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FDAnews Device Daily Bulletin
Sept. 17, 2012 | Vol. 9 No. 182
Some QMS Audit Lengths to Increase Under New International Standards
Devicemakers seeking ISO 13485 certification can expect longer initial audits of their quality management systems (QMS), thanks to a new mandatory document by the International Accreditation Forum. The document, called MD9, increases the duration of certification bodies’ initial QMS audits on average by three days for larger devicemakers and two days for smaller companies, Gert Bos, head of regulatory and clinical affairs at the British Standards Institution, said.
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