Quick Tip - A culture of quality naturally leads to excellence in risk management

In a quality culture, risk management is not separated from quality management.

In the medical device industry, we talk a lot about having a Quality Management System (QMS) to maintain compliance with regulatory requirements.

But having a QMS and expecting everyone to simply follow the rules is not the same as living and breathing Quality in everything we do.

When you focus only on compliance, risk management also becomes a check-the-box activity. But when you create a culture of quality, risk management becomes a natural part of your work processes. It is not a separate activity.

First, you must create awareness for change. This is the why before the how. Help your organization understand the business need for change by focusing on the needs of your patients, healthcare providers and other stakeholders.

Risk management is not about compliance. It is a way to get to the final goal of consistently delivering safe and effective medical devices that help change lives.

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