Myth Busters!

Think Your Quality System Is Solid? Think Again.
From "just follow the SOP" to "we passed the audit, we’re good"—common quality misconceptions are quietly holding teams back. Let’s bust some myths that could be putting your work, results, and reputation at risk.

"Quality is just about following standards." 

Myth: If you're compliant with ISO or similar standards, your product is high quality. 
Reality: Standards are a baseline. True quality involves continuous improvement and focusing on customer value, not just ticking boxes.  

"Quality is only the responsibility of the Quality department." 

Myth: Only the Quality team members are responsible for ensuring quality. 
Reality: Quality is everyone's responsibility—from design to delivery. Embedding quality into processes and culture yields better long-term results. The Quality Department provides the framework, tools, and oversight for maintaining standards. When quality is treated as “someone else’s job” errors go unreported, standards slip, and systemic issues go unaddressed. 

"If we have procedures and review in place, quality is covered." 

Myth: Just having the procedures is enough to ensure quality. 

Reality: Although procedures are in place, this does not ensure that they are being followed. Regular audits and consistent internal review ensure that issues do not go unnoticed and that these procedures are effective.   

“Our last external audit had minor findings, so we are compliant” 

Myth: If the last external audit was successful, we will always be successful. 

Reality: Compliance at a point in time does not mean ongoing compliance. Internal procedures need continuous improvement and monitoring to ensure compliance.   

“Quality systems are only needed for GLP/regulated studies because we have to have them” 

Myth: Only regulatory areas/studies require Quality Systems. 
Reality: Regulatory compliance may be the driver for implementing quality systems in GLP studies, but the benefits extent far beyond “ticking the box”. Even in non-regulated work, applying the same principles can improve efficiency, reduce rework, and safeguard your organization’s reputation.  

"If there are no customer complaints, the quality must be good." 

Myth: If nobody complains, then we must be doing great. 

Reality: Lack of complaints doesn't equal high quality. 
Customers may not report issues—they might just switch to competitors. Silent dissatisfaction is a risk. Proactive quality measurement and feedback collection are essential.