Across industries, there are countless regulatory agencies, some extremely niche and others covering much broader concepts and concerns. This offers businesses vital guidance, often contributing to staff and customer safety or privacy regulations, and that’s important, but unfortunately it can also be hard to keep up as regulations change. Amid all the new technology dominating today’s marketplace, then, regulation management tools will play a key role in business success, ensuring policy makers and organizations are on the same page at all times.
Start With The Basics
One of the major challenges that businesses face when attempting to navigate the maze of operational policies and documentation is that there are many different layers even within a particular industry or product category. For example, IEC 60601-1, which regulates medical electrical equipment, is considered the basic standard for electronic medical device safety, but it’s not the only one. As such, it’s easy for businesses to get bogged down in higher level demands or to struggle to match local guidelines to international requirements. Organizations need to be able to hold all of this information in mind, or at least keep it at hand, throughout product development work.
Even if your organization is clear about what guidelines it needs, it can be hard to physically keep track of them. Most standards are provided in digital formats, but can easily get lost and are hard to share across users, especially if team members are working remotely without easy access to a shared server. Luckily, there’s at least one simple solution to the problem: maintaining your standards in an e-library.
Depending on your industry, region, and other factors, you may not be able to access a single e-library that meets all of your needs. That’s okay. When you need to reference a document, even having several libraries based on the regulatory agency is still better than having a confused jumble of folders.
Staying Up To Date
Part of navigating the world of industry regulations involves staying up to date with recent changes. This can be challenging, as regulatory bodies don’t have any obligation to keep product developers abreast of new publications. Instead, you need to identify the organization’s standard communication procedures. This may mean bookmarking an update page or signing up for the organization’s listserv – and then actually checking the notifications. Developers are responsible for ensuring their devices are always in compliance, and that means staying vigilant.
Know Who Is In Charge
Speaking of the importance of responsibility for meeting regulatory standards, it’s important to know who within your organization reports to various regulatory bodies. You may have to appoint an authorized representative or a “person responsible” whose role it is to communicate with these bodies. Depending on the size of your organization, how many products you produce, and other variables, that representative’s job may exclusively involve evaluating regulations at different levels, organizing all requirements, filing paperwork, and otherwise managing these processes.
Regulations, whether for medical products, other electronics, sustainability efforts, or another category, are critical to cross-organization and -region collaboration, for ensuring safety, reducing waste, and many other functions – their importance can’t be overstated. Still, as complicated as all these regulations can be, the bottom line is simple: stay organized, stay up to date, and you’ll stay in compliance.