ISO-13485 Internal Auditor Training

Bring your own Quality Management System Documentation and conduct actual audits (Control of Documents, Control of Records, Internal Audits and Corrective and Preventive Action) on your system.

These audits will be completed as we cover the specific clauses using your quality manual, procedures and forms. You will also learn auditing techniques and auditor etiquette’s as well as learning unique and different ways to audit from others in the class.

Auditing can be fun! By auditing your system, using case studies and being involved in attention-getting activities, we will keep you interested as well as help you keep your facility compliant.

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

Course Length:
3 Days, 9:00 A.M. to 5:00 P.M.

Cost:
$695.00 per person

For more information about Quality Services, contact us at 256.824.LEAN(5326).