Documents of External Origin - Periodic or annual verification of revision status

M

maxwell

Greetings

Is there a requirement in ISO 13485:2003 section:4.2.3 For the periodic or annual verification of revision status of "Documents of External Origin"

:thanx:
 

GStough

Leader
Super Moderator
Re: Document of External Origin

Greetings

Is there a requirement in ISO 13485:2003 section:4.2.3 For the periodic or annual verification of revision status of "Documents of External Origin"

:thanx:

No. 4.2.3(f) is the only statement in that section making mention of "documents of external origin", and it states "...to ensure that documents of external origin are identified and their distribution controlled..." (speaking of the documented procedure to define this as a control).

I don't see the harm in checking your sources to determine whether a more current revision might be in circulation, though, so you can be proactive in requesting and obtaining the most current revision.

Hope this helps. :bigwave:
 
In ISO 14969:2004 section 4.2.3.2 it says:
Documents may be reviewed at various times throughout the life of a document, for example, as
a result of:
• facilities, personnel or organizational changes,
• audit activities,
• acquisitions,
• new products, technologies or software,
a requirement of the organization's quality management system for periodic review.
Thus – it will be a good advice to add a requirement in your quality plan to make an external document review periodically
:agree1:
 

somashekar

Leader
Admin
For a system to work better, stipulate the reasonable period for review (say quarterly) and have a mechanism for recording the review result and actions taken thereoff. Perhaps such an effort will make someone responsible for the periodic action and can also be reported to management for timely actions and record same in management review minutes. (see 5.6.2 h) of ISO 13485:2003) Management needs inputs on the new or revised regulatory requirements and as we know lot many things are changing very often and get uploaded on the regions health websites.
If we get to know our purpose, our action will get the clarity.
 

AndyN

Moved On
Don't waste time checking for revisions so frequently - if you did that for ISO 9001 you'd have checked 32 times before there was a revision! (more or less).

Better still, sign up with one of those organizations that provide such a service! Give them a list of all the regs and ISO's and other documents created by standards authorities (ANSI, ASME, IEEE etc) and then let the service advise you. Simple!
 
R

Roland Cooke

Whilst a notification service can certainly be useful, there is a long list of documents of external origin other than standards and regulations that a company could possibly require to maintain up-to-date,
 

AndyN

Moved On
Whilst a notification service can certainly be useful, there is a long list of documents of external origin other than standards and regulations that a company could possibly require to maintain up-to-date,

True, but a lot of folks don't know those services exist.......and many (most) can be updated that way..
 

somashekar

Leader
Admin
True, but a lot of folks don't know those services exist.......and many (most) can be updated that way..
Hii Andy.
Agree with you and as always the auditor comes in and says that we have an older version......
Can you share such references that will come handy for all updates concerning EU, Canada, and the USA regulatory. Many could subscribe to them and get timely updates.
Thanks for your help.
 
R

Roland Cooke

Obviously, in all cases, the responsibility for maintaining current documentation (and acting upon changes) remains with you. I would try to have the periodic check solely as a back-up, make it a documented requirement with the originating organisation that they must keep you up to date.



For (engineering / quality) standards, all the major sellers have a free update service.

For regulatory updates, these are usually free and online, albeit not necessarily easy to find, and not always easy to interpret the impact of the changes. For EU stuff I would recommend discussing with your Authorised Representative. If you have a regulatory person, get them on the task, it is their job. (N.B. they don't have to know it all, they need to know who to talk to).
Also, don't underestimate the value of the Cove. It's not perfect, but it is very, very good for this kind of thing.

For suppliers, your agreement with them should include a clause about updating you (i.e. on documentation both sides agree you need).


In the US especially, an easy auditor target are the Materials Safety Data Sheet binders that many factories have to have, and display prominently.
I imagine it is illegal, and certainly a liability, to have out-of-date MSDSs on the factory floor.
these documents are not written by the company, so by definition they are of external origin.
Are you really only going to check once a year? What would that check actually involve?

In reality, I often find there is no proper system, but that the binders are indeed usually up-to-date. It's "advanced luck" if you like. :tg:

So find out what the system really is for ensuring currency, review of changes, distribution and determing any required training? Then document that.

In terms of creating a procedure, check where this external doc control system needs to be different from your regular doc control system? (I.e. minimise the need for additional systems).



Edit: You then use to periodic reviews to ensure nothing critical has been missed.
 
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I

iansawyer

Wouldn't it be geat if Elsmar Cove maintained a user-updated document database.
 
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