ISO 13485 Lead Auditor Course

This five-day intensive course enables participants to develop the necessary expertise to audit a Quality Management System (QMS) for Medical Devices with Medical Devices Quality Management System (MDQMS) manufacturers and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this training, the participant will acquire the necessary knowledge and skills to proficiently plan and perform internal and external audits in compliance with the certification process of the ISO 19011 and ISO 17021-1 standards. Based on practical exercises, the participant will develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, communicating with customers and conflict resolution) necessary to efficiently conduct an audit.

Career Path

Who should attend?Internal auditors Persons responsible for the quality or conformity in an organization Expert advisors in Medical Devices Quality Management Systems Regulatory affairs managers