Scope Document - Does anyone happen to have an Example Scope Document (4.3)?

[perkins201]

Hi all,

Having finally gotten to grips with the 2008 version after 3 years of successful external audits, I'm now wrestling with the transition to 2015.

As with many of you, I have received absolutely no training, guidance or support from the auditing company to which we are affiliated...or from my own company. I have a full-time role but am also expected to achieve ISO compliance.

To my numerous questions, the auditing company have simply stated that all queries can be answered during the external audit...and "not to stress". Not particularly helpful. The only aid has been the Internet and in particular, this forum.

With that said...does anyone happen to have a sample scope document (4.3)? I always find it frustrating that there's nothing to compare you own efforts to just to see whether you're working along the right lines. I have found the odd Quality Manual online but they always seem to be missing the elusive scope document.

Any assistance would be greatly appreciated! Many thanks!

 

[Jen Kirley]

Yikes.

There must be a way for you to get some training. You will need it. Waiting for the CB auditor to give you information is not ideal.

You can start with a good book, I recommend ISO 9001:2015 in Plain English by our fellow Cover Craig Cochran.

There is also the Auditing Practices Group and their guidance documents, in your case the guidance document on defining QMS scope. Other guidance documents are on the ISO TC/176/SC2 Home Page and on the ISO 9001 Auditing Practices Group web page.

Writing a scope statement looks harder than it is, but without knowing your business it is hard to give specifics. There is no secret formula though.

 

[Marc]

Jen is right. There are quite a few QMS scope discussions here you might want to read through, such as How to define the scope of QMS as per ISO 9001:2015

Here are some more Elsmar "Scope" discussions.

 

[BoardGuy]

You just need to formalize your current scope within the quality manual per this example:

2.0 Scope Of The Management System [4.3]

2.1 Scope Statement

Based on analysis of [company name] business model, interested stakeholders, and in consideration of its products and services provided, [company name] has determined the scope of the management system as follows:

[Insert general description of services offered. Hint, it’s on you ISO 9001 Cert]

2.2 Facilities within the Scope

The quality system applies to all processes, activities and employees within the company. The facility is located at:

[Address, phone # and Fax #]

2.3 Permissible Exclusions

The following clause of ISO 9001 were determined to be not applicable to [company name]


[List each clause being excluded and the justification for its exclusions]

 

[es8alan]

I am a newbie for the ISO9001:2015. My company provides two services to customers. They are operation support services and maintenance services. I would like to ask whether I can putting only the maintenance services in the audit scope. Thanks.

 

[Kronos147]

I would like to ask whether I can putting only the maintenance services in the audit scope.

Yes. The scope can define your service activities.

 

[Sidney Vianna]

I would like to ask whether I can putting only the maintenance services in the audit scope. Thanks.

Yes, you can limit the scope of certification, but don't confuse the scope of the QMS and the scope of certification. For additional guidance, see this ISO TC 176 APG paper.

 

[Big Jim]

Hi all,

Having finally gotten to grips with the 2008 version after 3 years of successful external audits, I'm now wrestling with the transition to 2015.

As with many of you, I have received absolutely no training, guidance or support from the auditing company to which we are affiliated...or from my own company. I have a full-time role but am also expected to achieve ISO compliance.

To my numerous questions, the auditing company have simply stated that all queries can be answered during the external audit...and "not to stress". Not particularly helpful. The only aid has been the Internet and in particular, this forum.

With that said...does anyone happen to have a sample scope document (4.3)? I always find it frustrating that there's nothing to compare you own efforts to just to see whether you're working along the right lines. I have found the odd Quality Manual online but they always seem to be missing the elusive scope document.

Any assistance would be greatly appreciated! Many thanks!

You may have already received enough of an answer but I thought I may try to simplify it some more.

I assume since you said that you are transitioning that you have already been certified to ISO 9001:2008. That certification includes your scope of registration.

You simply need to have that documented or written down someplace. It was a requirement to be included in your 2008 quality manual, so you probably already have it somewhere.

I say probably because I have run into a few quality manuals that somehow missed this basic requirement and it was ignored for several years, but most likely you already have it.