NABL CERTIFICATION AND ACCREDITATION
In India, over 1,00,000 medical laboratories provide diagnostic facilities. Among these, nearly 80% of medical laboratories are small, 15% are medium and less than 5% are large. The management of quality in testing and calibration of laboratories is accredited by NABL. All NABL accredited laboratories follow ISO/IEC 17025. ISO/IEC 17025 is self-directed under the guidance of DST, India and listed under Societies Act, 1980. An outline for third party assessment of quality and testing of laboratories is provided to government and industry by NABL. Vision of NABL is “to be the world’s best accreditation body by providing high class services and to producing attentiveness among the stakeholders in its services by initiating new programs”. NABL’s accreditation is done on assessment of practical capability while ISO accreditation is based on endorsement of appropriate credentials. There are three main stages of NABL accreditation process, which are filing of application pre-assessment audit, Corrective reassessment and Granting of accreditation. Accreditation is given to testing, calibrating and medical laboratories. NABL accreditation with international criteria has many advantages like diminish the probabilities of retesting and dropping the financial load with that additionally increase of Confidence in testing and calibration of data and personnel performing work. Accreditation under NABL will help improve overall quality and standards of the diagnostics market.
Key words: NABL, Objective of NABL; Vision and Phases Of NABL, Accreditation
Process, Profits of Getting NABL Accreditation, future Scope of NABL.
NABL is an acronym for National Accreditation Board for testing and calibrating Laboratory. NABL is a part of Board of Quality Council of India (QCI). It was established by QCI with an intention to provide a general scheme of Conformity Assessment Body’s accreditation that is applicable for Government, Industry Associations and Industry. This involves third party assessment of the technical competency of testing incorporating medical laboratories, calibrating laboratories, proficiency testing providers and reference material producers. NABL offers accreditation benefits in a non-biased way. NABL has built up its accreditation framework as per ISO/IEC 17011: 2004 “Similarity Assessment – General necessities for Accreditation bodies authorizing congruity evaluation bodies?. NABL accreditation framework additionally observes the prerequisites of Mutual Recognition Arrangements (MRAs) of which NABL is a part. In the current worldwide situation, a fundamental pre – imperative of exchange is that any item or administration acknowledged formally in one economy should likewise be allowed to flow in different economies without undergoing broad re-testing. WTO perceives that rejection of test outcomes and estimation information is a Technical Barrier to Trade. Worldwide sourcing of segments calls for identicalness of estimation, which can be encouraged by a chain of certify CABs. Accreditation is considered as the principal basic advance for encouraging common acknowledgment of test outcomes and estimation information. . In the current worldwide situation, a fundamental pre – imperative of exchange is that any item or administration acknowledged formally in one economy should likewise be allowed to flow in different economies without undergoing broad re-testing. WTO perceives that rejection of test outcomes and estimation information is a Technical Barrier to Trade. Worldwide sourcing of segments calls for identicalness of estimation, which can be encouraged by a chain of certify CABs. Accreditation is considered as the principal basic advance for encouraging common acknowledgment of test outcomes and estimation information.
NABL offers accreditation benefits in the way of a non-prejudicial. NABL Established with goal to give conspire Government and industry for the outsider evaluation of research centres. There are open to all testing and adjustment research facilities in India and abroad, paying little respect to their proprietorship, legitimate status, size and level of freedom.
Why laboratory required accreditation?
Accreditation is the outsider authentication identified with a congruity appraisal body passing on the formal show of its capability to do particular similarity evaluation errand. Congruity Assessment Body (CAB) is a body which incorporates Testing including restorative Laboratory, Calibration Laboratory, Proficiency Testing Provider, Certified Reference Material Producer. The advancement of exchange and industry arrangements of the Government of India has made quality cognizance in household exchange and gave more prominent push to send out. As an outcome testing focuses and research facilities need to evidently work at a universally worthy level of capability. Research facility accreditation is a method by which a legitimate body gives formal acknowledgment of specialized ability for particular tests/estimations, in light of outsider evaluation and following global principles. So also, Proficiency testing Provider accreditation gives formal acknowledgment of ability for associations that give capability testing. Reference Material Producers Accreditation gives formal acknowledgment of skill to complete the creation of reference materials in light of outsider evaluation and following worldwide gauges. 1
Eligibility of Accreditation:
The candidate CAB must agree to all provisos of ISO/IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO Guide 34:2009/ISO 17034:2016 whichever is relevant. The candidate CAB should likewise conform to the significant NABL particular criteria. On the off chance that the lab performs site testing/alignment, it should likewise consent to NABL 130 ‘Particular criteria for site testing and site adjustment labs’ The candidate CAB probably led no less than one inside review and an administration audit before the accommodation of utilization. 1
Benefits of the NABL Accreditation:
Potential increment in business because of upgraded client certainty and fulfilment. Investment funds as far as time and cash because of diminishment or disposal of the requirement for re-testing of items. Better control of research centre tasks and criticism to labs in the matter of whether they have sound Quality Assurance System and are in fact capable. Increment of trust in Testing/Calibration information and faculty performing work. Clients can seek and recognize the research facilities licensed by NABL for their particular prerequisites from the registry of Accredited Laboratories. Clients of certify research facilities will appreciate more prominent access for their items, in both household and worldwide markets, when tried by authorize labs.
Scope and areas of accreditation:
NABL Accreditation is right now given in the fields and teaches. The multi-disciplinary CABs should need to apply in applicable teach independently relying on to which train the extension has a place.
