- Understand how to audit each and every ISO 13485:2016 requirements
- Learn fundamental auditing skills;
- Implement methods to comply with the ISO 13485:2016
- Audit process and techniques
- Improve Auditor’s skills and techniques
- Examine the requirements of ISO 13485 from an Auditor Perspective
- Write Audit reports process and follow up corrective actions
- Plan, Lead, Conduct and report an ISO 13485 audit;
- Effectively verify root cause analysis as part of the ISO 13485 Management procedure on corrective action
- Persons responsible for lead certification audits according to ISO 13485:2016 requirements
- Persons involved in the ISO 13485:2016 certification audits processes.
- Background and Development of ISO 13485:2016
- Interpreting the Requirements of the ISO 13485:2016 Standard
- The Process Management Approach
- Roles and responsibilities
- Management System Planning
- Document Management
- Inspection Operations managements
- Resource Management
- Subcontracting
- Process Improvement
- Monitoring and Evaluation
- Fundamentals of Auditing
- Auditing according to ISO 17011
- Managing Audit Program
- Audit Evidences
- Audit Process
- Audit Planning Preparation
- Leading an audit
- Conducting Onsite Audit
- Conducting Audit Follow-Up
- The Root Cause Analysis Process
- Certification Audit processes and criteria
- Revision and
- Examination
- Case Study
- Individual Exercises
- Role Play
- Group Exercises
- Group Presentation
- Examination