PECB ISO 13485 Medical Devices Quality Management System - Lead Auditor
Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.
Skill Level:
Advanced
Duration:
5 days/Self Study/eLearning
What You'll Learn
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
Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011
What's in the course?
This training is based on both theory and best practices used in MDQMS audits
Lecture sessions are illustrated with examples based on case studies
Practical exercises are based on a case study which includes role playing and discussions
Practice tests are similar to the Certification Exam
Course Curriculum
Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
Audit principles, preparation and launching of an audit
On-site audit activities
Closing the audit
Examination
Certification
General information
📬 Let's keep in touch
Join our mailing list for the latest updates
Something went wrong!
Please try again.
