How to define QMS certification scope statement?

R

Roody5617

#1
#1
Hi guys, I have some confusion in certification registeration scope statement,please help me, thanks!
the processes in my company include CNC machining, metal-sheet and assembly, before our company just manufactured components for commercial printer, the ISO9001 certificate scope is defined as " Machining and sales of components for commercial printer", right now,more and more customers with different products are introduced into my company, so I have to extend the certificate scope.because my company just manufacture components for customers, and the processes of all components are similiar, so I want to just define the scope as " Machining, metal-sheet,assembly and sales of Precision Mechnical components" , the statement of what product the components are used for is excluded, but the certificate body does not agree,they said I must specifically stated what products the components were used, and the fee of adding each product will occure.
please give some advice, whether my statement is compliant with ISO requirement,how to better define the statement. thanks!
 
Last edited by a moderator:
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
somashekar

somashekar

Leader
Admin
#2
#2
Try ...
" Design and Manufacture of precision machined parts, sheet metal parts, for electrical and electronic equipments "
OR
" Supply of precision machined parts, sheet metal parts, for electrical and electronic equipments "
~
~~
~~~ ... Welcome to the COVE
 
Last edited:
A

AndyN

Moved On
#3
#3
Your scope is fine. I'd drop the "sales" part - I've yet to find an organization that doesn't sell and have never, in 25 years, found it necessary to include sales in the scope.

Also, find another CB. It's useful to discuss scope with the CB, but it's NOT their call to be so prescriptive.

Beware of "design" if you don't control the specs and "supply" doesn't mean YOU make them.
 
R

Roody5617

#4
#4
Thanks for your posts, also I think my new revised statement is clear and specific, I suspect the CB just want to charge me more fee, because every time you add a new product, you should pay some fee. for exemple, if I started to produce parts for commercial server, the CB will ask me to define the scope statement as "Machining and sales of components for commercial used printer,server", so I have to pay for new added product.
The ISO criteria of scope statement just provide a guideline, not stipulate how you must define the certificate scope.
Design is not included in my business, customer is responsible for design, I just contract manufacture parts as per customer SPEC.
 
A

AndyN

Moved On
#6
#6
somashekar said:
You could very well use "Contract manufacture" word within your scope statement...
Click to expand...
Probably insufficient to describe what they do. Manufacture cover too broad a range of activities when they do machining and assembly. Don't forget that a scope statement is a "store front". They should represent their capabilities accurately.
 
R

Roody5617

#7
#7
maybe, it's better to cancel the modifier as "Machining, metal-sheet, assembly and sales of precision mechanical parts", which is much more universal, now matter whah products my mechanical parts are used for, dose it conform to ISO criteria?:lol::lol:
 
A

AndyN

Moved On
#8
#8
Roody5617 said:
maybe, it's better to cancel the modifier as "Machining, metal-sheet, assembly and sales of precision mechanical parts", which is much more universal, now matter whah products my mechanical parts are used for, dose it conform to ISO criteria?:lol::lol:
Click to expand...
Try this: "Precision machining, sheet metal fabrication and assembly". I see such a scope on a regular basis. Drop sales. Why? Because who doesn't sell? Otherwise you should - to be clear - add "purchasing" too. And then training and so on...

Just use my example. Simples!:cool:
 
D

dkavanaugh73

Starting to get Involved
#9
#9
I too have a question on scope with a possibility of an exclusion. We manufacture air conditioning units for buses. Our design team is in Germany but our plant is in the US. Being we do not design the units in our facility or in NA, only assemble, can I put in the exclusion to design into our scope? Also, how would I tie our certificate back to our corporate office in Germany? Would they have to tie their cert to our location as well?
 
A

AndyN

Moved On
#10
#10
dkavanaugh73 said:
I too have a question on scope with a possibility of an exclusion. We manufacture air conditioning units for buses. Our design team is in Germany but our plant is in the US. Being we do not design the units in our facility or in NA, only assemble, can I put in the exclusion to design into our scope? Also, how would I tie our certificate back to our corporate office in Germany? Would they have to tie their cert to our location as well?
Click to expand...
You don't share a QMS? Or certification? From my 25 years in the certification area, your scope should probably read:

The manufacture of air conditioning systems for automotive application, to designs provided by *parent company name here*
