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ISO 13485 Internal Auditor Training Courses

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ISO 13485 Internal Auditor Training

ISO 13485 Internal Auditor Class Objectives:

  • Understand quality management definitions, concepts, and guidelines
  • Understand the purpose of the ISO 9000 series
  • Understand the requirements of the ISO 13485:2016 standard
  • Understand the roles and responsibilities of the auditor

Outline (Typical Agenda)

Day 1

  • Introduction and Welcome
  • Chapter 1 – Introduction to ISO 13485
  • Chapter 2 – The ISO 13485 Standard Explained
    • MD Written Exercise 1 (individual
  • Chapter 3 – Overview of ISO 13485:2016 Requirements
    • MD Written Exercises 2a, 2b (Audit Scenarios)

Day 2

  • Overview of ISO 13485:2016 Requirements (cont’d)
    • Breakout Exercise 2c (Audit Scenarios)
    • MD Written Exercise (individual)
  • Introduction to Management System Audit Trails
    • AU Breakout Exercise 1: Scope and Objectives
  • Management of Audit Programs
  • Management System Audit Planning and Preparation
    • AU Breakout Exercise 2: Documentation Review
    • AU Breakout Exercise 3: Audit Plan

Day 3

  • Performing the Audit
    • AU Breakout Exercise 4: Conducting the Audit
  • Writing Nonconformity Statements
    • AU Breakout Exercise 5: Writing Nonconformities
  • Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Closeout
    • AU Written Exercise (individual)

Who Should Attend?

  • Medical device professionals
  • Professionals from FDA regulated industries
  • Quality professionals
  • ISO Managers/Management Reps
  • Internal Auditors
  • Process owners
  • Systems professionals or people who want to understand how management systems work
  • Improvement Specialists
  • Buyers in FDA regulated industries
  • Leaders/managers/professionals in the Medical Device industry

ISO 13485 Internal Auditor Certification

This course comprises the following two Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:

  • MD -Medical DeviceSystems
  • AU – Management Systems Auditing

Attendees successfully completing this course receive a Certificate of Attainment for each of Exemplar Global Competency Units listed above.

Special Features

  • TPECS – Some organizations have the ability to provide TPECS modular instruction. TPECS: Training Provider Examination Certification Scheme.
  • TPECS Ensures:
    • Improved assessment and evidence of competence;
    • A more effective and efficient personnel certification process; and
    • Greater involvement of training providers in the personnel certification process.
  • AATT.
  • Other Special Features may vary.