Center for Quality and Applied Statistics
Internal Auditing to ISO 13485 for Medical Device Standard
Internal Auditing to ISO 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.
- 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.
Wednesday, September 24 - Thursday, September 25, 2014 8:30 AM - 4:30 PM
$750.00. This cost includes continental breakfast and lunch for each day.
The RIT campus at the Center for Quality & Applied Statistics located in the Hugh L. Carey Building (building 14)
Meet your instructors
John T. Burr is the lead trainer for the ISO 9000 related seminars offered at RIT CQAS. He is a retired CQAS faculty member and spent 24 years as an analytical chemist, quality consultant and director of quality audits for Eastman Kodak Company. He is an ASQ fellow, a Certified Quality Engineer, and also a Certified Quality Auditor. He has been teaching the use of ISO Standards and auditing to these Standards since 1990.
Robert Berg worked as a chemist at Eastman Kodak Company for 30 years. During that time he provided chemical testing and technical support for toner, synthetic chemical and polymer manufacturing operations. He supervised several laboratories, in which he implemented and maintained ISO Guide 25 compliant quality systems. He has been involved in ISO/QS 9000 quality documentation and auditor training since 1998. He is currently a certified RABQSA Lead Auditor currently specializing in agricultural audits for Bureau Veritas.
Director Bus. Dev.