Training Features

ISO 13485: Lead Auditor

Become a certified lead auditor and master the skills to plan, execute, and manage ISO 13485 audits with confidence.
Format

Virtual Training

Level

Advanced

Date

21 and 28 October 2026

Time

09:00 - 17:00 CET

Duration

2 x 8 hours

Trainer

René Schings

Certificate

Certificate included

Price

€ 1195 or equivalent currency

Advanced Lead Auditor Training for ISO 13485:2016

Lead auditors play a crucial role in the internal auditing process, ensuring that an organization’s Quality Management System (QMS) under ISO 13485:2016 is effective, compliant, and continuously improving. As the lead auditor, one must be capable of planning, coordinating, executing, and reporting on audits, as well as managing audit teams and communicating findings to senior management. This advanced training is an add-on to basic internal audit training and is designed to equip participants with the necessary skills and knowledge to conduct audits at a higher level of responsibility, including managing multi-departmental audits and ensuring compliance with regulatory requirements like MDSAP. 

Led by René Schings, this interactive training covers how to prepare for and execute external audits, where lead auditors play a critical role in managing the process and ensuring that all findings are addressed properly. Participants who complete this course will be certified as lead auditors and gain the expertise to manage ISO 13485 audits at an organizational level.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Lead auditors are essential for ensuring that an organization’s Quality Management System (QMS) under ISO 13485:2016 is effective, compliant, and continuously improving. This advanced training builds on basic internal audit skills, equipping participants to plan, coordinate, execute, and report audits with higher responsibility.

The training covers managing audit teams, handling multi-departmental audits, and ensuring compliance with regulatory requirements such as MDSAP. Participants will also learn best practices for preparing for and conducting external audits, addressing findings effectively, and using audit results to drive continuous improvement. Upon completion, attendees will receive lead auditor certification and the skills needed to manage ISO 13485 audits at an organizational level.
Key Learning Objectives
  • Understand the role and responsibilities of a lead auditor in the ISO 13485 audit process.
  • Learn how to plan and organize ISO 13485 audits, including setting objectives, scope, and criteria. 
  • Develop skills to lead an audit team and effectively manage the auditing process. 
  • Understand how to integrate MDSAP compliance into ISO 13485 audits and manage multi-country regulatory audits. 
  • Gain expertise in writing audit reports, managing non-conformances, and implementing corrective actions. 
  • Learn how to follow up on audit findings and contribute to continuous improvement of the QMS. 
  • Prepare for both internal and external audits, ensuring readiness for inspections and regulatory reviews. 
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in one sessions, lasting 16 hours in total, providing a focused and efficient learning experience. The sessions will take place on 21 and 28 October 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 1 and 5 March, 22 and 29 April, and 3 and 6 August 2026. Visit the registration pages to learn more.
Who Should Attend?
  • Experienced internal auditors looking to take on the role of lead auditor for ISO 13485. 
  • Quality Management System professionals responsible for overseeing audits and compliance. 
  • Regulatory Affairs professionals involved in managing audits for MDSAP compliance. 
  • Senior management overseeing quality audits and corrective actions. 
  • Employees with previous auditing experience who want to advance their skills in leading audits. 
  • Internal audit coordinators or team leaders preparing for certification or external inspections. 
  • Any professional responsible for ensuring the effectiveness of the ISO 13485 QMS within their organization.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Introduction to Lead Auditing and ISO 13485:2016: Understanding the lead auditor’s role and responsibilities, ISO 13485 audit requirements, and the importance of the lead auditor in the audit process 
  • Planning and Preparing for ISO 13485 Audits: Developing the audit plan, defining objectives, scope, criteria, and schedule, preparing audit teams, assigning roles, and documenting procedures and checklists 
  • Conducting ISO 13485 Audits: Leading audit teams, auditing processes and systems for compliance, interviewing staff, gathering evidence, and managing client and department relationships 
  • MDSAP Compliance and Lead Auditor Responsibilities: Key differences between ISO 13485 and MDSAP audits, managing multi-country audits, conducting MDSAP audits alongside ISO 13485, and understanding MDSAP audit reports 
  • Audit Reporting and Corrective Action: Writing clear audit reports, documenting non-conformances, reporting findings to management, and handling CAPA with timely resolution 
  • Audit Follow-Up and Continuous Improvement: Lead auditor’s role in follow-up actions, ensuring corrective actions, monitoring improvements, using results to enhance the QMS, and conducting post-audit evaluations 
  • Preparing for External Audits and Inspections: Leading internal audits to prepare for external ISO 13485 and MDSAP audits, managing audit preparation and closing findings, and ensuring successful external audit outcomes.

Comprehensive Regulatory Expertise

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

René Schings

René, with over 20 years of management experience in Quality Management, Research & Development, and more, serves as a lead auditor at Qserve, specializing in ISO audits, and brings expertise in building QMS for start-ups, managing complex change projects, and overseeing multi-site, multi-cultural teams, having previously held senior positions in the Medical Device and Consumer Electronics industries.
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