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Description
This BSI Management Systems course is designed for those with knowledge of medical device manufacturing and starts with one full day of review of ISO 13485:2003. Students gain a broad understanding of the ISO 13485:2003 quality management system requirements. In addition, the concepts of ISO/TR 14971:2001, “Application of Risk Management to Medical Devices,” are introduced.
Through small group activities, audit role-plays, lively discussions, and instructor-led lectures, students gain a thorough understanding of the principles of auditing. Students also learn how to apply the guidance of ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing,” to implement effective internal audit programs for medical device manufacturing organizations.
This course is certified by the RABQSA. Students successfully completing this course (by
passing the continual evaluation and the written examination) fulfill the RABQSA training
requirements for an internal quality systems auditor.
This course has also been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Learning Objective
- Interpret All Clauses of ISO 13485:2003
- Understand Differences between ISO 13485:1996 and ISO 13485:2003
- Apply Principles of ISO/TR 14969:2003-WD2 and ISO 14971:2001
- Understand the Quality Management Principles
- Apply Principles of ISO 19011:2002 to the Auditing Process
- Plan, Conduct, and Report Effective Internal Audits to ISO 13485:2003
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 working knowledge of quality management systems, ISO 9001:2008, or ISO 13485:2003.
Duration
The course is taught as a three day class.
Class Hours
Day 1: 8:00 AM - 5:30 PM
Day 2: 8:00 AM - 5:30 PM
Day 3: 8:00 AM - 5:30 PM
Students taking the Understanding ISO 13485 course will also attend the first day of this course .
CEUs
The student certificates display 2.1 continuing education units for the class.
Fee
The class is $1195 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 $100 discount, reducing the fee to $1095.
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.
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