In this two-day course, learn the full range of internal auditing skills that will help you become a strong advocate and leader in your company's effort to obtain maximum value from your commitment to ISO 13485. Through individual participation and group activities, participants will acquire the necessary skills to conduct successful internal quality system audits for ISO 13485. This course includes a simulated audit, based on documentation from an actual organization, so participants can develop and refine their newly acquired knowledge and skills.
Prerequisite: Completion of Understanding ISO 13485 is recommended. Individuals without this class/knowledge may not be able to successfully complete the internal audit training.
NOTE: Attendance to the entire course is required to receive a Certificate of Attendance with CEUs.
* Courses are scheduled based on demand. If you are interested in attending this course, please provide
us with your information and
we will contact you when a course date is scheduled.
Who Should Attend
Recommended for new internal auditors or experienced auditors that need a thorough refresher. Representatives from key functional groups, members of an ISO 13485 implementation team, and risk and quality managers will also find this course beneficial.
Course Outline
Utilize the ISO 19011:2002 Standard on performing audits
Comply to the ISO 13485:2005 Standard by applying the Process Approach to your quality management system
Form an audit team
Choose who needs to be on it
Determine roles & responsibilities of each individual
Conduct an audit meeting
Choose who needs to be there from the audit team
Choose who needs to be there from the organization receiving the audit
Create an Agenda
Determine what reports are needed and how to form them
Choose appropriate documentation
Determine what is needed
Organize according to the ISO 19011:2002 Standard
Classify Nonconformities
Classify, record and resolve nonconformities
Implement preventative measures to avoid future nonconformities
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For onsite training information and a price quote please call (248) 358-3570.
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