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Volume 8 · Issue 5 · May 2003


Page 3…
ISO 19011 and ISO/FDIS 13485 Balloted as US Standards

Three standards completed the balloting process recently on the international and/or US level. Once published, these measurements, medical devices and auditing standards will have an impact on QMS and/or EMS usage. However, the process forward for some still involves additional steps. Information is provided on international approval of ISO 10012:2003, balloting of ISO/FDIS 13485 on the international and American National Standard level and ISO 19011 on the American National Standard level, with QE 19011S approaching the WD stage.