Medical Devices - Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016) (IRCA)

Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques against the requirements of ISO13485:2016.

Consolidate your expertise with the latest developments and contribute to the continuous improvement of your quality system, leading to greater patient safety. You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”. 

Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. You’ll acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.

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