CPDEquivalent to 14 hours
CERTIFICATESAll delegates will receive a certificate on completion.
An Internal QMS Auditor Course based on ISO 13485:2016 for the Medical Devices industry.
This 2-day interactive course will help individuals understand the purpose of the quality management system, and the structure and content of ISO 13485, including its relationship with regulatory requirements such as 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 a management system and will develop audit skills and techniques to evaluate the conformance and effectiveness of processes.
On completion of the course students will have learned practical and effective auditing techniques and increased their understanding of audit principles, enabling them to audit against ISO 13485 and other important global standards.
- 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
- heads of departments
- 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 undertake internal audits of part of a QMS based on ISO 13485.
For those with little or no prior knowledge of ISO 13485 we recommend attending our Introduction to ISO 13485 training course (delivered the day before the Internal Auditor course) to gain an understanding of ISO 13485. We offer a discount of £100 when booking these courses together.
Learn more about prior knowledge requirements and test your understanding with our ISO 13485 Quiz.
- overview of quality management systems and the purpose, structure and content of ISO 13485
- what internal audits are 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
- UK MDR
- EU Medical Device regulations overview
- MD SAP (Medical Devices Single Audit Programme), IMDRF (International Medical Device Regulators Forum) and MDCG (Medical Devices Coordination Group)
- placing medical devices on the marking – CE marking, UKCA marking and FDA requirements
- 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 and related internal and regulatory requirements
For Scheduled Training courses, please select from the Course Dates and Venues table below.
Course dates and venues
The FDA in the US and Notified Bodies in the EU take responsibility for assessing products for compliance with relevant rules and regulations before they are placed in the market. The assessment of medical devices is performed through audits.
If you are planning to place medical devices in the US market, you may like to look at the Quality System Regulations for Medical Devices course. For those aiming at the European market, the Understanding the European Directive 93/42/EEC concerning Medical Devices training course may be helpful.
Having internal auditor experience in other fields will be helpful to learning about auditing for medical devices. We do recommend though that you gain some knowledge of ISO 13485 before taking this course to ensure you can attain maximum benefit. We offer a discount of £100 if you book our 1-day Introduction to ISO 13485 training course together with this ISO 13485 Internal Auditor training course. Delivered on consecutive days, the courses give you a practical 3-day training experience.
Yes, you will receive a certificate of attendance after completing this ISO 13485 Internal Auditor course.
We employ tutors who combine significant practical expertise in the real world with an ability to make complex information easy for delegates to understand.
Past attendees to this course have highlighted the tutor’s willingness to tailor the course content to the business needs of the delegates. In their feedback they also point to the tutor’s ability to illustrate each topic with an entertaining story from their own experience, keeping delegates engaged throughout the course.
NWROCU|4th Dec, 2023
Metropolitan Police Service|16th Nov, 2023
Sense Biodetection Ltd|13th Nov, 2023
Premier Partnership|10th Nov, 2023
Sense Biodetection Ltd|8th Nov, 2023
Animal and Plant Health Agency (APHA)|7th Nov, 2023
Animal and Plant Health Agency (APHA)|27th Oct, 2023
Orthoplastics Ltd|27th Oct, 2023
The Royal Mint|25th Oct, 2023
Private|24th Oct, 2023
DSTL|17th Oct, 2023
Swann-Morton Ltd|13th Oct, 2023