ISO 13485 Medical Devices Lead Auditor Training

Course details

Who should attend?

Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
Management representatives
Quality directors, managers, and engineers
Consultants
This course teaches auditing principles using ISO 13485, therefore a knowledge of ISO 13485 and its application within a Medical Device organization is strongly recommended together with internal audit experience.
"Very good course, well presented and offers good value." Grant Courtney, Logical Freight Solutions
What will I learn?

On completion of this training, participants will be able to:
Interpret the requirements of ISO 13485 in the context of an audit
Describe the purpose of a quality management system and explain the 8 principles of quality management
Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485
Manage the duties of a lead auditor in their organization or for a third-party
What are the benefits?

Benefit from effective ISO 13485 audits and compliance
Maintain and improve quality standards with regular audits
Be confident that your organisation can rely on ISO certified lead auditors
Increase credibility and competitive advantage
Motivate employees through CPD and build your customer base.
What is included?

Refreshments
Lunch
Training course notes
Pen