The Genetic Link

Welcome to The Genetic Link, a blog providing new insights into DNA and RNA sample collection by DNA Genotek. DNA Genotek is a subsidiary of OraSure Technologies, Inc.

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Article by: Shauna White

A peek into what quality really means to DNA Genotek


You’ve heard us say that our commitment to quality spans all aspects of our internal procedures from customer support to product development and manufacturing – but what does this really mean? Does a quality program really make an impact?

First, let’s define what quality means to us. You probably know quality when you see it but putting it into words is more difficult. Let’s try this definition: Quality is a well-defined process for creating a reliable product that adds value for customers. If we agree this can define quality, what does a quality program do? Our quality program allows us to consistently manufacture products that perform according to their stated promises and will endure normal, everyday use. Our quality program includes strategies and check points that ensure consistency and excellence in the delivery of products and services to our customers.

For a quality program to be effective, it must stem from the top of the organization and infiltrate every member of the team.  Is this the case at DNA Genotek? We have a dedicated quality team that is responsible for implementing and managing the quality program but quality is not solely the responsibility of this team. DNA Genotek’s leadership team has instilled a passion for quality across the organization and as a result, the entire DNA Genotek organization is committed to quality through all aspects of our business. Every person at DNA Genotek plays a role by placing quality management practices at the center of each project from product development, to marketing, to sales, to support, to finance and more. This focus effectively makes each employee a quality manager that is responsible for quality being built-into all of our activities.

Let’s take a quick look inside the company with Dan Fullerton, Vice-President Operations, Quality and Regulatory Affairs, and see what he thinks quality means to DNA Genotek.


For many businesses, a quality program is often viewed as a luxury – something that can be sacrificed, if necessary, for added functionality, faster development or lower costs. That’s not the case for DNA Genotek. In 2006, we achieved ISO:13485:2003 certification, which is a quality management system standard specific to the medical device industry. We’ve been subject to annual ISO audits since 2006 to ensure we adhere to the principles of the standard in all we do, providing customers with confidence in our products and services. We’re also subject to inspections from regulatory bodies from several countries including Health Canada and the U.S. Food and Drug Administration. But it doesn’t stop there. One of the primary goals of our quality program is to continuously improve our products and services. Through data collection, measurement, and analysis, aspects of our products or services that demonstrate opportunities for improvement are identified and prioritized. And if at any time our customers experience any challenges with our products, we have documented procedures to resolve them quickly.

So, does a quality program really matter? We think it does. We implemented our quality program to raise the standard of excellence in our business. That means we will live up to the commitments we make to our customers. We listen, understand and respond to our customers. A commitment to quality underpins everything we do at DNA Genotek. It is a core value of our organization and is designed to ensure that our customers and DNA Genotek achieve success together.

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