ISO 13485:2016 Process Based Internal Auditor

The goal of auditing a process based management system is to ensure the system is effective, improves the business, and satisfies the standard requirements. The course will give you a solid grasp of the concepts that lead to effective audits through workshops and class discussions. Internal audit is a mandatory requirement of a management system based on the ISO 13485:2016 Standard.

COURSE SCHEDULE
Date
Location
Enrollment
2017
11/29-30, 12/07-08
Phoenix, AZ
Tucson, AZ
  • Understand the principles and methods of a process based auditing system
  • Knowledge of the ISO 13485:2016 Standard clauses, elements, and auditors perspective
  • Know how to use a “process based” model to analyze a process
  • Develop audit checklist and questions from process based model
  • Key principles of planning and controlling audits
  • Understanding auditor responsibilities, methods, tools and techniques
  • How to identify and document a system nonconformance using objective evidence
  • Knowledge of problem solving methodologies and process application
  • How to identify and document effective corrective and preventive actions
  • Conducting a simulated process based audit

A short examination will be administered to ensure the course content has been retained. A comprehensive student workbook is provided for students to keep and a certificate of completion will be awarded.

Duration

This two-day course starts at 8:00 AM and ends at 5:00 PM.

Audience

The course is intended for anyone involved in scheduling audits, performing audits, or managing an audit program. It will be of special interest to new internal auditors wanting to understand how to conduct audits using the process based approach.

Prerequisite

Previous training on ISO 13485:2016 and internal auditing is not required.

Fee

The course is $650.00 per student (reduced pricing available based on the number of students). To confirm your enrollment, pre-payment through PAYPAL or company confirmation is required.

Contact

If you have any questions about this course, please call us toll free at 888-572-9642. You can also e-mail us at admin@sustainingedge.com