Conducting and Leading Medical Devices Management Systems Audits

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

SAI Global is an Exemplar Global certified TPECS provider. Attendees who successfully demonstrate competence during this course will receive a Certificate of Attainment for the following knowledge competency units:

• Exemplar Global – AU – Management systems auditing
• Exemplar Global – TL – Leading management systems audit teams