ISO 13485:2016 Auditor Transition

Course Description

For Existing Auditors. This 1-day workshop is intended to provide an understanding of the ISO 13485:2016 changes and how to audit to the new requirements.

Audience

Trained ISO 13485:2003 (EN ISO 13485:2012) Auditors who are looking to upgrade to audit to ISO 13485:2016 requirements and individuals responsible for the oversight of ISO 13485 compliance.

Course Objectives

Upon completion of the course the participants will be able to:

Understand the detailed requirements of ISO 13485:2016
Have the ability audit to ISO 13485:2016 requirements
Understand the relationship between ISO 13485 and other regulatory standards
Understand how the relationship between ISO 9001 and ISO 13485 has broken
Envision the impact the changes will have on the organization

What the Attendees Walk Away With:

Comprehensive ISO 13485:2016 workbook
ISO 13485:2016 Audit Checklist
ISO 13485:2016 Auditor Certificate

1 Day

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Contact Information

Email
paulette@pyyoungassociates.com

Phone
1 (650) 967-2700

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

Course Outline:

Overview of ISO 13485 Quality Management System Standard
Class Objectives
History of ISO 13485 and its relation to ISO 9001:2015
ISO 13485 Quality Management Systems Terms and Vocabulary
Information on transitioning from ISO 13485:2003 to ISO 13485:2016

Interpreting the differences between ISO 13485:2003 & ISO 13485:2016
Element by Element Review Including:

Changes to each Element
What to look for during an audit
Who is audited
Role Plays

Presentation of Final Exam