Announcing Bywater’s new ISO 13485 Lead Auditor course, certified by CQI and IRCA
19 Jun, 2025
Bywater is pleased to announce that our ISO 13485 Lead Auditor training course is now certified by CQI and IRCA.
The ISO 13485 Lead Auditor course has been developed by subject matter experts and is available in venues across the UK and in our Virtual Classroom.
Why did we create this course?
Bywater had already been running a successful ISO 13485 training courses. Enquiries from customers and our own watchful eye on the market revealed a growing demand for a similar certified course for lead auditors. We answered the need by creating and delivering this new ISO 13485 Lead Auditor training course, certified by the professional standards body CQI and IRCA.
With appropriate training, ISO 13485 lead auditors can bring significant value to the medical device industry by helping manufacturers to consistently meet regulatory, quality and safety requirements.
How we created the course
To create a course that meets customer meets and the standard required by CQI and IRCA, we engaged two of our highly experienced subject matter experts, Liz Mansfield and Peter Lomas who designed and developed the course from scratch.
Leading expert Liz has been registered with the International Register of Certificated Auditors (IRCA) as a lead auditor since the mid-1990s. Working as an independent consultant, she runs regular training courses for auditors, lead auditors and management system representatives across a wide range of sectors. Amongst her many training and consultancy roles, Liz takes part in the development and delivery of trainer training programmes, including development of accelerated learning programmes for IRCA, delivered to certification bodies and training organisations in the UK and around the world.
Together Liz and Peter have many years of practical experience in developing and delivering lead auditor training courses, and really understand how make them work from a participant’s perspective.
Liz explains their process: ‘We wanted to build a “from the ground up” medical devices course, not an ISO 9001 course with a few extras. And we wanted to create a course that is credible, with realistic scenarios to help learners develop and apply their learning in a way they can easily transfer back to their workplaces’.
Liz and Peter designed the course against course specification, alongside a course development team, to get it ready for customers and CQI and IRCA submission.
Why certification?
When organisations are looking for auditor training, they will find that they can choose certified or non-certified courses.
Certification is not compulsory, but it does offer reassurance that the appropriate standards body has thoroughly assessed the training course to stringent criteria and judged it to be of high quality.
Because quality is at the heart of everything we do, we are always keen to certify our courses where appropriate, and this ISO 13485 Lead Auditor course takes our total to 14 CQI and IRCA certified courses.
What does certification involve?
CQI and IRCA has clear and stringent criteria that must be met to achieve course certification.
And collaboration is key. While our partner experts author the course, our experienced training team take on the process of submitting the application and managing timelines and communication between all parties.
Once the application has been made, a Technical Assessor evaluates the information supplied about the course against its criteria. Any nonconformities that the Assessor finds must be shown to have been addressed before certification is granted.
We continue to improve courses after certification by requesting and acting on feedback from attendees.
What makes our ISO 13485 Lead Auditor course different?
As well as industry knowledge, Liz and Peter have a deep understanding of training design and how people learn. The course they have developed is a fully interactive, learner-centred course that engages participants throughout – not just ‘chalk and talk’.
Over the duration of the 5-day course, delegates will work through exercises, activities and case study scenarios, that will reinforce learning around key topics such as pre-audit activity, document review, audit planning, checklists and sampling plans, interviews, internal communication, reporting and nonconformities, real audits, surveillance audits, and presentations of conclusions.
The course is suited to those who already have a basic understanding of ISO 13485 and quality management systems, and now want to participate in 1st, 2nd and 3rd party audits of medical device quality management systems. We offer an Introduction to ISO 13485 training course to those who need to develop ISO 13485 knowledge before attending this course.
Find out more
This ISO 13485 Lead Auditor course is now available at face-to-face venues around the UK and online in our Virtual Classroom.
We run a range of certified courses for lead auditors, internal auditors and those making the transition to new versions of standards. These include courses for ISO 9001, ISO 14001, ISO 27001 and ISO 45001.