However, the Practical Guide gives guidance on both the new and old requirements of ISO 13485, not just the new ones. If you are like most manufacturers, you are already compliant to ISO 13485:2003 or EN ISO 13485:2012 and you need guidance on transitioning to the new ISO 13485:2016 requirements. The Practical Guide does not differentiate between new ISO 13485:2016 and old (2003/2012) requirements That’s a lot and any one of those documents can be overwhelming in and of itself.
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So to better understand expectations for the implementation of ISO 13485:2016, you have to triangulate between the standard, the Practical Guide, and at least five other guidances to get the full picture.
The Guide contains specific references to the following additional guidances: GHTF/SG3/N15R8, GHTF/SG3/N17:2008, GHTF/SG3.N99-10, and GHTF/SG3/N18 and ISO/TR 10017. With all of these pages, surely the Practical Guide has everything we need and more, right? The Lean Team didn’t think so. Many would consider the ISO 13485:2016 Practical Guide to be more of a detailed reference guide than a general guide for understanding and implementing the new ISO 13485:2016 requirements. The Practical Guide is huge…but it still doesn’t contain all the details industry needs.ĭon’t be surprised: it took the Practical Guide 214 pages (not counting the Bibliography) to provide pointers on interpreting the 25 page ISO 13485:2016 Standard! The Practical Guide does include all text of the 2016 Standard (which you should take advantage of if your organization has not picked up a copy yet) but many organizations expecting to get a practical Practical Guide will be overwhelmed by the size and complexity of the document. Consider this the launch of The Practical Guide to the ISO 13485:2016 – A Practical Guide.īefore you commit to buying the Practical Guide and invest the time to read it (and it is indeed an investment), you should consider the following.
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We have delved in to the Practical Guide and dedicated this blog and resource series to make the Practical Guide, well, actually practical. However, we are committed to digging ourselves, and you, out of what feels like a black hole of requirements. 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 guidance needed to fully understand recommendations. We, as much of industry, were a bit disheartened with document’s content given its hype. Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2016, hoping September’s release of the ISO 13485:2016 – A Practical Guide(hereafter known as the “ Practical Guide” or “ Guide”) would bring the “practical” guidance promised.Įven the Lean Team eagerly looked forward to the insights that waited as we scavenged our copies for hidden gems. Three things to consider before picking up the ISO 13485:2016 Practical Guide
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