Medical Labs

Medical laboratories accredited to ISO 15189:2007 are recognized as meeting the management system principles of ISO 9001:2008 according to a joint communiqué by ISO (the International Organization for Standardization), ILAC (the International Laboratory Accreditation Cooperation), and the IAF (the International Accreditation Forum).

The ISO-IAF-ILAC communiqué was issued to address the misconception that medical laboratories accredited to ISO 15189:2007 do not operate a recognized management system. Until now, accredited medical laboratories were often requested by their customers to undertake the additional step of certification to ISO 9001:2008 to demonstrate that they were in full control of their processes.

This recognition will reduce redundant, costly, and time-consuming audits and, at the same time, enable medical laboratories to better meet their customers’ needs.

Note: ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories. The standard is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognizing the competence of medical laboratories.

While ISO is the developer and publisher of ISO 15189 and ISO 9001, it does not carry out auditing and certification. These services are performed independently by accreditation and certification bodies. ISO does not control such bodies, but does develop voluntary International Standards to encourage good practice in their activities on a worldwide basis.

ILAC is the world’s principal international forum for the development of laboratory accreditation practices and procedures and the promotion of calibration and testing laboratory and inspection accreditation. This accreditation ensures that decisions on international trade, public health, and environmental issues are based on reliable, reproducible, and accurate data. As well as working in other fields, national accreditation bodies that are members of ILAC assess and declare the competence of medical laboratories against the requirements of ISO 15189.

IAF is the world association of accreditation bodies and other bodies interested in the accreditation of conformity assessment bodies providing certification and inspection services. Its primary function is to develop worldwide programs of accreditation that promote the elimination of non-tariff barriers to trade. Accreditation bodies declare the competence of certification bodies in the fields of management systems, products, services, personnel, and other similar programs of conformity assessment.