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ISO, ILAC, IAF Streamline QMS Requirements for Medical Labs

Recognition to reduce redundant, costly, and time-consuming audits.

ISO
Wed, 11/04/2009 - 12:03
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(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.

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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.

 …

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