ISO 13485:2003 helps medical device industry excel

February 18, 2013 8:00 am Published by

Medical DevicesOne of the most rewarding things about being in this business is seeing how many industries are grasping the benefits of quality management systems.

The growing medical device industry is a good example. To produce quality equipment and devices – stuff that saves lives – companies need world-class standards.

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 and regulatory requirements applicable to medical devices – anything from bandages and examination gloves to cardiac heart valves and pacemakers.

One of the main differences between ISO 9001 and 13485 is the deletion of customer satisfaction and continual improvement in 13485. This standard is intended to facilitate the harmonization of regulatory quality management systems around the world. There are some requirements in 13485 not found in 9001.

As a result, ISO 13485 includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this international standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all requirements of ISO 9001.

Companies need to know, understand and comply with the country’s regulations and statutory requirements. Having an ISO 13485 certificate in one country does not mean that they fulfill all the regulations and statutory requirements in another country.
We recently added an expert in medical device quality systems, Beth Steuart. And she’ll be teaching an upcoming course on this standard. It’s a great way to learn how the benefits of international standards are being applied to this exciting and vital industry.

Make plans now to join Beth. See the course calendar to sign up.


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This post was written by Roy D'Ardenne