Course description
CQI IRCA Certified ISO 13485:2016 Internal Auditor Training Course - Quality Assurance and Auditing - Open Course
This ISO internal auditor training course equips delegates with the skills and knowledge to conduct internal audits to ISO 13485. Over the course of two days, delegates will learn how to interpret the requirements of the ISO 13485 medical devices standard from an auditing perspective, conduct effective audits and develop audit findings.
Delegates will learn a detailed understanding of:
- Medical devices, quality and auditing terminology
- Auditing skills
- Structure & intent of the medical devices standard ISO 13485 :2016
- Planning, preparation and management of audits
- Types of audit
- Checklist development
- Internal audit objectives
- Conducting process audits
- Internal audit scope and criteria
- Reporting audit findings
- The audit process
- Verifying corrective action
- Roles and responsibilities of the internal auditor
- Interviewing skills
The format of the ISO 13485 Internal Auditor course utilises accelerated learning techniques and is therefore highly interactive, with tutor-led sessions interspersed with individual and group exercises. A realistic case study and role-play activities provide an excellent opportunity to practice ISO 13485 auditing skills.
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?
- People new to auditing and have been asked to conduct internal audits
- Anyone involved in planning, managing and implementation of internal audit systems
- Those needing to identify gaps in the effectiveness of your MS
- Those wanting to achieve continual business process improvement
ISO 13485 specifically requires that staff are trained and that auditors are competent, this course satisfies this requirement.
Outcome / Qualification etc.
Upon successful completion of this course, delegates will be awarded a CQI IRCA approved certificate.
Reviews
Average rating 4.6
Despite not generally enjoying role play activities, the simulated audit was a good way to learn. I enjoyed the trainers commitment to the various characters he was playing, plu...
I thought the pre-course materials were good for prep providing a brief overview without being too time-consuming. The structure of the course and the way the information was pr...
Expenses
The fees for this course are £945 + VAT.
This fee is inclusive of full delegate manual, lunch, refreshments & certificate.
Special offers may be available for this course, please enquire for details.
Robert is an excellent tutor. He made the very dry course into interesting and easy to understand training. He left a very positive and lasting impression. Thanks.