ISO 13485:2016 Internal Auditor Course
This is a Practitioner level course, focused on delivery of effective internal audits of a medical device quality management system (MD-QMS) designed to meet the requirements of ISO 13485:2016. This practical and interactive 2-day course will help you get the best from your internal quality audits providing a clear understanding of the purpose of a Quality Management System (QMS) for the manufacture of medical devices.
£1,075.00 +VAT per delegate
Course Details
£1,075.00 +VAT per delegate
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What will I learn?
This training course will cover the following topics:
- How to get maximum benefits from your internal audits.
- Basic understanding of a process-based quality/medical device management system.
- Steps to ensuring you become a value-added internal auditor.
- Key steps you should follow to plan, prepare and perform an effective audit.
- How to effectively perform the audit by knowing the right questions to ask.
- How to write a nonconformity to deliver effective corrective action every time.
- Relationship between quality management, production service conformity, regulatory requirements, and customer satisfaction.
This course is for anyone who wishes to conduct effective internal audits on their medical device quality management system. Specifically, this course is aimed at:
- Anyone new to internal auditing
- Anyone involved in the process of auditing or auditing systems
- Anyone wanting to improve their existing audits or medical device management system.
- Those who have completed our ISO 13485 Foundation Course.
Our ISO 13485 Foundation Course will give you a good one-day introduction in preparation for this audit training course.
This ISO 13485 training course will give you a thorough understanding of how to perform value added internal audits of your organisation’s processes. This will help you and your organisation to identify gaps in your medical device quality management system as a basis for improvement of regulatory compliance and system effectiveness.
Completing this training also allows you to demonstrate to your certificate body that your internal auditors have been trained to a recognised standard.
Our experienced trainers will assist in the interpretation of ISO 13485:2016, sharing their knowledge and experience, combining both soft audit skills and an appreciation of the standard’s requirements and the likely evidence available to you as an auditor. The ability to plan for and to conduct an audit are key. Gaining this ability will support your audits time after time allowing you to benefit from a defined framework, structured to consistently allow you to undertake effective internal audits. A real ‘how to’ guide for the audit of management systems.
We were the first training organisation in the UK/Europe to hold IRCA approval for our internal and lead auditor courses within the medical device sector and we continue to be the leader in preparing IRCA-registered auditor courses.
This course is both CQI and IRCA certified (18203). Our company and our trainers undergo intensive inspection and assessment every year with the International Register of Certificated Auditors (IRCA). This means that the qualifications obtained from completion of this course are valid and will be recognised by your customers and certification body.
Build confidence. Sharpen skills. Audit with assurance.
The Audit Mentor service from QCS International is designed to support auditors who want to turn theory into confident, effective practice. Following your CQI & IRCA registered training, this service provides personalised, practical coaching to help you develop your auditing capability in real-world settings.
Delivered as a one-to-one or small group session, you will be accompanied by an experienced ISO audit professional who will mentor you through a live audit. You’ll receive hands-on support, constructive feedback, and expert guidance throughout the process—helping you refine your approach and gain confidence in your audit role.
What you’ll gain
• Live audit coaching during an on-site or remote audit
• Practical advice on audit structure, approach, and questioning techniques
• Guidance on audit format, evidence gathering, and reporting
• Real-time feedback to strengthen your audit skills and professional judgement
• Increased confidence and competence in conducting audits independently
How it works
• Half-day mentoring session
• Includes a pre-audit planning call to prepare objectives, scope, and approach
• Available for on-site or remote audits, offering flexibility to suit your organisation
BSI Standards
A copy of ISO 13485:2016 will be available to you for the duration of your training – you now have the opportunity to obtain your own copy of the standard for use during and after the course.
QCS International are an authorised BSI Distributor of publications including ISO standards and can make available to purchase a full, licenced copy of ISO 13485. This option will be available to you at checkout.
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