When

Tuesday, September 19, 2017 at 9:00 AM EDT
-to-
Wednesday, September 20, 2017 at 5:00 PM EDT

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Where

Ivy Tech Community College 
200 Daniels Way
Bloomington, IN 47404
 

 
Driving Directions 

Contact

Kathy Heuer 
Indiana Medical Device Manufacturers Council 
260-609-2802 
imdmc@imdmc.org 
CLASS   

ISO 13485: 2016 INTERNAL AUDITOR TRAINING offered in 2 locations in September & October

  • October 10 & 11 (Indiana Wesleyan North Education & Conf. Center, 3777 Priority Way South Drive, Indianapolis...off of 96th St. 
  • Class is Almost Filled. 
  • Deadline to Register is October 5

In these two-day workshops, you will gain the knowledge and skills you need to audit your quality system to the ISO 13485:2016 standard. Course topics include updates to the ISO 13485 standard, ISO 13485:2016 requirements, auditing principles, and techniques for conducting effective audits. You'll also receive hands-on practice using auditing tools and techniques and have ample opportunities to get answers to questions you have about conducting IOS audits.

Class objectives include the following:

  • Purposes of the ISO 13485 standard
  • Structure and elements of ISO 13485:2016
  • Describe changes included in ISO 13485:2016
  • Explain the "Process Approach" and what the strategy of a process approach means for organizations
  • Explain basic principles, techniques and steps for auditing to ISO13485
  • Teach techniques for effectively working with others when conducting audits

Certifications from Purdue University will be given to all attendees at the completion of the two-day workshop.

Attendees should bring a copy (hard copy or downloaded copy) of the ISO 13485: 2016 Standard with you to class. If you do not have a copy, one can be purchased at this website: https://www.iso.org/home.html

Who should take this training? All personnel involved in conducting or supporting ISO internal audits!