- Easy to access online course
- Learn at your own pace, on a date and time to suit you
- Support from a dedicated e-learning team
Medical Devices
MD-QMS ISO 13485:2016 Lead Auditor Course (Medical Device)
★★★★★ 4.8/5
During this engaging Lead Auditor course, delegates will learn the knowledge and skills required to plan, conduct, and report audits of a Medical Devices Quality Management System (MD-QMS) against ISO 13485:2016.
Designed around real-world scenarios and extensive audit simulation, the course enables delegates to develop the competence expected of a medical device auditor, ensuring audits meet international best practices, regulatory expectations and CQI IRCA requirements.
Our virtual course is perfect for anyone who requires online ISO 13485 Lead Auditor training; alternatively, we also offer traditional classroom courses.
5 days – 08:45-17:30 (13:00 finish on the last day)
CQI and IRCA training level – Professional
CQI and IRCA ref – PR369
(ATP No. 2759)
Online Training
Public Training
- For bookings of 1-3 people
- Choose from a timetable of scheduled course dates throughout the year
- Attend the course at one of our UK training venues, or in a live virtual classroom
From 1895 pp + VAT
In-House Training
- For a team of 4-10 people
- Dedicated training on a date, time and location to suit you
- We can come to any workplace in the UK or overseas, or we can teach via a live virtual classroom
From 1075 pp + VAT
We are proud to have a 100% pass rate for this course (data source CQI IRCA)
Secure yourself a no-obligation provisional place on your chosen public course
Supporting you through your training, we offer a FREE exam resit on all Lead Auditor courses
Who should attend this MD-QMS ISO 13485 Lead Auditor Course?
- Any new or existing auditors that wish to be able to conduct 1st party (internal), 2nd party (supplier) and 3rd party (external/certification) audits of a quality management system (MD-QMS) that conforms to ISO 13485:2016 for medical devices.
- Anyone planning, managing or implementing an ISO 13485:2016 medical devices quality management system.
- Staff/managers who need to identify gaps in the effectiveness of an ISO 13485:2016 quality management system to help ensure the organisation remains compliant.
- Individuals involved in medical devices quality management, regulatory compliance, manufacturing, engineering or device lifecycle management.
- This course satisfies the training requirement for anyone registering as an Auditor with IRCA (International Register of Certified Auditors).
Anyone attending this CQI and IRCA-certified ISO 13485 Lead Auditor course must have existing knowledge of ISO 13485:2016 – please take our ISO 13485 quiz to check your level of understanding.
It is highly recommended that delegates first attend an MD-QMS ISO 13485 Foundation course to secure prior knowledge. As part of our COURSE BUNDLE offer, a £50 discount will be applied to the online shopping basket when booking both a Foundation and Lead Auditor course.
What will delegates learn on this MD-QMS ISO 13485 Lead Auditor Course?
During this Lead Auditor training course, delegates will be taught the following –
- The purpose, structure and intent of a Medical Device Quality Management System based on ISO 13485:2016
- MD-QMS requirements, including risk-based processes and regulatory alignment
- Audit types, audit programme design and risk-based audit planning
- Plan, prepare and manage effective audits, including: audit scope, criteria and objectives, audit plans and working documents, opening/closing meetings
- Conduct process-based audits using ISO 19011 best practice
- Collect, verify and record objective evidence
- Lead audit teams and apply interview techniques
- Identify, grade and write traceable and compliant nonconformities
- Produce concise, credible and value-adding audit reports
- Follow up audits, verify corrective actions and evaluate effectiveness.
Delegates will also gain insight into auditing areas specific to medical devices, such as: design and development controls, risk management (ISO 14971), software lifecycle controls (IEC 62304), sterilisation and cleanroom controls, post-market surveillance and complaints, global regulatory expectations and MDSAP considerations.
MD-QMS ISO 13485:2016 specifically requires personnel to be competent – this course provides essential skills and knowledge to help delegates become fully competent auditors.
What you need to know
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What is the format of the course?
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- This MD-QMS ISO 13485 Lead Auditor training course combines tutor-led sessions and interactive exercises, including audit planning, audit simulation, team-based workshops, report writing and non-conformity activities (approx. 25% theory and 75% practical).
The balance of theory, facilitated discussion and hands-on audit practice ensures that delegates leave ready to apply their skills in the workplace.
- A case study is used throughout the course to assist with practical skills development.
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What is the course assessment?
- The tutor will assess a delegate’s general participation in the course, including any case study activities and audit simulations.
- On the final day, delegates must complete a 2-hour written MD-QMS ISO 13485 lead auditor exam. If the course is taught via a virtual classroom, the exam will be taken remotely – a webcam, microphone and speakers are required for the exam.
- Delegates are required to attend 100% of the course (a CQI and IRCA requirement).
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What type of certificate will I receive?
- A CQI IRCA certificate is supplied after completing the assessment and passing the MD-QMS ISO 13485 Lead Auditor exam.
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What's included in the course fee?
