Minor non-conformance for not controlling local regulation laws?

[qualprod]

Just to clarify,
The root question was , Why do we have to control into a QMS, documents (rules/laws/regulations) which dont apply directly to products and services.
According to what Sidney said... that is an environmental regulation that has ZERO impact on product quality

Hoep I ve explained clearly.

Thanks

 

[Sebastian]

Let's imagine a case, where product was perfect, delivery brilliant and "does not matter what" agency closed whole/part of company for breaking "does not matter what" regulation. This is an effect of very narrow understanding what quality management system boundaries are. Non-operating company damages product quality totally.

 

[AndyN]

Hello everyone.
An external auditor auditing compliance with 9001 2015, raised me a minor nc for not referencing anywhere into my qms other standards apart from Iso 9001.
The point is, in my policy I state " complying with legal and statutory reglamentation " just to say that if I'm requested to comply some requirements of my client, I Will do it, currently I produce paper bags, and nobody askd me to comply with some additional regulations.
Into my qms, I only have the iso 9001 as an external document, my business is clean and secure.
So you think does this nc apply?
She says that even if a manage only products, I must have other local standard controlled as external documents, such as those for environment and accounting.

Thanks for your inputs

It's a rubbish finding...

 

[Sidney Vianna]

This is an effect of very narrow understanding what quality management system boundaries are.

There. I fixed it for you.

You are welcome.

 

[SpinDr99]

For years I thought I understood what controlling of documents was. Now I'm completely in the dark. I THOUGHT it was about control by giving it a name, number, revision, the review and approval process. However, when it comes to external document, I have no control over them. I can only control having ACCESS to the latest revisions be that in hard copy or electronic copy. In my previous company we rarely got drawings for parts the customers wanted us to make. They got samples, created drawings, and having a customer approve a drawing was something we all got a huge roar of laughter about. NOT going to happen. And the parts BETTER be right!
Furthermore, on the rare occasion they were handed a drawing, I didn't create, revise or control the revision level in any way. So HOW was I supposed to control the drawing IF I was lucky to have received a revised copy?

And let's not get into how a QUALITY Management System manages a business. I firmly believe ISO has gotten WAY beyond the scope of
what a QUALITY Management System is, by definition.

Can someone help me with HOW to control external documents?

Much thanks!

 

[Marc]

<snip> Can someone help me with HOW to control external documents? <snip>

A lot of companies I have worked with put documents of external origin in their calibration system software.

Some companies, for documents such as standards, use a paid service for notifications of revisions/changes.

Two thoughts - I'm sure others here will have more ideas.

 

[Ninja]

We always just assigned a number to the doc like {ExtDoc-001}, stamped it "Controlled" in red, then treated it like any other procedure or method.

Same approvals, same "Change/Release" process...the only difference was that it was already written.

Rev tracking was handled just like any other internal controlled document.

 

[SpinDr99]

Thanks Marc, but now I'm really scratching my head mixing documents with calibration. To me, they're two different beasts.

So in order to keep on topic, I still need help on how I'm supposed to "control" documents of external origin when they're not my documents. Any takers?

 

[Ninja]

They ARE your documents. You just didn't write them.

 

[Golfman25]

Thanks Marc, but now I'm really scratching my head mixing documents with calibration. To me, they're two different beasts.

So in order to keep on topic, I still need help on how I'm supposed to "control" documents of external origin when they're not my documents. Any takers?

You "control" them just like any other document. There is a process for updating, reviewing, approving, and making available for use. Don't over complicate it.

Take something as common as a customer print. You get it, review it to make sure you can do it, "approve" it by your acceptance, and then you file it some how for retrieval when needed.

Or a customer specification -- you might keep a log and file for future use. Things like that.