EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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44 | Spring 2014 European Medical Device Technology emdt.co.uk special report with their critical subcontractors and crucial suppliers to ensure they will grant access to auditors and submit to the unan- nounced audit. This step is imperative, according to Notified Body BSI Group, because if these designated suppliers or subcontrac- tors deny access to auditors, they put the manufacturer's compliance status at risk. Ultimately, a lack of cooperation by the supply chain becomes a manufacturer's headache. Notified Bodies have always had the power to conduct a supplier audit if deemed necessary to respond to a qual- ity concern, but the circumstances have changed. "In the past, we would have usually accepted that a supplier is already certified by either the same Notified Body or another Notified Body and has a cer- tificate for the parts or processes that are outsourced by the manufacturer," Havel says. "But following the logic of unan- T E C H N O L O G Y As Notifed Bodies begin con- ducting unannounced audits, here is a rundown of what medical device manufacturers should do to prepare: ✓ Put a concrete plan in place for an unannounced audit—and a Plan B probably wouldn't hurt, either. ✓ Make sure all subsidiaries are aware of the potential for an unannounced audit and are adequately prepared. ✓ Consider performing an internal mock audit to assess trouble spots or weaknesses. ✓ Determine your critical subcontractors and crucial suppliers. ✓ Review your contracts with critical subcontractors and crucial suppliers, and revise as necessary to accommodate for the needs of unannounced audits. ✓ Review your contract with your Notifed Body. ✓ Budget for the new costs associated with unannounced audits. Unannounced Audit Check List Visit us at MEDTEC Europe Stand 5E41 Visit us at MEDTEC UK Stand 223 ES433888_EMDT1405_044.pgs 05.02.2014 14:04 UBM black yellow magenta cyan

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