Day 1: Introduction to Medical Devices Quality ManagementSystems (MDQMS) and ISO 13485

Day 2: Audit principles, preparation and launching of anaudit

Day 3: On-site audit activities 

Day 4: Closing the audit

Day 5: Certification Exam

• Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits 
• Managers or consultants seeking to master a Medical Devices Quality Management System audit process
• Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
• Technical experts seeking to prepare for a Medical Devices Quality Management System audit
• Expert advisors in Medical Devices Quality Management

ISO 13485 Lead Auditor trainingenables you to develop the necessary expertise to perform a Medical DevicesQuality Management System (MDQMS) audit by applying widely recognized auditprinciples, procedures, and techniques.During this training course, you willacquire the knowledge and skills to plan and carry out internal and externalaudits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.

Based on practical exercises, youwill be able to master audit techniques and become competent to manage an auditprogram, audit team, communication with customers, and conflict resolution.

After acquiring the necessaryexpertise to perform this audit, you can sit for the exam and apply for a “PECBCertified ISO 13485 Lead Auditor” credential. By holding a PECB Lead AuditorCertificate, you will demonstrate that you have the capabilities andcompetencies to audit organizations based on best practices.

• Understand the operations of a Medical Devices Quality Management System based on ISO 13485
• Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
• Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
• Learn how to lead an audit and audit team
• Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit

شهادة معتمدة من البورد البريطاني للتقييم المهني ( PECB( Professional Evaluation And Certification Board والمعتمد من معهد المعايير الوطنية الامريكية ANSI

Certified ISO 13485 Lead Auditor