Quality Management Systems that Comply with ISO13485: 2016 2017

Topics

• The basic principles of a quality management system
• The relationship between standards and quality management systems
• Critical elements of a quality system
• Incorporating the Plan-Do-Check-Act approach
• Risk throughout the quality system
• Creating a documentation structure that is consistent with the system requirements
• The differences between ISO 9001, ISO 13485: 2003 and ISO 13485: 2016
• Comparing the requirements of ISO 13485 to the FDA QSR
• Plan for implementing the revised requirements of ISO 13485: 2016
• QMS requirements of the proposed EU Medical Device Regulation that are not in ISO 13485: 2016

Who should Attend

• Quality Assurance
• Quality Management Systems
• Risk Management
• Regulatory Affairs
• Design Controls
• Project Manager
• Standards & Regulations
• Compliance
• Packaging
• Labeling
• Operations
• Sterilization