Like many of you, I have been slogging through the Practical Guide to ISO 13485:2016 since it came out end of September. To be honest I found it anything but practical. The guidance is a behemoth at 214 pages, contains circular references with vague language, and, even with its size, is not self contained, referencing additional guidances needed to fully understand recommendations. Here are some of the main reasons it does not deliver the clarity expected:
– The practical guide is huge…but it still doesn’t contain all the details industry needs.
– The practical guide does not differentiate between new ISO 13485:2016 and old (2003/2012) requirements
– The Practical Guide’s guidance on the risk-based approach (perhaps one of the most significant changes to the 2016 standard) is limited.

I discuss these points in detail in my latest blog. What were you expecting of the guide? What did you like or dislike? What was helpful to you?

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The Practical Guide to the ISO 13485:2016 Practical Guide

Three things to consider before picking up the ISO 13485:2016 Practical Guide Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2…

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