Getting ISO 13485 Certified in El Paso, Texas (TX)

In several countries, the standard is mandatory for any medical device manufacturer and any other organization involved in the supply chain. In the U.S, the FDA combined its FDA 21 CFR 820 rule with ISO 13485 and its latest version in order to harmonize the requirements and guidelines from both and obtain final certification. This action made the standard to be mandatory for every medical device manufacturer since it sets very specific norms that are required to ensure the organization is able to meet its customers’ needs.

When producing, manufacturing, and providing the devices, it is hard to maintain a quality management system, and even harder to ensure its improvement. However, you cannot ignore the need for its implementation but rather focus on it as a medical device company. Although most people look at them as a way to meet regulations and laws, it is also a benefit for the processes and operations in the company.

Yes, implementing it will bring a lot of improvement thanks to the focus on the QMS, and since it aims to guarantee a standard in what the manufacturer offers, you are very likely to grow as a business. In our company, we like to look at standards as a new and incredible way to bring more value to the business, and they actually are. It isn’t a matter of mandatory and legal regulations—although they exist and this is one of them—but rather about how good they are for your organization as well. Medical device manufacturers have it really hard when it comes to standards and norms, after all, guaranteeing high-quality devices and top services isn’t simple but it is absolutely necessary.

Based on all this so far, here’s our short answer to the question: yes, you are obligated to implement ISO 13485 as a medical device manufacturer. But you will gain more from it compared to the resources and time you will invest in implementation and certification.

When you are just starting in the industry or have been in businesses for a few weeks or months. It is never too early to start implementing it for your audit, after all, the process isn’t something that takes only a few days. Besides, although medical device manufacturers can operate without the formal certification for a few months, that doesn’t mean you should ignore its implementation but rather focus on it during your first months. Therefore, the short answer would be: anytime.

At IQC The ISO Pros, we can assist you as soon as you contact us and allow our experts to assess your company. We will determine a series of things:

• If you have been implementing it for a while, we will identify the requirements you already meet from the standard.
• Find out the best approach to follow all the guidelines and implement them in your business while focusing on its needs and goals.
• Do you need to make changes and add new elements? We will determine it for you.

Also, keep in mind it is important to get trained in standards you decide to implement in your company, either if they are mandatory or voluntary. After all, ISOs may not change every year but they do go through revisions yearly or quite often to ensure they are updated and address old and new aspects and needs in the industry they are aimed for. When this happens, you must know what was implemented in your processes and organization when following the standard.

In this way, it will be possible to keep your quality management system updated and continue improving it thanks to the guidelines. When it comes to standards, there’s a ‘rule’ among companies and organizations: the sooner, the better. Remember that getting certified also brings benefits to your company, like having an advantage over other medical device manufacturers that aren’t certified, or being able to offer more to your clients. The main goal with ISO 13485 is to guarantee customer satisfaction and when you achieve this goal, there are many ways to improve your company in other aspects directly and indirectly.

More than the products, it is about the processes and operations to obtain them. The goal for ISO 13485 is to have a well-designed and established quality management system that guarantees a continuous production process that will not make the quality of the products decay. Therefore, saying that the ISO makes sure that your products meet the desired results and customers’ needs is a good statement.

But when many people consider it to be one that focuses on the products themselves, it’s completely wrong. The whole concept is to control the processes in the supply chain, guarantee their continuous improvement, and finally be able to deliver high-quality and functional medical devices. Since obtaining the devices isn’t a process that takes two or three steps, it is necessary to be meticulous at the moment of following the guidelines. One requirement met is the base to meet the next one and this keeps going until fulfilling all of them.

Many companies we have helped and implemented the standard for them, still have doubts about what the ISO actually does. This is why we encourage companies to not only hire someone to implement the ISO but also train them. Since every standard—including ISO1 3485—go through revisions yearly or every 2 to 5 years, it is important to know how you will proceed after one of them. During every revision, many things are considered, and one of them is the possibility of adding new requirements and guidelines to address new needs and problems in the quality management system of your company. Therefore, you cannot expect it to be always the same and have a certification that is valid for a very specific version of the ISO.

But what does this have to do with the standard being focused on processes rather than the products themselves? Everything. Since you have to aim for the improvement of your processes, you cannot expect your organization to meet the same revisions and standards. In other words, as a medical device manufacturer, you need to be very aware of everything the ISO entails to make sure you are aiming for the right goals and processes of the company to guarantee customer satisfaction.

In our company, IQC The ISO Pros, we are ready to offer you all the assistance and help you need to get this done. After all, it isn’t simple to focus on your processes even when you have several guidelines provided by the standard. In our experience, the beauty of implementing ISO 13485 goes beyond the fact it is mandatory. Yes, we already mentioned it helps to improve processes, but you’re only looking at it as a way to have more opportunities in only the quality management system of your company. But the truth is that when you improve your processes, you are aiming for general growth in the organization.

If you harmonize your needs and the ISO properly, you will achieve more than just obtaining the desired results for your products. With that said, always remember it isn’t about working on the devices directly but rather in every step it takes to obtain them.

There’s a common mistake when it comes to standards: people believe they get certified as soon as they implement them. Well, that’s a bit far from what actually happens. To get certified, companies have to go through audits after they finish implementing the standard. Implementing the ISO isn’t something that will take only a few days neither weeks but rather months.

With that done, you have to schedule an official audit to determine you have met every requirement in the standard. Just when you have demonstrated compliance is when you can get certified in ISO 13485. Now, is it too hard to actually get certified? That will depend. We have mentioned many times that ISOs aren’t regulations and requirements you will deal with in a very short period of time.

Instead, they take time and you have to commit to the implementation. We are not trying to say you cannot deal with other aspects in the process, but you need to invest time and resources in the standard. Based on that, you’re more prone to obtain the certification during your audit. Many companies in El Paso, Texas, and all over the state, have problems getting ISO 13485 certified for one reason: they don’t meet all the requirements since they tried to deal with the process in less time but with less precision. As a result, they have to go through the entire standard once more and schedule another audit in the next months.

This only means more time and resources invested in something that could have done during the first time. The main reason why we said ‘it depends’ is exactly the previous one: because you don’t know if you will obtain it or not during the first audit you have for it. However, you should always aim for this goal in order to invest just enough in its implementation. With that said, obtaining the certification you need to meet every requirement, ensure you are committed to future revisions, and guarantee continual improvement just like the ISO wants you to do.