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ISO 13485 Internal Auditor Training Materials Package

Once you have set up your ISO 13485 Quality System you will need to perform regularly scheduled internal audits. This shows you how the system is working and how you can continue to improve it.

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

The 1 and 1/2 day training package includes:

• Comprehensive Trainer's Guide (This sample outlines entire course contents)
• 4 hours understanding ISO 13485 and Auditing Techniques
• 8 hours of Internal Auditing course material.
• View Agenda
  
  
• Student Manuals
  
  
• (3) PowerPoint presentations with notes:
• Guide to Internal Auditing
• Requirements of ISO 13485
• Steps of an ISO 13485 Audit
  
  
• Exercises and answers
  
  
• Case Study: Sticky Bubble Gum Company:
• Quality Manual, Procedures and Forms from "Sticky Bubble Gum", a company that needs an Internal Audit from your team.
• Internal Audit Forms to plan and conduct the practice audit
  
  
• Certificate of Completion

RABQSA compliant. 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.

The course is divided into two sections:

1. Understand the ISO 13485 standard

2. Perform complete audit of mock company

The training covers the ISO 13485 Standard, gives the students a chance to work with it and get familiar with the requirements. Then the training guides the students through the audit process. They will prepare an audit plan, conduct opening meetings, audit documents and records, document their findings, hold a closing meeting and write the audit report.

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

• Your trainer's guide prepares you to conduct this training.

• The training is recommended for groups of 6 to 12 students at a time, but can be used many times.

The purpose of this ISO 13485 Internal Auditor Training Package is to:

• Provide you with the course content and information you need to present an interactive training for your Internal Audit Team

• To effectively train Auditors by providing them with a chance to practice each step of the audit process

• To train auditors on the requirements of ISO 13485 so they will be confident in evaluating your Quality Management System

Internal Auditor Training 

If you are interested in the InternalAuditor Training Package, you may also be interested in our "Internal Audit Checklist Package" With these materials you will be able to conduct your own in-house Internal Auditor Training Program.

Buy both the Internal Auditor Checklist Package and the Internal Auditor Training Materials together and save $25.