CQI IRCA Certified QMS Lead Auditor

  • Overview
  • Course Overview
  • Learning Outcomes
  • Who Should Attend?
  • Trainer Profile

Medical device auditing requires a high degree of technical and process knowledge and a thorough understanding of the international medical device regulations. The auditor's critical roles include planning, conducting, reporting and following up on a quality management system (QMS) audit in accordance with ISO 13485:2016, the Medical Device Single Audit Program (MDSAP) and ISO 19011 scheme requirements. This course provides extensive practical training to prepare medical device auditors to perform medical device audits that identify critical nonconformities and meet international regulatory requirements.

In order to successfully perform in-course tasks and complete course requirements, students are required to have prior knowledge of ISO 19011, ISO 13485:2016 and the regulatory requirements of at least one country participating in the MDSAP* or the EU. For details, please see the Prerequisites tab.

*MDSAP participating countries include Australia, Brazil, Canada, Japan and the United States.

Course Overview

This five-day course offers intense hands-on instruction in a classroom setting. Students will work in teams and utilize in-depth case studies to learn all aspects of Medical Device Lead Auditor roles and responsibilities. During the course, you will plan and prepare audits based on case studies that simulate both supplier and third-party audits utilizing the Medical Device Single Audit Program (MDSAP) audit requirements. Throughout the course, you will participate in simulated auditing exercises that include planning, preparation and evaluation of audit evidence. You will also practice the application of ISO 13845:2016 and the MDSAP requirements. You will be assessed throughout the course, which concludes with a comprehensive exam.

Learning Outcomes

After completing this course, you will understand how to:

  • Plan, conduct, report and follow up on a QMS audit in accordance with ISO 19011, ISO 13485:2016 and MDSAP
  • Apply the MDSAP audit strategies adopted by auditing organizations in the MDSAP program
  • Identify nonconformities, grade nonconformities and prepare an audit report in accordance with the MDSAP criteria

Who Should Attend?

This course is vital for medical device quality professionals with responsibility for conducting or implementing internal audits, supplier audits, corporate audits or third-party audits. Quality directors, regulatory managers and those responsible for managing internal, corporate, supply chain or registration audit programs will also benefit from this course.

Students must have prior knowledge of the following concepts:

  • The process approach used in quality management
  • The plan-do-check-act (PDCA) cycle in the context of processes
  • The structure, content and requirements of ISO 13485:2016 and ISO 19011
  • Commonly used terms and definitions and the seven quality principles of ISO 9000
  • The relationship between quality management and regulatory compliance
  • Regulatory requirements of at least one Medical Device Single Audit Program (MDSAP) participating country or the EU

Trainer Profile

NSF's courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainers for this course:

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In CQI IRCA Certified QMS Lead Auditor
  • "The day was excellent. The technical content and relevance were very good.”Simon Redfern / Smiths Medical
  • “This course has perfectly provided the learning needed for current projects at work.”Wolfgang Angermann / Stryker
  • “Great course; challenging with nowhere to hide in the background and plenty of chances to ask general questions.” Peter Iddon / Neotherix