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:
The organization’s boundaries
of the ISO 9001 QMS requirements to the organization.
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
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
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.