Title: Why is ISO 13485 Important?
Course: PW-Course-Import-Test > Section: Module 8: ISO 13485

Module 8

Every country has a sovereign right to establish country specific regulations to protect their citizens. The United States has established  21 CFR 820 to provide controls and protections for the health and safety of the American consumers as it relates to Medical Devices.  Many countries have their own set of medical device regulations - such as China, Japan and Canada.

ISO 13485 exists to provide a harmonized Quality System Guidance that would allow any given country the ability to adopt the standard and establish a Quality System that is consistent with other countries that follow the standard.

With a goal of Quality System Harmonization, the International Standards Organization (ISO) has worked with countries from around the world (including the USA) to create ISO 13485. The ISO standard is the accepted medical device compliance standard in Europe and other countries. Although 21 CFR 820 and ISO 13485 are substantially similar, they are not the same.

Let’s begin the comparison between 21 CFR 820 and ISO 13485.

Watch

First we will review the ISO 13485 presentation.

Read

Read a detailed comparison between 21 CFR and ISO 13485: Correspondence between ISO 9001:2000 and ISO 13485 which will help you see similarities and differences between the QSR and ISO. You can find another comparison in the “additional resources” section of this module.

Read ISO 13485 and review the table in the back that describes the differences between 21 CFR 820 and ISO 13485.

(You can find a version ISO 13485 by typing “ISO 13485 download” into the Google search box. The first four or five that appear in the results list are sponsored ads and likely they charge something to view it or require registration, but the first one that is not an ad in the list is the standard that you can download as a pdf.)

After reviewing the comparison between the regulation and the ISO standard - it’s time to test your knowledge. The Learning Community exercise on the next page will test your ability to map the following sections of 21 CFR 820 to a corresponding section of ISO 13485.