In India , medical laboratories ( Pathology Labs ) are around 70000 and out of these 70000 labs only 1000 are comes under credible labs !
So, what is credible and accredited labs ?
Any medical laboratory which works in accordance with NABL and has live accreditation of NABL – Govt of India are considered as credible , reliable and has method and system to generate accurate lab report.
So , what is non credible & non accredited labs ?
Medical laboratories which does not follow any standard operating system ( SOP ) of system, process and technology , which can provide credibility and system process and procedure of medical laboratories through prescribed norms of laboratory testing . All such labs may not be considered as credible , reliable , accredited & accurate , because they follow their own system and does not adhere to any world class norms of testing.
Find below the details of NABL – Govt of India
What does NABL stand for? What’s its use?
NABL stands for National Accreditation Board For Testing And Calibration Laboratories. NABL has agreements with ILAC (International Laboratory Accreditation Conference) and APLAC (Asia Pacific Laboratory Accreditation Cooperation). These are especially valuable for International recognition and mutual acceptance of test results. In short accreditation has worldwide acceptance.
NABL is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. It is only one of its kinds that assess laboratories in
for quality and consistency in the results. The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing.
Does NABL follow any ISO guidelines?
NABL follows ISO 15189:2007, which is specific ISO followed world wide for medical laboratories. This standard is used by APLAC (Asia Pacific Laboratory Accreditation Cooperation) and ILAC (International Laboratory Accreditation Co-operation) etc.
This means that an NABL accredited laboratory in
follows the same guidelines as any other accredited laboratory in the world.
What is the difference between ISO certification and NABL accreditation?
NABL accreditation is based on evaluation of technical competence whereas ISO certification is based upon verification of proper documentation. Though documentation forms an essential and important part of NABL, it lays down great emphasis on quality and the lab can be denied accreditation if one does not comply with the quality standards.
Is the activity of NABL monitored by some independent authority?
NABL has established its Accreditation System in accordance with ISO/IEC 17011:2004, which is followed internationally. In addition NABL has to also comply with the requirements of APLAC (Asia Pacific Laboratory Accreditation Cooperation) MR001 which it satisfies.
Is NABL accreditation mandatory in the country?
No. It is purely voluntary.
How many labs are currently NABL accredited in the country?
At present only 650 Labs are accredited in the entire country as of Apr 2016 and counting.
Is accreditation a one-time phenomenon?
NABL accreditation is not a one-time phenomenon. Laboratory accreditation is valid for a period of 2 years only. During these 2 years NABL conducts periodical surprise surveillances of the laboratory on an annual basis. Accreditation can be revoked if the laboratory fails to maintain the standards of NABL even during these two years.
Is NABL like any other inspection with all its nuances?
NABL is a very professional and ethical body and the assessors give guidance rather than do policing
Who comprise the NABL assessing team?
For each inspection, there is one lead assessor and other technical assessors for assessing different departments of the laboratory. These are qualified people from government, semi government and private organizations who have got special training from NABL.
What does this all mean for the common man, patient and the doctor?
It means that your lab is continuously striving for quality and this will further progress our cause of providing quality services. Laboratory Accreditation provides formal recognition of competent laboratories like ours, thus providing a ready means for customers to find reliable testing services in order to meet the demands.
National Accreditation Board for Testing & Calibration Laboratories, New Delhi
National Accreditation Board for Testing and Calibration Laboratories (NABL) is a Society registered under Societies Registration Act, 1860 and is an autonomous body under the aegis of Department of Science & Technology.
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 Conformity Assessment Bodies (Testing including Medical, Calibration Laboratories, Proficiency Testing Providers and Reference Material Producers).
The laboratory accreditation services to testing and calibration laboratories are provided in accordance with ISO/ IEC 17025 ‘General Requirements for the Competence of Testing and Calibration Laboratories’ and ISO 15189 ‘Medical laboratories – Requirements for Quality and Competence’ The accreditation to Proficiency testing providers are based on ISO/IEC 17043 “Conformity Assessment – General Requirements for Proficiency Testing” and to Reference Material Producers based on ISO Guide 34 ”General Requirements for the Competence of Reference Material Producers.”
These services are offered in a non-discriminatory manner and are accessible to all Conformity Assessment Bodies (CABs) in India and abroad, regardless of their ownership, legal status, size and degree of independence.
NABL has established its Accreditation System in accordance with ISO/IEC 17011 “Conformity Assessment – General requirement for accreditation bodies accrediting conformity assessment bodies”, which is followed internationally.
NABL maintains linkages with the international bodies like International Laboratory Accreditation Co-operation (ILAC) and Asia Pacific Laboratory Accreditation Co-operation (APLAC). NABL is signatory to ILAC as well as APLAC Mutual Recognition Arrangements (MRA) for accreditation of Testing including Medical and Calibration laboratories, which is based on mutual evaluation and acceptance of other MRA Partner accreditation systems. Such international arrangements facilitate acceptance of test/ calibration results between countries which MRA partners represent.