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

[howste]

Re: 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?

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.

I don't believe the considerations need to be included in the scope statement. ksmith814, can you provide more details of the finding your student was given? Based only on what you've posted here, I would think an appeal would be justified.

 

[ksmith814]

Amazingly, no! That is is. I saw the non-conformance myself and that was all that was written - that there was no documented scope that considered a-c. I just advised her to include after her scope, as statement like:

“this scope of our QMS has been developed in consideration of the external environment and markets in which we operate and the best interests of our employees, customers and other key stakeholders”

I absolutely don't think it is necessary and don't think it is a value-add, but this is one I haven't seen before so we are going to see what happens.

 

[charanjit singh]

I agree with Howtse. I think it is a fit case for appeal. A reading of clause A3 of Annex A of the standard would justify your position.

 

[Raffy]

Hi,
Good day!
With regard to Scope, how to make a statement on how to exclude a clause which the company is not capable to do, ex. If the company main business is providing services such as selling projectors. What could be a sample statement to use with regard to its service? Please advice.
Thanks in advance,
Raffy

 

[Big Jim]

When auditing a requirement of the standard, if procedures or records are not required by the standard or by the organization, the auditor still needs to determine your practice. That's done by interview and observation.

If the auditor is requiring a record when none is required he is out of line and that nonconformance should be appealed.

If the auditor interviewed top management and asked did you consider a-c and the top manager responded with I have not made any such consideration, I just used the old scope statement, then the auditor learned by interview that no such consideration had been made. If that is what happened, it is a legitimate nonconformance.

It does sound as though the auditor could have better described his finding though.

Since this is a new requirement, questions dealing with some of the new topics are showing up in the workbook the certification body requires the auditor to use. You should expect auditors to be interviewing top management with a set of questions that deal with what top management is supposed to do.

 

[Paul Simpson]

Re: 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?

Hmmm! Looks like the auditor hasn't grasped any of the idea of 'Context' and 'Interested Parties' or, more importantly IMHO, how organisations work. All of the stages outlined in my earlier post are carried out by the organisation to capture information, analyse it and decide from this what the QMS should look like.

It eventually leads to a documented scope statement but there is No requirement for any aspect of this process to be included in the scope statement. Definitely worth an appeal!

 

[Alienraver]

The requirement for scope did not change with the new standard, it just now says that a-c have to be considered, not documented within the scope itself. A little further down 4.3, the second to the last paragraph states that the scope SHALL contain. I would certainly appeal that finding, there is no basis in the standard that requires those things be included, just considered. I just went through my audit and I didn't change a thing in my scope, because our business didn't change the way it functions or what we produce. We did well.

 

[glade]

I am just musing this problem - how does the consideration of a-c affect the content of the scope? And how do I easily demonstrate that I made the consideration.

I understand there is no requirement to include within the scope a statement that shows that 4.3 a-c were considered...

HOWEVER... some statement referencing a - c, right there in the scope could provide something documented to show the auditor that we are aware that it must be considered and did something.

For the lazy or hard of thinking auditor he sees this statement, ticks the box and moves on with life.... and it doesn't hurt me to add some extra words??

 

[ARC05]

For those who aren't aware the IAQG put out an auditor reference guide for AS9100, which is ISO9001 with additional requirements. It explains what auditors should consider.

A quick google search for "AS9100 auditor guidance material" will find it.

For 4.3 (which is same between AS9100 and ISO9001), things to consider include:
Document written and maintained by the organization that describes the scope of the QMS, including:
o A statement of the types of products and services covered
o Assessment of the applicability of the 9100 requirements
o Justification for any 9100 requirement(s) that is/are determined as ‘not applicable’
• Alignment between the documented scope of the organization’s QMS and their agreed scope of certification

 

[ARC05]

What I forgot to mention also is that AS9100:2016 has on top of ISO9001:2015 a requirement for the organization to "establish and maintain documented information that includes... the scope of the quality management system, including boundaries and applicability (see 4.3).