In this half-day course, gain an understanding of the purpose and intent of the ISO 9001:2008 standard, the ISO 13485:2003 standard and the regulatory/customer focus of these standards. Learn to communicate the structure, intent and benefits of ISO 13485 and determine the next steps your organization must take for the standard to become a valuable part of your business management system. Innovative exercises will help you focus on decision-making as it relates to the implementation of ISO 13485. This course will provide a thorough executive-level background on the principles and practices of managing a quality management system to the ISO 13485 standard.
NOTE: Attendance to the entire course is required to receive a Certificate of Attendance with CEUs.
* Courses are scheduled based on demand. If you are interested in attending this course, please provide
us with your information and
we will contact you when a course date is scheduled.
Who Should Attend
Recommended for executives who need to learn about ISO 13485, trainers who want a simple, effective method of explaining ISO 13485 to employees, quality and regulatory affairs managers, and steering committee members.
Course Outline
Demonstrate an understanding of the purpose and intent of ISO 9001 and ISO 13485
Identify the primary objective of ISO 13485
Demonstrate and understanding of ISO 13485, including Section 5 Management Responsibility
Explain the benefits of ISO 13485
Complete a matrix of responsibility and authority
Develop processes for functional implementation and
management review of ISO 13485
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For onsite training information and a price quote please call (248) 358-3570.
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