Program Objective
The primary goal of the program is to determine whether the Medical Devices Management System standard requirements are met, effectively implemented, and maintained, as well as to train internal audit auditors within the organization.
Training Content
Referenced Standards and/or Documents
- Terms and Definitions
- ISO 13485 Standard Requirements
- Basic Concepts
- Audit Criteria
- Auditor Characteristics
- Types of Audits
- Audit Phases
- Audit Planning
- Audit Preparation
- Preparation of Questionnaires
- Audit Execution
- Nonconformities
- Audit Reporting and Follow-up
Who Should Attend
All first and middle-level managers.
Duration
2 Full Days