Implementation of ISO 13485 MasterClass

The Implementation of ISO 13485 MasterClass is dedicated to the basic principles of a quality management system.

Topics

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

Who should Attend

• Quality managers
• Quality associates
• Project Managers
• Document Control coordinators
• Middle management in regulated industries
• Regulatory Affairs professionals
• Independent service organizations