Essential Requirements Checklist references

[katastic2908]

Good Morning,

I have a quick question. I am considering changing our QMS a little in hopes we can reduce the amount of change notices that have to be processed for actives such as when standards revise.

Currently in the Essential Requirements Checklists for our various product groups we list the applicable standard along with the year designation, for example EN ISO 14971:2012. What I would like to do is just put the reference as, EN ISO 14971 and leave off the year. We have another controlled reference document that lists all of our applicable standards along with the year designation. I would like to add a reference in the Essential Requirements Checklist(s) to that document which would give them the proper year designation. If I did this we could avoid revising all of the essential requirements checklists everytime a standard revises.

What are your thoughts on this? Would it be ok to do it this way? TIA

 

[Marcelo]

In terms of "standards talk" (and this is true in standards development and normative references, for example), when you put a standard without the date, you mean the last version of the standard.

Not everyone knows this, but as some may, it may cause confusion. I would avoid it then.

 

[katastic2908]

Thank you. I certainly didn't know that, but I like it.

 

[Kronos147]

Some specs, for example SAE AMS-2700, have requirements to specify a revision on "procurement documentation" or something to that effect.

Unless the standard says use the rev, I think leaving it off for the very reason of eliminating the need to revise so much/often is a wise decision.

 

[Joeem]

Good Morning,

I have a quick question. I am considering changing our QMS a little in hopes we can reduce the amount of change notices that have to be processed for actives such as when standards revise.

Currently in the Essential Requirements Checklists for our various product groups we list the applicable standard along with the year designation, for example EN ISO 14971:2012. What I would like to do is just put the reference as, EN ISO 14971 and leave off the year. We have another controlled reference document that lists all of our applicable standards along with the year designation. I would like to add a reference in the Essential Requirements Checklist(s) to that document which would give them the proper year designation. If I did this we could avoid revising all of the essential requirements checklists everytime a standard revises.

What are your thoughts on this? Would it be ok to do it this way? TIA

Absolutely! Stating the spec is only for reference... Because that should rarely change. A table of contents, or revision control form/record/spreadsheet, whatever show sure the current rev. You only then have to update one document. Archive the old. Retain indefinitely.

Sent from my Pixel 2 using Tapatalk

 

[Noemi1976]

First of all, if you don't indicate the edition year, you're assuming you comply with the latest edition.
Second, if a standard is updated, surely there will be new requirements or changed requirements that will require that you update your essential requirements checklist. Or at least you should indicate anywhere that the new edition of the standard is not affecting your technical file.
Moreover, I can tell you that our notified body doesn't accept any reference to a standard without indicating the edition year.
Hope it helps.

 

[QuinnM]

Hi katastic2908,

I have done something very similar. Our quality manual identifies the standard and the year of referenced standards. Other QMS documents do not indicate the year. We added statements that the quality manual supersedes other documents and provides the years. When standards change we only update the quality manual. Prior to this change, we had many QMS documents to update. We have been audited – internal, internal contractor, and ISO 13485:2003 and no identified standard year issues.

All the best,
Quinn

 

[Wolf.K]

In our SOPs and standards lists we have written "current version" instead of the year of publication, so we do not need to update all documents if a new version of a standard is published. But we have a SOP for updating the standards list - they are all listed in our Master Document List as external documents. This includes necessary risk evaluations or updates of technical documentations.

 

[Remus]

In terms of "standards talk" (and this is true in standards development and normative references, for example), when you put a standard without the date, you mean the last version of the standard.

Not everyone knows this, but as some may, it may cause confusion. I would avoid it then.

Do you have a reference for this information.

 

[Marcelo]

Do you have a reference for this information.

Your comment is not a joke, right? Reference for references

Anyway, it's in 10.4 and 10.5 of the ISO/IEC Directives Part 2.