As a medical device firm, your quality management systems are under constant surveillance, threats, risk, and regulatory scrutiny. Simplifying those systems will streamline your operations AND compliance efforts, reducing risks and allowing for flexibility and growth. Complicating any effort to implement lean quality systems is the advent of ISO 13485:2016, which is set to replace ISO 13485:2003. While it is currently acceptable to adhere to the previous standard, transition to the new standard must be complete by Q1 2019. A streamlined QMS will not only help this transition, but will allow you to implement and test your compliance prior to the transition deadline.
Through this course you will be able to assess your existing quality system processes and understand the changes that will need to be implemented in your organization to comply with the revised ISO 13485 standard and to meet expectations from notified bodies. You will learn how you can prepare your quality and compliance teams to prepare for the new requirements while greatly improving existing processes.
This 90 minute session will cover the latest updates and timelines around the 3rd revision of ISO 13485. Discussion topics include:
- Understanding the most critical changes in the ISO 13485:2016 Standard.
- Conducting a gap assessment of a quality system based on ISO 13485:2003 vs ISO 13485:2016
- Discussing key additions to ISO 13485:2016
- Understanding the objective evidence that would need to be in place to satisfy the new ISO 13485 Requirements and the areas of increased emphasis
- Analyzing transition periods and discussing best strategy to upgrade to the latest ISO 13485 standard
- Understanding best practices to implement new requirements of the standard
- Analyzing tips to simplify your Quality Management System while upgrading to the new standard