plan of action for obtaining accreditation and nominate a Prepare application for NABL responsible person to coordinate all accreditation, giving all desired activities related to seeking information and enlisting the test(s) / accreditation. The person nominated calibration(s) along with range and should be familiar with laboratory's measurement uncertainty for which the existing Quality System and should be laboratory has the competence to formally designated as the Quality perform. Laboratory can apply either for Manager. all or part of their testing / calibration facilities.
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Laboratory has to take special care in A copy of Pre-Assessment Report will be filling the scope of accreditation for provided to Laboratory for taking which the laboratory wishes to apply. In necessary corrective action, if any. case, the laboratory finds any clause (in The laboratory shall submit Corrective part or full) not applicable to the Action Report to NABL. laboratory, it shall furnish the reasons. After laboratory confirms the completion Laboratories are required to submit three of corrective actions, Final Assessment sets of duly filled in application forms of the laboratory shall be organised by for each field of testing / calibration NABL. along with two sets of Quality Manual and Application Fees. Stage III NABL Secretariat on receipt of NABL Secretariat shall appoint an application will issue acknowledgement assessment team for the Final to the laboratory. After scrutiny of Assessment at the laboratory site(s) for application for it being complete in all its compliance to NABL Criteria. respects, a unique Customer Registration The Assessment Team shall comprise of Number will be allocated to laboratory a Lead Assessor and other Technical for further processing of application. Assessor(s) in the relevant fields NABL Secretariat shall then nominate a depending upon the scope to be assessed. Lead Assessor for giving Adequacy Assessors shall raise the Non- Report on the Quality Manual / Conformance(s), if any, and provide it to Application submitted by the laboratory. the laboratory in prescribed format so A copy of Adequacy Report by Lead that it gets the opportunity to close as Assessor will be provided to Laboratory many Non-Conformance(s) as they can for taking necessary corrective action, if before closing meeting of the any. The laboratory shall submit Assessment. Corrective Action Report. After satisfactory corrective action by The Lead Assessor will provide a copy the laboratory, a Pre-Assessment audit of of consolidated report of the assessment the laboratory will be organised by to the laboratory and send the original NABL. Laboratories must ensure their copy to NABL Secretariat. preparedness by carrying out its internal Laboratory shall take necessary audit before Pre-Assessment. corrective action on the remaining Non- Stage II Conformance(s) / other concerns and shall submit a report to NABL within a NABL will organise the Pre-Assessment maximum period of 2 months. audit, which shall normally be carried by Lead Assessor at the laboratory sites. Stage IV Pre-assessment of the laboratory is After satisfactory corrective action by conducted to: the laboratory, the Accreditation Committee examines the findings of the o check the preparedness of the Assessment Team and recommend laboratory to undergo Final additional corrective action, if any. Assessment. Accreditation Committee determines o have better understanding of whether the recommendations in the documentation and operations of the assessment report is consistent with laboratory. NABL requirements as well as o ascertain number of assessor / man- commensurate (match with) with the days required for Final Assessment claims made by the laboratory in its commensurate with the Scope of application. Accreditation. 6|P ag e R.S.Bhat- 2010 M.Pharm- QA & QC Laboratory shall have to take corrective and NABL Observer. Sometimes, NABL action on any concerns raised by the may at its own cost depute a newly Accreditation Committee. trained Technical Assessor as "Observer". Accreditation Committee shall make the appropriate recommendations regarding Stage V accreditation of a laboratory to NABL Accreditation to a laboratory shall be Secretariat. valid for a period of 2 years and NABL Laboratories are free to appeal against shall conduct periodical Surveillance of the findings of assessment or decision on the laboratory at intervals of one year. accreditation by writing to the Director, Laboratory shall apply for Renewal of NABL. accreditation to it at least 6 months Whenever possible NABL will depute its before the expiry of the validity of own technical personnel to be present at accreditation. the time of assessment as Coordinator
NABL accreditation Vs ISO 9000 certification
NABL Secretariat & Registered office
NABL Secretariat administers and co-ordinates all activities of NABL including accreditation related activities for Testing and Calibration laboratories.
NABL Secretariat office situated at 3rd Floor, NISCAIR, 14, Satsang Vihar Marg, New Mehrauli Road – New Delhi 110067.
Registered Office of NABL is located in Department of Science & Technology, Technology