Description:
This course begins with a review and explanation of the Gap Analysis Assessment Report, and provides a practical approach to evaluating and preparing documentation and processes needed to implement an ISO 13485 quality management system. Participants learn how to analyze ISO 13485 documentation and process requirements. In addition, organizational processes are thoroughly reviewed and identified.
Course Topics Include:
- Reviewing the Gap Analysis Report
- Reviewing the requirements of ISO 13485
- Reviewing and discussing specific examples of required documentation
- Identification and discussion of specific organizational processes
- Assignment of responsibility to complete specific tasks
- Completion of a Project Plan
- Training of other personnel within the organization
Who Should Attend?
Process Owners within your organization and top management within the proposed scope of registration.
Prerequisites:
No prior knowledge of ISO 13485 is required. Participants should read the Gap Analysis Report prior to attending the course.
Duration: 2 Days (16 hours)
Type: On-Site Training
Price: $7500 (for up to 15 people)
Optional Third Day can be added to this course to begin mapping organizational processes using MS Visio for an additional $2500. Process Owners would bring additional employees into this third day to work on mapping their specific processes. NOTE: The organization must purchase its own copy of MS Visio. The course price does not include a copy of this software.