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?
Medical Lab
Pathological Lab
Who can issue this Accreditation?
Quality Council of India
Document required for NABL Medical Entry Level Lab
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Scope of Certificate (Clinical Biochemistry,Clinical Haematology,Microbiology,Emphasis Disease Serology,Histopathology,Cytopathology,Flow Cytometry,Cytogenetics,Molecular Testing)
- Location
- Resource Availability
- Testing parameter cover
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
- Finding the GAP between existing system related to Accreditation Body requirements
- Application to Accreditation Body
- Based on the scope of your business & Accreditation Body you choose
Week 1
Developing Documents
- Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
- Awareness training for the top management and staff
- Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to Accreditation Body requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Accreditation Body
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the Accreditation Body
Week 12
Accreditation Body
- Accreditation certificate issued for 3 years
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
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.