The ISO 13485:2016 Standard continues to facilitate the global alignment of quality management systems with related regulatory requirements for the medical device supply chain. The revised Standard focuses greater attention on an organization’s ability to meet applicable customer and regulatory requirements, with an added emphasis on risk and change management. In this one-day workshop, you will learn about all the changes in the ISO 13485:2016 Standard and will be able to assess how they will affect your organization. On completion of this course, your knowledge of the requirements of ISO 13485:2016 will enable you to plan for the successful transition of your organization’s quality management system.
By the end of the course, participants will be able to:
- Describe how the different sections of the ISO 13485 Standard work together within the framework of the Plan-Do-Check-Act cycle to enable effective operation of the quality management system.
- Explain the key changes from ISO 13485:2003 to ISO 13485:2016.
- Explore the relationship between ISO 13485:2016 and the risk management standard ISO 14971, the related cGMP requirements (Title 21 CFR Part 820 QSR), and how ISO 13485:2016 aligns to the new high level structure of ISO 9001:2015.
- Assess your organization’s quality management system to identify the implications for processes and the changes needed in order provide objective evidence of conformance to the revised ISO 13485:2016 Standard.
- Create an action plan to achieve and maintain certification to ISO 13485:2016.
Who Should Attend:
People responsible for upgrading their organization’s ISO 13485:2003 Quality Management System to meet the new requirements of ISO 13485:2016 and for those people tasked with auditing to the new requirements. Organization Leaders, Managers, Regulatory Affairs and Quality Managers, Auditors and Document Control personnel will benefit from attending this training course.
A basic understanding of ISO 13485:2003 and for auditors, experience performing internal and/or supplier audits against the ISO 13485:2003 Standard.
Cost: 1-day class
Location: Location and driving directions will be emailed separately upon registration.