Course #618 ISO 13485:2003 - Implementing the ISO Quality Management System (QMS) for Medical Device Organizations, April 6 & 8, 2010 http://www.acteva.com/booking.cfm?bevaid=190856
Course Description: The ISO 13485:2003 Standard is the current standard for Medical Device organizations and a quality management system (QMS) based on the 21st Century ISO standards. This course will give participants an understanding of the ISO 13485:2003 standard and the similarities and differences with the FDA Quality System Regulations (QSR's). Learning objectives: - Explore the similarities and differences between the ISO Standard and the FDA QSR's - Identify the technical and non-technical requirements for organizational readiness for effective QMS implementation - Given a problem in Standard interpretation, be able to resolve it to meet compliance Using lecture, case examples and interactive exercises, the course will include: - Comparisons of the ISO 13485:2003 standards and the FDA QSR's. - The opportunity to develop a map and methods to transition from an existing registration or QMS to the replacement ISO 13485:2003 - Methods to identify organizational readiness for third party registration, particularly Gap Analysis and Internal Audits. - An understanding of the business value of registration to a QMS standard for the organization - Exploration of non-technical issues (the human element) that impact effective registration Course length: two 8 hour sessions Instructor: Marieann Shovlin
