Before and during the course FAQs

Failure Mode and Effects Analysis is a technique for exploring where and how failure can occur in the development and manufacture of a product, enabling organisations to better control or eliminate those failures.

FMEA can be applied in the design and manufacturing of many products. This Risk Analysis and FMEA for Medical Devices training course focuses on the how designers and manufacturers of medical devices can reduce failures.

Yes, to get the most out of this training course you do need to know about the requirements of ISO 9001 and the principles of quality management. If you do not have that knowledge yet, then you can achieve an understanding by first attending our Introduction to ISO 9001:2015 training course.

Many delegates have found this a useful approach, and we offer a discount of £100 to anyone who books both of these courses together.

If you are not sure whether your level of knowledge is adequate, or you would like to take advantage of the discount, please contact us and we can help.

No, this course includes our Introduction to ISO 9001:2015 training course, which describes and explains the latest version of the standard, so you will gather all the knowledge you need during training.

Six Sigma is a set of quality management methods, techniques and tools for improving the quality of products and processes by identifying and removing the causes of defects and minimising variability. Originally developed by Motorola in the 1980s, it has since been adopted by many other companies around the world.

Six Sigma is based on the (DMAIC) five steps:

• Define the problem or opportunity that you want to improve
• Measure the current state of the process and identify the root causes of defects
• Analyse the data to identify the root causes of defects
• Improve by eliminating changes to the process to eliminate the root causes of defects
• Control to ensure that the improvements are sustained over time

Our expert tutors use workshops, exercises and discussions to illustrate their teaching, and give delegates a chance to test their understanding of the skills being learned. Whether attending face-to-face training or taking part in our Virtual Classroom, delegates are encouraged to work together to practise techniques and share experiences.

We believe this hands-on approach builds confidence and enables delegates to return to their roles with the tools and knowledge to improve their negotiation achievements.

One delegate commented that: ‘The role plays were really useful. The tutor was very clear and used very good real life examples’, while another added that: ‘The practical sessions and influencing techniques sessions were a useful part of the course’.

This carbon footprinting course is designed to complement our 2-day ISEP certified Pathways to Zero training course. The two courses are scheduled to run together in our training calendar.

We additionally offer other ISEP approved training courses on waste management, sustainability skills for the workforce and for management, and a Foundation Certificate in Environmental Management.

This is the process for a manufacturer to analyse, specify, design and evaluate usability, as it relates to safety of a medical device. The usability engineering process is specifically developed to reduce everyday errors, lower risks and ensure general equipment safety. Human Factors and Usability Engineering in medical device design is also required by the FDA’s Quality System Regulation (QSR).

As with all our training courses, we believe that the best way to learn is in an interactive environment where delegates can share their learning and questions in workshops and discussion with the tutor and other delegates.

On this course you will apply risk management techniques within a case study to consider how to identify risk and how to manage it.

Yes, you will receive a certificate after completing this 1-day course, demonstrating that you have gained extended knowledge in the field of waste management. The course is also valued at 7 hours for your CPD.

Yes, you will receive a Certificate of Completion after you have completed the full 2-day course. This will indicate that you have gained new skills and can be used to enhance your CV and LinkedIn profile, as well as being notified to managers and colleagues within your organisation.

The course is equivalent to 14 hours of CPD.