Quality Management Systems

If you've ever reviewed FDA 483 observations or warning letters, you've noticed something: document control issues are everywhere. They show up in medical device inspections, pharmaceutical manufacturing audits, laboratory GLP inspections, and every other regulated industry the FDA oversees. The reason document control failures are so common isn't that they're technically difficult to prevent. It's that document control touches literally everything your organization does - ev

If you've spent any time reviewing FDA warning letters, you've probably noticed a pattern: supplier-related issues show up everywhere. Incoming materials that don't meet specifications. Components with undisclosed changes. Test results from unqualified laboratories. Suppliers who can't demonstrate their own quality systems are adequate. The FDA's FY2024 Report on the State of Pharmaceutical Quality drove this point home. Over the past five years, 72% of regulatory actions aga

Choosing between ISO 13485 vs ISO 9001 can feel overwhelming, especially when regulatory compliance, market access, and customer requirements all hang in the balance. Both are internationally recognized quality management system (QMS) standards, but they serve different purposes and industries. If you're asking "Do I need ISO 9001 or ISO 13485?" - you're not alone. Many organizations in pharmaceuticals, medical devices, and laboratory testing face this exact decision. The wro