This 1-day course provides n in-depth study of the new ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes.
Learn the new requirements through hands-on exercises and class discussion, and review in detail the changes from the ISO 13485:2003 standard to this new ISO 13485:2016 edition. This course provides critical knowledge for leadership, management and team members who need to understand the new requirements of ISO 13485:2016 as they prepare to transition the organization’s QMS.
Who Should Take It
Individuals with responsibility for management, operation, implementation or maintenance of an ISO 13485 QMS. This includes, but is not limited to:
- Those responsible for transitioning their organization’s QMS to meet the new requirements
- Senior Management
- ISO Coordinators & Quality Managers
- Members of the Quality Team and/or Internal Audit Team
- ISO 13485 Auditors, Quality Specialists and Consultants
- Become familiar with the new standard’s requirements (review of each section and its requirements).
- Recognize the changes relative to the previous ISO 13485:2003 standard.
- Understand the timeline for transition and how it will affect your quality program (documentation, training, registration, etc.).
- Identify the general approach to implementing the new requirements of ISO 13485:2016.
- Build the confidence of quality team members as you prepare your transition project.
Public Course Dates
On-site group training is delivered at your place of business and can be customized to meet your specific requirements. Contact The Business Resource Centre to schedule your next on-site group training event.
Please call 1-888-535-1401 or fill out the form below to request a quote.
Public training is available for this course. Locations and dates can be found using the form below. Please fill out and submit the form to register for this course.
Online training is available for this course. Please fill out and submit the form to register for this course.