For Internal Auditors (4 Days) and Certified Lead Auditors (4 1/2 Days)

This comprehensive course enables participants to develop the necessary expertise to audit a Quality Management System (QMS) based on ISO 13485:2003 and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this training, the participant will have an opportunity to 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 standards.

Based on practical exercises, the participant will have an opportunity to develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, communicating with customers, conflict resolution, etc.) necessary to efficiently conduct an audit of a Quality Management System for Medical Devices. The daily agenda of the Class appears below.

Lead Auditor Certification Examination and Registration by the Professional Evaluation and Certification Board, an ANSI Accredited Program for Personnel Certification #1003.

Who should attend?

• Auditors wanting to perform and lead Quality Management System (QMS) certification audits in the medical device industry
• Expert advisors in Quality Management Systems
• Internal auditors
• Members of a quality team
• Persons responsible for the quality or conformity in an organization
• Project managers or consultants wanting to master the Quality Management System audit process
• Regulatory affairs managers
• Technical experts wanting to prepare for a Quality audit function in the medical device industry