Internal Auditor Training

INTERNAL AUDITOR TRAINING COMPLYING WITH ISO 13485 REQUIREMENTS (COURSE CODE:IS/11)

Course Objective & Benefit

1. Fully understand and successfully interpret the ISO 13485:2003 requirements
2. Understand how to audit using the process approach
3. Ask audit questions that get results
4. Identify and document nonconformities
5. Audit to the ISO 9001:2000 Quality Management Systems
6. Quality additional staff to conduct internal audits
7. Provide ciritical knowledge for your management staff
8. Gain insight into the ISO 13485:2003 audit requirements to augment/sustain your existing program
9. Gain knowledge to help manage a successful ISO 13485:2003 implementation project
10. Provide professional credentials to your internal auditors
11. Provide ciritical knowledge for your staff and management

Course Outline

• Quick review of ISO 13485:2003 version
• Process Approach
• Management Process and Supporting Process - Quality Management System
• Responsibilities and duties of Lead Auditor, Auditor
• Audit planning and preparation
• Objectives collection and analysis of evidence
• Review, report and follow-up

Who Should Attend
Those responsible for planning and scheduling an internal audit program for ISO 13485:2003 and those who must perform audits to ISO 13485:2003, Quality Assurance Managers, Quality Assurance professionals, ISO Project Managers, ISO Project Team Members or anyone designing in in-depth understanding of the ISO 13485:2003 requirement.

About the Facilitator
The tutor is registered ISO 13485 Lead Auditor, CMDCAS Auditor, JPAL Auditor.
He has audited over 50 organizations on Medical Device Certification.