ISO 13485 Internal Auditor Training Courses

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.