Generally, ISO 13485 is harmonized with ISO 9001; however, there are key differences.

While ISO 9001 requires organizations to demonstrate continual improvement and has requirements to ensure customer satisfaction, ISO 13485 requires the organization demonstrate only that its quality system is maintained and effective and it does not rely on customer satisfaction as a metric.

In addition, ISO 13485 has other differences involving the areas of risk management, design control, corrective and preventative action management, and others we’ll discuss in the appropriate sections of this program.

Updates Every Five Years

ISO’s goal is to update its standards approximately every five years. ISO 13485 was originally released in 1996 and was updated in 2003 and most recently in 2016.

After each update, there is typically a period of three years to allow companies to adapt to the new standard. Typically, these updates incorporate changes and additions but are not major overhauls, as the main sections and most of the subsections remain consistent.

If we look at the recent update from the 2003 version to the 2016 version, we can see all of the sections and subsections are the same; however, delineation of each subsection has been added to add more specifics and more detail.