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Benefits of NABL Accreditation vs certification Process of NABL 
Consultants in Chennai NCs in Biochem Lab Terms used in accredited lab
                                                                                         
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      PROCESS OF ACCREDITATION

 

  STEP 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 & 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.

STEP 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.

STEP 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.

  STEP 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.

STEP 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.  
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             why use of accredited lab        The advantage of being accredited

 

      

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