External Standards List - Should this document include previously revised standards?

Ed Panek

QA RA Small Med Dev Company
Super Moderator
Should this document include previously revised standards or just current ones we utilize today? For example, ISO 13485:2016 is the new standard but we utilized the previous revision during the initial development 6 years ago.


Quite Involved in Discussions
Your revision history on the standards list would capture this. Also, the records you create that hopefully include a cite that relied on a prior version of a standard would tell this story. Good morning, Ed.


Involved In Discussions
Current standards only. You can archive the old standards if you want, but there is no reason to list old standards.

If an auditor is getting into "state of the art" arguments, just ask him "where is the requirement"? You're audited to requirements, although some auditors like to show how much they know.

We took the year reference to standards out of our documents, it was an audit trap. You should be reviewing your QMS and documents when a standard is updated as part of the implementation process, and have hopefully documented that.
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