Before and during the course FAQs

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, you will need to attend the course in full, and then log into an external platform to take an exam within 30 days of course end.

As well as the exam you will be given access to a portal providing practice questions, which we recommend you try, to ensure your best chance of success. We will also talk you through the exam during the course.

The online exam, with multiple types of questions, has replaced the essay-type exam previously set for lead auditors by CQI and IRCA.

ISO 27001 is an international standard that specifies the requirements for an information security management system (ISMS). An ISMS is a framework that helps organisations manage their information security risks and improve their information security.

Although ISO 27001 is a voluntary standard, many organisations choose to be certified to it. They see certification as an opportunity to demonstrate to customers, suppliers, and other stakeholders that the organisation has a commitment to information security.

Further benefits of implementing ISO 27001 include:

• Reduced information security risks
• Improved compliance with information security regulations
• Increased efficiency and cost savings
• Enhanced reputation and brand image
• Increased customer satisfaction
• Improved employee morale and motivation

Key concepts of ISO 27001 include:

• Information security risk - the potential impact of a threat on an organisation's information assets
• Information security controls -  measures taken to reduce information security risks

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

Bywater’s ISO 45001 internal auditor training course will equip you with the knowledge and skills, as well as essential practice, to start carrying out internal audits in your organisation – from preparation right through to follow up. As a result you will be in an excellent position to make a valuable contribution to the management and improvement of your OH&S management systems.

It will be useful to you to bring a copy of the standard so that you can refer to it as we talk through its requirements. If you do not have a copy at the office, you can purchase one from the ISO’s website or one of its global resellers.

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 can provide replacement certificates at a cost of £35 + VAT each. Please contact us on 0333 123 9001 or contact@bywater.co.uk with the delegate name, course start date and name of the course you attended and we will be pleased to assist you.

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.’