NABL Awareness Training Session

WELCOME
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Accreditation
Procedure by which an authority body (NABL) gives formal recognition that a body (laboratory) or person (signatory) is competent to carryout specific tasks (scope)

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Certification

Procedure by which a third party (certification body) gives a written assurance that a product, process or service (of an organization) conforms to specified requirement.

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ABOUT NABL
NABL is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. These are especially valuable for International recognition and mutual acceptance of test results. In short accreditation has worldwide acceptance.

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ABOUT NABL
NABL has agreements (MRA) with ILAC (International Laboratory Accreditation Conference) and APLAC (Asia Pacific Laboratory Accreditation Cooperation). These are especially valuable for International recognition and mutual acceptance of test results. In short accreditation has worldwide acceptance.
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NABL follows ISO 15189:2007, which is specific ISO followed world wide for medical laboratories. This standard is used by APLAC (Asia Pacific Laboratory Accreditation Cooperation) and ILAC (International Laboratory Accreditation Co-operation) etc. This means that an NABL accredited laboratory in India follows the same guidelines as any other accredited laboratory in the world.
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Difference between ISO certification and NABL accreditation?

NABL accreditation is based on evaluation of technical competence ISO certification is based upon verification of proper documentation

Though documentation forms an essential and important part of NABL, it lays down great emphasis on quality. The lab can be denied accreditation if one does not comply with the quality standards.
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Who Monitors NABL

NABL has established its Accreditation System in accordance with ISO/IEC 17011:2004, which is followed internationally. In addition NABL has to also comply with the requirements of APLAC (Asia Pacific Laboratory Accreditation Cooperation) MR001 which it satisfies.

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NABL accreditation is not a one-time phenomenon. Laboratory accreditation is valid for a period of 2 years only. During these 2 years NABL conducts periodical surprise surveillances of the laboratory on an annual basis. Accreditation can be revoked if the laboratory fails to maintain the standards of NABL even during these two years.

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Inspectors
For each inspection, there is one lead assessor and other technical assessors for assessing different departments of the laboratory. These are qualified people from government, semi government and private organizations who have got special training from NABL.

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NABL for the People

It means that, since your lab is continuously striving for quality and this will further progress our cause of providing quality services. Laboratory Accreditation provides formal recognition of competent laboratories like ours, thus providing a ready means for customers to find reliable testing services in order to meet the demands.
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Benefits of Accreditation
Assurance to the clients of good laboratory practice. Saves resources by getting results right the first time Better public acceptance National and International recognition Decision makers cam rely on test results Ensure better support in the eventuality of legal consequence Improve staff motivation and esteem.
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Medical Laboratories: Particular Requirements for Quality & Competence

Criteria to demonstrate that - Laboratory is technically competent - Able to operate an effective Quality System - Able to generate technically valid test results - A standard for Accreditation
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Scope of Accreditation
Clinical Biochemistry Clinical Pathology Haematology and Immunohaematology Microbiology and Serology Histopathology Cytopathology Genetics Nuclear Medicine (in-vitro tests only)
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Road Map to proceed .

Understand the importance of Accreditation We all get ourselves pumped up and get to know the Accreditation process. Implement the ISO 15189 systems and ensure that these are followed meticulously. Ensure that the necessary documents are prepared and are in routine use. Fill in the Application form with fees giving the desired information in the prescribed format with carefully deciding the scope of the accreditation. NABL sends an acknowledgement and scrutinizes the application.
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Contd..
NABL issues a Customer Registration number to a duly filled application form. NABL Secretariat shall appoint a Lead Assessor to assess and give an adequacy report on the Quality Manual. This shall be forwarded to the lab for corrective actions if any. Lab shall submit a corrective action report. After satisfactory corrective actions, Preassessment Audit by NABL lead assessor at the laboratory site.
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Contd..
Lab needs to work on the pre assessment results and submit corrective action report to secretariat. After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory shall be organised by NABL. 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.
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Contd..
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 NonConformance(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.
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Contd..
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. Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to NABL Secretariat. Accreditation is awarded.

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Let us jointly lead the path towards excellence

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