There are FOUR distinct stages for accreditation process as explained below.
• Prepare your laboratory’s application for NABL accreditation, giving all desired information and enlisting the test(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 facilities. (Format NABL 153 is to be used by Medical Laboratories 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 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 is allocated to the laboratory for further processing of application.
• NABL Secretariat then nominates a Lead Assessor for giving Adequacy Report on the Quality Manual / Application submitted by the laboratory. A copy of Adequacy Report by Lead Assessor is provided to the Laboratory for taking necessary corrective action, if any. The laboratory thereafter submits a “Corrective Action Report”.
After satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory is organized by NABL. Laboratories must ensure their preparedness by carrying out its internal audit before Pre-Assessment.
• NABL Secretariat organizes 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 is provided to the Laboratory for taking necessary corrective action on the concerns raised during audit, if any.
• The laboratory has to submit a “Corrective Action Report” to NABL Secretariat.
• After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory is organized by NABL.
• NABL Secretariat organizes the Final Assessment at the laboratory site(s) for its compliance to NABL Criteria and for that purpose appoints an assessment team.
• The Assessment Team comprises of a Lead Assessor and other Technical Assessor(s) in the relevant fields depending upon the scope to be assessed.
• Assessors 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 provides a copy of consolidated report of the assessment to the laboratory and sends the original copy to NABL Secretariat.
Laboratory has to take necessary corrective action on the remaining Non-Conformance(s) / other concerns and has to submit a report to NABL within a maximum period of 2 months.
• After satisfactory corrective action by the laboratory, the Accreditation Committee examines the findings of the Assessment Team and recommends additional corrective action, if any, by the laboratory.
• Accreditation Committee determines whether the recommendations in the assessment report are 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.
Accreditation to a laboratory is valid for a period of 2 years during which NABL shall conduct periodical Surveillance of the laboratory at intervals of one year. Laboratory should apply for Renewal of accreditation at least 6 months before the expiry of the validity of accreditation.
It is always better to catch the early bird to derive the maximum benefits. The Healthcare delivery Managements should seriously consider accreditations of their respective establishments – be it their laboratories or the hospitals, big or small.