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 organizations QMS scope is determined by two factors:
1. The organizations 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 organizations 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 organizations 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 stageone
audit, for appropriate planning of the
stagetwo
audit.
And finally, the organizations 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.