NABL.pptx

B.PHARM VI SEM

1. N A BL Accreditation BALASUNDARESAN M. MB 1

2. What is NABL ?  NABL specifies the general requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. MBS 2

3. National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government, Industry and Society in general with a scheme for third- party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for Testing and Calibration laboratories. In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with NABL criteria based on internationally accepted standard for laboratory accreditation ISO/IEC 17025. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence. NABL has established its Accreditation System in accordance with ISO/IEC 17011:2004, which is followed internationally. NABL also compiles to the requirement of APLAC MR001 for the fulfillment of APLAC MRA and ILAC Arrangements. 192 MBS 3

4.  Location of NABL Office : NABL Secretariat is functioning from its office situated at 3rd Floor, NISCAIR, 14, Satsang Vihar Marg, New Mehrauli Road – New Delhi 110067. NABL Secretariat administers and co-ordinates all activities of NABL including accreditation related activities for Testing and Calibration laboratories. Registered Office of NABL is located in Department of Science & Technology, Technology Bhavan, and New Mehrauli Road, New Delhi – 110016. Office Timing : The working days of NABL are from Monday to Friday. The office timings are from 9-00 a.m. to 5-30 p.m. MBS 4

5. CON C EPT 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 competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence. MBS 5

6. Benefits of Accreditation: Potential increase in business due to enhanced customer confidence and satisfaction. S a v i n gs i n terms o f time an d mon e y du e to reduction or elimination of the need for re-testing . Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent. MBS 6

7. Increase of confidence in Testing / Calibration data and personnel performing work. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the directory of Accredited Laboratories. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories. MBS 7

8. Types of Laboratory can seek Accreditation: Laboratories undertaking any sort of testing or calibration in the specified fields. Private or government laboratories. Small operations to large multi-field laboratories. Site facilities, temporary field operations and mobile laboratories. MBS 8

9. TESTING LABOR A TORI E S CALIBRATION LABOR A TORI E S MEDICAL LABOR A TORI E S Biological Chemical Electrical Electronics Fluid-Flow Mechanical Non- Destruc t i v e Testing Photometry Radiological Thermal Forensic Electro-Technical Mechanical Fluid Flow Thermal & Optical Radiological Clinical Biochemistry Clinical Pathology Haematology & Immunoha e mato l o g y Microbiology & Serology Histopathology Cytopathology Genetics Nuclear Medicine (in- vitro tests only) PROFICIENCY TESTING PROVIDERS REFERENCE MATERIAL PRO D U C E RS Testing Calibration Medical Inspection Chemical Composition Biological & Clinical Properties Physical Properties Engineering Properties Miscellaneous Properties 198 MBS 9

10. 10 Step Approach To Accreditation Awareness Training Quality Policy & Objectives Finalization Gap Analysis Documentation / Process Design Documentation / Process Implementation Internal Audit Management Review Meeting Shadow Audit Corrective –Preventive Actions Final Certification Audit MBS 10

11. Step 1:- Awareness Training Separate training sessions for top management, middle management and junior level management. Creates a motivating environment throughout the organization for ISO 17025 implementation. MBS 11

12. Step 2:-Quality Policy & Objectives Work shop with top management on development of quality policy. Work shop with top management and middle level functional management on development of quality objectives. MBS 12

13. Step 3:-Gap Analysis Understanding of all the operations of the organization. Development of process map for the activities of the organization. Comparing existing operations with requirements of ISO 17025:2005 standard. MBS 13

14. Step 4:-Documentation / Process Design Quality Manual Functional Procedures Work Instructions System Procedures Formats MBS 14

15. Step 5:-Documentation / Process Implementation Work–shop on process / document implementation as per ISO 17025 requirements. Departmental / Individual assistance in implementing the new processes / documents. MBS 15

16. Step 6:-Internal Audit Internal Audit Training & Examination (Optional). Successful employees / we carry out internal audit of the organization covering all the departments and operations. Suggest corrective and preventive actions for improvements in each of the audited departments. MBS 16

17. Step 7:-Management Review Meeting Quality Policy & Objectives Results of internal audit Results of supplier evaluation Results of customer complaints Results of customer feedback etc. MBS 17

18. Step 8:-Shadow Audit A replica of final certification audit. Finds degree of compliance with ISO 17025 standard. Gives an idea to the employees about the conduct of the final certification audit. MBS 18

19. Step 9:-Corrective – Preventive Actions On the basis of shadow audit conducted in the last step, all the non-conformities will be assigned corrective and preventive actions. A check will ensure that all the NCs are closed and the organization is ready for the final certification audit. MBS 19

20. Step 10:-Final Certification Audit  Upon completion of various stages of accreditation audit, the audit, your organization will be awarded accreditation.

21. Reference http:// www.nabl-india.org MBS 21

22. MBS 22 TRY TO REMEMBER THIS FOR GPAT 2021???????? Abbreviation of NABL. Location of NABL office. Benefits of Accreditation. Types of laboratories can seek accreditation. 10 step approach.

23. MBS 23 THANK YOU ALL THE BEST MBS