ISO 13485 Compliance

The International Standards Organization (ISO) creates documents that provide guidelines to ensure that products, processes or services are fit for their manufactured use. Standards ensure the quality we’ve come to expect in goods and services we purchase.

Standards such as ISO 13485 are created by technical committees whose members are experts in their fields. These committees are comprised of ISO members from around the world.

Standards may take years to develop and approve and once approved, they may supplant other well-known standards. For example, FDA is working with the ISO Technical Committee to combine certain parts of 21CFR Part 820 with ISO 13485. Professionals working in quality administration need to stay current on these types of international developments.

ISO 13485 - Change? Do I Have To?