Medical Devices-Quality Management Systems Auditor/Lead Auditor Course (ISO 13485 & EN ISO 13485)-IRCA Certified Course (A17579)

This course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011, “Guidelines for Quality and/or Environmental Management Systems Auditing.”

Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

Course No A17579 Certified by IRCA

This course is certified by the International Register of Certificated Auditors (IRCA) and meets the training requirements for IRCA QMS 2008 auditor certification.




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 

Before attending this course, delegates are expected to have:

  • Knowledge of the following quality management principles and concepts:

-       The Plan, Do, Check, Act (PDCA) cycle

-       The relationship between quality management and customer satisfaction

-       Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000

-       The process approach used in quality management

-       The Model of a Process Based Quality Management System, the structure and content of ISO 13485

  • Knowledge of the requirements of ISO 13485

It is advisable that delegates have either attended an internal auditors course, or had experience with conducting internal or supplier audits

Prerequisite for the Course:

This course teaches auditing principles using ISO 13485, therefore a basic 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