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 us at 256.824.LEAN(5326).

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