National Accreditation Board for Testing and Calibration Laboratories

Introduction to NABL
Benefits of NABL accreditation
Types of laboratory can seek accreditation
Approaches to obtain accreditation
NABL accreditation process

1. (NABL) National Accreditation Board for Testing and Calibration Laboratories Mr. Vinayak R. Bodhankar M. Pharm. (Ph.D.*)

2. Content Introduction to NABL Benefits of NABL accreditation Types of laboratory can seek accreditation Approaches to obtain accreditation NABL accreditation process

3. INTRODUCTION NABL is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act . Accreditation — the action or process of officially recognizing an organization or person as having a particular status or being qualified to perform a particular activity. NABL Accreditation provides the accreditation to Conformity Assessment Bodies (Laboratories). 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. 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. NABL assesses laboratories in India for quality and consistency in their results .

4. BENEFITS OF NABL ACCREDITATION Potential increase in business due to enhanced customer confidence and satisfaction Savings in terms of time and money due to reduction or elimination of the need for re-testing Better control of laboratory operations as they have sound quality assurance system and are technically competent. Increase of confidence of testing/calibration data. Customers can search and identify the laboratories accredited by NABL for the 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.

5. 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.

6. APPROACHES TO OBTAIN ACCREDITATION 10 approaches for Accreditation Awareness training: It should be given to the management and all the personnel involved. Quality policy & Objectives should be established Gap Analysis Analysis of all the departments in the company and the relationship between each departments. Understanding of all the operations of the organization. Development of process map for the activities of the organization. 4. Documentation / process design Quality Manual Functional Procedures Work Instructions S ystem Procedures Formats

7. 5. Documentation / process implementation Workshop on process / document implementation as per ISO 17025 requirements. Departmental / Individual assistance in implementing the new processes /documents. 6. Internal audit by the company itself C arry 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. 7. Management review meeting Quality Policy & Objectives Results of internal audit Results of supplier evaluations Results of customer complaints Results of customer feedback

8. 8. Shadow audit Finds degree of compliance with ISO17025 standard. Gives an idea to the employees about the conduct of the final certification audit. 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. 10. Final certification audit Upon completion of various stages of accreditation audit , your organization will be awarded accreditation.

9. NABL ACCREDITATION PROCESS Application for accreditation Acknowledgement & scrutiny of application by NABL secretariat Adequacy of quality manual Pre-assessment of laboratory by lead assessor Final assessment of laboratory by assessment team Scrutiny of assessment report by NABL secretariat Recommendation for accreditation by accreditation committee Approval for accreditation by chairman of NABL Issue of NABL Certificate by NABL secretariat. During steps 2 - 6 feedback to laboratory is given and they are recommended to do the necessary corrective action.