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S API Spec Q1 - How to define Management Representative competency for QMS Oil and Gas Industry Standards and Regulations 12
G How to define the scope of QMS as per ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Q Criteria to define QMS processes in ISO/TS 16949:2009 IATF 16949 - Automotive Quality Systems Standard 23
S Define Documents/Records needed for the QMS? Records and Data - Quality, Legal and Other Evidence 4
B How FDA define a new variant/generation or a new device US Medical Device Regulations 11
F How to define/identify emerging risks? EU Medical Device Regulations 7
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
M Define voltage and frequency to perform tests 61010-1 and 61326-1 for CE certification CE Marking (Conformité Européene) / CB Scheme 4
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
M How To Define ISMS (information Security Management System) Scope IEC 27001 - Information Security Management Systems (ISMS) 18
K How to define Expected life service life of medical device Other Medical Device Related Standards 4
S How to Define Importers under EU MDR / Brexit EU Medical Device Regulations 3
M Should Potential Customer Complaint Outcome Define Registrar NC Rating? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K ISO 9001:2015 clause 9.2.2 a. - Define the audit criteria and scope Internal Auditing 2
Q QI Macro Histogram - Can someone define *sorted data*? Capability, Accuracy and Stability - Processes, Machines, etc. 7
H How to define Root Cause when some points are out of control chart Statistical Analysis Tools, Techniques and SPC 6
I How do you define Risk (Medical Device)? ISO 14971 - Medical Device Risk Management 30
M SOP or template for a study to Define Storage Conditions of Orthopaedic Implants EU Medical Device Regulations 3
D Definition Client - How does the government define their clients? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
R Review of "Key Data" for contract labs, but SOP doesn't define "key data". Problem? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
G Procedure to define Signing Authority for Procurement Limits ISO 13485:2016 - Medical Device Quality Management Systems 2
P Can a company define new quality standards for special industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Are there any requirements to define barcode requirements ? Misc. Quality Assurance and Business Systems Related Topics 2
X How to define Calibration Acceptance Criteria General Measurement Device and Calibration Topics 3
H ISO 17025 - How to define a "Test Equipment" ? ISO 17025 related Discussions 2
J Where do you define Internal Auditor qualifications? Internal Auditing 9
V Is there an approach to define the "must 'or' should" in supplier audits? US Food and Drug Administration (FDA) 2
T Internal Audit - How to define the Importance of Departments and Processes Internal Auditing 8
T Help me understand how to define Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
L How to define R & D Receiving (Incoming) Inspection Plan Design and Development of Products and Processes 18
B How to define and implement Configuration Management Document Control Systems, Procedures, Forms and Templates 5
C How to Define and Document Controls of Outsourced Processes Food Safety - ISO 22000, HACCP (21 CFR 120) 5
S Please help me define training requirements for a Career in Regulatory Affairs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K How to define the Acceptances Criteria for all equipment? Manufacturing and Related Processes 7
L Definition Program - How do you define Program with regard to ISO 9001? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
A Supplier Evaluation SOP - How do I Define Major and Minor Suppliers? Supplier Quality Assurance and other Supplier Issues 14
Q Where to define Authorities and Responsibilities in Documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Define Energy Used/Delivered - Applicable to Electrical or Mechanical Power or both? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R 820.50 (A) (2)Define the Type and Extent of Control to be exercised over Vendor Misc. Quality Assurance and Business Systems Related Topics 5
A Where to define Process Tailoring Form used in CMMI in the ISO 9001 Quality Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S How to define New Equipment? Device is Returned, Refurbished or Repaired Misc. Quality Assurance and Business Systems Related Topics 3
C Controlling Documents: Beyond the standard, how do we truly define what to control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C How to define Process Special Characteristics (SC) FMEA and Control Plans 4
kedarg6500 What is the meaning of "define/defined" in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Crusader Local Control Document procedure....define it or not? Document Control Systems, Procedures, Forms and Templates 24
M Excel Templates for Plan & Define Phase in NPI Process for Tire Manufacturer Excel .xls Spreadsheet Templates and Tools 1
R Define Data from Taguchi to Response Surface Methodology in Minitab Using Minitab Software 2

Similar threads

Top Bottom