Understanding ISO 13485:2003

Description
This BSI Management Systems course gives students a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485:2003. The course focuses on teaching the process approach for quality management and how ISO 13485:2003 and GMPs complement each other.

In addition, students gain an introduction to the concept of risk management as described in the standard ISO 14971:2001, “Application of Risk Management to Medical Devices.” The course includes exercises to provide students with the opportunity to practice the information taught in the course. Our instructors also encourage discussion and debate as part of the learning process.

*Date*	*Location*	*Enrollment*
2010
08/11	Atlanta, GA	*Enroll Now*
08/23	Dallas, TX	*Enroll Now*
09/13	Reston, VA	*Enroll Now*
09/27	Philadelphia, PA	*Enroll Now*
10/04	San Diego, CA	*Enroll Now*
10/18	Minneapolis, MN	*Enroll Now*
11/01	Atlanta, GA	*Enroll Now*
12/06	San Jose, CA	*Enroll Now*
12/15	Orlando, FL	*Enroll Now*
12/15	Philadelphia, PA	*Enroll Now*

Learning Objective

Interpreting All Clauses of ISO 13485:2003
Understand Differences between ISO 13485:1996 and ISO 13485:2003
Interpret All Clauses of ISO 13485:2003
Understand the Role of Management in ISO 13485:2003 Implementation
Understand the Proper use of ISO/TR 14969:2003-WD2
Recognize the Relationship between Risk Management and ISO 14971:2002
Understand the Linkage between ISO 13485:2003 and GMPs

Course Materials
Students receive comprehensive course manuals with reference materials.

Audience

Quality managers
RA managers
Auditors of medical device manufacturing firms (internal and external)
Cross functional team members implement ting the standard

Prerequisite
Participants should have a basic knowledge of quality management systems, ISO 9001:2008, or ISO 13485:2003

Duration
The course is taught as a one day class, from 8:00 AM - 5:30 PM .

The course content for Understanding ISO 13485 and the first day of the ISO 13485 Internal Auditor Course are identical.

CEUs
The student certificates display 0.7 continuing education units for the class.

Fee
The course fee is $595 per student. To confirm your enrollment, pre-payment will be required.

Early Bird Discount
If you pay at least 60 days in advance, you will receive a $50 discount, reducing the fee to $545.

Group Discount
If you enroll three students, the fourth student is free, which equates to 25% off each enrollment.

Contact
If you have any questions about this course, please call us at 770-517-7944 or send an e-mail to Larry@WhittingtonAssociates.com.

-top-

Copyright © 2000 - 2010 Whittington & Associates, LLC. All Rights Reserved. 242 Highlands Drive, Woodstock, GA 30188 770-517-7944 or fax 770-517-7945	Frogtown's North Georgia Web Design
Whittington & Associates provides training, consulting and auditing services for management systems based on ISO 9001, ISO/TS16949, TL 9000, AS9100, ISO 13485, ISO 27001, ISO 20000, and ISO 14001.