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Will a Business Plan be included in an ISO 9001 Audit?

John Broomfield

Staff member
Super Moderator
#11
If a business plan isn't explicitly included in the scope of the QMS, an auditor would be out of bounds in asking to see it for any reason.
Jim,

You may be referring the third party auditors.

The scope of the management system is not usually determined by its evidence of effectiveness.

John
 
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Jim Wynne

Staff member
Admin
#12
If a business plan isn't explicitly included in the scope of the QMS, an auditor would be out of bounds in asking to see it for any reason.
Jim,

You may be referring the third party auditors.
Whether one is dealing with an internal QMS audit or a third-party QMS audit, it's still a QMS audit, and its boundaries should be circumscribed by the scope of the QMS.


JThe scope of the management system is not usually determined by its evidence of effectiveness.
I'm not sure what you mean. The scope of the management system, outside of the requirements of the standard, is determined by the organization. If the organization decides to include the business plan or cleaning of the washrooms, or anything else not specified by the standard as required, those things should be considered within the scope of QMS audits. On the other hand, if those things are not included in the scope of the QMS, they should not be considered within the scope of audits.
 

John Broomfield

Staff member
Super Moderator
#13
Whether one is dealing with an internal QMS audit or a third-party QMS audit, it's still a QMS audit, and its boundaries should be circumscribed by the scope of the QMS.



I'm not sure what you mean. The scope of the management system, outside of the requirements of the standard, is determined by the organization. If the organization decides to include the business plan or cleaning of the washrooms, or anything else not specified by the standard as required, those things should be considered within the scope of QMS audits. On the other hand, if those things are not included in the scope of the QMS, they should not be considered within the scope of audits.
Jim,

I think you are talking about using the business plan as audit criteria. In this case I agree with you.

I was talking about the possibility of using the business plan as evidence of conformity to the five criteria listed.

John
 
V

vanputten

#14
Hello Sidney

Please will you further explain this concept? I don't think I understand what you are saying and I would like to.

"Further, remember that, the standards that apply to the CB's and their auditors ask for certain things that are not covered in the standard the registrant is being certified against."

Thank you,

Dirk
 

John Broomfield

Staff member
Super Moderator
#15
Business Plan as audit criteria or as objective evidence?

Our discussion has confused audit criteria with objective evidence.

Audit criteria (requirements) are declared as part of the audit plan as necessary to fulfill the audit objective.

The scope of the audit is also declared in the audit plan and is as necessary to fulfill the audit objective.

Objective evidence is gathered and evaluated by the auditor as necessary to determine conformity with the audit criteria.

As audit criteria all of the system standards require sufficient resources.

As objective evidence, a business plan (or funded plan) could be evaluated for determining the sufficiency of resources. This request remains in scope and legitimate if necessary to fulfill the audit objective.

It is not necessary to use the business plan as audit criteria for determining the conformity of management systems to the majority of system standards. IRIS and ISO/TS 16949 are exceptions.
 
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J

JaneB

#17
Hi, can anyone advise if a business plan is mandatory for ISO 9001? I think this is also needed in a company, but not sure if ISO also include this in the audit.. any advise? Can anyone also advise where I can get a good sample of a business plan? thanks,
As other people have said, a specific document called a business plan isn't mandatory.

However, every organisations needs to (or should!) do some business planning. They may call the output from that planning a 'business plan' or they may call it many other things, from a Strategic Direction to 'the output from that workshop we had'.

Some companies may do an annual plan, and have their 'quality objectives' in that. Others do other things.

IF your company says something (verbally or in its quality manual) like 'we produce an annual business plan which sets our direction for the year/includes company objectives' then yes, any decent auditor would ask to see it. If you didn't say anything like that, they'd ask questions to see how else you accomplish the relevant elements of 9001 that they're auditing.

As for a 'good sample BP', try Googling. There's an absolute stack out there on the net.

Question: Shouldn't your senior management be providing this?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#18
Hello Sidney

Please will you further explain this concept? I don't think I understand what you are saying and I would like to.

"Further, remember that, the standards that apply to the CB's and their auditors ask for certain things that are not covered in the standard the registrant is being certified against."

Thank you,

Dirk
Dirk, I don't understand what you don't understand. I gave two examples in my previous post. If you would like a third one, here it goes:

ISO 17021 8.4.2 requires
A certification body shall not permit its marks to be applied to laboratory test, calibration or inspection
reports, as such reports are deemed to be products in this context.
So, this is a requirement that applies directly onto the CB and indirectly onto the registrant. ISO 9001, for example, has no mention whatsoever to "certification marks", since there is no requirement in ISO 9001 for certification altogether.
As I said before, examples of such indirect requirements abound.
 
J

JaneB

#20
The auditor only sees the output of Business Planning which is basically the Measurable Objectives.
While true that objectives are an output of business planning, I think to take the view that they're the only output is a bit too narrow, and ignores some important clauses. Like, say, 5.4.2, 7.1 and so forth.

The structure, resources and processes of an organisation are also - or should be! - the result of business planning.
 
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