Do we need to reference Standards in our Procedures?

S

sardonyx

#1
Do we need to reference Standard documents into our procedure? If we reference those standards (ex. ISO 14155-1, ISO14971, ISO19011, etc), do we need to have the current edition on hand? What if we reference a 1998 edition and found out there is already a 2002 edition do we need to check our procedure and see if this will comply with the current edition?:bonk: Thanks in advance for any help.
 
Elsmar Forum Sponsor
#2
Re: Do we need to reference Standards into our procedures?

No. Emphatically, no!

But for others, why do you ask this intriguing of questions...............??

Andy
 
F

fireonce

#3
Re: Do we need to reference Standards into our procedures?

It' not necessary for you to do this.If the standards update,you may evaluate your procedures' compliance.
 

Jim Wynne

Staff member
Admin
#4
Re: Do we need to reference Standards into our procedures?

Do we need to reference Standard documents into our procedure? If we reference those standards (ex. ISO 14155-1, ISO14971, ISO19011, etc), do we need to have the current edition on hand? What if we reference a 1998 edition and found out there is already a 2002 edition do we need to check our procedure and see if this will comply with the current edition?:bonk: Thanks in advance for any help.
I'm going to partially disagree with sardonyx and Andy, and say, "It depends." If you require that a certain process be performed in accordance with a published standard (e.g., salt spray testing per ASTM B117), then yes, it should be referenced and yes, you should have a current copy on hand, or ready access to one. If you don't reference the revision status of the standard, it should be assumed that the most current version will be used. On the other hand, if you do reference a revision level, then that revision level must be used, even if it's been superseded.

It's best to avoid referencing standards as much as possible, but when you have to, you have to also consider the document controls that will be necessary.
 

Manoj Mathur

Quite Involved in Discussions
#5
Re: Do we need to reference Standards into our procedures?

My Ans. to this Question is parrtially YES. Because in certain procedures, Like Calibration SOP of perticular Instrument we used to refer a standard of calibration.
 
A

andygr

#6
Re: Do we need to reference Standards into our procedures?

Here is my personal take.
What made your write the procedure?
IF you created it based on the guidlines or requirements of some other document I would allways referance this documents and their revisions.
Why?
Well when you get an offer an leave for real money the underpaid person who gets your slot will have some basis in 5 years for understanding why the procedure says what it says ie the old revision of B117 that was in effect at the time had this requirement and the current revision now has this requirement ( which is why they just received an audit finding ;-) ).

If you are just creating a procedure based on observing the process ( writing a "How To") then this probably not required.
:2cents:
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#7
Re: Do we need to reference Standards into our procedures?

I'm going to mirror what Jim said and add an example:

we got an observation from our notified body in a CE marking audit that our technical file for the par showed the standards, but when he checked our standards library he found a couple out of date.
Now a technical file for this EU directive must contain a list of reference standards, which we must have on habd and keep current.

We do have a few procedures and work instructions that reference standards and part of the document control guy's job is to periodically check that we are current.

I think the bottom line is that if you reference a standard in a procedure/work instruction you ought to have it on hand and have the latest rev. But I think you should avoid referencing standards where possible.
 

GStough

Staff member
Super Moderator
#8
Re: Do we need to reference Standards into our procedures?

...I think the bottom line is that if you reference a standard in a procedure/work instruction you ought to have it on hand and have the latest rev. But I think you should avoid referencing standards where possible.

I agree, as well. :agree1: :yes:
 
#9
Re: Do we need to reference Standards into our procedures?

The OP didn't state anything about technical specs being referenced, simply "ISO's", hence my (emphatic) reply.
I agree that if a procedure contains details of how a organization goes about some testing etc. then (perhaps) it should include a reference to a standard (as Jim put it).

And, yes, you gotta have a copy and you should have a system of finding out if it's been updated and not get this information 'by chance'.

If it comes to writing a procedure, say for 'Purchasing', would it be appropriate to refernce ISO 9001:2000 7.4 in that procedure?

NO!

Andy
 

SteelMaiden

Super Moderator
Super Moderator
#10
Re: Do we need to reference Standards into our procedures?

If you are making it a requirement of your system to follow some standard (whatever that standard may be...ISO, ASTM, SAE, whatever) then you should reference it in the Quality system somewhere, and you should have a current copy available.

But, if you are only using a standard as a sort of guideline, no requirement to use it, you do not have to refer to it. Depending on how often you choose to refer to said standard will probably dictate to you whether or not to update it whenever a new revision is released.
 
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