Designed by your partner in learning as an intensive course for medical device quality professionals, this ISO 13485 internal auditor training builds knowledge for an effective quality management system.
The two-day training is delivered either in person or live online in a classroom environment. Guided by experienced instructors, you will learn how to explain the structure and scope of the standard and identify an auditor’s key responsibilities. You’ll also discuss every stage of the internal audit process through role-play, workshops and tutorials, plan and conduct an audit and assess if it was done effectively.
Although some prior understanding of ISO 13485:2016 is useful, you’ll leave the course with all the knowledge you need. You’ll be able to maintain compliance and internal processes and motivate colleagues to do the same.
Prerequisites
There are no formal prerequisites for this course.
Pedagogical objectives
- Able to fully grasp and comply with ISO 13485:2016
- Confidence that your organization is using competent auditors•Maintain rigorous internal processes
- Write factual audit reports and suggest corrective actions
Skills to be acquired
On completion of this training, participants 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
Targeted audience
- 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
What is included?
Course materials including:
- Introduction to the training, detailed program and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
Assessment specifics
- Questionnaire to assess theknowledge at the end of the training
- Customer survey
What is included?
- Course materials, providedelectronically
- Letter of attestation
- Official certificate
Do you need more information?
If you have any concerns, please do not hesitate to contact our service department on the following numbers:
Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com
You will be put in touch with our team if necessary.
