Why ISO 13485 Matters in Medical Device

Why ISO 13485 Matters in Medical Device Manufacturing
Today we live in a world oversaturated with abbreviations. Without a bit of context, you wouldn’t know whether or not ISO stands
for an Incentive Stock Option or NASA’s Infrared Space Observatory. If you are reading this, ISO can only really mean one thing
– the International Organization for Standardization.
ISO is an independent, non-governmental organization comprised of 161 national standards bodies whose sole purpose is to
bring together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards
that support innovation and provide solutions to global challenges. To put it in layman’s terms, ISO exists to create worldwide
standards of quality in almost every industry known to man, from technology to healthcare to printing.
Over the last 70 years of ISO’s existence, it has published more than 21,000 International Standards –
documents that offer guidelines, specifications and/or requirements meant to ensure products, services,
materials and processes utilized to create them are fit for their intended purpose.
The ISO Difference in Medical Device Manufacturing
Remember when the first iPad was released? It was quite expensive and had a hard time meeting demand.
While Apple was scrambling to get more units out and researching how to make the iPad more affordable,
other companies decided to pounce on the demand. The competition quickly released their own, more
affordable facsimiles of iPads.
However, these knockoffs were just that. They were built with cheaper or counterfeit components, buggy interfaces and did
not have near the functionality they claimed to have on the packaging. They were largely a massive waste of money for any
consumer who bought these “wanna-be” versions of the product. For almost every piece of expensive electronic equipment,
you can find various knock-off models that cut prices by cutting corners with everything from parts procurement to testing
to fabrication. Thus, producing an inferior product riddled with field failures, product returns, and bad online reviews. While
this is a predictable cycle in personal entertainment devices, this is not an acceptable cycle with life-saving or life-enhancing
medical devices.
Millions of people rely on medical devices to live, for treatments, diagnostics and thousands of other medical uses. Standard
medical devices have very precise calibrations and must function consistently and accurately in order for the physician or
medical attendant to determine the correct course of treatment for a patient. In the event that a device fails, it doesn’t just end
up costing money, it could also cost someone their life, well-being or quality of life.
ISO Compliance vs. ISO Certification
The vast majority of electronics manufacturers and those vendors in the supply chain will likely state they are in ISO
compliance, which is not the same as being ISO Certified. ISO Certification is an annual investment for those companies that
are committed to their standards and the end results for the customer. ISO Certification is more than a step above just being
ISO compliant, it is an overall view of how compliance is maintained within a company. Electronics manufacturers like MJS
Designs maintain a culture of compliance and willingly supply proof of current certification to potential customers.
MJS Designs has shared stories of device developers who have come to them specifically for the ISO Certification credential.
Legitimate device developers require more than a statement of compliance, they require proof that ISO 13485 standards are
met and maintained as part of the electronics vendor’s commitment to quality.
In addition, there are occasions where a device is developed and the individual circuitry or a specific part of the functionality of
the device must be produced by an ISO 13485 Certified manufacturer.
In the summer of 2015, as part of a massive, worldwide investigation, the US Food and Drug Administration participated in
Operation Pangea VIII, an aggressive collaboration between 115 countries that resulted in more than 2,400 websites being
shut down and the seizure of $81 million worth of potential dangerous illegal medicines and medical devices worldwide.
The reality is, drug and device counterfeiting pose serious threats to public health, both in the United States and abroad.
Every day new websites crop up with counterfeit credentials selling knock-off versions of common and highly specialized
medical devices.
The FDA issued the following statement:
“Through our framework for strategically safeguarding supply chain security and integrity and combatting counterfeit
and substandard drugs and devices, we know we are on the right path with the right goal: Protecting public health by
helping to ensure that the prescription medications and devices used by health care professionals and patients are
safe, effective and of high quality.”
What this means is that no matter how common the device or how simple the manufacturing, reputable developers must
seek out manufacturers who can prove traceability with a credible supply chain, and adhere to the highest manufacturing and
documentation standards. One way for a company to make this determination is to have its vendors who provide PCB designs,
PCB assembly, electromechanical assembly, parts procurement and any other form of manufacturing to have acquired the ISO
13485 credentials and not only be compliant but certified.
The Current Standard for Quality
ISO 9000 is the current standard of quality management systems that the organization stands behind. It was designed to help
businesses and organizations ensure they meet the needs of customers and stakeholders while still adhering to statutory and
regulatory requirements to a product. The standard deals with the fundamentals of quality management systems in general,
therefore applying to a wide range of businesses and organizations. It’s often referred to as a family of standards, with ISO 9001
focusing on the requirements that businesses and organizations must fulfill in order to meet the ISO 9000 standard.
Over the last 30 years, ISO 9000 has seen 5 major evolutionary revisions. The latest change happened in 2015, which saw a
variety of key changes including more emphasis on building a focused management system suited to serving an organization’s
specific needs and a requirement that company leaders become more involved and accountable in order to align quality with a
wider business strategy.
