What are the Benefits of Having an ISO 13485 Certificate for Medical Devices?

What are the Benefits of Having an ISO 13485 Certificate for Medical Devices?

Regulators and potential customers alike must be convinced that medical devices are safe and reliable. It’s possible for consumers to attain both of these goals and more by making a strong commitment to quality. In this article, we walked through the benefits of having ISO 13485.

Improvement in a systematic way

To promote efficiency and effectiveness, it’s important for everyone in an organization to use the same terminology when discussing inefficiencies and process improvements.

An effective quality management system includes not just good communication channels but also systematic strategies for improving processes using six sigma and lean techniques.

A benefit of ISO 13485 certification is that it provides a framework for continuous improvement.

Improved Retention of Clientele

Customer satisfaction is improved as a result of reduced costs associated with non-conforming items thanks to quality control systems.

This applies to raw material suppliers as well as the rest of the supply chain, and it has the potential to improve customer satisfaction.

As a result, there is limited room for error or client returns when it comes to medical products. SPC can help remove specific cause variation from machining processes, such that products rarely depart from design parameters, for instance.

Medical gadgets that are able to tolerate environmental stress and still perform their intended function can improve people’s lives in the long run.

Greater Prestige

Companies in the medical device business can better promote their products and services if they meet ISO regulations. Having attained an objective level of quality, they have an edge in the marketplace when they are certified.

While establishing a company with a quality management system is not an easy task, it is well worth the effort and the time and energy invested. For this reason, business success and failure are directly linked to quality.

Medical devices must achieve the highest quality and service requirements in order to remain competitive in the global economy. In the fiercely competitive and ever-expanding world of medical device suppliers, ISO certification sends a message to all possible business partners that certified companies are world-class organizations capable of giving value and long-lasting assistance.

Obtaining ISO:13485 certification is well worth the time and effort it takes to maintain it. Medical device quality, operational profitability, and staff morale will all rise to new heights as a result of these changes. The key to improving company results is process excellence.

Easier Processes

Manufacturing-related processes must be found in every way possible, even if they are only tangential. Creating defined methods for determining which elements potentially expose the product to risks is the next step.

Threats could include polluted machinery and under-trained workers. After highlighting the dangers, company representatives must identify and explain how they plan to avoid them.

ISO 13485 does not specify how device makers should go about ensuring their products are safe. The certification, on the other hand, helps people understand that quality is a continuing process and that efforts are necessary to maintain high standards.

Less Likely to Have Problems

ISO 13485 also mandates regular management evaluations to determine whether or not previously applied controls are yielding the intended outcomes and whether or not additional changes are necessary.

Unfortunately, some top executives view these evaluations as nothing more than box-checking exercises, which leads to an unhealthy sense of urgency to complete them.

In order to conduct thorough and non-hurried ISO 13485 evaluations, it may be helpful to collect and create processes to keep relevant data current and accessible.

As an example, looking at customer feedback, audit results, new regulatory requirements, and any specifics of corrective measures performed so far might assist decision-makers in determining whether quality controls connected to ISO 13485 are having the expected results.

Periodic assessments also increase the likelihood of spotting problems that could lead to subpar products or inefficient operations. They promote improved visibility, which reduces the risk of an issue going unattended for an extended period of time.

Increasing the Level of Competition in the Market

Companies that are ISO 13485-compliant must demand that any subcontractors adhere to the standard as well. That means that the quality commitment extends beyond the boundaries of a single company.

The fact that working with a new company can be a difficulty is appreciated by many potential customers. Many of them are reduced by ISO 13485’s emphasis on quality.

Because ISO 13485 is a globally recognized standard, it can aid in the expansion of a company’s product line into new markets. Leadership in an organization might better communicate their commitment to high quality by obtaining certification.

Because medical devices directly affect people’s lives, it is critical to persuade stakeholders that efforts to promote quality are being prioritized. Increasing the likelihood of success while reducing the likelihood of failure helps prospective clients gain confidence in a business and evaluate whether or not it makes sense to collaborate with or purchase from it.

Contributing to the long-term viability of products

There are an estimated 4,500 medical gadgets and pharmaceuticals that are recalled each year. With regular audits by management of ISO 13485 processes, a company is less likely to suffer problems that result in the removal of products from shelves.

Recalls can have a long-term effect on a company’s reputation, causing many people to see a damaged brand as dangerous.

However, the ISO 13485 framework incorporates remedial and preventative activities, allowing company representatives to recognize and address problems more quickly than they would without. As a bonus, certification can help build and maintain a culture of personal responsibility in the workplace.

When a person realizes that a single omission or violation of protocol can have far-reaching consequences for the quality of the entire business, they are more likely to take responsibility for the decisions and actions they do at work.

If there is a recall, the certification should make it easier to pinpoint the source of the problem and prevent it from happening again. As a result of these actions, the public’s confidence in a gadget manufacturer should rise.


In the medical device market, innovation is lauded as long as it does not jeopardize the safety of the end-user. Ventilator demand spiked during the COVID-19 pandemic, for example, and manufacturers had to adapt.

Quality and process improvements can be made more permanent by obtaining an ISO certification. As a result, ISO 13485 has been found to improve the resilience of companies that have been certified. It’s not for everyone, but the related rewards are worth the effort.

Leave a comment