Understand the elements that constitute a quality system, and the audit evidence necessary to comply with ISO 13485 requirements. The course includes hands-on workshops that allow you to replicate the working environment of the medical device industry. The curriculum will reinforce key topics critical to your success in this field.
- Minneapolis, MN (5322)
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- August 27 – 31, 2012
- Member: $1595.00
- List: $1795.00
- Saint Petersburg, FL (5248)
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- December 10 – 14, 2012
- Member: $1595.00
- List: $1795.00
- Durham, NC (6062)
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- April 1 – 5, 2013
- Member: $1595.00
- List: $1795.00
- Milwaukee, WI (5992)
- Schedule and Travel Info Register
- June 17 – 21, 2013
- Member: $1595.00
- List: $1795.00
- On-Site Training
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- Need to train a group of five or more? Consider on-site training.
This training course is an RABQSA-certified course and meets the training requirements for certification of individual QMS auditors, QMS senior auditors, and QMS lead auditors. Successful completion satisfies the training requirements for individual auditor certification by accrediting bodies such as IRCA and RABQSA.
With an emphasis on hands-on training, this course features workshops tailored to the working environment of the medical device industry. You will discuss a range of topics including ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes, as well as ISO 9001:2008. Workshops reinforce key topics including documentation of audits, opening and closing meetings, auditor interpretations, listening and questioning techniques, checklists, and nonconformance reports.
- Learning Objectives
- Understand the elements that constitute a quality system.
- Interpret the requirements of ISO 13485.
- Compare and contrast ISO 9001 and ISO 13485.
- Understand the audit evidence necessary to comply with ISO 13485 requirements.
- Apply the skills necessary to develop an ISO 9001:2008/ISO 13485 auditing system based on the ISO 19011 auditing requirements.
- Learn how to plan audit activities, develop checklists, and perform pre-assessment visits.
- Demonstrate the skills needed to conduct opening and closing meetings tailored to the medical device industry.
- Practice the skills needed to collect audit evidence, handle confrontations, and improve listening and questioning techniques.
- Who Should Attend
Professionals involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier QA effort should attend this training.
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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: 4.40
- ASQ RU: 4.40
- Audience: Advanced
- Provider: ASQ
- Course ID: CLAMD
- Course Length: 44 hours
- Cancellation Policy
- Instructors
