ISO 13485 & 21CFR820 (QSR) Internal Assessor

Course Description

 2-day (16-hour course) designed to provide participants with auditing skills to ISO13485 & 21CFR820. Class typically taught in two consecutive days.


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

Course Outline:

Overview of ISO 13485 & 21CFR820 and Quality Management System Standards
Class objectives
History of Quality Management Standards
Quality Management System Terms and Vocabulary

Understanding ISO 13485 & 21CFR820
Customer Perspective of ISO13485 & 21CFR820
Benefits internally of ISO13485 & 21CFR820Certification
History of the ISO 13485 & 21CFR820 Standard

Interpreting ISO 13485 & 21CFR820
Overview of the QMS Model
Element Analysis Exercise
Element by Element Review including:

  • Element key points
  • 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:
Creating the Audit Report
Presenting Findings
Follow-up Activities

Auditor Skills
Audit Responsibilities
Communication Skills
Do’s and Don’ts During the Audit
Audit Role Plays

Presentation of Final Exam


16 Hours

Contact Information


1 (650) 967-2700

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