ISO 13485:2016 – Putting off compliance until the last minute could cost you dearly

By Stewart Eisenhart, Emergo Group

This is part one in a series of blog posts Emergo will be publishing during 2016 discussing the rollout of ISO 13485:2016 and how companies can prepare. 

Now that the highly anticipated update to the ISO 13485 quality management system standard has been published, medical device manufacturers have a three-year transition period to come into compliance with the new version of the standard. That’s a long time right? Don’t be so sure.

Although the ISO 13485:2016 compliance deadline is not imminent, advance planning is essential to avoid panic closer to March 2019. The primary reason you should not wait too long is that European Notified Bodies are busy—really busy. Since 2013, Notified Bodies have been obliged to conduct random compliance audits of manufacturers at least once every three years. This has created a massive amount of additional work for Notified Bodies. Add to this the fact that ever since the PIP breast implant scandal, NBs are under much more scrutiny from Competent Authorities.

This has led to some of the weaker NBs pulling out of the market and also created a massive resource problem for the NBs. They simply do not have enough auditors to do all the work. Unfortunately for device manufacturers, this means you will likely be paying higher prices and waiting longer periods of time for Technical Files reviews and certification audits. Thus, if you think you can wait until mid- to late 2018 to get ready and schedule your recertification audit, you will be in a very long line and run a very serious risk of letting your ISO 13485 certification lapse. I don’t think you want to have to explain that one to your boss.

First steps toward ISO 13485:2016 compliance

To properly manage required changes by the 2019 implementation deadline, companies should act sooner rather than later. Early preparation for updated ISO implementation will be especially important for small- and mid-sized companies, as these firms may need more time to identify which resources they have in place and which they need to add in order to meet all new ISO requirements.

The updated ISO 13485 standard will have a broad and deep impact on manufacturers’ quality management processes and procedures. ISO 13485:2016 makes significant changes in terms of:

• Documentation control
• Management responsibilities
• Resource management
• Product realization and design controls
• Measurement, analysis and improvement
• Risk management

We will talk about some of these changes in a future blog post but if you want to take a deep dive into the changes right now, download our ISO 13485:2016 white paper.

Effective planning for full implementation

Each device manufacturer has its own issues to address in order to launch an effective ISO 13485:2016 implementation plan, but a general approach that any firm can take to manage its implementation project should include the following steps:

• Identify resources necessary to implement the new standard, and update any procedures, training and staffing processes to ensure that those resources are in place. Again, take a look at our 13-page white paper on the changes.
• Go over timing and transition requirements and issues with your Notified Body (NB) as early as possible.
• Make a plan. Develop a quality plan that contains all activities that need to be completed during the transition period, with the knowledge that everything takes longer than you expect.
• Ensure that all necessary staff are trained to the updated ISO standard as well as the firm’s own quality plan.
• If necessary, perform a gap analysis, either internally or with the help of an external consultancy such as Emergo, to determine what changes need to be made to your current ISO 13485 quality system in order to align with new ISO requirements.
• Make sure that all internal quality system audits going forward incorporate changes required by ISO 13485:2016.

Don’t procrastinate. Start working with your Notified Body soon

As reported by Emergo in January 2016, the European Notified Body sector is now issuing fewer CE Mark certifications and performing more thorough ISO 13485 audits due to pressure from European regulators. Indeed, these pressures have actually played a significant role in some NBs refusing to take on new clients, leaving a smaller number of these entities to address what will no doubt be high demand as ISO 13485:2016 implementation deadlines draw closer.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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