Quality Management: The Need for ISO 13485

January 1, 2011
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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 defibrillation 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



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 certified to ISO 13485 or 13488. Adoption of the standard is still under consideration by the FDA.

ISO 13485: 2003, “specifies 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 beneficial 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 well the organization assesses and manages risk, identification 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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