what is the difference between iso 13485 and 21 cfr 820?

In fact, the 2016 versions ISO 13485 has gone the other way around, because we ended up including more detailed requirements in some sections. So, if you get ISO 13485 now, the thing is the requirements are basically the same as 21 CFR 820, however, 21 CFR 820 has more detailed requirements in some sections. One way of thinking is that older versions were more 'prescriptive', because they detailed more requirements. The 2000 edition introduced the process approach, which changed the view to a higher level view (where the standard focused more on high level requirements and the implementations had to define more specific requirements and how to comply with). Until the 2000 edition of ISO 9001, one of the focus of the standard was really more on 'internal compliance', with a great focus on documentation. The 1996 version of 21 CFR 820 was created based on the ISO 9001 and ISO 13485 of the time. An example of this is 21 CFR 820 supplier controls compared to ISO 13485:2016 outsourced suppliers and purchasing controls and the need for quality agreements, the report says. ISO 13485 (an international standard) was created in 1996 based on the idea of EN 46000, and the understanding that an international medical device quality management standard was important. The document also maps 21 CFR 820 to ISO 13485:2016 and vice versa, as AAMI explains that companies should review the alterations in both directions. EN 46000 (and European standard) was created in 1993 based on the ISO 9001 version at the time to include more specific requirements related to medical devices (this was necessary because, due to the Global Approach to conformity assessment of the European Directives, an study concluded that the requirements of iso 9001 were not enough. More that the length of time of teh audit, ISO auditors do not have the same power of investigation, and they are limited by the content of the ISO 13485 standard - and one can remind the PIP scandal several years ago : the manufacturer was cheating, and the certification body was unable to detect it (nowhere in the ISO standard there is a clause about the fact that the quantity of raw material purchased must match the quantity of finished goods sold) Regarding the inspection process, the fact that the FDA inspectors are federal agents makes a very big difference. I made an overview of the ISO 13485 content - if you can read french. Surprisingly, those 2 files do not even match exactly the content of the technical documentation requested by the EU directives. There is a wide overlapping betwen the US DHF/DMR/DHR and the ISO 13485 files (MD file and MD R&D file), but they still are a little different. But there are some formal differences, including the content of the technical documentation. I agree that basically, the content is very similar. 21 CFR 820 is designed for medical devices inside the US market. ISO 1385 is designed for the medical devices market inside the UE, it contains what the EU law (directives) request.

I might leave a late reply, but there are some differences between 21 CFR 820 and ISO 13485.

What is the difference between iso 13485 and 21 cfr 820?