Before and during the course FAQs

We have enjoyed the company of delegates from many organisations within the medical manufacturing industry, including those involved in products such as ventilators and wound protection.

As one delegate reported: ‘It was very useful to learn about the gold standard from many different industries and where we sit with regards to other companies within medical devices, and to learn of all the ways that we can improve.’

Bywater offers a wide range of complementary training courses around standards for medical devices, including:

• introduction to and auditor training for ISO 1345
• risk analysis
• introduction to ISO 15189 and auditor training for medical laboratories
• in vitro diagnostic regulations (VDR)
• quality system regulations
• BS EN 62366 usability engineering

No, there is no exam associated with this course. You will receive a certificate confirming your training after full attendance and completion of the course.

While both of these ISO standards relate to quality management systems, there are some significant differences. For example, ISO 9001 focuses on achieving increased customer satisfaction through continuous improvement. Device safety is the important factor in ISO 13485 and medical device regulation (MDR), and the aim is to maintain effectiveness. The two approaches also differ in the demands for documentation, record keeping and risk management.

Yes, we will send you a certificate as evidence of your attendance after the course. You can use the certificate to demonstrate your achievement on your career history and LinkedIn profile, as well as sharing it with your employer and colleagues.

The course is equivalent to 7 hours CPD.

You will need some basic understanding of ISO 9001 and quality management systems to get the most out of the internal auditor training. If you do not have that knowledge you can first attend our 1-day Introduction to ISO 9001:2015 course, which we run on the day before the internal auditor training course. Book both these courses together and you can receive a discount.

You may receive pre-course work to do, and we advise completing this as it will give you a head start in maximising benefit from the course.

We will send your course materials in advance, and you should bring these with you if you are attending in person.

You may find it useful to bring a copy of the ISO 9001:2015 standard to reference throughout the course. If you do not have a copy in the office, you can purchase one from the ISO’s own website or from its international resellers.

All delegates completing this 1-day course will receive a certificate confirming their attendance.

While the course does talk about UK legislation, there is plenty of knowledge shared that is pertinent to any country or individual organisation that is seeking to manage and reduce its carbon output. You will learn about the terminology, the key drivers, and how to develop a carbon footprint strategy. The course also looks at capturing data and ensuring its quality. All these lessons can be applied wherever you work. Training run in our interactive Virtual Classroom is accessible globally.

We deliver the 1-day Quality System Regulations for Medical Devices training course as a dedicated course for your organisation. This gives you the opportunity to determine where you would like the course to run – at your offices, at another venue, or online. You can also choose a date that is most convenient for you.

Yes, the Medical Device Single Audit Program (MDSAP) can significantly aid your organisation in achieving continual improvement.

Based on the ISO 13485 standard, MDSAP supports continual improvement by providing a robust framework for managing quality management. The approach emphasises risk management and encourages a culture of quality.

By aligning with global standards and focusing on corrective actions, MDSAP can help organisations identify opportunities for improvement, and implement effective strategies to enhance their processes and products.