Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation efforts, do you know which quality function demands the attention, or should you make improvements to both?

More often than we may like to admit, a vast majority of medical device professionals do not have a full grasp on the acronyms and meanings of core industry terminology relevant to their role.

Quality assurance and quality control are complementary parts of a quality management system, yet they serve very distinct roles with different purposes. Without knowing how the two quality functions differ and intersect, your QMS processes will struggle, and more importantly, you’ll struggle to ensure your medical device is safe and effective.

This article will clear up any lingering confusion around the two terms quality control and quality assurance, explain how they differ from one another and how they intersect, and how professionals in these roles can leverage certain tools and methodologies to successfully control quality and assure quality.

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