Course/Product Description Title: Understanding an ISO 13485 Quality Management System Metropolitan Area: Minneapolis Event Venue: TBD Address: Minneapolis, MN Contact Phone: 770-410-9441 Starting Date / Time: 3/17/2010  -  8 am - 5 pm EST Duration: 2 days Description: Get the information you need to understand the ISO 13485:2003 and ISO 9001 standards and how they impact your organization. Dynamic group discussions focus on: When compliance or registration is required or desirable How to document and design an effective quality management system what the revised requirements mean for the worldwide medical device industry What auditors are looking for and finding Also covered are the steps and potential benefits of registration, such as: Increased Productivity Cost Effectiveness Higher Perceived Quality Enhanced Internal & External Communication Competitive Advantage For a complete week of FDA regulatory training, combine this two-day interactive program with our Understanding FDA's Medical Device Quality System Regulation (2 days), and FDA Quality System Inspectional Techniques (QSIT) (1 day). Select from one of the following options: Boston, MA (January 2010) Edison, NJ (February 2010) Minneapolis, MN (March 2010) Los Angeles, CA (April 2010) Boston, MA (June 2010) Minneapolis, MA (July 2010) Course Objectives Understand and describe the purpose, benefits and objectives of ISO 13485:2003. Explain the similarities and differences between ISO 9001 and ISO 13485:2003. Discuss the recent changes to ISO 13485:2003. Understand the implications of the medical device industry's changing standards and regulations. Learn how changes to ISO 13485:2003 affect the worldwide medical device community. Know how and when to implement your quality system. Choose an implementation plan. Prepare for a compliance or registration audit. Look for common system deficiencies found by external auditors. Ensure your system is compliant and effective Course Topics Introduction to ISO 13485:2003 ISO 13485:2003 sections Documentation requirements Quality system procedures ISO 13485:2003 analysis Sample procedures Introduction to ISO TR 14969 Who Should Attend This course is recommended for medical device and diagnostics industry quality and regulatory professionals, who need the latest information on ISO 13485:2003 and ISO 9001. Those responsible for implementing or transitioning to the revised standards should also consider taking this course. * Includes discussion of ISO TR 14969 revision Licenses / Designations / Educational Credits: CEU All US States: 1.5 All Canadian Provinces: 1.5 About The Provider: Founded in 1968, STAT-A-MATRIX is the world's leading consulting and training organization dedicated to improving business processes, management systems, and quality and regulatory compliance. We offer ongoing consulting and training in every aspect of business process improvement. Our approach is a unique blend of concepts, methods, techniques, and tools designed to transfer skills and knowledge to your organization's personnel. Our distinct approach integrates quality, regulatory, and business management systems to help improve your bottom line. Price: $1,095.00 More Info: Contact Us For More Information Click Here For More Cities And Dates To order this product by check/invoice or credit card, enter desired quantity here >>> Qty:

Keywords For This Course:
ISO standard, increased productivity, cost effectiveness, higher perceived quality, enhanced internal, external communication, competitive advantage