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ISO 15189:2012

What is ISO 15189: 2012 ?
ISO 15189: 2012 is a international standard that specifies the quality management system requirements particular to medical laboratories. It is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

Benefits of  ISO 5189: 2012

  • ISO15189:2012  demonstrates a laboratory’s commitment to delivering results that meet internationally recognized standards for quality and competence.Assures that clinical laboratory services are safe, reliable, and of good value. 

  • Provides a tool for measuring quality improvements and supporting consistency.

  • Recognizes and promotes the technical competence of staff.

  • Assures client results are technically valid and saves costs associated with retesting.

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NABL Accreditation

The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the guidance of the Dept. Of Science & Technology, Govt. of India whose purpose is to provide accreditation to testing and calibration of clinical laboratories in the country.

Aswadh Infinite provides consultancy to all organizations involved in testing and calibration, as well as for medical Laboratories. We support our customers for NABL in:

  • New Accreditation

  • Renewal Accreditation

  • Desktop Surveillance

  • Internal Audit as per ISO 15189: 2012

  • Medical Testing laboratories of RT-PCR RNA Virus/ COVID-19

The scope of accreditation is applicable to the following disciplines of medical laboratory:

  • Clinical Biochemistry

  • Haematology

  • Clinical Pathology

  • Microbiology & Infectious disease serology

  • Histopathology

  • Cytopathology

  • Flow Cytometry

  • Cytogenetics

  • Molecular Testing

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