{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F6dcd4d41-bc8b-4fae-91ae-05c0ff17a655","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Tips, Tricks & Best Practices for Complying with ISO 13485:2016","description":"When it comes to 13485:2016, are you scrambling to meet requirements? Are you trying to figure out the how, what, or when regarding its timeline? Or, maybe you just don\u2019t know what you need to do. You are not alone because a lot of companies are behind. Don\u2019t wait until it is too late. Now is the time to take action. \n\nToday\u2019s guest is Kyle Rose, president of Rook Quality Systems, which helps companies achieve 13485 certification by using the Greenlight Guru\u2019s Quality Management Software platform. Kyle shares some tips and tricks for dealing with 13485 because time is ticking!\n\nSome highlights of this episode include:\nThe February 2019 deadline is approaching for most auditing organizations. If you have your audit scheduled before then, it has to be to the new standard.\nIf you don\u2019t have your new ISO 2016 certificate by February 2019, you risk losing your ISO certification and other items.\nCreate a gap analysis or internal audit plan to review your current QMS and highlight what is missing for the new standard.\nCompanies should perform quarterly management reviews. There is a growing expectation that executive management knows the effectiveness of their QMS.\nAn element regarding QMS software validation has found its way into the new standard. Refer to Section 4.1.6.\nHow do Dropbox, Google Drive, and others play into QMS software validation? Assess, evaluate, and keep a paper copy on hand.\nIf you are using software packages or working with a company, that becomes a supplier. Have written agreements that describe the supplier\u2019s role in the QMS.\nEven if you are working with a contract manufacturer that is certified, you still need a QMS and be responsible for your product.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/f4c393fb-65a7-4f2f-9ab9-3b329a32447c/c1dcc130-1a6b-455f-b5b8-7a097e6a2def.jpg"}