ISO 13485 & 21CFR820 (QSR) Internal Assessor

Course Description

 3-day (24-hour course) designed to provide participants with auditing skills to ISO 13485:2016 & 21CFR820. Class typically taught in three consecutive days. The session includes auditing techniques and approach that aligns with ISO 19011:2018

Audience

Auditor candidates which ideally include Quality Assurance personnel, as well as cross-functional representation from Engineering, Operations, and Supply Chain. Participants will utilize both analytical and communication skills.

Course Outline:

Overview of ISO 13485 & 21CFR820 and Quality Management System Standards
Class objectives
Auditing and Medical Device Glossary/Lexicon
History of Medical Device Management Standards

Understanding ISO 13485 & 21CFR820
Customer Perspective of ISO13485 & 21CFR820
Benefits internally of ISO13485 & 21CFR820 Certification
History of the ISO 13485 & 21CFR820 Standard; ISO 13485/21CFR820 Comparison Matrix

Interpreting ISO 13485 & 21CFR820
Overview of the QMS Model
Element Overview and Element Analysis Exercise
Element by Element Review including (ISO 13485/21CFR820 related elements):

• Element key points

• What to look for during an audit

• Who is audited

• Role plays

Audit Process

Audit Preparation Activities, Including:

Defining Audit Criteria and Scope
Assignment of Auditors (Lead Auditor, Auditors, Technical Experts)
Documentation Review
Reviewing Previous Audit History
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 and Auditor Code of Conduct
Communication Skills
Do’s and Don’ts During the Audit
Audit Role Plays and Remote Auditing

Presentation of Final Exam

24 Hours

Contact Information

Email
paulette@pyyoungassociates.com

Phone
1 (650) 967-2700

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