Quick Tip: Avoid these red flags during audit of your risk management process
Insight from a conversation with Rick Rios
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LTR 31: Focus on the purpose to measure process effectiveness
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The increasing adoption of Medical Device Single Audit Program (MDSAP) has led to a major shift in current auditing practices in the medical device industry. MDSAP has forced auditors to apply a process-based audit approach rather than a checklist-based approach. The focus in a process-based audit is on process effectiveness and not just element-by-elem…