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Understanding ISO 9001:2015

Clause 4.3 Determining the scope of the QMS  

In clause 1 we discussed the scope of the ISO 9001 standard and the flexibility it provided in selecting those requirements that applied to your business and being able to tailor them to suit your QMS requirements.  

Here we will discuss the scope of your QMS. Again you have quite a bit of latitude in defining your QMS scope. An organization’s QMS scope is determined by two factors:  

1.    The organization’s boundaries  

2.    Applicability  of the ISO 9001 QMS requirements to the organization. 

Boundaries  refer to the scope of business activities you want to include in your QMS. 

In my eBook, I discuss 15 items and issues that must be taken into account to determine your organization’s QMS boundaries. 

Applicability  refers to how the requirements of the standard apply to your organization. Clause 1 states that all the requirements of the ISO 9001 standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the product and services it provides.  

In my eBook, I discuss several factors that will help you determine what ISO 9001 requirements can and cannot be excluded from your QMS and the reasons why. 

Your documented Statement of QMS Scope  must be  clear to all employees, outside auditors, potential customer or other interested parties. A clear statement of QMS scope can help to focus the organization’s QMS efforts and prevent unnecessary discussion relating to activities performed that are not applicable to your QMS certification.  

In my eBook I discuss several factors that will help you define a clear statement of QMS scope. 

Certification bodies will look very closely at how your organization has defined its scope, ensuring that it is both appropriate and is reflected accurately in the documented statement of QMS scope and also in the scope on the certificate they issue. 

It should be noted that documented statement of QMS scope is not the same as the scope stated on the Registrar certificate that is awarded to your organization after successful demonstration of conformity to ISO 9001. The certificate will usually include a summarized description of the scope of QMS certification, and will not list details of the ISO 9001 requirements that have been excluded. However, it may add a reference to the audit file during the stage-one audit, for appropriate planning of the stage-two audit. 

And finally, the organization’s Quality Manual; marketing materials; website; etc. must be clear on the scope of its QMS certification to avoid confusing or misleading customers. 

Who should the Statement of QMS scope be made available to? 

·       The organization and its employees; 

·       Customers and relevant interested parties. 

The factors and action items discussed on this topic in my eCourse ‘Understanding ISO 9001:2015” will help you nail this very important requirement that most organizations have difficulty doing correctly.


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Understanding ISO 9001:2008