In the meantime, the medical device industry can rely on AAMI TIR102:2019, which is a bi-directional mapping tool that was released on August 30, 2019.
ISO 13485:2012 ISO
FDA 21 CFR 820 with ISO 13485:2016, making ISO 13485 the FDA’s mandatory QMS for Medical Devices (the rule is expected to be released in 2019).
the FDA has proposed a rule which would harmonize U.S. This global standard is mandatory in some countries, and in the U.S. In addition, the documentation and safety requirements are much greater under ISO 13485:2016, whereas ISO 9001:2015 puts focus on customer satisfaction and continuous improvement. (Yes, 2008, not 2015.) This is because it does not follow the high-level structure (Annex L) of the latest version of ISO 9001 (which is 9001:2015). While ISO 13485:2016 remains a stand-alone document, it aligns with ISO 9001:2008. For the most part: ISO 13485 = ISO 9001 + Additional Medical Device Requirements. ISO 13485:2016 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices.Ĭertification to the standard requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit.
ISO 13485 PowerPoint Training Materials.ISO 13485 Online Training Course Listing.ISO 13485 Internal Auditor Training Courses.ISO 13485 Lead Auditor Training Courses.Simple Steps to ISO 13485 Certification Follow our proven and manageable step-by-step process for a successful ISO implementation project.
0 kommentar(er)
