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Tips, Tricks, and Best Practices for Complying with ISO13485:2016


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’t know what you need to do. You are not alone because a lot of companies are behind. Don’t wait until it is too late. Now is the time to take action.

In this Global Medical Device Podcast, sponsored by Greenlight Guru, Kyle Rose, president of Rook Quality Systems, shares some tips and tricks for dealing with 13485. Because time is ticking!

Some of the highlights of the show include:

  • The 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.
  • If you don’t have your new ISO 2016 certificate by February 2019, you risk losing your ISO certification and other items.
  • Create a gap analysis or internal audit plan to review your current QMS and highlight what is missing for the new standard.
  • Companies should perform quarterly management reviews. There is a growing expectation that executive management knows the effectiveness of their QMS.
  • An element regarding QMS software validation has found its way into the new standard. Refer to Section 4.1.6.
  • How do Dropbox, Google Drive, and others play into QMS software validation? Assess, evaluate, and keep a paper copy on hand.
  • If you are using software packages or working with a company, that becomes a supplier. Have written agreements that describe the supplier’s role in the QMS.
  • Even if you are working with a contract manufacturer that is certified, you still need a QMS and be responsible for your product.

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