An Internal QMS Auditor Course based on ISO 13485:2016 for the Medical Devices industry.

This two day interactive ISO 13485 internal auditor training course will equip participants with the knowledge and skills they need to carry out effective, value adding audits in accordance with ISO 13485.

It will help individuals understand the purpose of the quality management system, the structure and content of ISO 13485 and its relationship with regulatory requirements including the European Medical Devices Regulations (MDR) and the USA’s FDA Quality System Regulation (QSR).

Through a central case study, participants will learn how audits can support the implementation and improvement of the management system and will develop audit skills and techniques to evaluate the conformance and effectiveness of processes. Delegates are assessed through continuous assessment.

This training course focuses on internal audits and will also be helpful for those conducting supplier audits or preparing for certification/ notified body audits.

  • An overview of quality management systems and the purpose, structure and content of ISO 13485
  • What an internal audit is and the benefits they can bring
  • Internal audit requirements of ISO 13485
  • Medical device requirements
  • A structured, step by step approach to planning and preparing for an audit
  • Auditing skills, including;
    • Preparing a checklist and sampling plan
    • Building rapport with the auditee and creating a constructive environment for the audit
    • Questioning, listening and note taking
    • Gathering audit evidence and evaluating it against defined criteria/requirements
    • Writing clear, concise audit reports
  • The correction and corrective action process
  • Follow up and close out of non conformances
  • Overview of Medical Device Regulations including the Medical Device Regulation 2017/745 and Medical Device Regulation 2017/746
  • Placing medical devices on the marking – CE marking, UKCA marking and FDA Requirements

This course will be helpful for anyone who is tasked with carrying out audits, particularly internal audits but also supplier audits and those who may be involved in audits as an auditee, helping them prepare for the audit and demonstrate their understanding of the quality management system.  This may include:

  • Internal quality management systems auditors
  • Supplier auditors
  • Medical device professionals
  • Quality / Audit / Compliance / Regulatory Affairs managers
  • Auditees preparing for certification audits, including
    • Top management
    • Heads of departments
    • Process owners

Delegates are recommended to have a prior knowledge of the requirements of ISO 13485 Medical Devices – Quality Management Systems. Prior knowledge can be obtained by attending our Introduction to ISO 13485 training course. We offer a discount of £100 when booking the introductory course alongside our ISO 13485 Internal Auditor training course.

By the end of this two day internal auditor training course, participants will be able to:

  • Explain the purpose, structure and content of ISO 13485:2016 Medical Devices
  • Outline the content of EU MDR and the USA FDA requirements for medical devices and their relationship with ISO 13485
  • Describe the roles and responsibilities of an auditor
  • Plan, conduct, report and follow up an internal audit in accordance with ISO 13485
  • Evaluate conformance of processes to ISO 13485 related internal and regulatory requirements

Led by a ISO 13485 expert tutor, the two-day ISO 13485:2016 Internal Auditing training course can occur at your premises, a venue of your choice or online. Interactive workshops encourage team discussions on how to successfully perform internal audits within your organisation. Dedicated training is often more cost effective and convenient for organisations with several employees requiring training.

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For Scheduled Training courses, please select from the Course Dates and Venues table below.