ISO 13485:2016 Internal Auditor - Exemplar Global Certified
Duration: 3 Days = 2.4 CEUs
List PriceIn-House Training
$1,395.00Call for Quote

DateCityVenueRegister
November 28-30, 2017Hartford - CT - USVenue to be confirmed.REGISTER ONLINE NOW
February 21-23, 2018Boston - MA - USVenue to be confirmed.REGISTER ONLINE NOW
March 13-15, 2018Nashville - TN - USVenue to be confirmed.REGISTER ONLINE NOW
May 9-11, 2018Orange County - CA - USVenue to be confirmed.REGISTER ONLINE NOW

SAI Global is an Exemplar Global certified TPECS provider. This course meets the knowledge examination requirements of the Medical Devices Quality Management Systems (MD) certification scheme.

Learn the necessary skills and activities required to successfully perform effective internal audits of your organization’s quality management system against ISO 13485:2016 Medical Devices.

This highly participative course is presented by SAI Global’s instructors, each of whom have decades of experience in the medical devices industry and extensive experience conducting and leading audits in FDA regulated industries.

This course is based on quality management systems ISO 9001 and ISO 13485.

To register for the ISO 13485 FDA Regulated Auditor Lead Auditor Exemplar Global Certified course, please contact us today.

Course Objectives

This 3 day course is designed to provide participants with the knowledge and skills required to perform an internal audit of a quality management system based on ISO 13485. It will also provide a hands-on approach to planning, conducting and reporting on internal audits in accordance with ISO 19011 and meets the training requirements for Exemplar Global (TPECS) Auditor Certification for Quality Auditors.

Prerequisites

Before starting this course, it would be an advantage for participants to understand some of the quality management principles and concepts:
  • The process approach used in quality management

  • The Model of a Process Based Quality Management System

  • The Plan, Do, Check, Act (PDCA) cycle

  • The relationship between quality management and customer satisfaction

  • Commonly used quality management terms and definitions and the 7 Quality Principles as given in ISO 9000

Who Should Attend?

  • Quality coordinators/QMS management representatives

  • Quality professionals

  • Any personnel who will act as internal auditors

Key Session Topics

  • Module 1: Quality Management Systems

  • Module 2: Audit Fundamentals

  • Module 3: ISO 13485:2016 Standard

  • Module 4: Managing an Audit Program

  • Module 5: Audit Planning and Preparation

  • Module 6: Conducting Audit Activities

  • Module 7: Preparing and Distributing the Audit Report

  • Module 8: Completing the Audit and Conducting Follow-up

Course Outline

At the end of the course, participants will have obtained a sound appreciation of:
  • Explain the purpose of a Quality Management System

  • Explain the purpose of the ISO 9000 Standards

  • Explain the audit process – plan, conduct, report and follow-up in accordance with ISO 19011

  • Undertake an audit of a Quality Management System against the requirements of the ISO 13485 Standard

Certification


SAI Global is an Exemplar Global certified TPECS provider. This course meets the knowledge examination requirements of the Medical Devices Quality Management Systems (MD) certification scheme.

Attendees who successfully demonstrate competence during this course will receive a Certificate of Attainment for the following knowledge competency units:
  • Exemplar Global - MD - Medical Devices Quality Management Systems

  • Exemplar Global - AU - Management systems auditing


Please note: Additional experience/qualification requirements must be met to achieve certification as an auditor. These are provided through Exemplar Global. Additional information can be found at http://exemplarglobal.org.


How to Register

  • Online: Click the "Register Online Now" link to access the online registration form and pay by credit card.
  • Call: USA: 1-800-374-3818, CANADA: 1-877-426-0714. Group Bookings available!
  • Email: Training.Americas@saiglobal.com.