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. To effectively meet the requirements, top management must strategically apply risk based thinking and a process approach to the planning, monitoring and evaluation of the organization’s quality management system.
This briefing will familiarize managers with the intent and framework of the Standard, highlight the changes between the 2003 and 2016 versions of ISO 13485, and reference tools and techniques that will enable managers to address their responsibilities as well as support those involved in more detailed implementation efforts.
By the end of the course, participants will understand how 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 how a process approach can help an organization meet customer and regulatory requirements more effectively and efficiently.
- Describe how risk-based thinking can be used at a strategic level to address both risks and opportunities.
- Identify the key changes between ISO 13485:2003 and ISO 13485:2016.
- Understand the requirements for top management and describe the objective evidence needed to demonstrate conformance.
- Recognize the implications of the revisions for the management of the organization’s quality management system.
Who Should Attend:
Management personnel in organizations that are either making the transition from ISO 13485:2003, or beginning the implementation to, ISO 13485:2016, and others involved in planning, implementing and maintaining a Quality Management System based on ISO 13485:2016.
The are no prerequisites for this training course.
Cost: Half-day class
Location: Location and driving directions will be emailed separately upon registration.