ISO 13485 — Medical Device Companies

(Quality Management Systems)

The latest revision of ISO 13485 is the second edition published in 2003 by the International Organization of Standardization. This standard includes most of the requirements of ISO 9001, modifies some requirements of that standard, and adds new requirements. ISO 13485 also has a limited scope and application. Only companies producing a Medical Device for use on humans can obtain registration. The standard also defines what it considers to be a Medical Device and therefore companies seeking registration should first verify that they the standard applies to its product.

Challenges to Registration and Beyond

Due to the nature of medical devices, safety is of course paramount. Therefore ISO 13485, unlike other standards based on ISO 9001, modifies key terminology to remove the concepts of "continuous improvement" and replace it with "effectiveness". The result is that ISO 13485 does not allow for companies to have poor quality or ineffective systems that it then takes steps to "improve", but rather it demands a quality product and effective systems at the time of registration.

The focus on safety through product quality and system effectiveness will not come as a surprise to companies already producing a regulated product. However, it is still a challenge to create a Quality Management System that is not only effective, but efficient.

The tendency to create a detail rich document system for ISO 13485 is common, but it must be tempered with practicalities of ensuring personnel can comply with the requirements on a regular basis, giving personnel flexibility where needed, and providing for the efficiencies necessitated by company goals. As part of our Accelerated Registration Program®, we seek to ensure a balance of these goals and strive to show how more often than not these seemingly disparate and contrary concepts can be integrated into a coherent, effective, efficient, and meaningful Quality Management System.

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