Our ISO 13485 Internal Audit Training Course focuses on both the requirements of ISO 13485:2016 and the audit process and methods (ISO 19011) to ensure the manufacturer or supplier is compliant with the requirements of the standard. Our approach is to educate on the intent and purpose of the standard so that the participants are able to make informed decisions in the future. Our training is helpful for regulatory, quality, production, and engineering roles, both management and contributors.
The current standard format course covers the topics listed below:
- Quality terminology
- Management responsibility
- Resource management
- Product realization and relationship to design controls, usability, cybersecurity, and software lifecycles
- Purchasing
- Production and service provision
- Control of monitoring and measuring devices
- Measurement, analysis, and improvement
- Control of non-conforming product
- Analysis of data and improvement
- Principles of auditing
- Managing an audit program
- Preparing for audit activities
- Conducting audit activities
- Audit reporting clause
- Completing the audit
- Audit follow-up
- Selection and training of auditors
- Practical, real-world examples and discussion
- Workshops and exercises integrated throughout teaching modules
Full credentials on our website: https://www.softwarecpr.com/consultation/
This course can be provided live, onsite or remotely (requires camera on for entire course).
COST: 3 Full Days (9:00 am to 4:30 pm) for $21,000 for up to 21 students. Extra cost per student over 21.
Course tailoring available for a fee.
To schedule the course or have a discussion, please email us at: training@softwarecpr.com
