Understanding an ISO 13485 Quality Management System

Onsite Training & Consulting
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Course Description

Get the information you need to understand the ISO 13485 and ISO 9001 standards and how they impact your organization. Dynamic group discussions focus on when compliance or registration is required or desirable, how to document and design an effective quality management system, what the revised requirements mean for the worldwide medical device industry, and what auditors are looking for and finding. Also covered are the steps and potential benefits of registration, such as increased productivity, cost effectiveness, higher perceived quality, enhanced internal and external communication, and competitive advantage. 

For a complete week of medical device regulatory training, precede this two-day program with our Understanding FDA's Medical Device QSR and QSIT (3 days).

To register for both courses and save $200, click here



CEUs:1.5
Number of days:2
Code:QSF
Cost:$1495.00

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Objectives
  • Understand and describe the purpose, benefits and objectives of ISO 13485:2003.
  • Explain the similarities and differences between ISO 9001 and ISO 13485:2003.
  • Discuss the recent changes to ISO 13485:2003.
  • Understand the implications of the medical device industry's changing standards and regulations.
  • Learn how changes to ISO 13485:2003 affect the worldwide medical device community.
  • Know how and when to implement your quality system.
  • Choose an implementation plan.
  • Prepare for a compliance or registration audit.
  • Look for common system deficiencies found by external auditors.
  • Ensure your system is compliant and effective.
Topics
  • Introduction to ISO 13485:2003
  • ISO 13485:2003 sections
  • Documentation requirements
  • Quality system procedures
  • ISO 13485:2003 analysis
  • Sample procedures
  • Introduction to ISO TR 14969
Who Should Attend

Recommended for medical device and diagnostics industry quality and regulatory professionals who need the latest information on ISO 13485:2003 and ISO 9001, and those responsible for implementing or transitioning to the revised standards.

Upcoming dates and locations
Please contact us if you need additional information or if you don't see a date that works for you.
To register by phone, call 800.472.6477

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Course Name On-Site Public Dates
Location Start Date Days Cost Registration
Understanding an ISO 13485 Quality Management System CONTACT US Dallas, TX 06/21/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Chicago, IL 06/28/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Indianapolis, IN 06/28/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Edison, NJ 07/12/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US San Francisco, CA 07/19/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Orlando, FL 07/26/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US St. Louis, MO 08/02/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US San Diego, CA 08/09/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Raleigh, NC 08/16/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Columbus, OH 08/23/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Boston, MA 09/13/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Minneapolis, MN 09/13/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Dallas, TX 09/20/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Chicago, IL 09/27/2012 2 $1495.00 Add to Cart
Understanding an ISO 13485 Quality Management System CONTACT US Indianapolis, IN 09/27/2012 2 $1495.00 Add to Cart
 
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