To the scope of the accreditation that there are different types of that laboratories 1
Thermal ; Optical
Microbiology and Serology
Nuclear Medicine (in-vitro tests only)
PROFICIENCY TESTING PROVIDERS
REFERENCE MATERIAL PRODUCERS
·Biological ; Clinical Properties
NABL Accredited laboratories
There are add up to 3873 NABL accreditated research facilities in India. Out of these 3581 research centres were accreditated in states, 264 NABL accreditated labs had a place with association domain under domain of focal government and remaining 28 accreditated labs that was arranged to obscure class involved labs from various nations. 2
List of NABL laboratory in India:
Filling of Application
Granting of Accreditation
Research center can apply either for all or part of their testing/adjustment offices. Configurations NABL 151, NABL 152 and NABL 153 are to be utilized by Testing, Calibration and Medical Laboratories separately to apply to NABL for accreditation. Research center needs to take extraordinary care in filling the extent of accreditation for which the lab wishes to apply. In the event that, the research facility finds any condition not appropriate to the lab, it might outfit the reasons. Labs are required to submit five arrangements of properly filled in application frames for each field of testing/adjustment alongside five arrangements of Quality Manual and Application Fees. NABL Secretariat on receipt of utilization will issue affirmation to the research center. After investigation of utilization for it being finished in all regards, a remarkable Customer Registration Number will be assigned to lab for additionally preparing of use. NABL Secretariat might then select a Lead Assessor for giving Adequacy Report on the Quality Manual/Application put together by the lab. A duplicate of Adequacy Report by Lead Assessor will be given to Laboratory to making essential restorative move, assuming any. The research center might submit Corrective Action Report. 4
NABL Secretariat might compose the Pre-Assessment review, which should typically be conveyed by Lead Assessor at the lab locales. The pre-appraisal causes the lab to be better arranged for the Final Assessment. It likewise encourages the Lead Assessor to evaluate the readiness of the research center to experience Final Assessment separated from Technical Assessor(s) and Total Assessment Man-days required opposite the extent of accreditation according to application put together by the lab. A duplicate of Pre-Assessment Report will be given to Laboratory to making corrective actions move on the worries raised amid review, assuming any. After lab affirms the culmination of restorative activities, Last Appraisal of the research center might be composed by NABL. 4
NABL Secretariat should arrange the Final Assessment at the lab site(s) for its consistence to NABL Criteria and for that reason name an evaluation group. The Assessment Team should involve a Lead Assessor and other Technical Assessor(s) in the applicable fields relying on the extension to be evaluated. Assessors should raise the Non-Conformance(s), assuming any, and give it to the research facility in recommended organize with the goal that it gets the chance to close the same number of Non-Conformance(s) as they can before shutting meeting of the Assessment. The Lead Assessor will give a duplicate of united report of the appraisal to the research center and send the first duplicate to NABL Secretariat. 4
After corrective action by the research facility, the Accreditation Committee analyzes the discoveries of the Assessment Team and suggests extra remedial activity, assuming any, by the lab. Accreditation Committee decides if the proposals in the evaluation report is predictable with NABL prerequisites and additionally comparable with the cases made by the research center in its application. Lab might need to make remedial move on any worries raised by the Accreditation Committee. Accreditation Committee might make the proper proposals in regards to accreditation of a research facility to NABL Secretariat. 4
Accreditation to a research center should be substantial for a time of 3 years and NABL might lead periodical Surveillance of the lab at interims of one year. Research center should apply for Renewal of accreditation to it no less than a half year before the expiry of the legitimacy of accreditation. 4
Technical Requirements of NABL Certification:
Following are the technical requirements of ISO/IEC 17025 certification for Laboratory has to identify during implementation of system –
Nominate one person as Quality Manager for establishing and monitoring of effective implementation of the management systems requirements.
Nominate one person as Technical Manager for establishing and monitoring of effective implementation of the technical requirements
Test / calibration parameter, its range of testing, limit of detection and Uncertainty of measurement.
Calculation of Uncertainty of Measurement of each test / calibration parameters, Analysis of re–test or re–calibration results statistically,
Inter Laboratory Comparison and identification of “Z” Score or En Value based on statistical analysis. 3References:
NABL Internet. cited 2017Nov 27. Available from: http://www.nabl-india.org/List of NABL Accredited Laboratories in India (2017)
file:///D:/ARTICLE%20SEM%202%20NABL/NABL%20Certification%20%20ISO%2017025%20Accreditation%20Consultant%20in%20Gujarat%20India.htmfile:///D:/ARTICLE%20SEM%202%20NABL/nablcertification-13179617714157-phpapp02-111006235105-phpapp02(1).pdfNABL ACCREDITATION | CEPCI Laboratory ;amp; Research Institute Internet. cited 2017 Nov 27. Available from: http://cepclab.org.in/?p=34List of NABL Accredited Calibration laboratories in India 2017 | LABGO Internet. cited 2017 Nov 27. Available from: http://www.labgo.in/nabl-accredited-calibration-labs-IndiaNABL, OHSAS, BIS Approved Labs, Accreditations ;amp; Certifications Internet. cited 2017 Nov 27. Available from: http://www.spectro.in/Accreditations.htmlCommon Questions about NABL Internet. cited 2017 Nov 27. Available from: http://www.topranilabs.com/library/nabl.htm