ISO 13485 Certification Becoming More Essential
for Medical Device Manufacturers
With billions of dollars in contracts at stake, medical device manufacturers are
pushing steadfast to conform to ISO 13485 regulatory requirements. Despite its
widespread commercial implications, the popular standard is squarely focused on
improving patient safety.
by Rogel Balbuena, Quality Assurance & Regulatory Affairs Manager
Value Plastics, Inc., a Nordson Company
ISO 13485, published in 2003 (officially designated ISO 13485:2003), represents the
requirements for a comprehensive quality management system for the design and
manufacture of medical devices. The standard requires manufacturers to demonstrate
their ability to provide medical devices and related services that consistently meet
customer and regulatory requirements. ISO 13485 supersedes earlier documents such as
ISO 13485:1996, and ISO 13488 (also published in 1996), EN 46001 and EN 46002 (both
published in 1997).
Authored by the International Organization for Standardization (ISO), based in Geneva,
Switzerland – an umbrella organization composed of standards writing bodies in each of
its 160 member countries – ISO is the world's largest developer of international standards
which are recognized globally for their stringent criteria. Centered on improving patient
safety, the importance of having a robust quality management system (QMS), like ISO
13485, ensures that the appropriate requirements are captured and properly documented.
Medical device manufacturers are being pressured to comply, or the competitiveness of
their company’s products will be compromised. For such companies seeking access to
international markets, conformity with ISO 13485 regulatory requirements is becoming
universally a prerequisite.
Growth in ISO 13485 Certification Escalates
According to the International Standards Organization, from 2004 through 2012 a total of
22,237 ISO 13485 certificates were issued worldwide throughout 93 countries. The United
States leads with the highest number of companies that have become ISO 13485 certified,
followed by Germany and Italy.
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From 2010 to 2012, company certifications rose a cumulative 18 percent for the
three-year period, an average of 6 percent per year. In 2012 alone, the percentage of
certifications doubled, showing a 12 percent increase in the number of organizations
becoming ISO 13485 certified, up 240 percent over certifications in 2011. In 2012, Italy,
the U.S. and the United Kingdom led with the highest number of medical device
manufacturers becoming certified.
A 2011 survey of 900 medical device manufacturers, commissioned by global healthcare
products company Covidien, showed 37 percent of responding companies became ISO
13485 certified to meet regulatory requirements. 31 percent became certified to support
regulatory approval of products or services, and 28 percent of companies became
compliant to meet customer requirements.
Achieving ISO 13485 Compliance
The ISO 13485 standard defines a medical device as any instrument, apparatus,
implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article, intended by the manufacturer to be used,
alone or in combination.
The process of receiving certification under ISO 13485 requires an evaluation of all aspects
of the company’s business processes and procedures to confirm conformity with the
requirements outlined in the standard. Registration to these standards signifies that a
manufacturer has implemented an integrative management system that complies with the
applicable regulatory requirements for quality management.
To achieve ISO 13485 certification, a company must develop written policies for the
following functions:
a) Document and record controls;
b) Internal auditing procedures;
c) Controls for non-conformance;
d) Corrective and preventative actions;
e) Process and design controls;
f) Record retention;
g) Accountability and traceability.
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Here is what medical device manufacturers can hope to gain from having an ISO
13485 certification:
1) Access to markets that recognize or require the certification, including
Canada and Europe;
2) Reduced operational costs by highlighting process deficiencies and
improving efficiency;
3) Increased customer satisfaction by consistently delivering quality products and
systematically addressing complaints;
4) Proven commitment to quality through an internationally recognized standard;
5) Added transparency to the way complaints, surveillance or product recalls
are handled.
ISO 13485 versus ISO 9001
Requirements for both ISO 13485 and ISO 9001 are among the most comprehensive of
the approximately 19,000 standards established by the International Standards
Organization, and serve as the model for quality management systems.
