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

[gaurav16949]

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

 

[Coury Ferguson]

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.

 

[charanjit singh]

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.

 

[gaurav16949]

Thanks Mr Coury Ferguson and. Mr. Charanjeet singh for your valuable inputs.

 

[gaurav16949]

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

 

[charanjit singh]

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]

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]

Just another view on how you should look at the clause and satisfy the requirements.

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.

 

[ksmith814]

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]

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.