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Internal Auditor Training for ISO 13485:2003 (RABQSA Certified)
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CRSE IAT13485
Revision: 1 - 4/1/2009 03:31 PM Eastern
Description: This training course is certified by the RABQSA and satisfies the training requirement for individuals seeking registration under the RABQSA QMS Internal Auditor Registration Scheme. Learn the necessary background to develop, implement and audit an internal quality system that meets the requirements of ISO 9001:2008 and ISO 13485. This version of our RABQSA-certified QMS internal auditor course includes workshops tailored to meet the medical device industry and discussions of ISO 13485 medical devices-quality management systems requirements for regulatory purposes. Hands-on workshops reinforce the methods and techniques discussed. There is a one-hour exam on the last day.

Note: Due to stringent international standards guidelines, a maximum course enrollment is strictly enforced. If you are told you are on the waiting list or have registered and have not received a confirmation letter prior to the course, contact ASQ immediately to verify your status before you make travel arrangements.

List/Forum/Division Price: $1,145
Member Price: $1,045
 
 
Length: 28.55 Source:  Contact: ASQ Customer Service
CPEs: 0.00 RU Hours: 2.50 CEU Hours: 2.50
Goals: 
- Become familiar with the elements of a sound quality system.
- Understand the audit evidence necessary to comply with ISO 13485 requirements.
- Using ISO 19011 as a guide, learn preaudit activities, conducting the audit, and post-audit and follow-up activities.
- Know how to prepare for an audit and effectively manage your resources.
- Know how to collect audit evidence and document observations, including techniques for effective questioning and listening.
- Understand how to verify effectiveness of corrective action, close out an audit, and conduct follow-up surveillances.
Delivery Method: Classroom-based only
Audience: Professionals who will conduct or participate in internal audits in the medical device industry.
 
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