Chemical Quality Assurance

Module 6. Setting-up of laboratory for chemical

Lesson 21
ACCREDITATION OF ANALYTICAL LABORATORIES

21.1 Introduction

Accreditation is a procedure by which the accrediting body gives formal recognition that a body or organization is competent to carry out specific tasks. The concept of laboratory accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Laboratory accreditation provides formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing, measurement and calibration services. To maintain this recognition, laboratories are re-evaluated periodically by the accreditation body to ensure their continued compliance with requirements, and to check that their standard of operation is being maintained. Laboratory accreditation uses criteria and procedures specifically developed to determine technical competence. Specialist technical assessors conduct a thorough evaluation of all factors in a laboratory that affect the production of test or calibration data. The criteria are based on an international standard called International Organization for standardization/ International Electrochemical Commission (ISO/IEC) 17025, which is used for evaluating laboratories throughout the world. Government of India has authorized National Accreditation Board for Testing and Calibration Laboratories (NABL) as the sole accreditation body for the purpose of accreditation of Testing and Calibration laboratories. NABL is an autonomous body under the aegis of Department of Science and Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government, Industry Associations and Industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. NABL is a full member of both ILAC (International Laboratory Accreditation Cooperation) and APLAC (Asia Pacific Laboratory Accreditation Cooperation).

21.2 Process of Accreditation

21.2.1 Stage 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 organized by NABL. Laboratories must ensure their preparedness by carrying out its internal audit before Pre-Assessment.

21.2.2 Stage II

• NABL Secretariat shall organize 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 organized by NABL.

21.2.3 Stage III

• NABL Secretariat shall organize 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.

21.2.4 Stage IV

• 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 assessed.

21.2.5 Stage 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.