ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. This 24-hour ISO 13485:2016 Lead Auditor course provides training on the standard itself, but also on how to lead or conduct internal audits and supplier audits using ISO 13485 and ISO 19011:2018.
By participating in this online course, you will be able to:
This course is for you if you want to:
Find answers to FAQs.
Email CustomerService@sae.org, or call 1-877-606-7323 (U.S. and Canada) or 724-776-4970 (outside US and Canada).