National Accreditation Board for Testing and Calibration Laboratories (NABL)

Detailed description about the NABL Accreditation

1. National Accreditation board for testing and calibration laboratories ( nabl )

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

3. Introduction NABL– N ATIONAL A CCREDITATION B OARD FOR TESTING AND CALIBRATION L ABORATORIES Accreditation - The action of process of officially recognizing an organization or person as having a particular status of being qualified to perform a particular activity. NABL Accreditation – NABL provides the accreditation to Conformity Assessment Bodies (CAB) laboratories. 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. Recognition of NABL in International Level NABL maintains the relationship with several international bodies like: International Laboratory Accreditation Co-operation (ILAC). (Regional Body) Asia Pacific Accreditation Co-operation (APAC). (Apex Body)

5. Advantages of NABL ACCREDITATION NABL accreditation has many advantages for the organizations, PTPs and RMPs. Some of them are: Increases credibility of the testing reports (issued by the specific lab). Building up of confidence for the organization in calibrating and testing the reports. Accreditation ensures the quality assurance systems of the organization. Customers’ satisfaction. Customers of these accredited organizations/ laboratories can have greater access for their products, in both domestic and international markets. Market acceptability and increased potential in business. Elimination of need of re-testing. Monitoring of maintenance of efficacy for long time.

6. TESTING LABORATORIES CALIBRATION LABORATORIES MEDICAL LABORATORIES PROFICIENCY TESTING PROVIDERS REFERENCE MATERIAL PRODUCERS Biological Chemical Electrical Electronics Fluid-Flow Mechanical Non-Destructive Testing Photometry Radiological Thermal Forensic Electro-Technical Mechanical Fluid Flow Thermal & Optical Radiological Clinical Biochemistry Clinical Pathology Hematology & Immunohematology Microbiology & Serology Histopathology Cytopathology Genetics Nuclear Medicine (in- vitro tests only) Testing Calibration Medical Inspection Chemical Composition Biological & Clinical Properties Physical Properties Engineering Properties Miscellaneous Properties TYPES OF LABORATORIES :

7. Approaches to obtain accreditation 10 Approaches for Accreditation are: Awareness training should be given to the management and all the personnel who are 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

8. NABL accreditation process Application for Accreditation : CAB applies the application form in the form of triplicate and two copies of their quality manual describing the quality management system as per ISO guidelines. CAB also pays the application fees prescribed by NABL. Acknowledgement & Scrutiny of application by NABL secretariat: On receiving the application with quality manual and fees, NABL secretariat will issue an acknowledgement number with a unique ID. NABL scrutinize the application and may ask for any clarification or information. Adequacy of Quality Manual: NABL appoints a Lead Assessor who organizes a pre-assessment visit to the CAB premises and evaluate any non-conformity in quality system implementation.

9. 4. Pre-assessment of laboratory by Lead Assessor: Lead assessor submit a report of the pre-assessment visit to NABL secretariat. A copy is also sent to the CAB also. Final assessment of laboratory by assessment team: CAB takes corrective measures regarding the non-conformity pointed out in pres -assessment report. CAB sends a report on this to NABL secretariat. Scrutiny of assessment report by NABL secretariat: Based of the satisfactoriness of the CAB’s corrective actions, NABL set up the assessment team after consulting with the CAB. Along with the lead assessor, this team will include experts in the fields in which accreditation is sought by the CAB. Follow–up Actions: NABL examines the assessment report and initiates any follow-up action for non- conformity.

10. Recommendation for Accreditation by accreditation committee: 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 to the director of the NABL Issue of NABL Certificate by NABL Secretariat: Once all the non-conformities have been addressed, the Chairman of NABL gran the accreditation to CAB . The accreditation certificate includes; Unique Identification Number. Certificate of NABL Approval. Hologram having the NABL signs. Dare of Validity of the certificate. Discipline.

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