- Pre-course work to help prepare for training (Training Toolkit)
- Delegate training manual
- Case Study documents
- Post-course notes
- CQI and IRCA certificate
- Lunch and refreshments (applicable when training at one of our venues)
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Do you have prior knowledge of ISO 13485? Save £50 when booking a Foundation + Lead Auditor course
FREE Training Toolkit
Our classroom and virtual courses come with a unique toolkit which helps you prepare for training, including:
Pre-course exercises
Series of training videos
Training manual
Test your prior knowledge with our ISO 13485 Quiz
Anyone attending an ISO 13485 Lead Auditor course is required to already have an understanding of the Standard.
We’ve created a helpful quiz to help you test your knowledge
Book your course
- Easy to access online course
- Learn at your own pace, on a date and time to suit you
- Support from a dedicated e-learning team
| Delivery | Location | Date | Price (+ VAT) | |
|---|---|---|---|---|
Workshop |
via Zoom | 22 Jun 2026 - 26 Jun 2026 |
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Event is fullJoin waiting list |
Workshop |
Bristol | 28 Sep 2026 - 02 Oct 2026 |
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Workshop |
via Zoom | 28 Sep 2026 - 02 Oct 2026 |
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Workshop |
via Zoom | 30 Nov 2026 - 04 Dec 2026 |
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We can travel to any workplace worldwide and teach your team on a date to suit you. Alternatively, we also offer online team training which is ideal for larger organisations with employees at several locations. Simply send us your requirements to receive a quote.
- OFFER
ISO 13485 Foundation + Lead Auditor = £50 off
Find out when new dates are added, register your interest today.
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Learning styles for this course
Classroom Training
Traditional, face-to-face training delivered by an expert tutor in a physical classroom setting. Learn at one of our 6 UK training venues, or we can teach your team at your workplace.
Virtual Training
Access the course online via Zoom and interact with the tutor and other delegates in real time. Perfect for anyone who wants to learn from home or work without the need to travel.
In-House Training
Dedicated ISO training is available just for your team on a date and time to suit you. Suitable for a group of 4-12 auditors, we can travel to any workplace worldwide.
CQI and IRCA certified course
We are proud to be an Approved Training Provider for CQI and IRCA; the only organisation in the world that can award quality professionals with a Chartered status, making its brand one of the most trusted.
When choosing a CQI IRCA-certified course, delegates can feel confident that the training will meet the requirements of an internationally recognised set framework.
ELCAS approved course
Run by the MOD, the Enhanced Learning Credits Administration Service (ELCAS) offers financial support to those currently serving or leaving the armed forces.
We have a long history of delivering training to the armed forces and are proud to have been an ELC Approved Learning Provider since 2019.
Some of our happy customers
He was a fantastic engaging trainer, interactive and challenging ways of thought and approach in audit situations. He approached everyone fairly and equally and always actively listened and responded to queries.
Adam Gregory Advanced Medical Solutions ISO 13485 Lead AuditorGreat service from Batalas, very supportive admin support with pre-course. Great course well pace from an expert instructor.
Jamie Cook Alchemy SCS Ltd ISO 13485 Lead AuditorThe contact persons at Batalas were very helpful in answering our queries and in the pre-course preparation. The trainer was very engaging and the teaching method was very effective.
Jose Magbanua Sphere Medical ISO 13485 Lead Auditor
I have undertaken two lead auditor courses with Batalas, one via virtual classroom and the other classroom-based - I found both very enjoyable.
Erling Smith ISO 13485 Lead Auditor
What an amazing tutor, patient, understanding and approachable. Able to keep everybody engaged.
Katie Jennings ISO 13485 Lead Auditor
The tutor's knowledge and his expertise together with his experience, make this course very engaging.
Stefan Thomi Coltene ISO 13485 Lead Auditor
The trainer is the main reason behind the success of the course. He is very knowledgeable with the standard and approaches the course discussion with enthusiasm and engagement with the participants.
Rodrigo Petoral Jr Coloplast ISO 13485 Lead Auditor
It is best interactive and immersive course I have ever attended. It was engaging and I have learnt so much.
Kathryn Prattley Elekta Ltd ISO 13485 Lead Auditor
Best course I have ever been on in 25 years in compliance.
Jonny Do Armstrong Medical ISO 13485 Lead Auditor
The course was really good. I especially liked all the practical case studies and exercises.
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Let's level up your career together
Are you a new auditor looking for ISO training advice? Or do you want to build on existing auditing skills to boost your career?
Whatever your need, our experienced and knowledgeable Batalas team can guide you on the right training path to help you reach your professional goals.
ISO 13485 Lead Auditor Training for your team
Do you have a group of employees who require ISO 13485 Lead Auditor Training? One of our expert tutors can visit your workplace and teach your team on a date to suit you, or we can even deliver the course virtually if you prefer.
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Let’s level up your career together
Are you a new auditor looking for ISO training advice? Or do you want to build on existing auditing skills to boost your career?
Whatever your need, our experienced and knowledgeable Batalas team can guide you on the right training path to help you reach your professional goals.
