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 LevelAdvanced
Duration5 days/Self Study/eLearning
CertificateYes
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 Included
- 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
Curriculum
