The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.
Why Should You Attend:
This webinar will focus on changes to the QMS requirements contained in the latest version of the ISO 13485 standard. ISO 13485:2003 has served for many years as the international standard for QMS for the medical device industry. Many of the individual and regional medical device QMS requirements are based on the requirements contained in this standard. ISO Technical Committee 210, Working Group 1, has been working for the past three years to revise this standard. The revisions address new technological developments currently being employed by medical device companies (e.g., use of risk-based decision making within their quality management systems and the use of electronic IT systems). The revisions also reflect the current compliance expectations of the US FDA and other national and regional QMS regulations.Areas Covered in the Webinar:
- Making risk-based decisions related to issues outside of product realization (e.g., personnel competency, complaint handling, corrective actions, preventive actions)
- Focusing management review on the suitability, adequacy, and effectiveness of your QMS
- Validation of all kinds of software related to your QMS
- Handling corrective actions without undue delay
Who Will Benefit:
- Quality Managers
- Quality Professionals
- HR Managers
- Regulatory Professionals
- Production Managers
- Risk Managers
- Project Managers
- Production Supervisors
- Process Owners
- Quality Audit Managers
- Company personnel who manage or operate directly within their organization’s quality management system
Course Provider
Edward Kimmelman,
