About the Course
This course includes hands-on practice process auditing exercises utilizing specially developed, actual QMS documentation that was designed by professional auditors so as to help students progressively understand and learn to develop process audit skills.
This course provides the chance to practice auditing with other individuals at like skill levels (beginners and intermediates) in a controlled, classroom environment under the guidance of internationally certified auditors and course facilitators.
Students leave this course with actual audit experience having participated in at least two fun and interactive mock audit scenarios staged by QAI course designers. This is probably the best class of its type available to help new and intermediate auditors to become practiced auditors.
It is 16 hours of fast paced learning. As always and with all QAI classes the course is taught by professional and internationally certified ISO auditors.
To develop, know, and understand the purpose of an ISO13485 internal auditing system that is based on the ISO 19011 auditing guidelines
Understand the Process Approach of ISO9001:2000 and ISO13485
To Learn Process Auditing
Learn to interpret medical device standards from an auditor's point of view
How to plan and prepare for an internal audit
How to construct effective audit checklists to help find the objective evidence needed to make internal audits work for your company, not to just find fault
Understand that the audit checklist is just the starting point for an
ISO process audit
Learn what to look for in the company's documentation to help you audit
Learning to follow the audit trail and the sequence of events for a process
How to write the audit report
Learn how to be objective
How to discard non-objective evidence
Students leave this course with hands-on auditing experience.
* Introduction to ISO13485
* Learn how ISO 13485 is built on the ISO9001:2000 Quality Management System
* Course and individual objectives
* Understand the Process Approach: inputs and outputs.
What is it and how it works.
* Overview of the ISO13485 standard
* Process Auditing overview
* Class Size Case Studies
* Group Size Case Studies
* Designing an Audit System for Success
* Introduction to the Mechanics of Auditing
* How to Prepare for an audit
* QMS System Practice - Self Assessment (Students perform gap analysis)
* Audit Checklist Development
Course Agenda Day Two - QMS Process Auditing
* QMS Process Auditing
* How to follow the Process Audit trail
* The Process Audit approach: inputs and outputs.
* Interview Techniques - how to ask open ended questions
* Opening Meeting - raising the audit to a professional level
* Auditing for non-documented activities
* Perform Process Audits Mock Audits - 3 way practice sessions
* Preparing for Closing Meeting - How to summarize audit findings
* Presenting Audit Findings like a professional with supporting data
* Audit Report Writing and Distribution
* Discuss and describe how we learned that the ISO Clauses are Linked
* Prepare for Closing Meeting
* Present Audit Findings - supporting the findings
* Course Review and Evaluations