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?
 
Elsmar Forum Sponsor

Al Rosen

Holed-up in a Hotel in South Florida
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

Holed-up in a Hotel in South Florida
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

Holed-up in a Hotel in South Florida
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.
 
Thread starter Similar threads Forum Replies Date
R TS16949 Clause 7.6.3.1 - Internal laboratory - Facility shall have a defined scope IATF 16949 - Automotive Quality Systems Standard 5
D Limiting TS 16949 registration scope - Heat Treating facility IATF 16949 - Automotive Quality Systems Standard 2
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
G APQP Scope and scale tool APQP and PPAP 2
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
C IATF 16949 - Scope or not? IATF 16949 - Automotive Quality Systems Standard 2
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 1
Q To raise a NC beyond the audit scope? Two signatures were missing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M ISO 27001 ISMS scope for companies with subsidiaries IEC 27001 - Information Security Management Systems (ISMS) 0
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
R Scope of ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 2
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Scope of MRB (Material Review Board) Responsibilities Misc. Quality Assurance and Business Systems Related Topics 5
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
F API Spec Q1 Scope - Limiting the scope of certification Oil and Gas Industry Standards and Regulations 3
M How To Define ISMS (information Security Management System) Scope IEC 27001 - Information Security Management Systems (ISMS) 9
Q ISO 9001:2015 8.5.1 f - Scope with customer special process requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
A Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11
F Information Technology in IATF 16949 audit scope IATF 16949 - Automotive Quality Systems Standard 12
S MDSAP Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
K MDSAP scope vs ISO 13485 Scope Canada Medical Device Regulations 4
S Regulatory Certification Exam (RAC) - Global Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
P Injection Molding Machine Validation Scope Capability, Accuracy and Stability - Processes, Machines, etc. 6
S ISO 9001:2015 - Scope of Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
T Restricting scope of AS9100 certification to a couple of customers AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
Q AS9120B Clause 8.4.1.1 External Providers Scope of Approval AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
S Scope change in Japan - Class I disposable medical devices Japan Medical Device Regulations 0
a_bardi Is it possible to exclude internal audit from qms scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A AS9120 External Provider Registry Scope of Approvals AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
K CQI-23 Molding System Assessment Scope IATF 16949 - Automotive Quality Systems Standard 3
F Definition Commercial Distribution - Definition - Scope of Commercial Distribution Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J AS9100 - Working Outside of Scope of Certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
M Service Industry - Scope of the QMS & Scope of Certification Service Industry Specific Topics 13
Similar threads


















































Top Bottom