ISO 13485:2003 Incorporating Key Requirements as a Quality Management System

Are you new to the 2003 version of ISO 13485? In this course, you will get an understanding of the requirements, learn key steps for implementing an ISO 13485 quality management system, and examine internal auditing procedures. You’ll also learn how to draft process-based documentation.
The course provides an overview of process validation, risk management, proper internal audits, and CAPA. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of Quality System Management, including direct work experience.

Note: All attendees are required to have their own copy of the ISO 13485:2003 standard for this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (Item #T13485)

• Learning Objectives
  • Apply ISO 13485 as a valuable business tool
  • Relate common QMS and compliance issues (FDA and others)
  • Describe the process approach
  • Identify business drivers
  • Use key steps to write effective documents
  • Recognize the role of risk management
  • Interpret the objective of internal auditing
• Who Should Attend

  This course is recommended for professionals directly involved in the development of an ISO 13485 quality management system and have a need to provide regulatory compliance in Canada, Japan, and Europe. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of an ISO 9001 quality management system, including direct work experience.

• More Information

  Prerequisites

  You must have your own copy of the ISO 13485:2003 standard for this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (Item #T13485).

  Course Data

  • CEU Hours: 0.70
  • ASQ RU: 0.70
  • Provider: ASQ
  • Course ID: VISO1348
  • Course Length: 7 hours
  • Cancellation Policy
• Instructors
  • Rand E. Winters, Jr.