ISO 9001:2015 is the international standard that defines the requirements for a Quality Management System (QMS). A Quality Management System enables organisations to manage their processes and systems in order that customer and other stakeholder requirements can be achieved. At its core is the principle of continuous improvement.

In this course participants will learn about the fundamentals of ISO 13495:2016. This training will also help participants understand the impact of not adhering to ISO 13485:2016 requirements.

On completion of this training, participants will be able to:

• Understand the ISO 9001:2015 requirements
• Understand the terms and definitions within the standard
• Interpret the clauses of ISO 9001:2015
• Identify QMS documentation requirements
• Communicate the importance of understanding regulatory requirements
• Learn the importance of ISO 9001:2015 to the organisation

• Those individuals working in an ISO 9001:2015 complaint environment
• Individuals who are new to working in a quality management environment
• Internal auditors
• Supplier auditors
• Quality engineers

Dr. Fiona Masterson

With over 25 years’ experience in quality management, operations management, and higher education, Fiona combines technical expertise with highly engaging training. She has worked in fast-paced manufacturing environments including medical device companies, and lectures part-time in universities. She is a lead quality auditor and has conducted numerous ISO 9001:2015 audits.

She has Bachelor and Master of Science degrees, and a Doctorate in Mechanical Engineering. Fiona has published in peer reviewed journals on topics such as medical device and pharmaceutical regulatory affairs, on-the job training and innovative training technologies and strategies.