ISO 13485:2016 Internal Assessor

Course Description

Three-day (24 hour course) designed to provide participants with auditing skills to ISO 13485:2016. Highly interactive session limited to 15 attendees. Session is based on the guidelines provided by ISO 19011 (Guideline standard for internal auditing).


Quality professionals, supervisors/managers, engineers, senior technicians. Attendees will utilize both analytical and communication skills.

Course Outline:

Overview of ISO 13485 and Quality Management Medical System Standards
Class objectives
History of Quality Management Standards (Medical Standards focus)
Quality Management System Terms and Vocabulary

Understanding ISO 13485:2016
Risk based approach and Process Orientation
Philosophy and Principles with ISO 13485
History of the ISO 13485 Standard
Documentation pyramid
Good documentation practices

Interpreting ISO 13485:2016
Element Analysis Exercise
Element by Element Review including
Element key points and intent
What to look for during an audit
Who is audited
Role plays

Audit Process
Audit Preparation Activities, Including:

  • Documentation Review
  • Reviewing Previous Audit History
  • Creation of Element Application Matrix
  • Creating the Audit Checklist

Audit Performance Activities, Including:

  • Providing Introductions
  • Framing Questions
  • Recording Objective Evidence

Audit Report Writing Activities, Including:

Auditor Skills
Audit Responsibilities
Role of Lead Auditor
Being a participative auditor
Remote audits (methodologies and applicability) o Communication Skills and Conflict Resolution
Do’s and Don’ts During the Audit
Audit Interaction Role Plays

Presentation of Final Exam

3 Days

Contact Information


1 (650) 967-2700

P.O. Box 2103
Sunnyvale, CA 94087-0103