Past event: ISO 13485:2016 Implementation Workshop

The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard in over a decade, and the upcoming changes to the EU's Medical Device Regulation expected to be passed later this year. All of these events have far reaching effects on Quality Management Systems so it is critical to understand what has changed with in ISO 13485: 2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification.

This interactive session will include lectures, roundtable discussions and activities all aimed at understanding key strategies and identifying specific actions to effectively improve Quality Management System Compliance. The program will also include detailed, step-by-step guidance on how to develop, implement and maintain strategies in order to achieve a specific goal. Participants will want to come to the sessions with a thorough knowledge of improved company strategies and a willingness to discuss aspects of it in a confidential learning environment.

Why you should attend:

Quality management systems are now, more than ever, a requirement rather than an option for sustainable businesses, both for increasing internal efficiency and for creating a competitive advantage. The easiest route for establishing a QMS is to base it on a proven method rather than starting from scratch. Medical device service providers, contract manufacturers, service providers and OEMs will benefit from implementing quality systems based on ISO 13485.

The first part of the seminar will provide you with training on quality systems and the requirements of the revised standard. The second day will focus on developing a plan for implementation and will provide helpful tools you can take back to your organization to kick-start the project.

Areas Covered in the Session:

• Gaining an understanding of the relationship between standards and quality management systems
• Understanding the basic principles of a quality management system
• Incorporating the Plan-Do-Check-Act approach
• Identifying the critical elements of a quality system
• Creating a documentation structure that is consistent with the system requirements
• Assessing and applying risk throughout the quality system
• Comparing the requirements of ISO 13485 to the FDA QSR
• Understanding the differences between ISO 9001, ISO 13485: 2003 and ISO 13485: 2016
• Understanding the QMS requirements of the proposed EU Medical Device Regulation that are not in ISO 13485: 2016
• Establishing a plan for implementing the revised requirements of ISO 13485: 2016