What kind of accreditation does the Maintrac test have and how is that relevant to the country in which I practice?
This is an extremely important question that practitioners often and must ask. Practitioners need to know that the test performed in Germany meets the medical testing standards required by their own countries.
And it does.
The Maintrac laboratory (SIMFO) is accredited by the German laboratory accreditation organisation, DAKKS. DAKKS is a signatory to the International Laboratory Accreditation Coorporation, ILAC. Signatories to ILAC agree to a Mutual Recognition Arrangement (MRA) whereby testing performed in accredited laboratories is recognised as equivalent to testing in other equally accredited laboratories.
The accreditation bodies of countries listed below are also signatory to ILAC and the MRA (only countries relevant to where Maintrac testing is being performed are listed, however many more countries' accreditation systems are also signatory to ILAC
- Australia: National Association of Testing Authorities (NATA)
- New Zealand: International Accreditation New Zealand (IANZ)
- United Arab Emirates: Dubai Accreditation Centre (DAC)
- Malaysia: Skim Akreditasi Makmal Malaysia (SAMM)
- Thailand: Bureau of Laboratory Accreditation Thailand (BLA-DSS)
- India: National Accreditation Board for Testing and Calibration Laboratories (NABL)
Medical Testing Standard: ISO15189
The International Standards Organisation (ISO) is a worldwide federation of national standards bodies. ISO15189:2012 specifies the quality and competence in medical laboratories. For medical testing, ISO15189 is the highest standard attainable. "Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work." (ISO).
The Maintrac test laboratory, SIMFO, is an accredited ISO15189 medical testing laboratory. The accreditation body in Germany, DAKKS, is a signatory to ILAC and the Mutual Recognition Arrangement (MRA)
About ILAC - International Laboratory Accreditation Coorporation
ILAC is the international organisation for accreditation bodies operating and involved in the accreditation of conformity assessment bodies including medical testing laboratories (using ISO15189). "Accreditation is the independent evaluation of conformity assessment bodies against recognised standards to carry out specific activities to ensure their impartiality and competence. Through the application of national and international standards, government, procurers and consumers can have confidence in the calibration and test results, inspection reports and certifications provided." (ILAC)
The accreditation bodies that are signatories to ILAC Mutual Recognition Arrangement have been peer evaluated according to ISO/IEC 17011 to assess and accredit laboratories and inspection bodies to the relevant international standards.
The Maintrac test laboratory, SIMFO, is an accredited ISO15189 medical testing laboratory. The accreditation body in Germany, DAKKS, is a signatory to ILAC and the Mutual Recognition Arrangement (MRA). As DAKKs are part of the ILAC MRA, testing in a DAKKS-certified laboratory should be recognised in all other countries that are also signatories to the ILAC MRA
Genostics is facilitating the Maintrac CTC test in various countries across the world. It is vital to us that the medical testing that we offer through SIMFO is not only of the highest standard, but also that this standard is officially recognised across the globe.
This is exactly the case.