AAMI to Host Free Demonstration of Its Online Quality Management System Benchmarking Tool

The Association for the Advancement of Medical Instrumentation (AAMI) will host a free demonstration of its online quality management system (QMS) benchmarking tool on Wednesday, Nov. 18, 2015, from 2 p.m. to 2:30 p.m. EST. With the Food and Drug Administration continuing to increase its focus on quality, Benchmarking Solutions-Quality Management System for Medical Devices provides device designers and manufacturers with a way to determine how their QMS compares with that of their peers in areas such as QMS policies, processes, procedures, and performance. The tool also can be used by an individual company to benchmark its various manufacturing facilities and operations.

During the online demonstration, quality system expert Ed Kimmelman and Betsy Delfosse, head of product marketing and development for Dynamic Benchmarking, will show participants how the tool uses answers to in-depth questions about two important QMS processes-corrective and preventive action (CAPA) and risk management-to compare organizations. Participants also will be able to see how output results are displayed using simple, intuitive charts and graphs.

Overall, the demonstration will provide participants with the opportunity to:

- Assess their adherence to industry standards Examine process performance, issue escalation, and CAPA management and prioritization

- Explore staff training and policy development Learn about preventive action statistics

Anyone interested in learning more about the QMS benchmarking tool should register online. Current subscribers are also welcome to join the discussion to share their experiences and ask questions. The QMS benchmarking tool was developed by a team of eight subject matter experts that was overseen by committee of regulatory, industry, and technology representatives. AAMI plans to expand the benchmarking tool each year with additional QMS process areas, including design and development and process validation. To learn more about all three of AAMI’s benchmarking tools, visit www.aami.org/benchmarking.

Source: AAMI