ISO13485 Internal Quality Auditor training
www.TrainingForQuality.com QAI Training LLC
5665 N. Post Road Suite 200
Indianapolis, IN 46216
317.202.9000

Print Course Info:   Course Offered:
Course Hours: 16      

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. 
 
COURSE OBJECTIVES             

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.
 
Course Agenda
 
* 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 
 

·         QMS Team Members

·         Persons seeking to become a QMS Internal Auditor

·         Supplier Quality Auditors

·         ISO Implementers

·         Business owners

·         General Managers

·         Quality Manager

·         Engineering Manager

·         Purchasing Personnel

·         Consultants-Advisors

·         Professional Auditors

·         Persons interested in auditing professionally

·         Anyone that wants to learn about ISO13485

·         Internal auditors for other ISO systems that need upgrade training

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www.TrainingForQuality.com QAI Training LLC
5665 N. Post Road Suite 200
Indianapolis, IN 46216
317.202.9000

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