ISO 13485:2016 is the latest greatest update to the quality system standard specifically for medical device companies, who have until March 2019 to update their current ISO 13485 certificate to the new version.
Whether you’re an emerging startup, an SMB or public enterprise, medical device companies of all sizes will be required to meet the new regulatory requirements of ISO 13485:2016. Medical device companies involved at any stage in the product development life-cycle, ranging from design and development to distribution to technical support, are all governed by the long-arm of the ISO 13485: 2016 law — even suppliers of the tiniest components and parts.
But here’s the catch for medical device OEMs.
If you’re a medical device organization and one of your suppliers does not meet the requirements of ISO 13485:2016, it’s not just the supplier or the supplier's supplier who gets in trouble but the medical device OEM, itself. This is explained clearly by the following statement: “The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.”
This suggests you need a training solution embedded in a product realization platform that offers you superior supplier visibility.
Arena Training Management is a cloud-based solution embedded in our product realization platform that ensures regulatory and corporate compliance, increases effectiveness for training programs, and streamlines training processes. It helps you create and manage your employee and partner training plans, with a single secure system connected to your product and quality processes.
With Arena Training, you can create, manage, and track individual or role-based group training plans. Easy to configure quizzes provide evidence that employees demonstrate their understanding of policies, SOPs, and other training materials.
With automated training processes and notifications, you can create new training assignments and retrain as your processes and procedures change.
Why are the quizzes important? Because they are the written documentation you need to prove your teams are properly trained to achieve compliance. In fact, the primary change to Clause 6.2 in ISO 13485 was the addition of the phrase, “shall document the process(es) for establishing competence, providing training and ensuring awareness.” This doesn’t represent a change in the intent of the standard, but it does signal that certification bodies should be emphasizing the importance of assessing effectiveness of training and competency–not just verifying the existence of training records.
Arena Training offers companies an easier way to ensure training compliance for internal employees and external partners. Leveraging Arena’s product realization and quality processes, managers can create, manage, and track training plans to ensure training excellence. This reduces audit stress and costly non-compliance warnings that may result in severe penalties. Most importantly, Arena Training frees your team to keep your primary focus on delivering high quality products to market.
The new requirements listed in ISO 13485:2016, which includes an augmented attention on risk management, supplier controls, and feedback mechanisms may appear daunting, especially with time running out to make the upgrade. But don’t despair. The good news is if you already have ISO 13485 certification, then you are most likely 85% or more compliant with the new requirements. And with Arena’s training management solution, you can ensure your medical device company achieves complete training compliance.