Referencing of a standard's year in routine regulatory compliance documents

Nash27

Involved In Discussions
#1
In routine regulatory compliance documents such as Essential principle / requirements checklist, declaration of conformity we use to list year number of a standard for e.g. ISO 13485: 2003, ISO 14971: 2007, ISO 10993-1: 2009 etc. However, increasingly I noticed that this format may be an un-necessary burden that you will carry of replacing the entire document, if the reference standard is updated.

We are trying to swift away from this trend. If regulator ask, we have a rationalised document (yet to finalised) that states currency of all standards is maintained in Master Register. For any revised standard we would do a gap analysis and see if we require to make any changes in pertinent document, if No, all good we do not need to review entire document. However, if gap analysis proposes to make changes, then that document or other relevant documents will be revised.

Just wondering, if any of forum members following similar approach or doing this may stir- up any regulatory compliance requirements? I have read one ELSMAR forum Referencing Standards in Procedures - Current version or actual? and it appears that all agree with our approach.
 
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Jean_B

Trusted Information Resource
#3
I'll also drop this thread/specific post:

Quality Policy - Standards and reference numbers

TLDR Extract:
The same holds for the essential requirements. If you use it in submission, then it is your claim that it complies (present tense) with these standards, and thus specific revisions are important. It is not a plan or intent document (e.g. checklist). If a standard you claim compliance with updates, you usually cannot substantiate your claim for compliance to the newest standard immediately.
 
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