Accreditation detail

NABL

NABL (National Accreditation Board for Testing and Calibration Laboratories) is a Constituent Board of Quality Council of India which comes under the Union Ministry of Commerce and Industry. NABL offers unbiased accreditation services. It is mutual recognition arrangement signatory to International bodies such as International Laboratory Accreditation Co-operation (ILAC) and Asia Pacific Accreditation Co-operation (APAC) for accreditation of testing including medical and calibration laboratories. NABL accredited laboratory results are accepted in over 80 countries across the globe. The standards followed by NABL for quality and Competence of Medical laboratories is ISO 15189: 2012.

Quality Assurance Scheme for Basic Composite Medical Laboratories (Entry Level)

To improve healthcare system NABL encourages diagnostic laboratories performing basic tests to adopt quality practices by introducing entry level accreditation scheme for basic composite labs (small).

The labs which comes under this scheme are the ones which perform only basic routine tests like blood glucose, blood counts, rapid tests for common infections, liver and kidney function tests and routine tests of urine and has 50 or less samples in a day. The scheme requires minimal documentation and a nominal fee. The elements of competence assessment have been added for assuring quality and validity of test results. The laboratories may upgrade to accreditation as per ISO 15189 at any point of time.

Promoting laboratories follow requirements of quality in all their operations will result in bringing quality in India’s health system from the floor layer. This will lead to physicians offering evidence-based patient care and treatment. The system will gradually incorporate the habit of quality and enable the laboratories to achieve benchmark accreditation of ISO 15189 over a period. The successful laboratories will be issued a certificate of compliance by NABL and they will be permitted to employ a distinct symbol on the test reports as a mark of endorsement to the basic measure for 2 years. After this period the CAB may opt for renewal or transit to full accreditation as per ISO 15189.

ISO 15189

The accreditation services are currently given in the following disciplines- Clinical Biochemistry, Clinical Pathology, Haematology & Immunohematology, Microbiology & Infectious Disease Serology, Histopathology, Cytopathology, Flow Cytometry, Genetics, Nuclear Medicine (in-vitro tests only), Molecular testing etc.

The laboratory’s compliance to requirements of the standard and its technical competence are assessed by NABL for accreditation.

Accreditation shall be considered only for those tests for which the laboratory itself is capable of and competent to carry out. The tests, for which quality cannot be assured, shall not be included in the scope. The requirements for medical laboratories applying for NABL accreditation remains the same regardless of their level (small / medium / large / very large / laboratory with multiple locations) or the place in which they are located (village / town / district / city) or whether they are private / government / quasi-government attached to a hospital / stand-alone etc.

The accreditation is valid for 2 years after which the CAB may apply for renewal.