NOTE: regardless of which standard you purchase, there's always an ISO 9001 comparison table, that will help you identify the relationship/gaps between ISO 9001 clauses and ISO 13485 clauses. Ultimately you'll eventually want to certify to the latest 13485 version (2016), which has diverged from ISO 9001 - so this route will likely entail more work. If time and resources are limited, perhaps consider certifying to ISO 13485:2003 (the previous version), as this version is not significantly different from ISO 9001. The new version of ISO 13485 (2016) has just been released, and there is a 3-year transition period, so how you want to proceed at this point is up to you: I'd say that the main decision for you is likely not EN versus ISO, but rather 2003 version versus 2016 version. For example, if you intend to market in Canada, they'll tack on CMDCAS requirements (to meet Canadian medical device regulations requirements). When you start to shop around for a Certification Body (CB), they will ask you about your devices and where your intended markets are, and tack-on any "extras" accordingly. (2) might be cheaper, but as was pointed out in this thread, you can also get a single-license copy of the EN version from Estonian Standards for only 20 Euros! In this amendment you can find: Annex ZA which covers the relationship between EVS-EN ISO 13485 and the and the requirements of Regulation (EU) 2017/745. The relationship with EU Regulations can be found in informative annexes. Purchase the ISO 13485 version, and supplement with the free preview of the Z-annexes from the webstores (see link in previous post).Įither will give you the same content. EVS-EN ISO 13485:2016/A11:2021 supports the requirements of EU Regulations. Purchase the EN ISO 13485 version (with Z-annexes included) orĢ. Click to expand.The answer is: it doesn't matter for this standard.
0 kommentar(er)
