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ISO 13485 vs. 21 CFR Part 820 Management Summary wanted

Q

QualityTime

#1
I am looking for a management summary (high level) of the differences between ISO 13485 and 21 CFR Part 820.
 
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harry

Super Moderator
#3
A

arios

#4
Re: ISO 13485 vs 21 CFR Part 820

Indeed ISO 13485 and the 21 CFR 820 (QSR) are different, but their similarities are more common than their differences.

1. The Concept of CAPA could be considered the same
2. The Content of Management Review is more prescriptive on ISO 13485 than in the QSR
3. The requirements of a DHR is more prescriptive on the QSR
4. Document control is very similar on both
5. The concept of internal audits is very similar but you are not required to show audit reports to FDA inspector, but otherwise attest they have occurred. Similarly with Management reviews.
6. The QSR does not have a concept per se of Customer supplier product, but does not limit the receipt of materials to purchased products, as they can be also otherwise acquired. It is more evident in the QSR that consultants need to be qualified too as suppliers.
7. There are more prescriptive requirements for the content of customer complaints on the QSR. In that area ISO 13485 is more generic, but 13485 is designed to allow the application of other regional regulations, in that case, you will need to consider the Canadian SOR 98-282, or the MDD 93/42/EEC requirements, MED DEV 2-12.1 and so on as applicable
8. The DMR in ISO 13485 is named a "file" in 4.2.2., and the DHR is called "batch record" in 7.5.1.
9. Lastly, ISO 13485 is designed to be used as an international std, whereas teh QSR is intended for the USA market of Finished Devices

Hope this helps. I wrote this by memory so I may have some omissions, I tried to be as brief as possible :2cents:

take care
Alberto
 
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