Training Features

Supplier Audits & Control: Compliance with ISO 13485, MDSAP, and 21 CFR 820 QSR

Strengthen your supplier oversight. This training on 27 April 2026 will equip you with the tools to conduct compliant audits and meet global regulatory standards including ISO 13485, MDSAP, and 21 CFR 820 QSR.
Format

Virtual Training

Level

Intermediate

Date

27 April 2026

Time

09:00 - 17:00 CET

Duration

8 hours

Trainer

René Schings

Certificate

Certificate included

Price

€ 1995 or equivalent currency

ISO 13485 Lead Auditor Training for Medical Devices

In the highly regulated medical device industry, compliance with ISO 13485 is critical to ensuring product quality, meeting customer expectations, and maintaining market access. Auditing plays a key role in sustaining a robust Quality Management System (QMS), with trained auditors essential for navigating regulatory requirements and driving continuous improvement.

Led by René Schings, this interactive training, equips participants with the knowledge and hands-on skills needed to plan, conduct, and report QMS audits in line with ISO 13485:2016. The training helps professionals interpret ISO 13485 requirements and apply them effectively within their organization.

Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Supplier audits and effective control mechanisms are essential components of a robust Quality Management System (QMS) for medical device manufacturers. Under ISO 13485, MDSAP, and 21 CFR 820 QSR, manufacturers are required to ensure that their suppliers meet regulatory requirements and consistently provide quality materials, components, and services. Supplier audits help to ensure that suppliers comply with applicable standards and regulations and are a key part of maintaining ongoing compliance. 

This training focuses on the requirements for supplier audits and control processes, specifically in the context of ISO 13485, MDSAP, and FDA 21 CFR 820 QSR. Participants will gain the skills necessary to assess suppliers effectively, ensure compliance, and address non-conformities. Upon completion, participants will be prepared to manage supplier audits and implement a comprehensive supplier control system.
Key Learning Objectives
  • Understand the regulatory requirements for supplier audits and control under ISO 13485, MDSAP, and FDA 21 CFR 820 QSR
  • Learn how to evaluate and select suppliers based on compliance and quality criteria
  • Gain skills to conduct supplier audits effectively, ensuring compliance with ISO 13485, MDSAP, and FDA QSR standards
  • Understand the key differences in supplier audit requirements across ISO 13485, MDSAP, and FDA QSR
  • Learn how to handle non-conformities in supplier audits and manage corrective and preventive actions (CAPA)
  • Develop strategies for ongoing supplier performance monitoring and continuous improvement
  • Understand how to implement a supplier control system that meets regulatory requirements and ensures long-term compliance.
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 8 hours, providing a focused and efficient learning experience. The sessions will take place on 27 April 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 11 March, 5 August, and 26 October 2026. Visit the registration pages for additional information.
Who Should Attend?
  • Regulatory Affairs professionals responsible for clinical performance evaluations 
  • Clinical Affairs and Clinical Research professionals conducting IVD studies 
  • Quality Assurance (QA) professionals ensuring compliance with ISO 20916 
  • IVD manufacturers seeking IVDR compliance for clinical performance studies 
  • Anyone involved in generating and maintaining clinical evidence for IVD devices 
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
  • Overview of Supplier Management and Compliance Requirements
  • Understand the importance of supplier audits for medical device manufacturers and learn how to meet key requirements of ISO 13485, MDSAP, and FDA 21 CFR 820 QSR through effective supplier selection, evaluation, and ongoing monitoring.
  • ISO 13485 Supplier Control Requirements
  • Learn how to implement a risk-based supplier evaluation and approval process in line with ISO 13485, including documentation requirements, performance auditing, and strategies to maintain ongoing compliance.
  • MDSAP Requirements for Supplier Audits
  • Gain insight into integrating MDSAP compliance into supplier audits by understanding key differences from ISO 13485 and addressing regulatory requirements for supplier management across jurisdictions including the FDA, Health Canada, ANVISA, PMDA, and TGA.
  • FDA 21 CFR 820 QSR Supplier Control and Audits
  • Understand supplier control requirements under FDA’s 21 CFR 820, including how to audit for QSR compliance, establish clear agreements and specifications, and effectively monitor supplier performance.
  • Conducting Supplier Audits
  • Learn how to plan and execute effective supplier audits by identifying audit criteria, developing checklists and audit plans, conducting on-site audits, gathering evidence, and interviewing key supplier personnel to assess compliance.
  • Managing Non-Conformities and Corrective Actions
  • Develop the skills to identify non-conformities during supplier audits, manage CAPA processes, report findings effectively, collaborate with suppliers on corrective actions, and ensure continuous post-audit monitoring.
  • Supplier Performance Monitoring and Improvement
  • Learn how to conduct ongoing supplier evaluation and performance monitoring using key performance indicators (KPIs), while effectively managing supplier relationships and driving continuous improvement initiatives.

Flexible Online Training Designed for MedTech Professionals

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 planning and conducting supplier audits, ensuring compliance with ISO 13485, MDSAP, and 21 CFR 820 QSR requirements.

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.
Write your awesome label here.