ISO 13485 Training – Internal Auditor Course on ISO 13485
ISO 13485 Training – Understand information safety management in organizations Gain knowledge of the main structure of an information safety management system in enterprises Promote the application of information safety management systems in businesses Improve quality and productivity in line with the information safety sector.
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GENERAL INTRODUCTION TO THE ISO 13485 TRAINING COURSE
Gain the knowledge and skills to conduct effective ISO 13485 audits and add value in our ISO 13485 Internal Auditor training course.
This course will help individuals understand the purpose of a quality management system, the structure and content of ISO 13485, including its relationship with regulatory requirements such as the European Medical Device Regulation (MDR) and the U.S. FDA Quality System Regulation (QSR). Through a central case study, participants will learn how audits can support the implementation and improvement of management systems, while also developing the auditing skills and techniques to assess the conformity and effectiveness of processes.
Upon completion of the course, learners will acquire practical and effective auditing techniques, as well as a deeper understanding of auditing principles, enabling them to audit against ISO 13485 and other key global standards.
WHO SHOULD ATTEND THE ISO 13485 TRAINING COURSE
- This course focuses on internal auditing but will also be useful for those conducting supplier audits or preparing for certification/Notified Body audits. Those who may benefit include:
- internal quality management system auditors
- supplier auditors
- medical device professionals
- quality, audit, compliance, and/or regulatory affairs managers
- auditees preparing for certification audits, including:
- senior management
- department heads
- process owners
The ISO 13485 Internal Auditor course is designed to build upon delegates’ prior knowledge of ISO 13485 and teach them the skills to conduct internal audits as part of a quality management system based on ISO 13485.
For those with little or no prior knowledge of ISO 13485, we recommend attending the Introduction to ISO 13485 course (delivered one day before the Internal Auditor course) to gain a thorough understanding of ISO 13485. We offer a £100 discount when booking both courses together.
Learn more about prerequisite knowledge requirements and test your understanding with our ISO 13485 Quiz.
KEY TOPICS OF THE ISO 13485 TRAINING COURSE
Topics covered in this course include:
- overview of the quality management system and the purpose, structure, and content of ISO 13485
- what internal auditing is and the benefits it can provide
- ISO 13485 internal audit requirements
- 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 audit environment
- asking questions, listening, and note-taking
- gathering audit evidence and evaluating it against defined criteria/requirements
- writing clear, concise audit reports
- corrective and preventive action process
- follow-up and closure of nonconformities
- overview of medical device regulations including MDR 2017/745 and IVDR 2017/746
- UK MDR
- overview of EU medical device regulations
- MDSAP (Medical Device Single Audit Program), IMDRF (International Medical Device Regulators Forum), and MDCG (Medical Device Coordination Group)
- medical device marking – CE marking, UKCA marking, and FDA requirements
WHAT WILL YOU ACHIEVE FROM THE ISO 13485 TRAINING COURSE?
By the end of this ISO 13485 Internal Auditor training, learners will be able to:
- explain the purpose, structure, and content of ISO 13485:2016 for medical devices
- outline the content of the EU MDR and the U.S. 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 on internal audits to ISO 13485
- assess the conformity of processes with ISO 13485 and related internal and regulatory requirements
BENEFITS THE ISO 13485 TRAINING COURSE BRINGS TO YOU
- Understand a globally recognized standard applicable to all organizations in the medical device management system
- Understand the requirements of the medical device management system
- Know how to improve the medical device management system
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