ISO 13485 Internal Quality Auditor Training

This two day course is targete and focused on delivering competent, ready-for-auditing Internal Auditors for your company with an emphasis on Federal Quality System requirement Part 820. This course includes hands-on practice process-auditing exercises designed by professional auditors.

Participants will learn:

An ISO 13485 internal system with an emphasis on Federal Quality System requirement Part 820, How to interpret ISO standards from an auditor’s point-of-view, How to plan and prepare for your interal audits, How to construct effective audit checklists--what to look for in the company's documentation, How to conduct opening and closing meetings, How to perform the audit report and ask the right questions, How to write the audit report and effective corrective actions. In addtion to the coverage of ISO 13485 standards, participants will have opportunities for: Small-group and class case studies as classes are divided into "departments". Hands-on auditing utilizing prepared document binders, complete with 4 levels of systems documentation. You will have the opportunity to interact with professionals from other organizations, enhancing both the course and their opportunities to learn.

Instuctor: Russ Ziebell is a RABQSA Certified Lead Auditor (#Q1807) and an ASQ Certified Qualtity Auditor. Russ has designed and delievered internationally recognized ISO 9001 Certified Lead ISO 9001 certification since 1992. Russ has audtied for the certified body KEMA Registered Quality, Inc.

ISO 13485 Internal Quality Auditor Tr...

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Date and Time

Tuesday Oct 28, 2008 Wednesday Oct 29, 2008

Registraion ( 7:45 am) Workshops ( 8 am - 5 pm)

Course Agenda

Day One:

1. Terms and Definitions

2 Introduction to Auditing

3. Introduction to ISO Standard

4. Case Studies

5.Understanding Documentation

6.Designing an Audit System for Success

7.Intro to the Mechanics of Auditing

8.Preparation Phase of an Audit

Day Two

1.Checklist development

2.Interview Techniques

3.Opening Meeting

4.Performing the Audit

5.Prepare Closing Meeting/Present Findings

6.Audit Report Writing

7.Corrective Action Systems

Location

Badger Room, Memorial Student Union, UW-Stout Campus, Menomonie, WI.

Fees/Admission

$550 per participant

$495 per participant (more than 3 people/company or organization)

Registration includes seminar instruction, continental breakfast and afternoon snack. Lunch is on your own, a conformation letter map, and parking permit will be sent when your registration is recieved.