13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification ISO 13485 Standard 13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification 13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification
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ISO 13485 Implementation Tools

ISO 13485 Internal Auditor Training Materials Package

iso-13485This is more than just presentations - we've created 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. RABQSA compliant.

You don't want to cut corners with audits - buy a complete solution!

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ISO 13485 Audit Checklist Package
Combine with Internal Audit Checklist Tools Package and SAVE! <Details>


ISO 13485 Internal Auditor Training Course Outline:

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

  1. First, it covers the ISO 13485 Standard, giving the students a chance to work with it and get familiar with the requirements.
  2. Next, it then guides the students through the audit process of a mock company. They will prepare an audit plan, conduct an opening meeting, audit documents and records, document their findings, hold a closing meeting and write the audit report.
Internal-Audit

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

  • Types of Audits
  • Why Audit?
  • Who Can Audit?
  • How to perform an Internal Audit
ISO 13485 Standard

Review of the ISO 13485 Standard (15 min)
This section reviews the standard, to helping students understand the structure

ISO 13485 Standard Copy of ISO 13485 Standard is NOT included. Buy Copy of Standard

Exercise: Is it a Requirement? ISO 13485 Standard

iso 13485 Requirements

Requirements of ISO 13485 Internal Audit Training 57 slide DETAILED PPT (2 hours)
This section covers a Clause by Clause Review of the ISO 13485 Standard

  • The Process Model/Process Approach
  • What are the requirements of ISO 13485?

Exercise: Find the Requirement ISO 13485 Standard (Tests comprehension)

iso 13485 audit steps

Steps of an ISO 13485 Audit Internal Audit Training 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.

  • Scheduling the Audit
  • Planning the Audit
  • Opening Meeting
    • Audit 4.2 Documentation
    • Audit 5.0 Management Responsibility
    • Audit 7.2 Customer-Related processes
    • Audit 7.4 Purchasing
    • Audit 8.5 Corrective Action
  • Auditors Document Findings
  • Final Audit Report
  • Closing Meeting
  • Creating the Audit File


This COMPLETE Audit Training Package also Includes:
13485internal auditor guide

98 page Comprehensive Trainer's Guide ISO 13485 Guide <View Sample> includes:

  • Detailed Speaker Notes
  • Quiz Answers & Non-conformance details
13485 Internal Audit Guide

63 page Student Manual ISO 13485 Internal Audit <View Sample> includes:

  • Section for taking notes & necessary Exercise Forms
  • Quizzes

 

13485 Audit Case Study

73 pages of Sticky Bubble Gum Company Case Study Materials 13485 Audit Docs <view sample> include:

  • QMS, PO's, Org Chart, and other data from Sticky Bubble Gum Co., a company that needs an Internal Audit from your team.
  • Internal Audit Forms to conduct the practice audit
ISO 13485 Audit Certificate

Customizable Certificate of Completion Template 13485 Auditor Training

13485auditcontents View Complete Package Contents

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.

Complete ISO 13485 Internal Auditor Training  Materials Package

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You don't want to cut corners with audits - buy a complete solution!

ISO 13485 Internal Audit Checklist

You may also want Internal Audit Checklist, which includes:

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ISO 13485 Audit Checklist Package

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Internal Audit checklist Package

Includes the ISO 13485 Internal Auditor Training Materials Package

AND

ISO 13485 Checklist


ISO 13485 Implementation Tools ISO 9001 & 9000 Certification ISO 9001 & 9000 Certification ISO 9001 & 9000 Certification ISO 13485 Implementation Tools
   
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