Poague & Associates, Inc.

Case Studies

St. Jude Medical

Poague & Associates, Inc. worked with two divisions of St. Jude Medical at 4 different facilities in 4 states to help them implement their ISO 14001 Environmental Management System. This involved working with their Facilities Group, and their Quality Group with an existing ISO 13485 Quality System, to design the best possible mix of integrated and stand alone processes. 

Medical Device manufacturing and ISO 13485, along with the FDA regulations, can be complex.  Poague & Associates, Inc. worked with the Quality group, and the Facilities Group to ensure all of the Management Systems requirements were met without any added complexity, and simplifying other processes.  This entailed keeping some of the environmental processes completely separate from the medical device manufacturing processes. In other words, not integrating the environmental into the quality system processes.  Keeping the environmental corrective actions separate kept it much simpler, it streamlined the environmental CA approvals, documentation requirements, as well as the overall process.  It also kept from "muddying the water" by adding more complexity to the ISO 13485 CA process. 

What does this mean for you ??
Some processes should be integrated, and others should not.  Poague & Associates, Inc. helps you determine the level of integration that fits within the context of your organization.