The Association for the Advancement of Medical Instrumentation (AAMI) has developed a new benchmarking tool to help medical device designers and manufacturers determine how their quality management systems (QMS) compare with that of their peer companies, just as the Food and Drug Administration (FDA) increases its focus on quality.
A free online demonstration of AAMI’s new benchmarking platform will be held on Wednesday, Oct. 30, 2013 at 3 p.m. Medical device designers and manufacturers can register for the free online demo by clicking this link and entering their contact information.
In recognition of a new FDA emphasis on promoting device quality, and not simply regulatory compliance, AAMI has created Benchmarking Solutions—Quality Management System for Medical Devices. The resource is designed to help medical device quality system professionals compare their organizations’ QMS policies, processes, procedures, and performance metrics against those of other organizations in the field. The tool also can be used by a company to benchmark its different manufacturing facilities and operations. This is AAMI’s third online benchmarking tool; the other two are targeted at the healthcare technology management (HTM) and sterile processing communities.
Through the new program, companies subscribe annually to anonymously enter their data into an online survey. They can update and revise their data at any point during the year.
Initially, the tool will feature in-depth questions on two important QMS processes—CAPA and risk management—and will expand into other quality system processes in the future. The benchmarking questions for the two QMS processes were developed by a team of eight subject matter experts. A steering committee that oversaw the development of the benchmarking tool included representatives from the FDA, industry, AdvaMed, and Dynamic Benchmarking—AAMI’s software developer that produced all three of the benchmarking programs. The work of the experts and the steering committee was facilitated by Ed Kimmelman, QMS technical consultant to AAMI and convenor of the ISO/TC210, WG1, the developer of ISO 13485:2003.
After answering the questions on risk management and CAPA, a subscriber can compare its results against other manufacturers based on organization size, complexity, market focus, and other criteria. Output results are displayed using simple, intuitive charts and graphs, which can be customized for internal presentations.
AAMI plans to expand the benchmarking tool each year with additional QMS process areas (e.g., design and development, process validation). A Benchmarking Advisory Task Force will review recommendations from subscribers and also make its own suggestions for improvement. Members of AAMI’s staff will review the task force’s recommendations.
For a single organization, a new one-year subscription is $1,100 for AAMI members and $1,450 for nonmembers. The “results only” option, intended for consultants and others who want to view aggregate benchmarking data but don’t have any of their own to enter, will cost members $2,200. The list price is $2,700.
Source: Association for the Advancement of Medical Instrumentation