CERTIFICATION IN INDIA

NABL MEDICAL ENTRY LEVEL TESTING LAB

What is NABL Medical Entry Level Lab?

NABL has launched a voluntary scheme namely “NABL Medical Entry Level Testing M(EL)T Labs Program” 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

The existing scheme has been revised and now this scheme is based on satisfactory proficiency testing (PT) performance and valid for one cycle of three years.

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 Medical Entry Level Lab

Save time and money

Increase in business

Performance guideline

Greater efficiency

Compliance assurance

Improved team morale

Who can be Certified NABL Medical Entry Level Lab?

Shamkris Group

Medical Lab

Shamkris Group

Pathological Lab

Who can issue this Accreditation?

Quality Council of India

Document required for NABL Medical Entry Level Lab

The extent of Documented Information differs as per:

Role of Shamkris and Process of NABL Medical Entry Level Lab

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

National Accreditation Board for Testing and Calibration Laboratories (NABL) provides accreditation to Conformity Assessment Bodies (Laboratories). … In addition, NABL offers accreditation for Proficiency testing providers & Reference Material producers for which it has APLAC MRA.

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.