Internal & supplier audit 25-26.11.2025
ISO 13485, ISO 9001, ISO 19011


Dates: 25-26.11.2025
Duration: 6 hours | 2x 8:30 – 11:30 AM US Eastern Standard Time | 2x 2:30 - 5:30 PM Central Europe Time
Speaker: Cédric Razaname

Training objectives:

• Learn basic methods on how to organize and conduct efficient internal and supplier audits
• Integrate an internal audit program into the Quality Management System
• Understand the importance of internal and supplier audits for the maintenance of effectiveness of a Quality Management System

Training content:

• Definition of the audit scope
• Communication before the audit
• Documents review and questionnaire preparation
• Internal and Supplier Audit methods
• Audit conduct and ethics
• Psychology of the auditees
• Classification of findings
• Communication after the audit
• Make effective use of audit results

Training format:

• Presentations with interactive discussions
• Group and individual exercises
• End of training assessment

Training certificate:
Participants will receive a certificate upon successful completion of the end of training assessment.

Who should attend:
This course is designed for professionals involved in the design, manufacture, distribution, or regulatory oversight of medical devices and in vitro diagnostic (IVD) devices, particularly regulatory affairs and quality assurance professionals, as well as internal and supplier auditors responsible for ensuring compliance with MDR/IVDR and ISO 13485 requirements.

Price:
EUR 625 incl. course material and certificate