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 13485:2016, 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.

Even the Lean Team eagerly looked forward to the insights that waited as we scavenged our copies for hidden gems. We, as much of industry, were a bit disheartened with document’s content given its hype. 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.

The Lean Team is right there with you. However, we are committed to digging ourselves, and you, out of what feels like a black hole of requirements. We have delved in to the Practical Guide and dedicated this blog and resource series to make the Practical Guide, well, actually practical. Consider this the launch of The Practical Guide to the ISO 13485:2016 – A Practical Guide.

Before 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.

The Practical Guide is huge…but it still doesn’t contain all the details industry needs.

Don’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. 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. With all of these pages, surely the Practical Guide has everything we need and more, right? The Lean Team didn’t think so. 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. 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. That’s a lot and any one of those documents can be overwhelming in and of itself.

The Practical Guide does not differentiate between new ISO 13485:2016 and old (2003/2012) requirements

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. However, the Practical Guide gives guidance on both the new and old requirements of ISO 13485, not just the new ones. Don’t expect new and old requirements to be differentiated or clearly labeled either (such as in ISO 13485:2016 Annex A). You’ll have to know what’s new and what’s old unless your organization is starting from scratch and needs guidance on all requirements. Expect this to increase the time it takes to find information you need. In fact, the Practical Guide doesn’t even break down its guidance into individual sub points (i.e., lists of a, b, c, etc.), and this layout makes it difficult to quickly identify specific information.

The Practical Guide’s guidance on the risk-based approach is limited.

If you’re like most of the industry, you look to the Practical Guide to decipher what is meant by the application of a ‘risk based approach to the control of the appropriate processes needed for the quality management system’ (ISO 13485:2016 4.1.2 b). The concept of a risk-based approach to the actual QMS itself is perhaps one of the biggest changes and paradigm shifts for a company to deal with. If you anticipated that the Guide would contain a significant amount of content to address this concept, you will be disappointed in the three and a half paltry pages of the 214 total dedicated to such a major topic. The advice on risk-based approach culminates in a reference to GHTF/SG3/N15R8, a 23-page guidance document on risk management within a QMS product realization process. Industry should anticipate lively debates with notified body auditors over what implementing a risk-based approach looks like and when “enough is enough.” The guidance document is new to everybody including Notified Bodies. Industry and Notified Bodies alike are going to be figuring out what compliance means.

We hope that this inside look into the Practical Guide better enables you to make an informed decision on whether the Practical Guide is the right tool for your organization, or at least better enables you to apply the guidance to your organization. Lean RAQA Systems promises simple solutions to complex problems. The ISO 13485 transition is no different. As we continue to work with the Practical Guide, the Lean Team will share insights, interpretations, and resources to make things “as simple as possible, but not simpler.” (Albert Einstein)


Michelle Lott has been the Principal and Founder of Lean RAQA since 2010. By 2018, Lean RAQA supported more than 100 companies with services including regulatory strategy, regulatory submissions, quality systems compliance, due diligence, and a considerable range of technical support services. Lean RAQA specializes in supporting startups' first quality system and submission as well as remediation services for large companies. Lott currently serves a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP); reviewing feasibility and reasonableness, recommending proposed good manufacturing practice regulations in manufacturing, packing, storing, and installing devices. She achieved a Regulatory Affairs Professionals Society Executive Leadership Certification from Northwestern Kellogg School of Management and a bachelor's degree in chemistry from Troy State University. Interesting fact: Lott formerly served as an expert witness in forensic toxicology at the Mississippi Crime Laboratory.

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