Course description
CQI IRCA Certified ISO 13485:2016 Foundation Training Course - Quality Assurance and Auditing - Open Course
This highly interactive 1 day course gives delegates a sound knowledge of the requirements of ISO 13485 and the fundamentals of a medical devices management system.
Delegates will leave this course with an understanding of :
- Quality/medical management systems
- Quality principles
- Management system structures
- Quality terminology
- Interpreting the requirements of the ISO 13485:2016 standard
- The Process Approach
- Continual Improvement
As part of our continued support in helping you get the best from our training course, all delegates will receive access to the Batalas Toolkit. This toolkit includes pre-course exercises and a series of e-learning/video tutorials that have been designed to support you in your preparation of this training course.
We also offer a 'no-pass no-fee' guarantee and 'book now pay later' policy with this course (t&c’s apply).
If you have a team of 4 or more auditors then this course can also be taught on an in-house basis, tailored to your organisation's needs as a cost-effective alternative – please enquire for a quote.
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Suitability - Who should attend?
This training course has been developed for:
• People new to ISO looking to gain the knowledge of the clauses of ISO 13485
• Those who already work as an auditor but need a refresher
• Those looking to attend an auditing course but do not have the necessary prior knowledge.
Outcome / Qualification etc.
Upon successful completion of this course, delegates will be awarded:
- a CQI IRCA certificate
- a CPD certificate (Continuing Professional Development)
Reviews
Average rating 5
Very interactive which is important when you are sat in a room for 8hours. It made a huge difference having a tutor that stayed objective whilst giving their opinion on a few ma...
Steve is very knowledgeable and delivered a complicated and somewhat dry topic well. We will consider other training days in the future.
Expenses
The fee for this course is £445 + VAT
This fee is inclusive of full delegate manual, lunch, refreshments & certificate.
Special offers may be available for this course, please enquire for details.
I really liked the way the training was delivered, especially the group work and discussions. It was so much easier to stay focused and absorb information. Geraldine Johnson, Eu...