Posted in News and Notices [Friday, December 30th, 2016 ]
1st stand alone NABL 15189 : 2012 Accredited Path Lab in Nepal.
What is ISO ?
ISO is an independent, non-governmental international organization with a membership of 163 national standards bodies. Its Central Secretariat is based in Geneva, Switzerland. They give world-class specification for products, services and systems to insure quality, safety and efficiency . It has been in operation since 23rd Feb 1947. “International Organization for Standardization” ISO is derived from Greek isos, mean equal.
Why ISO 15189 ?
If a laboratory seeks accreditation which is internationally acceptable, it should select an accrediting body which is an ILAC MRA signatory and operates in accordance with ISO/IEC 17011. In Nepal there is no accrediting body which is a signatory to ILAC MRA as of Nov. 2016.
Why NABL ?
National Accreditation Board For Testing And Calibration Laboratories (NABL) is one such accrediting body enlisted with International Laboratory Accreditation Cooperation Mutual Recognition Arrangement. This is especially valuable for International recognition and mutual acceptance of accredited test results. NABL ISO 15189:2012 accreditation has worldwide acceptance because NABL accredited laboratory follows the same guidelines as any other accredited laboratory in the world.
NABL is an autonomous body under the aegis of Department of Science & Technology, Government of India.
ISO 15189:2012 specifies requirements for quality and competence particular to medical laboratories.
Medical laboratory’s fulfillment of the requirements of this International Standard means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results.
The first version was published in 2003, it was revised in 2007 and the third edition of the standard was published in 2012. And hence it is called ISO 15189:2012.
ISO 15189 is becoming “the” measuring stick of quality for Laboratories
How many Signatories to the ILAC MRA (International Laboratory Accreditation Cooperation Mutual Recognition Arrangement ) are there ?
There are 91 Accreditaion bodies and 95 countries which are signatory to ILAC MRA.
Reference : Signatories to the ILAC Mutual Recognition Arrangement