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How To Define The Scope of The QMS According To ISO 9001
How To Define The Scope of The QMS According To ISO 9001
1. External and internal issues that are relevant to the purpose of the organization, the
strategic direction, and the ability to achieve intended results
In addition, the scope is to include any requirements of the ISO 9001 standard that can be applied,
and if a requirement is determined to not apply, the organization will not use this as a reason for
not ensuring conformity of product and service. The scope is to state the products and services
covered by the QMS, and justification for any instances where the ISO 9001 standard cannot be
applied.
So, your scope should identify the physical locations of the QMS, products or services that are
created within the QMS processes, and the industries that are applicable if this is relevant. It
should be clear enough to identify what your business does, and if not all parts of the business are
applicable, it should be easily identified which parts are. Some examples could be:
XYZ Consultants located in offices in Europe, Asia, and North American provide
Information Technology Support to companies in any industry.
XYZ Industries is a division of XYZ International that operates in Indonesia and provides
paper products to the Asian market.
Your scope does not have a size limit, and should include enough information to determine what
is covered by the processes of the QMS. However, it is important to make it clear what is
included and what is not. If it is not clear to you what processes in your company are covered by
your QMS, then how will it be clear to an outside auditor or other interested party? Making your
scope statement simple and easy to read can help to focus your QMS efforts and prevent
unnecessary questions about activities that you may perform that may not be applicable to your
QMS certification.