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Center for Quality and Applied Statistics

Internal Auditing ISO 13485 for Medical Device Standard

Tuesday, November 11, 2014 - 8:30am to Wednesday, November 12, 2014 - 4:30pm

Internal Auditing to 13485 Medical Device Standard

Through formal presentations, workshops, case studies and open-forum discussions, the ISO medical device 13485 standard and auditing skills are brought alive with humor.

You will be using the ISO 13485 standard and how to audit to the new process approach. You will learn how to plan and perform an audit as well as how to report findings and review corrective action.

Topics include:

•Overview of the ISO 13485 Medical Device Standard
•Characteristics of a good auditor
•Auditing a process and systems approach
•Planning the audit and setting objectives
•Developing questions and checklists
•Reporting findings
•Verifying corrective action

Who should attend: Individuals who will be conducting internal audits or supplier audits based on any quality system standard.

Dates: November 11 - November 12, 2014   8:30 am - 4:30 pm

Cost: $650.00. This cost includes continental breakfast and lunch for each day.

Location: The RIT campus at the Center for Quality & Applied Statistics located in the Hugh L. Carey Building (Building 14)


   Greg Evershed
   Director of Business Developement 



  Rochester Institute of Technology
One Lomb Memorial Drive,
Rochester, NY 14623-5603
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