NABL accreditation : Principles and procedures

NABL accreditation : Principles and procedures

1. NABL Accreditation Dr Bindiya Chauhan Pharmaceutical Quality Assurance

2. Difference b/w Accreditation and Certification

3. Difference b/w Accreditation and certification Accreditation is done by an approved agency that has been accepted as standard and organizations apply for. Educational institutions apply for accreditation with the state university or the Federal university. Accreditation is a stamp of approval by a third party about procedures.  Certification is mostly in the case of individuals OR team for conformation regarding to skills. Certificates are awarded to individuals to confirm the skills of people or individual. Combined we can say that it is a systematic procedure for evaluating, describing, testing and authorizing systems or activities prior to or after a system is in operation.

4. 1. Introduction and Objective of NABL: 1. Introduction and Objective of NABL: National Accreditation Board for Testing and Calibration Laboratories (NABL) is an self governing body under the Department of Science & Technology, Government of India. Objective: NABL has been established with the objective to provide a scheme for third party assessment of the quality and technical competence of testing and calibration laboratories to Government, Industry and Society in general.

5. 2. Laboratory Accreditation: 2.1 - Concept of Laboratory Accreditation: 2.2 - Requirement of Laboratory Accreditation: 2.3 - Benefits of Lab Accreditation: 2.4 - Types of Laboratory can seek Accreditation: 2.5 - Fields of Testing and Calibration Covered by NABL:

6. 2.1 - Concept of Laboratory Accreditation: 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 of laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands.

7. 2.2 - Requirement of Laboratory Accreditation: Society also needs to know the technically competent laboratory (Specification based testing laboratory) in fields such as Medical, Forensic, and Food Testing etc. Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories.

8. 2.3 - Benefits of Accreditation: 1. Potential increase in business due to enhanced customer confidence and satisfaction. 2. Savings in terms of time and money due to reduction or elimination of the need for re-testing of products. 3. Better control of laboratory operations as they have sound Quality Assurance 4. Increase of confidence in Testing / Calibration data and personnel performing work. 5. Customers can search and identify the laboratories accredited by NABL for their specific requirements. 6. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets , when tested by accredited laboratories.

9. 2.5 Fields of Testing and Calibration Covered by NABL: TESTING LABORATORIES CALIBRATION LABORATORIES MEDICAL LABORATORIES Biological Chemical Electrical Electronics Fluid-Flow Mechanical Photometry Radiological Thermal Electro-Technical Mechanical Fluid Flow Thermal & Optical Radiological Clinical Biochemistry Clinical Pathology Hematology and Immunohaematology Microbiology Histopathology Cytopathology Genetics Nuclear Medicine ( invitro tests only)

10. 2.5 Fields of Testing and Calibration Covered by NABL: Accreditation to a laboratory is given on the basis of its capability to perform test(s) / calibration(s) and provide accurate and reliable results. Classification of the Testing Laboratories has been done on the basis of basic fields of testing.

11. 3. Preparations Required by Laboratory for Accreditation: 1. Laboratory management should first decide about getting accreditation for its laboratory from NABL. 2. It is important for a laboratory to make a definite plan of action for obtaining accreditation and nominate a responsible person to coordinate all activities related to seeking accreditation. The person nominated should be familiar with laboratory's existing Quality System. S/he should be formally designated as the Quality Manager. 3. Procure all relevant NABL 4. Laboratory needs to ascertain the status of its existing Quality System and Technical Competence with regards to requirements for NABL Accreditation. Is the system documented and effective or does it need modification? Does it need to build the Quality System of the laboratory from scratch?

12. Preparations Required by Laboratory for Accreditation: 5. The laboratory must ensure that the procedures described in the Quality Manual and other documents are being implemented. 6. Relevant requirements for NABL accreditation should be discussed amongst concerned staff of the laboratory. This will enable them to understand their weaknesses and strengths. 7. Quality Manager must conduct an Internal Audit and take corrective actions before applying for accreditation.

13. 4. Process of Accreditation: 4.1 Stage I (Filling of Application): 4.2 Stage II (Pre-Assessment audit): 4.3 Stage III (Final Assessment): 4.4 Stage IV (Corrective Reassessment): 4.5 Stage V (Granting of Accreditation):

14. 4.1 Stage I (Filling of Application): 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 and 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. Laboratories are required to submit five sets of duly filled in application forms for each field of testing / calibration along with five sets of Quality Manual and Application Fees. After satisfactory corrective actions and application for accrediation 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

15. 4.1 Stage I (Filling of Application): 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 and 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. Laboratories are required to submit five sets of duly filled in application forms for each field of testing / calibration along with five sets of Quality Manual and Application Fees. After satisfactory corrective actions and application for accrediation 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

16. 4.2 Stage II (Pre-Assessment audit): 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 . 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.

17. 4.3 Stage III (Final Assessment): 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. 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 .

18. 4.4 Stage IV (Corrective Reassessment): 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 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 .

19. 4.5 Stage V (Granting of Accreditation): Accreditation to a laboratory shall be valid for a period of 3 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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