The Importance of ISO Certification in Medical Product Design

Businesses in a diverse set of sectors, including industrial medical design, often tout the importance of quality when it comes to their product or service offerings. Quality is a word that gets tossed around a lot with every industry and every offering. Terms such as quality customer service, quality ingredients, and quality time are so overused they have become almost ubiquitous. In some fields, such as health care, there has to be standards in place in order to allow customers the ability to truly assess whether a product development process is up to a standard of quality.

What Is ISO Certification?

It is from questions like these that experts and thought leaders from a wide range of industries determined that there had to be a way to objectively measure, evaluate and determine whether a product design process meets a high level of high quality. With the goal of universally defining “quality,” experts from diverse industries came together more than a half a century ago to form an unaffiliated, non-governmental international organization (ISO). In a volunteer capacity, ISO members define and delineate specifications or standards for products, services and systems to ensure metrics-based quality, safety and efficiency.

Certification Is Even More Important for Medical Design Companies

ISO has established thousands of quality standards in diverse industries and provides the guidelines for ISO proctors to follow when certifying companies with the designation. Within the U.S. and across the globe, it is largely viewed as the standard benchmark of quality processes.

Specifically, the widely-accepted ISO 9001:2015 is a set of established and clearly defined policies, processes and procedures for road mapping, developing and fabricating products or services. By adopting these methods, an organization can meet quality standards while also systematizing and streamlining its business processes. This way, medical design companies don’t have to reinvent the wheel and can instead follow established, proven methods and let their clients know that they keep those processes up to the most recent standards.

What Is ISO Certification and What Are Its Benefits?

The Certification is a way of demonstrating through auditing and testing that a medical product design company has gone through and met the rigorous ISO standards. As such a company that earns the sought-after ISO 9001:2008 Certification shows its commitment to — and attainment of — the highest quality standard.  

When medical product design company MindFlow earned its ISO 9001:2015 Certification earlier this year, Design Principal Chris Ross said of the achievement, “We now have additional evidence to present to clients that our processes, products and procedures are world class.” Such a certification goes above and beyond minimal requirements in showing a medical product development company’s pledge to quality and excellence.

Certification Makes Sense In Medical Design

Quality of course is important for all industries but particularly for those in the health care and medical field. It only seems logical that biotech, health care and medical product design firms would lead the way in seeking general and industry-specific ISO certifications. Add to this the fact that medical product design, development and manufacturing is a heavily regulated industry, one would think that industrial medical design companies would be first in line to obtain such certification.

Though medical product design or medical product development companies are required to do the minimum to comply with FDA mandates and their Quality Systems Regulations, only those that go the distance can earn ISO Certifications. Remarkably those companies that choose to strive for ISO certification are in the minority.

What Are ISO Certification Benefits?

More than meeting required minimum government standards, the ISO Certification shows that a company is willing to invest in itself, its products and its customers in performing at optimal levels.

Certified companies clearly benefit from the designation in that it announces to the world that they have met this high criterion for quality standards. They may also benefit in unexpected ways such as increased efficiency related to business processes. By adhering to standardized methods, teams can spend more time on creative or innovative endeavors and less time on redundant, repetitive work.

For customers of companies with ISO Certification, they can gain peace of mind in knowing that the company consistently meets rigorous quality standards. Customers can feel more confident working with a medical product design company that has a customer-focused outlook, established processes and procedures, and well-trained employees. All of these qualities and more are required for ISO 9001:2008 certification.

Is ISO Certification Worth The Effort?

Industrial medical design companies have long been asking whether or not it is worth the effort, time and investment to pursue ISO certification. Each individual medical product development company must answer this question themselves as the pursuit of certification is an undertaking not to be taken lightly. After all it involves extensive commitment, vision and fortitude to achieve ISO Certification.