The ISO 9000 standard is typically utilized in conjunction with more focused standards, like ISO 13485, which was published in
2003 and revised for the first time in 2016 and focuses on the requirements for a comprehensive quality management system
for the design and manufacture of medical devices. And that’s just one of over 1300 standards that seek to improve healthrelated products and services ranging from medical devices to dentistry.
The ISO’s commitment to business efficiency and revenue growth without sacrificing quality or the environment has already
had a lasting and significant impact on the world in the last 70 years and will surely continue to do so for many more decades
still to come.
But What Does International Organization for Standardization Actually Do?
ISO standards are built from the ground up with business growth and cost effectiveness in mind. The organization understands
its precarious position and is showing industries how they can cut costs while also increasing customer satisfaction, accessing
new markets, reducing environmental impact and documenting the practice standards inside of the organization.
ISO spends the time and money necessary to discover realistic solutions to difficult problems without cutting corners or falling
victim to unethical circumstances just to save money. The organization tackles everything, from food and water scarcity to the
automotive manufacturing and everything in-between. There is a direct connection between quality
products that perform as designed and to how they are manufactured.
There have been multiple case studies from over 20 countries that prove those who embrace ISO
standards in their business environment, see an increase in revenue over competing companies
who do not adhere to ISO standards. The point is that the use of standards has been injecting
billions into the annual GDP of a variety of countries since the 80s and those companies that
embrace ISO standards, simply are stronger in the marketplace.
ISO’s Beginnings - A History of Quality
ISO as we know it today was founded during a conference of
national standardizing organizations that took place in London
in 1946 from October 14th to the 26th. Twenty-five countries
were represented at the conference by 65 delegates, who
chose to merge the ISA (International Federation of National
Standardizing Associations) with the UNSCC (United Nations
Standards Coordinating Committee) to create the ISO.
While the ISA had been doing well, its activities were primarily
limited to continental Europe. It is predominantly a “metric”
organization, which refers to the form of measurement used
in its standards, and was therefore primarily ignored by the
United States of America and Great Britain. The UNSCC, on
the other hand, was based in London and had been making
progress with “inch” countries but was still in its infancy
after having been established only two years prior to the
conference. The merger sought to expand ISA’s reach and
impact while bringing a bit of aged experience to UNSCC,
creating an international standardizing organization that could
address the concerns of quality throughout the world as
opposed to just certain sections.
The merger also sought to create an organization that
wouldn’t crumble during an event like World War II. The ISA,
which had been around since 1926, was run by a Swiss
engineer named Huber-Ruf out of his home, where he
and his family handled everything from the translation and
reproduction of documents. Having all of the association’s
eggs in one man’s basket came to a head during World War
II though. As International communication broke down, so did
the ISA. Stewardship was entrusted to Switzerland but the
association had all but crumbled.
However, during the war, in 1944, the UNSCC was
established by the United States of America, Great Britain,
and Canada. It sought to better the remaining war and
subsequent reconstruction efforts through standardization
practices. Countries like France and Belgium joined the
UNSCC as they were liberated, but Axis and neutral countries
were not allowed membership, which greatly limited the UNSCC’s
reach in the post-war world.
At the time of the conference, UNSCC was headed by Charles
Le Maistre, who had played a major role in the creation of many
standardization organizations over the previous few decades.
Largely viewed as the father of international standardization,
Le Maistre was tasked with
creating a new global international
standardizing body after the
war was over. He informed the
Swiss caretakers of the ISA about
the formation and existence of
the UNSCC once international
communication channels opened
back up and asked if the association
would like to be incorporated
into a new postwar international
standardization organization.
As we’ve already discussed, the
merger eventually came to pass
and did so rather quickly, but that doesn’t mean it wasn’t met
with challenges. The fact that the ISA had pretty much became
non-existent made decisions about its future difficult. A General
Assembly could only be called by the ISA President or by two
members of the ISA Council, none of which existed anymore.
ISA members decided that the 1939 Council would suffice as
the current acting council as if the organization had been put in
stasis during World War II, and an ISA meeting was convened in
Paris in 1946.
Le Maistre pounced on the opportunity to address the ISA while
so many of its members were in one place. He convened a
UNSCC meeting in Paris during the exact same time as ISA’s
meeting and had the ISA agreeing to join with the UNSCC by the
end of the first day’s discussions. Both organizations decided to
reconvene in London three months later, ultimately founding the
ISO as we know it today.
Sources: http://www.iso.org/iso/home/about/the_iso_story.htm http://blogs.fda.gov/fdavoice/index.php/2015/06/a-global-fight-againstdangerous-counterfeit-and-unapproved-medical-products-from-operation-pangea-to-fdas-global-strategic-framework/
To find out more about how your company can benefit from the ISO services offered by
MJS Designs, contact our business development team at [email protected] or
submit for a quote at www.mjsdesigns.com.
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