Learn to develop and implement an internal quality system that meets the requirements of ISO 9001:2008 and ISO 13485. This course will help you prepare for an audit and effectively manage your resources. You’ll understand how to close out an audit and conduct follow-up surveillances.
- Atlanta, GA (5003)
- Schedule and Travel Info Register
- June 18 – 20, 2012
- Member: $1095.00
- List: $1195.00
- Minneapolis, MN (5326)
- Schedule and Travel Info Register
- August 27 – 29, 2012
- Member: $1095.00
- List: $1195.00
- Memphis, TN (5255)
- Schedule and Travel Info Register
- October 15 – 17, 2012
- Member: $1095.00
- List: $1195.00
- Arlington, VA (6046)
- Schedule and Travel Info Register
- April 29 – May 1, 2013
- Member: $1095.00
- List: $1195.00
- On-Site Training
- Request Information
- Need to train a group of five or more? Consider on-site training.
This training course satisfies the requirement for RABQSA’s 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.
- Learning Objectives
- 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 pre-audit activities and conduct the audit, 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.
- Who Should Attend
Professionals who will conduct or participate in internal audits in the medical device industry, and those seeking to develop an ISO 13485 compliant quality management system should attend this training.
- More Information
Prerequisites
All attendees are required to bring their own copy of the ISO 13485:2003 standard to this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (Item #T13485).
Course Data
- CEU Hours: 2.50
- ASQ RU: 2.50
- Provider: ASQ
- Course ID: IAT13485
- Course Length: 25 hours
- Cancellation Policy
- Instructors
