How to efficiently and compliantly reference external standards/regulations

#1
I am looking for advice on how to efficiently and compliantly reference external standards/regulations. I work for a small medical device company and we are rapidly expanding into new markets and with that we are now governed by over 100 standards/regulations. Historically we would cite 21CFR part 820, EU-MDR, ISO 13485, etc. but now that we have so many it to cite that when there is an update it has been shown this method will no longer work.

We are considering creating a master index of regulations/standards but I think that it would be so long that it would risk people missing applicable standards/references when updating or creating a new SOP.
 
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John Broomfield

Staff member
Super Moderator
#2
QSE,

Each publisher of the refs and regs should be the responsibility of someone to monitor for updates and changes. This person is usually the specifier of service, product, or process requirements.

Your specifiers may have already bookmarked their links to the websites where each of these refs and regs is kept up to date. They may also subscribe to notifications of planned changes.

Ask them how they’d like to share their links and notifications.

That sharing will help verify the links and open them up to your internal audits.

Creating and maintaining a master index reminds me of the 1980’s.

Best wishes,

John
 

Jean_B

Trusted Information Resource
#3
In short: avoid direct implementation for every occurrence by aligning your system to all of them.

The issueing organizations you have no control over, but you can monitor their current valid regulations/standards, etc. (These would be external documents to you, and that is what I will call them from now on). Let's call this part the 'awareness'
Every time an external document becomes applicable to you take note under the 'awareness' part in a central list (note that this listing is seperate from the documents that would indirectly prove your compliance as they follow your far more useful internal procedures). Note the state your system is at as well (e.g. aligned vs not-aligned).
  • Prime examples are market entry (usually under marketing or R&D) and new introduction to existing product (harder to trigger, usually done by a scan once every so often on the relevant categories you know of).
  • Take care to note when you need to retrospectively generate (especially technical) documentation due to updates to external documents. This occurs most often when you have been running a lean system and not necessarily been generating all kinds of information auditing organizations might assume you have but not often bothered to check since older editions seemed to have been more lenient or left wiggle-room.
Implement these through a QMS process which updates your own internal processes to align with or provide for their requirements (there is a lot of overlap). Let's call this part the 'alignment'. This takes the form of delta analysis (for updated external documents), gap analysis (delta to your current QMS), and alignment/implementation which changes your QMS to be compliant.
Through alignment you should far less often need to directly cite external documents in procedures as you have a method to keep your entire system aligned. The advantage should also be that you have less region specific work-instructions as you weave the requirements into the most appropriate process and the evidence should flow out naturally.

Schedule frequent audits on the process of effective alignemnt to external documents and you should (for a small device company) have a good argument that you are assuring compliance.

You still need to do some citing, especially when you are offloading work to standards/methods (and thus not in your system) or when you are claiming documents as evidence of meeting the requirements of certain (parts of) external documents (especially in technical files).
On detailed citing there's already an extensive post: Quality Policy - Standards and reference numbers
 
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