CERTIFICATION IN INDIA

NABL ACCREDITATION FOR MEDICAL TESTING LABORATORIES OF RT-PCR RNA VIRUS / COVID 19

What is NABL Accreditation for Medical Testing Laboratories?

NABL has launched a voluntary scheme namely the “NABL Accreditation for Medical Testing Laboratories” for sensitizing the medical testing laboratories performing basic testing to quality practices and access to quality health care for the majority of citizens especially those residing in villages, small towns.

This scheme is an independent quality assurance scheme, which is not covered under APAC & ILAC MRA

Laboratory application will be reviewed by NABL and decision on recognition will be taken based on performance in proficiency testing (PT). During the recognition period (within three years), on-site assessment (surveillance) will be conducted.

Benefits of NABL Accreditation for Medical Testing Laboratories

Save time and money

Increase in business

Performance guideline

Greater efficiency

Compliance assurance

Improved team morale

Who can be Certified NABL Accreditation for Medical Testing Laboratories?

Shamkris Group

Medical Lab

Shamkris Group

Pathological Lab

Who can issue this Accreditation?

Quality Council of India

Document required for NABL Accreditation for Medical Testing Laboratories

  • The laboratory has documented and implemented the management system in accordance with ISO 15189: 2012.
  • The laboratory is having competent personnel to perform the test and to report, review, and authorization of the test results.
  • The laboratory is equipped with the necessary infrastructure, equipment, and test kits/reagents/reference materials that are required for the correct performance of the test(s).
  • The laboratory is regularly performing quality control activities to ensure the quality of examination results.

The extent of Documented Information differs as per:

Role of Shamkris and Process of NABL Accreditation for Medical Testing Laboratories

Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.

The implementation process is described below:

Time Frame

Task

Process

Day 1

GAP Analysis
Cost Estimates
Application to Accreditation Body

Week 1

Developing Documents

Week 4

Implementing Management System

Week 8

Internal Audit
MRM
CAPA

Week 10

Accreditation Body
Audit
N-C Closing

Week 12

Accreditation Body

Year on Year

Yearly Compliance

FAQ

NABL has been established with the objective to provide Government, Industry Associations and Industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories.

In 2009-2010, the Central Government Health Scheme (CGHS) announced NABL accreditation as mandatory for empanelment of laboratories. … It is hoped that this will ensure quality of test results given by the laboratory and facilitate achieving ISO 15189 accreditation over a period of time.

The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the guidance of the Dept. Of Science & Technology, Govt. … It is the sole accreditation body authorized by the Govt. of India that provides a third-party assessment of quality and technical competence of labs.