How to define the scope of QMS as per ISO 9001:2015

G

gaurav16949

#1
Hello all
my name is gaurav
i have confusion over the clause 4.3 determine scope of QMS. As per standard while deciding scope of QMS we have to consider

a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.

I m not able to understand how point a) and b) is going to affect the scope of organisation of QMS?
Thanks in advance for your time and support
regards
gaurav
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
This is just my opinion on what you are asking and to provide a definition:

The External/Internal issues:

External force: This is used to identify the Customers, Suppliers, and Regulatory Agencies.

Internal force: This identifies the processes, personnel, machinery, utilities, policies, procedures, work instructions, work atmosphere, and general practices internal to the organization.

The Relevant interested parties:

Interested parties: Stock holders (if any), Customers, Suppliers, employees, Regulatory Agencies, and Society indirectly or directly. There are many more that could be considered interested parties.


As you can see by my opinion in the definitions, that they all interact somehow within the Organization, including the product produced. These all need to be considered when determining your Scope of the QMS/Organization.

But again, just my opinion. Maybe this helped you to determine how Points "A" and "B" interact to Point "C." If it wasn't clear enough to you, there are many more people, with a lot of experience, here in the Cove that will be able to add, subtract, or disagree with the opinion.
 
Last edited:

charanjit singh

Involved In Discussions
#3
Gaurav, you've got an excellent overview of the points to consider while deciding on the scope of your QMS.

Further to this - and this is my view only - consider what your organisation would like to cover in the scope. For example, if your are manufacturing say, bus bodies and supplying to an automotive manufacturer, put that down as the scope, e.g.:

"Manufacture and supply of Bus Bodies to automotive manufacturing industry...duly complying with applicable regulatory requirements..."

In this you have already taken into account the customers, regulatory bodies if applicable.

While not in the scope, as a part of QMS you will no doubt apply the necessary controls over your suppliers (external providers). You will also take suitable care about internal issues like upkeep of infrastructure, training and motivation of the personnel etc.

Well this is my opinion. I hope it helps.
 
G

gaurav16949

#5
Mr Coury Ferguson and Mr. Charanjeet Singh
External and Internal issues are identified in clause 4.1 and interested parties in clause 4.2 i m known to both them.But sir my basic confusion is that how will they affect the statement of scope of QMS. Do i need to mention some thing related to them in scope of QMS. For example if my scope for ISO 9001:2008 is " Manufacturing of Plastic Moulded components"
Then how will it be different for ISO 9001:2015
Charanjeet Sir
By writing "Manufacture and supply of Bus Bodies to automotive manufacturing industry...duly complying with applicable regulatory requirements." we have added you have already taken into account the customers, regulatory bodies if applicable. Bur sir what about other interested parties like external providers, people working in the organisation and many others. Similarly what about internal and external issues. How to mention them in scope of QMS
Sirs I in in state of confusion over this
A very big thanks for your help
 
Last edited by a moderator:

charanjit singh

Involved In Discussions
#6
Thank you Gaurav. As you would have noticed, Clause 4.3 states: "... When determining this scope, the organisation shall consider..."

Yes we can say that we have CONSIDERED other relevant interested parties (e.g. external suppliers) and included the necessary controls within our QMS. BUT there is certainly NO requirement in the standard to include the same the formal statement of the scope of QMS.

So there is nothing to worry about. No auditor can demand to see what the standard itself does not mandate.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#7
Mr Coury Ferguson and Mr. Charanjeet Singh
External and Internal issues are identified in clause 4.1 and interested parties in clause 4.2 i m known to both them.But sir my basic confusion is that how will they affect the statement of scope of QMS. Do i need to mention some thing related to them in scope of QMS. For example if my scope for ISO 9001:2008 is " Manufacturing of Plastic Moulded components"
Then how will it be different for ISO 9001:2015
Charanjeet Sir
By writing "Manufacture and supply of Bus Bodies to automotive manufacturing industry...duly complying with applicable regulatory requirements." we have added you have already taken into account the customers, regulatory bodies if applicable. Bur sir what about other interested parties like external providers, people working in the organisation and many others. Similarly what about internal and external issues. How to mention them in scope of QMS
Sirs I in in state of confusion over this
A very big thanks for your help
My easy way out would be to identify based upon "internal and external forces" the organization will consider these during management review, QMS review and internal auditing. That may meet the intent of the standard. But, it will be up to your Registrar.

Just my opinion.
 

Paul Simpson

Trusted Information Resource
#8
Just another view on how you should look at the clause and satisfy the requirements. :2cents:

Hello all
my name is gaurav
i have confusion over the clause 4.3 determine scope of QMS. As per standard while deciding scope of QMS we have to consider
In order to set a scope for the QMS you need to be able to look at your context (4.1) and the needs of interested parties

a) the external and internal issues referred to in 4.1;
In the notes 9001 suggests you consider the context in terms of PESTLE - so these areas (political / regulatory, economic etc.) tell you what factors help shape your QMS (and therefore define the QMS scope) thereby ensuring the QMS is appropriate for your business (and the context you are operating in).
b) the requirements of relevant interested parties referred to in 4.2;
Same thing here: If your customers have expectations / specifications etc. and regulators have laws your products and services need to comply with then these requirements shape your system and need to be considered as you design your processes.

c) the products and services of the organization.
So your QMS should cover all the products and services your customers rely on - hence the scope of your QMS.

I m not able to understand how point a) and b) is going to affect the scope of organisation of QMS?
Thanks in advance for your time and support
regards
gaurav
Hopefully this helps.
 
K

ksmith814

#9
A Scope Nonconformance

So I have seen the first non-conformance from the scope section in the new standard from one of my students. The non-conformance was simply written as follows:

"There was no documented scope that considered a – c in the requirement."

They had (and showed to me) a documented scope just as they did for the previous version of the standard, but it didn't fly this time. I am not really sure what they are looking for in terms of evidence of what was considered. I have some ideas, but they don't really seem too "value-adding". Has anyone run into this issue?
 

charanjit singh

Involved In Discussions
#10
Does the 'consideration' have to be part of documented scope? At least the standard does not stipulate that the consideration (i.e. what and how it was done) should be incorporated in the scope.
 
Thread starter Similar threads Forum Replies Date
R How to define QMS certification scope statement? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M How To Define ISMS (information Security Management System) Scope IEC 27001 - Information Security Management Systems (ISMS) 9
K ISO 9001:2015 clause 9.2.2 a. - Define the audit criteria and scope Internal Auditing 2
J How to define a Product's Realization Process and Scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Iso9001:2000 Clause 7.4.2 B - Help me define the scope of 'personnel' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
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
S API Spec Q1 - How to define Management Representative competency for QMS Oil and Gas Industry Standards and Regulations 12
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
MrPhish Should Potential Customer Complaint Outcome Define Registrar NC Rating? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
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
Q Criteria to define QMS processes in ISO/TS 16949:2009 IATF 16949 - Automotive Quality Systems Standard 23
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
K How to define PVC Pellet Quality Manufacturing and Related Processes 8
S How to define Permissible Error for Measurement and Test Equipment? Measurement Uncertainty (MU) 3

Similar threads

Top Bottom