The fundamental difference between ISO 13485 and ISO 9001, is that ISO 9001 requires
the organization to demonstrate continuous improvement, whereas ISO 13485 requires
only that the organization demonstrate that the quality system is implemented and
maintained. Although generally harmonized with ISO 9001, ISO 13485 includes particular
requirements for medical devices and excludes some of the requirements of ISO 9001 that
are not appropriate to quality standards in medical manufacturing. Because of these
exclusions, organizations whose quality management systems conform to ISO 13485 do
not inherently gain conformity to ISO 9001, unless they were certified ISO 9001 prior.
Therefore, many organizations maintain dual registration against both standards.
Specific differences in requirements and emphasis between ISO 13485 and ISO 9001 include:
+ ISO 13485 sees the promotion and awareness of regulatory requirements as a
management responsibility;
+ ISO 13485 expects controls in the work environment to ensure product safety;
+ ISO 13485 expects a focus on risk management activities and design transfer
activities during product development;
+ ISO 13485 contains specific requirements for inspection and traceability for
implantable devices, and specific requirements for documentation and validation
of processes for sterile medical devices;
+ ISO 13485 states that the company needs to maintain effective processes,
namely the processes specific to the safe design, manufacture and distribution
of medical devices.
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As a matter of note, the U.S. Food and Drug Administration (FDA) does not formally
recognize ISO 13485 certification, but the quality system requirements of the U.S. Good
Manufacturing Practices overlap with the standard in many areas.
International Compliance
The ISO 13485 standard addresses most, or all, of the quality system requirements in
markets including the United States, Europe, Australia, Japan and Canada.
Within the European Union, ISO 13485 is now considered to be the standard for
medical devices, even though such devices have previously adopted Global
Harmonization Task Force Guidelines (GHTF). GHTF guidelines are gradually becoming
universal standards for the design, manufacture and export of medical devices. The ISO
13485 standard, adopted by CEN, the European Committee for Standardization, has
been harmonized as EN ISO 13485:2012.
Compliance with ISO 13485 is a necessary step in achieving compliance with European
regulatory requirements. The conformity of medical devices, according to EEC (European
Economic Committee) decrees, must be assessed to acquire the CE mark and permission
to sell the medical device in the European Union. The preferred method to prove
conformity is the certification of the quality management system according to ISO 13485,
ISO 9001 and ISO 14971 (which details the requirements for application of a risk
management system for medical devices).
Patient Safety
Patient safety and risk management remain a critical focus for government and private
sector regulatory agencies, which are continually becoming increasingly stringent.
Tightening standards and regulations, like ISO 13485, are pushing medical device
manufacturers and suppliers to change their operating procedures and effect compliance
with these new guidelines, or risk losing market share to competitors or even the ability to
sell their products into specific markets.
Tens of thousands of medical device manufacturers and their suppliers internationally
have already adopted ISO 13485, and thousands more are moving through the approval
process at escalating rates. And ultimately, this is all for the benefit of the patients.
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About Value Plastics, Inc., a Nordson Company
Value Plastics manufactures and markets an innovative line of fluid management
components designed specifically for flexible tubing. Products include quick connect
fittings, luer fittings, check valves, tube-to-tube fittings, threaded fittings,
biopharmaceutical process components and blood pressure monitoring components.
Value Plastics products find global application in demanding healthcare OEM, research
and specialty industrial applications.
About Nordson Corporation
Nordson Corporation delivers precision technology solutions that help customers increase
throughput, productivity and up-time, enable new products and features, and decrease
material usage. The company engineers, manufactures and markets differentiated
products and systems used for dispensing adhesives, coatings, sealants, biomaterials and
other materials, fluid management, testing and inspection, and UV curing and surface
plasma treatment, all supported by application expertise and direct global sales and
service. Nordson serves a wide variety of consumer non-durable, durable and technology
end markets including packaging, nonwovens, electronics, medical, appliances, energy,
transportation, building and construction, and general product assembly and finishing.
Founded in 1954 and headquartered in Westlake, Ohio, the company has operations and
support offices in more than 30 countries. www.nordson.com,
For more information, contact Will Stone, Marketing Communications Manager, Value
Plastics, Inc.; 3325 South Timberline Road, Fort Collins, Colorado 80525; Phone
970-267-5200; email wills@valueplastics.com.com; www.valueplastics.com.
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