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How to Implement AS-9100 or ISO-13485

This half-day workshop provides hands-on practice using AS-9100 or ISO-13485, including the structure of the standard, management requirements, and the registration and auditing processes. Attendees will learn requirements of AS-9100 or ISO-13485 and have the opportunity to discuss application and implementation of the standard.

Objectives/Topics: 

•    Set up the Schedule (The “5” minute rule)
•    Management Team Assignments
•    Develop Timeline
•    Develop Implementation Action Plan
•    Overview Training (Management and or Staff)
•    Develop Manual, Procedure, Work Instructions and Forms)
•    QMS Training (Staff and or Management)
•    Interview Registrars
•    Train Internal Auditors
•    Conduct Audit (Phase I & II)
•    Conduct Management Review
•    Submit documentation to Registrar
•    Prepare for Implementation Audit by Registrar

Who Should Attend: 

Personnel from companies considering or pursuing AS-9100 or ISO-13485.

Course Length: 
4 Hours
Cost: 

$295.00 per person

For more information and pricing of Quality Services, contact Doug Craig at 256.824.2743



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