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Minor non-conformance for not controlling local regulation laws?
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Minor non-conformance for not controlling local regulation laws?
Minor non-conformance for not controlling local regulation laws?
Minor non-conformance for not controlling local regulation laws?
Minor non-conformance for not controlling local regulation laws?
Minor non-conformance for not controlling local regulation laws?
Minor non-conformance for not controlling local regulation laws?
Minor non-conformance for not controlling local regulation laws?
Minor non-conformance for not controlling local regulation laws?
Minor non-conformance for not controlling local regulation laws?
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Some Related Topic Tags
audit nonconformances and findings, document control, documents of external origin, legal requirements, regulations and regulatory requirements, regulatory requirements, statutory requirements
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  Post Number #9  
Old 25th February 2018, 03:45 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,315
Re: Minor non-conformance for not controlling local regulation laws?

Quote:
In Reply to Parent Post by Ninja View Post

It seems like the age old case of mixing up the noun and the adjective:

Quality Management System isn't the Management of the quality system.
It is the Quality of the Management System.
Says who? This kind of platitude just confuses users, in my opinion. The Quality Management System is the management of the quality system. What is a quality system? The parts, bits and pieces of the company operations that have an impact on product quality and customer satisfaction.

As an example, if there is a local regulation controlling storm water run-off in to the local sewer system, that is an environmental regulation that has ZERO impact on product quality. So, obviously, from a quality system perspective, this regulatory requirement is non-existent. From an organization's perspective, their EMS (environmental management system) has to identify, monitor and comply with that regulation.
Thanks to Sidney Vianna for your informative Post and/or Attachment!

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  Post Number #10  
Old 25th February 2018, 04:10 PM
Marc's Avatar
Marc

 
 
Total Posts: 26,502
Re: Minor non-conformance for not controlling local regulation laws?

Quote:
In Reply to Parent Post by qualprod View Post

<snip> If regulations/laws will be controlled out of a QMS, why could this be a NC into a QMS? <snip>
Document control in a company is not necessarily "controlled by the quality department", if that is what you're saying. Often it is completely independent of the quality department in a company.

Document Control is a company-wide "system" - A Business System. It is required by ISO 9001 and always has been, and it isn't, and never has been, only applicable to (for example) a specific subset of departments (or other company defined "sections").
  Post Number #11  
Old 25th February 2018, 10:04 PM
qualprod

 
 
Total Posts: 107
Re: Minor non-conformance for not controlling local regulation laws?

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
  Post Number #12  
Old 26th February 2018, 10:20 AM
Sebastian's Avatar
Sebastian

 
 
Total Posts: 291
Re: Minor non-conformance for not controlling local regulation laws?

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.
  Post Number #13  
Old 26th February 2018, 10:23 AM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,940
Let Me Help You Re: Minor non-conformance for not controlling local regulation laws?

Quote:
In Reply to Parent Post by qualprod View Post

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...
Thanks to AndyN for your informative Post and/or Attachment!
  Post Number #14  
Old 26th February 2018, 10:36 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,315
Re: Minor non-conformance for not controlling local regulation laws?

Quote:
In Reply to Parent Post by Sebastian View Post

This is an effect of very narrow understanding what quality management system boundaries are.
There. I fixed it for you.

You are welcome.
  Post Number #15  
Old 26th February 2018, 11:48 AM
SpinDr99

 
 
Total Posts: 61
Re: Minor non-conformance for not controlling local regulation laws?

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!
  Post Number #16  
Old 26th February 2018, 12:24 PM
Marc's Avatar
Marc

 
 
Total Posts: 26,502
Re: Minor non-conformance for not controlling local regulation laws?

Quote:
In Reply to Parent Post by SpinDr99 View Post

<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.
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