ISO 13485:2016 Implementation and Internal Auditor Training
Course Outline
The ISO 13485:2016 standards specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that meet customer and regulatory requirements. Major regulatory bodies worldwide require certification to ISO 13485 to allow organizations to market their products and services.
Objective
To provide all the essential tools on how to conduct internal audits that add value to the organization. Learn a range of internal auditing techniques that will help you become a top performing auditor. Gain confidence in your audit skills.
Prerequisite
It is recommended that each participant brings a copy of the standard. Only electronic copies will be made available during the course.
Topics Include:
- Introduction.
- ISO 13485:2016 Review of Requirements
- Auditing steps: – Preparing, – Performing, – Reporting.
- Practical Case Studies.
Who should attend:
- Company personnel wishing to perform audits against the ISO 13485
- Personnel involved with the implement of a system based on ISO 13485
- Managers, supervisors that need to understand what is involved in the audit process
Certification
- Upon completion of the course each attendee will receive an attendance certificate.
- Our courses are recognized by certification/accreditation bodies.
- CEUs: 1.6
Cost: CONTACT US FOR A QUOTE; includes course materials.