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Recognition to reduce redundant, costly, and time-consuming audits.
International Organization for Standardization ISO Published: 11/04/2009
(ISO: Geneva) -- Medical laboratories accredited to ISO 15189 (a sector-specific technical competence and management system standard) are now recognized as meeting the management system principles of ISO 9001.
The move was announced in a joint statement by the International Organization for Standardization (ISO), the International Laboratory Accreditation Cooperation (ILAC), and the the International Accreditation Forum (IAF) in September 2009.
The ISO-IAF-ILAC statement was issued to address the misconception in the market that medical laboratories accredited to ISO 15189 don’t 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 to demonstrate that they are in full control of their processes.
Based on the new procedures, medical laboratories accredited to ISO 15189 will now be recognized as meeting the management systems principles of ISO 9001. Accredited medical laboratories that are part of a larger organization certified to ISO 9001 should only need to be assessed once according to ISO 15189, and these results accepted as meeting the principles of the management system requirements of ISO 9001.
This recognition will reduce redundant, costly, and time-consuming audits, and at the same time, enable medical laboratories to better meet their customers’ needs.
ISO is the developer and publisher of ISO 15189 and ISO 9001, however, ISO does not carry out auditing/assessing and certification. These services are performed independently of ISO by accreditation and certification bodies. ISO doesn’t control such bodies, but it does develop voluntary international standards to encourage good practice in these accreditation and certification bodies’ activities on a worldwide basis.
ILAC is the world’s principal international forum for the development of laboratory accreditation practices and procedures, and for the promotion of accreditation of calibration, testing laboratory, and inspection services. This accreditation ensures that decisions on international trade, public health, and environmental issues are based on reliable, reproducible, and accurate data. National accreditation bodies that are members of ILAC assess and declare the competence of medical laboratories against the requirements of ISO 15189, and work in other fields as well.
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 global programs of accreditation that promote the elimination of nontariff 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.
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards. ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a nongovernmental organization that forms a bridge between the public and private sectors. ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. View the ISO Standards list.
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