Are you ready for ISO 15189:2012 to make a difference in your bottom line?

20 May 2021

Is it possible to get more efficiency in your conventional and specialty tests while maintaining ongoing quality? ISO 15189:2012 accreditation answers this question by delivering a comprehensive approach to quality management in medical, central and referral laboratories. Not only can these standards ensure quality, but they can reduce your risk of costly delays and ultimately save money in your trials.

“It’s no surprise that sponsors are concerned about the risk of regulatory findings and increasingly requesting ISO-accredited labs,” said Paul Kirchgraber, Vice President and Global General Manager at Central Laboratory Services. “They need a demonstration of increasing quality—and savings—across their outsource vendors. Adopting ISO 15189:2012 is a powerful way to highlight our broad quality standards that meet or exceed their expectations.”

How Continuous Improvement Drives Results

No process is foolproof. That’s why ISO put careful steps in place to correct and prevent errors through careful monitoring and auditing of issues. “Because ISO focuses on risk management and continuous improvement, it ensures we are looking at our processes to reduce risk, cost and turnaround time, while improving efficiencies for clients’ protocols with each iteration,” said Nancy Taylor, Quality Management System Lead, Central Laboratory Services.

The International Recognition of ISO

If you need global acceptance of your data, ISO 15189 has you covered. As a widely recognized standard, the core of 15189 promotes global harmonization of clinical laboratories to protect data, efficiently exchange information and ensure competence around the world. The 2012 revision of ISO 15189 details several of these changes, including specific language for the quality management system requirements and performance monitoring of external testing overseen by central laboratories for clinical trials.

Overseeing your Referral Labs

Clinical testing often relies on multiple laboratories for results. ISO 15189:2012 considers this factor as well. It requires that any data from external testing meets the rigorous standards for data inclusion in a regulatory submission. Referral labs’ performance is overseen by our Expanded Laboratory Management Solutions (ELMS), a team with more than 30 lab professionals dedicated to ensure that external lab testing—no matter where it takes place—follows strict quality standards to deliver globally combinable data. As an added advantage, the ELMS process also offers economies of scale and lower costs to sponsors.

Meeting Demands for Globally Consistent Data

ISO 15189 didn’t happen overnight. Starting in 2013, we began to certify each of its five central laboratories in the United States, Switzerland, Singapore, China and Japan. “As soon as we started on this journey, there was a strong commitment to continue on the path. To do it in less than two years for all five sites is quite an achievement,” said Marian Mutch, Director, Global QA, Central Laboratory Services.

From new approaches to improved efficiencies, central laboratories will continue to help sponsors address the trend of increasing clinical trial complexity. Now, sponsors can feel more confident that their clinical trial data packages meet the higher scrutiny of regulatory agencies through the holistic standards of ISO 15189:2012.

Learn more about how our ongoing commitment to quality management systems and continuous improvement in laboratory testing can make a difference in your results and help you achieve regulatory success.