An ineffective audit can mean severe consequences; resulting in process failure, patient dissatisfaction and regulatory noncompliance. Optimize your auditing skills with the internationally recognized ISO I3485:2016 and boost your internal audit capabilities. Gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary.
This course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits in accordance with ISO 13485:2016 and ISO 19011:2018.
Delegates learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
Qualification:This course forms part of our Auditor Qualification programme. To find out more, please visit our training auditor qualification page here.
Gain a Certificate of Achievement for this course
You can now qualify for a Certificate of Achievement, by passing the assessment requirements, including an end-of-course online exam, you’ll improve your professional profile and be able to:
- Provide evidence of your learning
- Demonstrate your competence
We will email your exam log-in details when you’ve finished the course. The exam is done online which means you can choose when and where to complete it. You are strongly advised to choose a time and a place where you will not be disturbed, and where you have access to a reliable internet connection. The exam takes approximately 80 minutes, is comprised with 40 multiple choice questions and you have up to 30 days to complete it – including one opportunity for a re-take.
Upon successful completion of this exam you will be awarded a Certificate of Achievement alongside your Certificate of Attendance. If, however, you decide not to complete the exam, you will still be awarded with a Certificate of Attendance.
Please talk to a member of our training team on +31 (0)20 346 0780 or via training.nl@bsigroup.com if you have any questions in regards to the online exam and your training course.
ISO 13485:2016 learning path and combination discount
The ISO 13485:2016 Internal Auditor learning path is modular. You can follow the training in all combinations. We recommend the following order:
In addition to this introduction training, the following training courses are part of the ISO 13485 course:
1. Introduction ISO 13485:2016 - € 740,-
2. Implementation ISO 13485:2016 - € 1.425,-
3. Internal Auditor ISO 13485:2016 - € 1.425,-
4. Lead Auditor ISO 13485:2016 - € 3.355,-
When you choose a combination of training courses, you benefit from a price advantage:
| Training course | Investment | Discount |
| Combination training 1 + 2 | € 2.065 | € 100 |
| Combination training 1 + 3 | € 2.065 | € 100 |
| Combination training 1 + 4 | € 3.920 | € 175 |
| Combination training 1 + 2 + 3 | € 3.365 | € 225 |
| Combination training 1 + 2 + 3 + 4 | € 6.545 | € 400 |
In-house training course
For more information about this course and/or the possibilities of an in-house training for your organization, please contact our Training Advisors on 0031 (0)20 346 0780 or send an email to training.se@bsigroup.com.
Who should attend?
- Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
- Individuals interested in conducting first-party or second-party audits
- Management representatives
- Internal auditors
- Consultants
Prerequisites:
You should have a good knowledge of ISO 13485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction training course.
Delegates will be able to:
- Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
- Identify the key principles of auditing and auditor responsibilities
- Plan an internal audit
- Conduct an effective audit based on process identification, sampling and questioning
- Determine if corrective action has been effectively implemented
Practical Information
- It's a 2-day course
- The training and materials will be provided in English
- Lunch and drinks are included
- On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.se@bsigroup.com or 0031-(0)20-346 0780.
