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?
Medical Lab
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:
- Scope of Certificate
- Location
- Resource Availability
- Testing parameter cover
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
- 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
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.
