What is ISO 13485 and why is it so important?

Aaron Hoare Date published: Sep 08, 23

ISO 13485 is an international standard that specifies requirements for quality and competence in medical device organizations. This can be a bit of a broad spectrum, but this incorporates organizations involved in the design, production, installation, servicing, and in some cases the distribution, of medical devices and related services.

The standard was last revised in 2016, which brought with it a number of changes including an increased focus on risk. It was last reviewed in 2021 (with ISO standards being reviewed every 5 years) and the decision was made not to revise the standard. This does, however, make it much more likely that it will be revised when the standard is next up for review in 2026.

It is based in large part on ISO 9001, which is the international standard that sets out the criteria for effective quality management in any type of organization. So, many of its clauses are similar in its specifications for what constitutes good quality management. However, ISO 13485 adapts many of these clauses and, naturally, has additional clauses that are specific to medical device organizations.

Recent changes made by the US Food and Drug Administration (FDA) have sought to harmonize its own regulations with 13485. Seeking a “comprehensive and effective approach to establish a QMS for medical devices” in ISO 13485 through the Medical Device Single Audit Program (MDSAP), this will allow inspections of medical device manufacturers based on ISO 13485 requirements.

If you want to learn more about this change, watch our webinar on the subject with Joanne Rupprecht. If you are still just learning about ISO 13485 in general, then read on.

Learn more about how to get ISO 13485 audit ready and the FDA’s Proposed Quality Management System Regulation, with the new role of ISO 13485:2016, by watching our webinar with Joanne Rupprecht.

Watch the webinar

Who is ISO 13485 for?

While we have already outlined this in brief, let’s go into a bit more detail on who the standard is for. Because it covers organizations that are involved in in the design, production, installation, and servicing of medical devices, some organizations can wrongly assume they wouldn’t benefit from accreditation because they only deal with one part of that process. There are many medical device organizations that are involved from design all the way up to production and delivery. However, there are also plenty that are just involved in just one part of the medical device production process. These organizations are still eligible for accreditation.

So, if your organization carries out servicing/repair of certain medical devices, you could benefit from accreditation. If you are just a research and development team who passes on device designs but plays no further part in the medical device production, again, you could still benefit from accreditation. Don’t make the mistake of assuming that just because your organization isn’t producing med devices, then ISO 13485 doesn’t apply.

As for what constitutes a medical device, this encompasses any product – whether that be an instrument, machine, implant or in vitro reagent – that is intended for use in the diagnosis, prevention, and/or treatment of diseases and other medical conditions. So, this can range from simple, low-risk devices like medical thermometers and disposable gloves, all the way up to complex, high-risk machines like MRI scanners and dialysis machines.

So, in the simplest terms, if your organization plays any role in the production and use of the type of devices mentioned above, then you would benefit from attaining ISO 13485 accreditation. This acts as a signifier of the quality and reliability of your practices, processes and, by extension, of the products you work to produce.

Is ISO 13485 a requirement for medical device organizations?

While ISO 13485 is not a mandatory requirement for medical device organizations, to say it is highly recommended would be an understatement. Especially since so many medical devices play a crucial role in the health and wellbeing of patients across the world, the consequences of quality failure in the production of these devices can have severe consequences.

Moreover, as a globally recognized indicator of quality, organizations that do not hold ISO 13485 may soon find they miss out on preferred supplier status, or even be ineligible for contracts as they do not meet the standards of rigorous tender processes altogether.

But these are not the only benefits of ISO 13485 that make certification to the standard so important, even if it is not a strict requirement. Below, we have listed a selection of additional benefits to ISO 13485 accreditation if you are not yet convinced of how important it is.

What are the benefits of ISO 13485 accreditation?

There are a number of important benefits to achieving ISO 13485 accreditation. This includes:

• Organizations around the world will be assured of the quality of your practices and, by extension, of the medical devices you work with
• Global recognition makes selling into international markets easier
• Increased chances of becoming a preferred partner with prospective and current customers
• Meeting a standard like ISO 13485 is often a prerequisite for tender/contract application processes
• Holding a clear reputational advantage over competitors not accredited to ISO 13485
• Bringing your organization on to the same reputational level with those already ISO 13485 certified
• Implementing an ISO 13485 compliant quality management system will reduce costs by resulting in more efficient practices and avoiding costly mistakes
• Robust quality practices reduce the chances of recalls or reworks, the costs of which can reach the millions
• Time is saved as time-consuming, everyday tasks are automated
• Risks are proactively managed, heading off potential negative impact on equipment and services
• Centrally held documents and key information creates a single source of truth across your organization
• You will be set up to work towards continual improvement, driving positive results for a range of KPIs

Making use of tried-and-trusted quality management software is undeniably the best way to achieve ISO 13485 accreditation and to reap the benefits of unbreakable quality. Using this software, you can move beyond simple compliance with ISO 13485 and towards continual improvement, which brings a wide range of benefits.

From automatically assigning training and competency requirements, to the robust management of corrective and preventive action, finding the right eQMS can help you to unlock growth through quality. Ideagen Quality management is that tried-and-trusted tool in medical device organizations across the globe.

How to attain ISO 13485 accreditation

If you are confident in your quality management systems, you can apply to a relevant accreditation body in your country. With most accreditation bodies, the application process is online.

In the US, the ANSI National Accreditation Board (ANAB) is one of the main accreditation bodies for ISO 13485. Through the British Standards Institution (BSI), medical device certification can be gained in the UK. The Integrated Assessment Service (IAS) are an organization who offer ISO 13485 certification across Europe, including France, Germany, Spain, Italy, and Netherlands.

Once you apply to one of these certification bodies, a pre-assessment will be carried out. Your accreditor will identify any significant issues that you will need to address before your “official” audit and assessment. This is often referred to as your “audit gap analysis” and is the stage at which you may realize your quality management system needs a significant overhaul or modernization. This can best be achieved by using tried and tested quality management software.

Once you have addressed these issues, you will then be audited against the criteria detailed in ISO 13485. Attaining certification will usually take somewhere between 3 and 6 months, but this can vary based on what quality management systems you already have in place, the number of issues that are identified, and even how busy the accreditation body you have applied to is. However, 3 to 6 months for a medical device organization to become certified is a common timeframe for most accreditation bodies.

Maintaining ISO 13485 accreditation

The normal process for maintaining ISO 13485 accreditation involves you entering a “surveillance” period, meaning your accreditor will check up on your processes every year to look for obvious non-compliance with the standard. At a pre-defined period, usually every 3 or 4 years, the accreditor will carry out a full re-assessment to make sure you are still upholding quality.

While the surveillance and re-assessment process varies depending on the accreditation body, the process will almost certainly follow a similar pattern: periodic surveillance check-ups with a full re-assessment after a pre-defined number of years.

The most effective way to ensure you remain compliant with the requirements of ISO 13485 is to use effective quality management software. The software will enable you to foster a culture of quality throughout your operation and therefore maintain compliance with ease.

Want to learn more about ISO 13485 compliance software?

At Ideagen, we provide software to medical device organizations all over the world that helps them to manage their ISO 13485 compliance with ease. Our modular, SaaS system has all the tools you need to simplify compliance, from clear audit trails, to the tracking of key risks, and even robust data visualization that will help you to identify trends and areas for improvement. Learn more about our quality management solutions today and book a demo to see it first-hand.

Learn more about how Ideagen Quality Management can help your organization meet the requirements of ISO 13485 with ease.

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