NABL ( NATIONAL ACCREDITATION BOARD DOR TESTING AND CALIBRATION LABORATORIES

NABL accreditation : Principles and procedures, benefits , committees

1. NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES {NABL} Presented By:- Miss. Gayatri K. Bahatkar Assistant Professor B. Pharm 6 th sem Pharmaceutical Quality Assurnace

2. Index Introduction  Principles of NABL Accreditation Importance of Accreditation Benefits of Accreditation Accreditation Areas Approaches to obtain NABL Accreditation Accreditation procedure

3. INTRODUCTION NABL – National Accreditation Board for Testing and Calibration Laboratories 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 Schemes- include accreditation of technical competence of testing, calibration, medical testing laboratories, proficiency testing laboratories and reference material providers. NABL is a constituent board of Quality Council of India NABL assesses laboratories in India for quality and consistency in their results.

4. IMPORTANCE OF NABL ACCREDITATION The concept of Laboratory Accreditation developed to provide a means of third – party certification of the competence of laboratories to perform specific types of testing and calibration. 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. Enhances customer confidence in accepting testing calibration reports issued by accredited laboratories.

5. 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 and feedback to laboratories as to whether they have sound quality assurance system and are technically competent. Increase of confidence of testing/calibration data and personal performing work. 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.

6. NABL ACCREDITATION AREAS TESTING LABORATORIES Biological, Chemical, Electrical, testing, Thermal, forensic CALIBRATION LABORATORIES Electro-technical, mechanical, Radiological, Thermal, optical, Fluid flow MEDICAL LABORATORIES Clinical biochemistry, Clinical pathology, genetics, cytopathology , serology area

7. REFERENCE MATERIAL LABORATORIES Biological Processes Engineering process Genetics industry Pharmaceutical industries PROFICIENCY LABORATORIES Medical Inspection Calibration

8. APPROACHES TO OBTAIN ACCREDITATION 10 approaches for Accreditation   Awareness training 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  Documentation / process design Documentation / process implementation Internal audit by the company itself.  Management review meeting  Shadow audit – external audit Corrective – preventive actions Final certification audit

9. Eligibility Criteria for NABL Approval To satisfy the requirement of the NABL, the institution Conformity Assessment Body (CAB) has to satisfy the following eligibility criteria: First and foremost, the institution must be a CAB carrying out relevant activities such as laboratory testing, calibration, food processing, research, and development. A CAB institution must either appoint a representative to start the formalities for the NABL approval process. The appointed representative must be aware of the existing quality processes followed by the CАВ. The institution (CAB) must have developed a manual that indicates the quality standards. Such quality standards must satisfy the requirements of :  a) ISO/ IEC 17025: 2005; or b) ISO 15189: 2012; or c) ISO/IEC 17043/2010.

10. The CAB must have an appointed manager who has relevant training up to 4 days on internal audit and management policies, which are followed. The quality document which is prepared by the CAB must be implemented immediately. The CAB must also satisfy the criteria as required, according to NABL 130- which provides the criteria for Site testing and Site Calibration Laboratories. Any applicant must participate in the Proficiency Training Program, which is conducted by the NABL or an international institution. If there is no form of training available, the institution can carry out an inter-lab comparison when it comes to quality assessment. If a lab wants to participate in the above event, then the minimum standard must be one parameter or one test. The CAB must carry out at least one internal audit and management review before applying for the NABL approval.

11. NABL ACCREDITATION PROCESS Application by CAB to NABL 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

12. 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.

13. Step 1- Make an Application by CAB to NABL In this step, the institution must make an application to the NABL. Along with the application, respective documents must be submitted to the NABL. An application must be made in triplicate (3 copies). Two copies must describe the quality manual of the management system. This must be in accordance with the requirement of the ISO/ IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016. Step 2- Acknowledgment & scrutiny of application The applicant has to pay the respective fee, which is present under NABL 100. If an applicant does not want to make any form of information disclosures, th same reasons must be provided to authority. Step 3- Receipt of Application  When the application is received by the NABL Secretariat (along with the requisite fee), a unique identification number (UIN) will be issued. The applicant must quote this number in all correspondences with the NABL.

14. Step 4- Pre-Assessment Visit by lead assessor If there are no discrepancies in the application, then a lead assessor will be appointed to carry out a pre-assessment visit to the CAB. The assessment is carried out to understand if there are no discrepancies in the quality control adopted by the CAB. Along with this, the assessor will find out if there is any other assessment required to be carried out by the NABL. Step 6- final Assessment by assessment Team When the CAB has taken all the measures to correct the issues, the NABL will form a team constituted by the lead assessor, technical experts, and other individuals who are experienced in relevant fields and disciplines. The team analyses and finds out if compliance is met in accordance with the required standards. If there are any forms of discrepancies found in the CAB, there report will be made and submitted Secretariat. In the report, remedies would also be included to address the discrepancies. A copy of this will be submitted to the respective CAB. Step 7-Crrective Action by CAB When the NABL secretariat reviews the report, the CAB must take follow-up action. This action must be taken within 60 days of the Report of the Assessment Team. In action, the CAB must mention the corrective action it has taken to mitigate difficulties.

15. Step 8- Scrutiny & Recommendations  After the follow-up action is taken by the CAB; the Accreditation Committee will make recommendations to the NABL Chairman. The Chairman’s decision is not binding, and it can be appealed the director of the NABL. discrepancies. A copy of this will be submitted to the respective CAB. Step 8- Grant of accreditation when the recommendation results in the grant of accreditation NABL issue an accreditation certificate which has a unique number & NABL hologram discipline date of validity along with the scope of accreditation. The NABL accreditation certificate is valid for a period up to 2 year. NABL conduct annual surveillance of the CAB at interval of one year which is aim to evaluating continue compliance to the requirement of ISO/ IEC and relevant specific criteria & NABL policies.