After the lead auditor asks, “Can you show me the change history on this document?” approximately ninety seconds into an
Every quality manager has met the small-business owner who treats “quality management system” like a phrase reserved for Fortune 500
The first time most small business owners hear “ISO 9001,” it arrives attached to a customer requirement. A prospective client,
Many pharmaceutical, medical device, manufacturing, and laboratory organizations still manage their audit programs through a combination of Excel spreadsheets, SharePoint
The regulatory ground under audit management just moved, and most quality teams in pharma and medical devices haven’t fully registered
The audit report lands in the quality manager’s inbox on a Tuesday. Twelve findings, three of them major nonconformances. By
By the third week of the quarter, an empty audit log starts to feel less calm and more like a
We can almost always expect organizational chaos to settle around audit season. Schedules circulate on shared drives. Checklists get printed,
A surprising number of audit findings have nothing to do with how a process was designed and everything to do
The word “audit” gets used so loosely inside organizations that its meaning has nearly collapsed. Understanding the three distinct audit
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