#Iso 13485 2016 upgrade
Upgrade your expertise from internally auditing with ISO 13485:2003 to ISO 13485:2016 Mandatory documents and records required by ISO 13485:2016.Improve your curriculum vitae and career opportunities with qualifications in ISO 13485:2016.Quickly and efficiently get a comprehensive training on ISO 13485:2016.Continuous assessment to check knowledge and application of key concepts.365 days of online single-user access (from date of purchase) to the approximately 10 hours of instruction.Explain how the requirements can be interpreted and implemented.Explain the process approach and its relationship to managing an organization.Summarize the high level requirements and intent of this international standard.Identify the clauses within the standard.
Objectivesīy participating in this online course, you will be able to: Estimated to take up to 10-hours to complete, this is a self paced course. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. 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 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry.