Winter Series- ISO 13485 Internal Auditor Training

Monday, February 03, 2014 (8:30 AM - 5:00 PM)

Feb. 3-4, 2014

To successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This two-day training course teaches auditing to the ISO 13485 standard and places a strong emphasis on promoting employee participation in the improvement process.

Participants in this course will learn how to:

  • State the goals and benefits of an internal audit
  • Determine the requirements of an internal audit
  • Explain how ISO 13485 differs from ISO 9001 and the areas of focus for Medical Devices.
  • Plan an internal audit, and develop a guide list
  • Perform an internal audit
  • Identify nonconformity to requirements during an audit
  • Report on an audit and follow up on corrective actions taken in response to audit findings
  • Describe the actions necessary for maintaining a successful  audit program

There are no prerequisites for this training class
, although a basic understanding of the ISO 13485 standard would be beneficial.
Course Duration
This course will take 16-hours (2-days) to complete.   

Training Course Fees
Cost is $595 per person and includes a comprehensive workbook and handouts for each participant.

Course Instructor Bethany Quillinan has 20 years of experience in Process Management and Improvement specializing in implementing and auditing ISO 9001-based Quality Management Systems. Her recent clients include Biotronik, Hewlett Packard, Leupold & Stevens, Oregon Bioscience Association, Precision Wire Components, Silicon Forest, TE Medical and Kaiser Permanente. An accomplished trainer and training course developer, Bethany holds a BS in Ceramic Engineering, an MA in Whole Systems Design for Organizational Systems Renewal, has passed the examination for Certified ISO 9001 Lead Auditor and is a Certified Six Sigma Black Belt.

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