This course is designed for people who need to conduct external audits of medical devices quality management systems or lead audits on behalf of their organization.
Typically, professionals who:
- Need to develop their knowledge and skills to lead internal audits of their organization’s management systems
- Want to obtain a formal qualification relating to the auditing discipline
- Are Quality Managers, Engineers, and Consultants
- Want to become a Certified Lead Auditor through their relevant certifying body such as Exemplar Global
- Want to lead their organization to ISO 13485 certification
- May also be useful for those implementing a medical devices quality management system in their organization
- Understand Auditing Principles and Practices as described in ISO 19011
- How to manage an audit program including the scope, objectives and criteria for the audit, and selecting an appropriate audit team
- Perform all aspects of a management systems audit in accordance with ISO 19011, from preparation through to conducting follow-up
- Evaluate evidence collected during the audit and prepare reports of conformity and nonconformity to the audit criteria, including writing a formal audit report
- Practice effective team leadership and communication skills
- Throughout the course a series of activities will provide the opportunity for attendees to demonstrate the knowledge they have gained. The course uses a detailed medical devices case study to conduct the practical in-class activities
Sorry, there are no Conducting and Leading Medical Devices Management Systems Audits public training courses scheduled at this time. View more courses here, or contact us.