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Scope of Facility - Our auditor asked us last week for our "Scope of the Facility"

doctall41

Involved In Discussions
#1
New topic (for me): We obviously have a Scope of the QMS as part of our Quality Management System (XYZ Machine manufactures small to large machined parts primarily out of hard and soft metals and completion of minor assemblies). Our auditor asked us last week for our "Scope of the Facility", which is what would tell people more specifically what we do, such as size of parts, specific to what we do. She said it is more of a marketing tool, but is required to be documented somewhere. I can't remember where she said it is called out, but it is the first time I have heard of it. Has anyone run across this?
 

Al Rosen

Staff member
Super Moderator
#2
New topic (for me): We obviously have a Scope of the QMS as part of our Quality Management System (XYZ Machine manufactures small to large machined parts primarily out of hard and soft metals and completion of minor assemblies). Our auditor asked us last week for our "Scope of the Facility", which is what would tell people more specifically what we do, such as size of parts, specific to what we do. She said it is more of a marketing tool, but is required to be documented somewhere. I can't remember where she said it is called out, but it is the first time I have heard of it. Has anyone run across this?
She didn't write a NC did she? That's because there's no requirement for that.

7.1.3 Infrastructure
The organization shall determine, provide, and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
NOTE: Infrastructure can include:
a. buildings and associated utilities;
b. equipment, including hardware and software;
c. transportation resources;
d. information and communication technology.
Where does it say "documented"?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
If the plant is part of a multi-site certificate, normally each site scope of CERTIFICATION is listed in the document.

Never heard of scope of facility. At least not for the QMS. For an EMS, it would make more sense.
 

doctall41

Involved In Discussions
#4
I asked my auditor. She said "It's a part of section 4.3 even though it is not specifically stated. It is implied within the context when it speaks of: determine the boundaries and applicability of the quality management system."
 

Al Rosen

Staff member
Super Moderator
#5
I asked my auditor. She said "It's a part of section 4.3 even though it is not specifically stated. It is implied within the context when it speaks of: determine the boundaries and applicability of the quality management system."
It says "determine the boundaries and applicability of the quality management system", not the facility. What else is "implied" in the standard? If it's not stated, it's not required.
 

Al Rosen

Staff member
Super Moderator
#7
If you continue reading 4.3 Determining the Scope of the Quality Management System, it states;
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
It doesn't address anything regarding the facility. If it was required, I would think it would be in 7.1 Resources, specifically 7.1.3 Infrastructure.

I think she may have used the word Facility, but wanted more detail in the scope. What are the bounderies of your capability? How small and how large are the parts? What soft and hard metals? What types of minor assemblies?
 

doctall41

Involved In Discussions
#8
She was actually ok with our Scope of QMS. She wanted a separate Scope written for Scope of Facility. More along the lines of what we would tell the customer in a presentation, using similar information that you brought up above.
We don't mind doing it, and she didn't write us up for it, just a point of discussion. We have our marketing team working on it now and will add it to our QMS Manual upon next revision. I'm just questioning because it is the first time that has been brought up to me in any audits.
 

Randy

Super Moderator
#10
"4.3 The scope of the organization’s quality management system shall be available and be maintained as
documented information
. The scope shall state the types of products and services covered, and provide
justification for any requirement of this International Standard that the organization determines is not
applicable to the scope of its quality management system."


Just did an Extension to Scope of a Multi-site certificate this week....It's fresh in my mind....And YES it was documented for that particular location and will be included on the certificate.
 
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