2/14/2023 0 Comments What does iso mean![]() The latest revision of ISO 13485 for ISO medical devices is from March 2016. For a good explanation on this, take a look at the article List of mandatory documents required by ISO 13485:2016.Ī survey of ISO 13485-certified companies shows that the number of companies that have implemented an ISO 13485 Quality Management System still shows a general positive trend worldwide (the drop in 2018 was mainly due to a different measurement methodology).ĭata taken from 2018 ISO Survey What is the current version of ISO 13485? Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service. Together, these define the overall scope and implementation of the Quality Management System. Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the Quality Policy, Quality Objectives, and Quality Manual. ![]() Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |