How to execute your Internal Audits? (Medical Device companies)
In this episode of the Medical Device made Easy Podcast, Monir El Azzouzi will explain to you how to perform Internal Audits for your company.
Internal Audit is necessary to verify that your Quality Management System is compliant, efficient, and maintained. But how to do that, who can do that, when to do that…? It is also a requirement for ISO 13485, FDA QSR 21 CFR part 820.
And if you need some guidance to implement your Internal Audit process you can also use ISO 19011 to help you. All the answers will be here but remember that the Internal Audit process is also a powerful tool to increase Quality Culture within your organization.
You can use this tool also to convert your departments which are working in Silo to departments that are working together.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links
- Blog post on audits: https://easymedicaldevice.com/medical-device-audit/
- Green Belt Program EU MDR 2017/745: https://school.easymedicaldevice.com/courses-2/
- ISO 13485.2016: https://www.awin1.com/cread.php?awinmid=3911&awinaffid=506189&clickref=&ued=https%3A%2F%2Fshop.bsigroup.com%2FAffiliateRedirect.aspx%3Furl%3Dhttps%3A%2F%2Fshop.bsigroup.com%2FProductDetail%3Fpid%3D000000000030353196
- ISO 19011.2018 : https://www.awin1.com/cread.php?awinmid=3911&awinaffid=506189&clickref=&ued=https%3A%2F%2Fshop.bsigroup.com%2FAffiliateRedirect.aspx%3Furl%3Dhttps%3A%2F%2Fshop.bsigroup.com%2FProductDetail%3Fpid%3D000000000030354835
- FDA QSR 21 CFR part 820.22: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.22
The post How to execute your Internal Audits? (Medical Device companies) appeared first on Medical Device made Easy Podcast.
