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