Referencing Standards in Procedures - Current version or actual?

#1
What is your preferred way to reference a standard in your procedures? For example, I want to reference a requirement from ISO 13485.

Do I say "current version of ISO 13485" or "ISO 13485:2003"? I don't want to be forced in to revising my library of procedures when we move into 13485:2016.

Thanks for your input.
 
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Michael_M

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#2
Re: Current version or actual

We typically state "....to latest revision", without actually putting the revision requirement in. We would put ISO 13485 to latest revision if we had this requirement.
 
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Sidney Vianna

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#3
Re: Current version or actual

Welcome to The Cove.

Certainly referencing the edition of the standard in your procedures will create busy work, when you adequate your documentation to the new edition. So, you DON'T want to do that.

But, going a step further: why reference the (ISO 13485) standard in your command media in the first place? Do you really have to? Consider NOT referencing it at all, as it simplifies your life even more.
 

ncwalker

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#4
What is your preferred way to reference a standard in your procedures? For example, I want to reference a requirement from ISO 13485.

Do I say "current version of ISO 13485" or "ISO 13485:2003"? I don't want to be forced in to revising my library of procedures when we move into 13485:2016.

Thanks for your input.
Just say ISO 13485. That implies current version. Then, when we go to a new version, you don't have to roll through and change everything.

It is important you also keep a list of what versions you operate to for ALL your standards, because when one changes, you need to see if it DOES affect the text around it.
 

WCHorn

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#5
We have a scope statement in the quality manual for our QMS. In the scope statement, I cite the applicable QMS standard(s) with revision. Then I have an explanation that any reference to those standards in subordinate documents implies the revision stated in the scope statement. The only place I cite a QMS standard revision is in the scope statement, so when we transition to a new revision, I just change the scope statement (and exceptions if applicable) and I'm done.
 

BoardGuy

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#6
[FONT=&quot]Adding to what has already been communicated I would not reference any QMS Standard in procedures or work instructions. Let your quality manual (ISO 9001:2008, Clause 4.2.2) or documented quality management system scope (ISO 9001:2015, Clause 4.3) state the international standards your system complies. All documents created to support this document (manual or scope) are part of the QMS and really don’t need a linked reference.[/FONT]
 
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