The document discusses the need for medical device manufacturers to comply with ISO 13485:2003 quality standards. It notes that situations like Medtronic paying $268 million to settle lawsuits over faulty defibrillator leads emphasize the importance of standards to ensure quality and manage risk. ISO 13485:2003 provides requirements for a quality management system to consistently meet customer and regulatory requirements. It shifts the focus from end-of-production quality inspection to quality control throughout the production process. Following the standard helps manufacturers realize better quality, cost-effectiveness and time to market for their medical devices.

1. Quality Management: The Need for ISO 13485
January 1, 2011
Nikki Willett
The increasing need for quality medical devices is matched by the need for compliance with ISO
13485: 2003.
In October 2010, Medtronic agreed to pay $268 million to settle U.S. lawsuits and claims related to
its Sprint Fidelis family of de brillation leads recalled three years ago due to faulty wires. In 2009,
the company estimated that at least 13 people may have died because of the problem. Situations
such as this emphasize why standards have been put in place, standards such as ISO 13485: 2003,
that help medical device companies maintain quality assurance and manage risk.
Medical devices such as pacemakers and diabetic pumps can save countless lives, but they also pose
a huge threat to human life if proper safety and quality procedures are not followed. ISO 13485:
2003 solves two concerns for medical device manufacturers:
Supplying customers and end-users with safe medical products and superior patient outcomes

2. Complying with FDA regulations
According to the U.S. Department of Commerce’s International Trade Association, the medical
devices industry is expected to grow to more than $285 billion by the end of 2012. Medical device
manufacturers need quality management systems to ensure quality, standardize manufacturing and
ensure that their devices are safe for the end-user.
Many standards such as ISO 13485: 2003 have become the global standard for those who
manufacture medical devices because they provide a proven guideline for maintaining assurance
and managing risk. The EU device directives require medical device companies to employ a quality
system consistent with this standard, and Canada requires device manufacturers marketing their
products in Canada to have a quality system certi ed to ISO 13485 or 13488. Adoption of the
standard is still under consideration by the FDA.
ISO 13485: 2003, “speci es requirements for a quality management system where an organization
needs to demonstrate its ability to provide medical devices and related services that consistently
meet customer requirements and regulatory requirements applicable to medical devices and related
services.”
The key word is consistently. Consistency helps to minimize errors.
How can consistency be achieved? The short answer is through documentation of processes,
incorporating quality control into every step of the production process and utilizing an automated
quality management system.
The primary objective of this international standard is “to facilitate harmonized medical device
regulatory requirements for quality management systems.” The standard is based on eight quality
management principles: customer focus, leadership, involvement of people, process approach,
system approach to management, continual improvement, fact-based decision-making and
mutually bene cial supplier relationships.
Revised in 2003, ISO 13485: 2003 shifts the importance from the role of quality inspection at the
end of production to responsibility for quality control throughout every aspect of production and
builds quality assurance procedures into the process itself. The revised standard focuses on how

3. Recent Articles By Nikki Willett
Nikki Willett is vice president of product marketing and
regulatory affairs, Pilgrim Software Inc. (Tampa, FL). For
well the organization assesses and manages risk, identi cation and traceability, and cleanliness of
the work environment.
The bottom line? ISO 13485: 2003 is a tool that reassures consumers that any hazards to them with
the medical devices they may come in contact with are being managed through a systematic
approach to making the products safer for use.
The key to this standard is a quality management system that builds the key themes of the standard
into its processes from the very beginning. As a result, medical device manufacturers can realize
better product quality, cost-effectiveness and time to market.
Quality Online
For more information on ISO 13485, visit www.qualitymag.com to read the following:
“ISO 13485: Medical Devices and Risk Management”
“Understanding ISO 13485”
Tech Tips
Medical device manufacturers need quality management systems to ensure quality, standardize
manufacturing and ensure that their devices are safe for the end-user.
Consistency can be achieved through documentation of processes, incorporating quality control
into every step of the production process and utilizing an automated quality management system.
ISO 13485: 2003 shifts the importance from the role of quality inspection at the end of
production to responsibility for quality control throughout every aspect of production and builds
quality assurance procedures into the process itself.

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