Helping Organizations Improve

Providing Quality Management System Expertise


Kathryn Roberts, with The BlueWater Group, Inc., assisted Drug Safety Alliance in developing our quality management system. She expertly analyzed our operations, developed an action plan and successfully implemented quality management system processes and procedures. Her professionalism, enthusiasm and guidance along the way made her a delight to work with.

 I consider The BlueWater Group, Inc. a strategic partner for Drug Safety Alliance and would not hesitate to use their services again.  I highly recommend The BlueWater Group, Inc. to any organization that wants to implement a quality management system successfully in a timely manner, as well as to any organization that wants to improve business processes and procedures.

Catherine C. Stokes
President and CEO
Drug Safety Alliance


As Executive Vice President of Regulatory Affairs and Quality Assurance for my company, I was tasked with bringing the company into compliance under ISO 9001.  Although at the time we were considered a small company, this was quite an undertaking.  Yes, we had standard operating procedures in place but we really did not know what we were missing.  We engaged Kathryn Roberts, of The BlueWater Group, Inc. to provide a gap assessment for us and then hired her to assist in the overall preparation for ISO certification. 

Kathryn helped in the development of timelines and provided valuable tools for our team to utilize as we begin to standardize processes and forms, and ensure that staff were adequately trained on the ISO standards.  Kathryn’s guidance was invaluable and I am proud to say that our company passed our certification audit with flying colors, and have remained compliance for over 3 years. We recently were recertified for another 3 years. Our clients are most impressed when we tell them that our company is certified under ISO and that we take such a vested interest in the quality of our work.  I highly recommend utilizing the services of The BlueWater Group, Inc. if you are anticipating venturing the world of ISO certification.

Elaine F. Wingate, MS
Executive Vice President, Operations
Clinical Monitoring & Regulatory Affairs
Novella Clinical, formerly PharmaLink FHI


The guidance we received from The BlueWater Group, Inc. throughout our ISO 9001 certification process literally is what made our goal a reality.  The certification process can be a long and arduous task.  Kathryn Roberts’ expertise and the goal oriented timeline she put in place allowed us to take a step by step approach to our certification.  By utilizing the timeline approach, it clearly outlined each step and allowed for the necessary time to not only develop each stage of our quality system, but understand each stage before moving to the next level. 

Our certification has been in place for five years.  I attribute the continued success of our quality system to two factors: employee commitment and our continued relationship with The BlueWater Group, Inc.  They continue to be an invaluable resource to us as our system evolves to meet our changing needs.

Brent Bell
Operations Manager
Industrial Packaging Group, Inc.


After having attended Kathryn Roberts’ ISO 9001 seminar at NCSU and being very impressed with her knowledge and experience, I contacted Kathryn and The BlueWater Group, Inc. for support and input into creating a robust Quality Management System from the very beginning stages to ISO certification.

Kathryn was able to quickly determine where we were in the process and work with us to map out a comprehensive strategy that set us on the road to success. She kept us focused and moving forward providing open and honest guidance to all functional areas and levels within our company.

Not only did we utilized Kathryn for helping us get ISO 9001 certified, we also  contracted with Kathryn to conduct all of our internal audits for us. This enabled us to have very unbiased & objective feedback.

 Kathryn was chosen by our company continuously due to her professionalism, dedication, extensive skill sets in quality management and superior people abilities that led to us all to think of Kathryn as “One of Ours”.

 After 10 years of working with Kathryn Roberts and The Blue Water Group, Inc.,  I would not hesitate to recommend them to anyone needing support for their business.

Robert Lancaster
Quality Assurance Manager
Cameron & Barkley Company
& Hagemeyer North America