This is more than just presentations - we've created an interactive training modeled after the Certified Lead Auditor Program. You will audit a mock company, and discuss the findings with the students. This kit includes Auditing notes, Work Instructions, Corrective/Preventative Action logs, CAPA Requests, etc.

Use this training to train your auditors and give them practice with each step of the audit process. Use it over and over within your organization.

This complete training package provides you with the course content and information you need to present an interactive training for your Internal Audit Team.

The training is three parts - enabling you a have thorough understanding of the process:

1. Outline the requirements of auditing a quality management system (objective, steps, etc.)

2. Understand each section of the ISO 13485 Standard

3. Complete the entire audit process of a mock company.

• Prepare an audit plan

• Conduct an opening meeting

• Create audit documents and records

• Document their findings

• Hold a closing meeting

• Write the audit report

This COMPLETE Audit Training Package includes:

• Guide to Internal Auditing 24 Slide PPT (15 min) - This section outlines the basics of auditing as a foundation

• Requirements of ISO 13485 57 slide DETAILED PPT (2 hours) This section covers a Clause by Clause Review of the ISO 13485 Standard and includes an exercise “Find the Requirement” to test their comprehension

• Steps of an ISO 13485 Audit 28 slide PPT (allow 4-8 hours) This section covers a complete audit of a mock company (Sticky Bubble Gum Company), and the instructor has a detailed guide to the non-conformances in the QMS for grading.

• 98 page Comprehensive Trainer's Guide

• 63 page Student Manual

• 73 pages of Sticky Bubble Gum Company Case Study Materials

• Customizable Certificate of Completion Template

This course meets RABQSA Internal Auditor Training Course requirements for course objectives, course content, training methods, & student evaluation of RABQSA TP5.INTRNL 1 January 2005.