Core Programme Clusters

Accreditation of Health Facilities

 

Laboratory Accreditation, 7 October 2005

Accreditation

Laboratory accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific test(s)/ measurement(s), based on third party assessment and following international standard.

Assures the client that the procedures are technically valid

*      Recognizes the technical competence of laboratory staff

*      Assures the client that the results are technically valid

*      Endorses the quality management system

Certification

Procedure by which a third-party (certification body) gives a written assurance that a product, process or service (of an organisation) conforms to specified requirements.

*      Specified requirements - ISO 9000 series;

*      Assures the client that the organisation has in place an effective quality or environmental management system

*      Does not confer technical credibility of the test result

Some Benefits of Laboratory Accreditation

*      Provides formal recognition to competent laboratories and ensures  that they perform their work in accordance with international standard.

*      Minimizes the risk of unreliable results.

*      Minimizes the chances of retesting and hence reduces chances of additional financial burden and time delays.

*      Enhances Customer confidence and Satisfaction.

*      International acceptability of test results. Based on Mutual Recognition Arrangements (MRA).

 

*     This is relevant in case of insurance coverage, placement agencies, overseas health authorities, labour department etc.

About NABL

        Government of India has authorized NABL as the sole accreditation body for Testing and Calibration laboratories.

        NABL has established its accreditation system in accordance with ISO/IEC 17011, which is followed internationally.

        NABL provides laboratory accreditation services to laboratories that are performing tests/  calibrations in accordance with ISO/ IEC 17025: 2005 (General requirements for the competence of Testing and Calibration Laboratories).

*      ISO 15189:2003 (Medical laboratories- Particular requirements for quality and competence).

Accreditation Procedure

 

Scope

*      Testing Laboratories

*      Biological

*      Chemical

*      Electrical

*      Electronics

*      Fluid-Flow

*      Mechanical

*      NDT              

*      Medical

*      Forensic

*      Calibration Laboratories

*      Electro-Technical

*      Mechanical

*      Radiological

*      Thermal & Optical

*      Fluid-Flow

Scope: Medical Laboratories

*      Clinical Biochemistry

*      Clinical Pathology

*      Haematology and Immunohaematology

*      Microbiology and Serology

*      Histopathology

*      Cytopathology

*      Genetics

*      Nuclear Medicine (in-vitro tests only)

Accreditation – Voluntary or Regulatory

*     Currently, NABL accreditation is on voluntary basis.  NABL has conducted awareness programmes in several locations of the country.

NABL Accreditation- Medical Testing

*      Several awareness programs were conducted.

*      Initially, laboratories were given subsidy in application fees

*      July 1998: First application for Medical testing

*      First certificate issued in July 1999

       Currently 57 labs are accredited and 47 are applicant. 

 

 

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