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NABL
an autonomous body under the guidance of the Dept. Of Science & Technology,
Govt. of India whose purpose is to provide accreditation to testing and calibration
of clinical laboratories in the country.
It is the sole accreditation body authorized by the Govt. of India that provides a
third-party assessment of quality and technical competence of labs.
? accreditation
? procedure by which an authoritative body gives formal recognition
that an organization is competent to carry out specific tasks
? competence
? demonstrated ability to apply knowledge and skills
The concept of competence is defined in a generic sense in this
International Standard
? The accreditation process involves a rigorous evaluation of the
laboratory’s competence, adherence to international standards and
quality management system
? NABL accreditation is recognized and valid through all the major
economies of the world, and by all regulators in India.
? NABL establishes trust and quality for labs where competence is
concerned.
? 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
The guidelines for NABL accreditation process include the following
steps:
Application: The laboratory submits an application for accreditation
to NABL.
? Document Review: NABL reviews the laboratory’s quality manual,
procedures, and other relevant documents to ensure compliance
with international standards.
? Pre-assessment: NABL conducts a pre-assessment visit to evaluate
the laboratory’s readiness for the accreditation process. This helps
the laboratory identify any gaps or areas of improvement.
? Assessment: NABL performs an on-site assessment of the
laboratory by a team of experts. This includes the evaluation of
facilities, equipment, personnel, and testing/calibration procedures.
? Evaluation: The assessment team prepares a report based on their
findings and submits it to NABL for evaluation.
? Corrective actions: If any non-compliance or non-conformities
are identified, the laboratory must take corrective actions to
address them.
? Final assessment: A final assessment is conducted after the
corrective actions have been implemented. If all requirements
are met, NABL grants accreditation to the laboratory.
Surveillance Audit and Renewal: A surveillance audit will be
carried out each year to take suitable corrective actions followed
by renewal to continually check the laboratory’s competence and
adherence to international standards.
? ISO 15189:2012 specifies requirements for quality and competence in
medical laboratories.
? ISO 15189:2012 can be used by medical laboratories in developing
their quality management systems and assessing their own
competence. It can also be used for confirming or recognizing the
competence of medical laboratories by laboratory customers,
regulating authorities and accreditation bodies.

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NABL.pdf NABL.pdfNABL.pdfNABL.NABL.pdfwwww

  • 1. NABL an autonomous body under the guidance of the Dept. Of Science & Technology, Govt. of India whose purpose is to provide accreditation to testing and calibration of clinical laboratories in the country. It is the sole accreditation body authorized by the Govt. of India that provides a third-party assessment of quality and technical competence of labs.
  • 2. ? accreditation ? procedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks ? competence ? demonstrated ability to apply knowledge and skills The concept of competence is defined in a generic sense in this International Standard
  • 3. ? The accreditation process involves a rigorous evaluation of the laboratory’s competence, adherence to international standards and quality management system ? NABL accreditation is recognized and valid through all the major economies of the world, and by all regulators in India. ? NABL establishes trust and quality for labs where competence is concerned.
  • 4. ? 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
  • 5. ? 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 The guidelines for NABL accreditation process include the following steps: Application: The laboratory submits an application for accreditation to NABL.
  • 6. ? Document Review: NABL reviews the laboratory’s quality manual, procedures, and other relevant documents to ensure compliance with international standards. ? Pre-assessment: NABL conducts a pre-assessment visit to evaluate the laboratory’s readiness for the accreditation process. This helps the laboratory identify any gaps or areas of improvement. ? Assessment: NABL performs an on-site assessment of the laboratory by a team of experts. This includes the evaluation of facilities, equipment, personnel, and testing/calibration procedures. ? Evaluation: The assessment team prepares a report based on their findings and submits it to NABL for evaluation.
  • 7. ? Corrective actions: If any non-compliance or non-conformities are identified, the laboratory must take corrective actions to address them. ? Final assessment: A final assessment is conducted after the corrective actions have been implemented. If all requirements are met, NABL grants accreditation to the laboratory. Surveillance Audit and Renewal: A surveillance audit will be carried out each year to take suitable corrective actions followed by renewal to continually check the laboratory’s competence and adherence to international standards.
  • 8. ? ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. ? ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.