ASQ Section 706 July Event: Shaun Waters - Principles of ISO 15189
Mandarin King Restaurant - Banquet Room
This event has already passed by. Sorry.
Event Description
Speaker Bio
Shaun Waters developed a year-long continuous improvement
project as part of Genzyme Genetics’ College of American Pathologists (CAP) ISO
15189 accreditation process. The project
was designed to determine the root cause of a recurring issue involving a
pervasive contamination problem with specimens that were received from certain
clients. Shaun presented the findings of
his project to the CAP auditors during the final evaluation. Genzyme Genetics became the 2nd
lab in the U.S. to achieve the ISO 15189 accreditation.
Shaun graduated from UC Riverside in 1999 with a Bachelor of
Science in Biochemistry. He began his
laboratory career at Genetics Center in Orange, CA, where he worked primarily performing
tissue culture for cytogenetics applications for 9 years. Shaun has been a CLSp(CG) licensed
cytogenetics technologist for 15 years.
He also earned his MBA from USC Marshall School of Business, while working
full-time in the laboratory and attending the MBA.PM program in the evenings,
specifically designed for working professionals.
Shaun continued his cytogenetics career with Genzyme Genetics working as part of the team to earn ISO 15189 accreditation. He is currently working as a product manager for the Cytogenetics and Classical Media lines for Irvine Scientific, a tissue culture media company, in Santa Ana, CA.
Abstract
This presentation will cover the principles of ISO 15189, which applies to accreditation of medical reference laboratories. It will also emphasize the key concepts of ISO 15189: developing a quality management system, designing continual improvement projects, and utilizing root cause analysis to assess problems. The differences between ISO 9001 and ISO 15189 will be discussed to emphasize the specificity of ISO 15189 to medical laboratories. The cyclical process of earning and maintaining accreditation will also be presented in detail.
Please join us!
Share this event