Before and during the course FAQs

Our lead auditor training takes delegates through the concepts and practical application of the standard as needed to conduct or lead management system audits in their own and/or other organisations. If you need to understand how to audit a quality management system in 1st, 2nd or 3rd party organisations, we recommend our ISO 9001 Lead Auditor training course.

If your focus is solely on performing internal audits of your organisation’s quality management system against ISO 9001:2015, then this ISO 9001 Internal Auditor course the right choice for you. On this course you will learn how to help ensure your organisation can become and remain compliant with ISO 9001 and how to support the process of continual improvement.

At present we deliver this training as a dedicated course for individual organisations. This give you the opportunity train a number of employees at a time and place that suits your business.

We run this dedicated course to suit your organisation’s requirements at a time and venue of your choice. This gives you the opportunity to train all those who are interested in the role of remote auditing at one time on a single day. It is not available as a public course.

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.

While not essential, it is helpful if you have some knowledge of statistical techniques, as we will talk about their application. As the training is live and interactive, you will be able to ask questions of your tutor to clarify your learning.

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

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.

Having internal auditor experience in other fields will be helpful to learning about auditing for medical devices. We do recommend though that you gain some knowledge of ISO 13485 before taking this course to ensure you can attain maximum benefit. We offer a discount of £100 if you book our 1-day Introduction to ISO 13485 training course together with this ISO 13485 Internal Auditor training course. Delivered on consecutive days, the courses give you a practical 3-day training experience.

The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area. The CE mark demonstrates that the manufacturer has checked that its products meet EU safety, health or environmental requirements.

This Medical Device Regulation course will introduce delegates to the concept of CE marking within the discussion around EU medical device regulation requirements.

Organisations often find that their efforts to identify and correct the root cause of failures and inefficiencies falter because they do not completely understand how and why to find and fix those problems. On our 2-day training course you will learn about a wide range of best-practice approaches and proven tools to help you review and correct processes across the business, including choosing the right tool for the task. Importantly, you will have the opportunity to practise these tools under the guidance of experienced tutors while you are in the classroom.