ISO 13485 Fundamentals Training – Virtual Training
February 1st 2021 @ 6:30 pm - 9:30 pm
€89 Price includes training, all training materials and certification. Need a quote for In-house Training email us today firstname.lastname@example.org
Understanding the general structure of a Quality Management System (QMS) and QMS standards such as ISO 13485 will allow the learner better prepare for working in Medical Device companies. Today most organisations have a QMS and therefore knowing the fundamentals of the internationally recognised QMS ISO 13485 will benefit all entering the industry or those transferring/returning for other industries.
Who should attend?
• Anyone who aspires to work in the Medical Device Industry.
• Management and Supervisors who are new or require a refresher on basic QMS.
• Those who are new to ISO 13485, or are scheduled to attend our IRCA Approved Foundation or Internal / Lead Auditor training courses.
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
Facilitated by experts working in the Quality Management field for many years, this is an excellent opportunity to listen and ask all the questions you may have in relation to the standard or your upcoming IRCA Approved Internal / Lead Auditor training.
The 3 hour online course on ISO 13485:2016 is delivered by Live Virtual Classroom.
By the end of the training learners will be able to:
Explain the purpose of a Quality Management System (QMS) and QMS standards.
Explain the importance of Organisational context and the use of Risk-based thinking in ISO Standards.
Describe the Process Approach and the Plan-Do-Check-Act Cycle advocated by ISO 13485.
Understand the ISO 13485:2016 requirements.
Explain how ISO 13485 can enable an organisation to achieve its objectives effectively.
Understand the European and International Regulatory connection with ISO 13485.