What is an ISO certification and what role does it play in the medical device industry?

November 12, 2020 / by John Kapitan / 5 minute read

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In order to commercialize medical devices in accordance with international standards, medical device and development companies must be familiar with the guidelines set forth by the International Organization for Standards (ISO). Kapstone Medical is proud to have an ISO-certified quality management system (QMS)—but what does it mean to have an ISO certification? How would your company benefit from Kapstone’s expertise in this area? Read on for the answers, and please do not hesitate to get in touch with a Kapstone consultant if you have further questions.

What does it mean to be ISO certified?

ISO standards and certifications exist in many industries. To be ISO certified in a particular industry is to be recognized for having a management system, manufacturing process, service, or documentation procedure that meets all the requirements set forth by ISO standards. Each ISO certification has different standards and criteria. Within the medical device industry, organizations with an “ISO certification” are certified to the ISO 13485 standard. We go into more detail on this standard below. 

Who is ISO?

ISO, or International Organization for Standards, is an independent international organization that aims to foster quality and consistency within industries through the implementation of standards. Its members are the standards organizations of each participating country; in the United States, that’s the American National Standards Institute, or ANSI. Together, ISO and its members have developed almost 24,000 international standards that encompass nearly every aspect of both technology and manufacturing. You can learn more about ISO here, or read on for what you need to know about their medical device standards and certification. 

What is ISO 13485?

ISO 13485 is just one of the organization’s thousands of international standards. This one pertains specifically to organizations involved in any part of the medical device industry, encompassing design and development, production, storage and distribution, installation, servicing, or provision of associated activities like technical support. The standard also applies to entities that provide quality management system (QMS)-related services to medical device companies (like Kapstone, for example).

ISO 13485 dictates the QMS requirements for any medical device company that falls into one or more of the above categories. Companies that adhere to these requirements will have demonstrated that they are consistently able to fulfill the needs of both their customers and regulatory bodies. 

ISO recognizes in this standard and in others that each organization’s quality management system will look different. QMS practices are dictated by factors unique to each company’s scope and medical device, like size, company objectives, and relevant regulatory guidance. To that end, ISO 13485 explicitly states that “it is not the intent of this International Standards to imply the need for uniformity in the structure of different quality management systems.” They also note that “there is a wide variety of medical devices and some of the particular requirements of this International Standard only apply to named groups of medical devices.” Basically, this standard is in place to ensure product and service quality—not total uniformity between the companies that provide them. 

Read on to understand the benefits of an ISO certification and how working with a company certified in these standards could help your organization.

What are the benefits of ISO certification in medical device manufacturing?


There are many! Some benefits are to be expected, but others might surprise you. 

Internal efficiency

ISO guidelines are standard for a reason: they are efficient, scalable, and work well for many different types of businesses. Adopting ISO 13485 can help your business optimize design, development, and manufacturing procedures that were previously not subject to any sort of quality control. Because standardized procedures are more predictable and consistent, your business is likely to see waste reduction, cost savings, and other efficiency outcomes once quality management systems are in place. 

One of the common challenges of quality control is workforce management. By nature, medical device companies employ many different types of employees, such as designers, developers, manufacturers, and even employees like accountants and administrative support. It can be difficult, particularly in larger companies, to manage all these distinct workflows and help employees see their common purpose. What’s problematic for an accountant, for example, may not count as “poor quality” for a designer. 

ISO 13485 can actually help to mitigate this challenge. It provides a common language to define “quality” and organizational excellence, establishes communication channels for employees to articulate difficulties, and altogether unites the organization around common processes. Together, these outcomes will help to increase your company’s overall efficiency. 

International market access

An ISO certification is like a passport. You don’t have to have one, but good luck traveling without it! Most regulatory authorities strongly prefer (or even require) medical device companies to have third-party quality management system certifications like ISO 13485. Even if you’re looking to commercialize in one of the rare countries that does not require this certification, having it will still expedite the market entry process. Plus, this certification will improve your company’s standing on the international stage—given that most medical device companies do have the certification, it is very difficult to compete without it. An ISO 13485 certification communicates that your company is committed to excellence, and it is well worth the investment. 

Remember that 165 countries participate in ISO and adhere to these standards for medical device QMS. Implementing them in your business, or working with a business that already has, expedites your market access in every one of those countries.

What are the benefits of working with a medical device company that is ISO certified?

Medical device companies do have the option to pursue their own ISO 13485 certification. However, they can reap many of the same benefits from working with a certified partner or borrowing from that partner’s QMS. Here are just a few of the contributions an ISO-certified partner can make to your business: 

  1. Expert project management that anticipates roadblocks and reduces delays
  2. Smart risk analysis and mitigation
  3. Established partnerships with compliant suppliers and manufacturers
  4. User-centric design expertise specific to your patient or provider market
  5. Standardized procedures that already conform to international standards
  6. Reliable evidence- and experience-based decision-making
  7. Engaged employees invested in improving their own work and the organization as a whole
  8. Holistic commitment to excellence, ensuring compliance and efficiency every step of the way

Kapstone has the experience in all areas that a medical device entity will endeavor. We have been through years of maintaining compliance and improving companies’ processes according to ISO 13485. We can establish and uphold a compliant Quality Management System that will successfully fit your company. – Katelyn Jessup, Quality Manager

Is ISO 13485 optional or mandatory for medical device companies?

As noted above, compliance with ISO 13485 is not mandatory. However, given that it is the international medical device industry’s most widely used standard for quality management systems, it can be viewed as mandatory for international commercial success! A 2018 survey of ISO 13485-certified companies shows that certification numbers continue to rise across the globe. Companies that do not adopt these standards may not be competitive with those who do, as ISO 13485 is widely understood as the barometer of excellence in the medical device industry. 

ISO 13485-certified quality management systems may be challenging to implement, particularly for smaller companies. However, the long-term gains far outpace the short-term pains. Making this investment in your business, or partnering with a company who has, is a surefire way to expand your market internationally. Even if you only wish to commercialize your product in the United States, adherence to ISO 13485 will still signal to your industry that you have committed to excellence and can be trusted to deliver results. 

As a product or service owner in the medical device industry, being ISO 13485 certified is proof of your organization’s credibility and commitment to quality. Having this certification will not only broaden market access but also improve those relationships with customers and business partners. – Katelyn Jessup, Quality Manager

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Why work with Kapstone Medical?


Kapstone Medical is proudly ISO 13485:2016 certified, meaning that we offer our partners all of the benefits listed above. We are happy to step into your medical device development process as an advisor, auditor, or even full redesigner of your QMS. Learn more about how we can help here.

 

John Kapitan

Written by John Kapitan

John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in the medical device industry as a design engineer and regulatory affairs executive. John is an entrepreneur and expert in medical device design and commercialization.

Prior to creating Kapstone, John was a founding member of Altiva Corporation, a spinal implant company that was sold to Exactech, Inc. in 2008. His experience also includes AcroMed Corporation, DePuy AcroMed, and the Cleveland Clinic Foundation.

John received his BSME from Cornell University and MBA from the Weatherhead School of Management. He has designed and managed development for dozens of commercialized products, is an inventor on over 20 patents and patents pending, and has authored multiple industry articles. John enjoys spending time on his farm in Asheville, NC with his large family.

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