Determining the Scope of the Quality Management System

Boundaries and applicability of the QMS must be determined in order to enable the definitions of the
scope of the QMS. The scope of the QMS refers to the areas, locations, product or lines of products (or
services), and processes or activities of the organization
Context of the Organization 19
to which the QMS is relevant and will be influenced by them. In other words, the scope of the QMS
defines its domain. The ISO 9001 Standard requirements are that
• The organization shall determine the boundaries and applicability of the QMS to
establish its scope.
• The scope shall refer to products and services of the organization as well as the processes and activities required to
realize them and the various locations which the
organization uses for the realization of the product or services.
• When determining the scope of the QMS, the organization shall relate to external as
well as internal issues as discussed in clause 4.1.
• When determining the scope, the organization shall relate to the requirements of
interested parties as mentioned in clause 4.2.
• The organization shall meet all the ISO 9001 Standard requirements as applicable
to the QMS.
• While determining the scope, the organization shall justify any decision for not
including any requirements of the ISO 9001 Standard in its QMS (i.e., exclusions).
• A justification for exclusion must prove that the exclusion of a standard requirement
does not affect the ability or responsibility of the organization to deliver products
or services with conformity to customer requirements and the ability to enhance
customer satisfaction.
• Claiming conformity to the ISO 9001 Standard is only possible when the exclusions
are proven not to affect the organization’s ability or responsibility to ensure the conformity of its products and
services and the enhancement of customer satisfaction.
• The scope will be documented and maintained as documented information.
Determining the Scope of the Quality Management System
The scope of the QMS defines in which areas and boundaries the organization is active and describes the
services, resources, processes, operations, and products the quality system applies to. In practice, it is a
text that will be maintained as documented information and also appear on the certification. An accurate
and correct definition of the scope is crucial because it determines which products and services are
included under the QMS and that determines the processes and activities that need to be planned,
controlled, and documented according to the ISO 9001 Standard requirements. The scope will relate to
the following issues:
• The products or services included under the QMS and that organization delivers to
its customers.
• All the applicable realization activities that will be under the QMS: research and
development, production, marketing, installation, service, and support.
• Locations of the organizational units that will be under the QMS (if applicable). Bear
in mind that each location that is included in the scope must be audited separately.
Reference to External and Internal Issues
As said before, external and internal issues are significant factors, conditions, influences, situations,
opportunities, or events that have an effect on the QMS and will
20 ISO 9001:2015—A Complete Guide to Quality Management Systems
affect the ability of the organization in achieving its objectives and the intended results. Such issues and
their influences were identified when we discussed the context of the organization. These issues shall
serve as inputs when determining the scope of the QMS.
For example, when the organization produces a product that is submitted to several regulations, this will
be mentioned in the scope: Developing and manufacturing a product while applying the relevant local,
regional, and international regulations.
Reference to Relevant Needs and Expectations of Interested Parties
Interested parties are persons or organizations that affect, or may be affected, or perceive themselves to be
affected by the organization or its activities. The interested parties and their relevant needs and
expectations were identified and discussed in clause 4.2 (Understanding the needs and expectations of
interested parties).
For example, if one need or expectation of your customer is distribution of your product with a certain
technology, for example, an online shop, the scope will indicate it: Marketing of products on an online or
an Internet platform.
Application of All the ISO 9001 Standard Requirements in the Scope
The Standard requires complete adherence to all the requirements mentioned in the standard when they
are applicable. In other words, you may not exclude or neglect any requirement of the standard unless this
requirement is not applicable to your QMS and you have an acceptable justification. For example, if you
are not purchasing any services or goods from an external provider, there is no sense in developing
quality management tools and controls for those areas.
List of Exclusions and Nonapplications
In the case one of the standard requirements does not apply to your QMS, you are entitled to exclude it.
Excluding means not implementing those requirements in the QMS. The scope of the QMS shall indicate
a list of exclusions of the standard requirements—requirements from the ISO 9001 Standard that the
organization for some reason decided are not applicable to the QMS and has chosen to exclude them. The
reason for the exclusions and nonapplications is that those specific standard requirements do not apply to
the operations, products, or services of the organization. For example, if your organization does not use
any monitoring and measuring devices on its products or processes, it may exclude the requirements of
clause 7.1.5—Monitoring and measuring resources.
Each exclusion requires a justification on behalf of the organization—a statement with the explanation of
an acceptable reason for excluding the requirement.
Context of the Organization 21
For example, I would manage a table with the relevant clause from the standard along with the
justification, which would look like this:
Exclusion Reason
7.1.5—Monitoring and measuring resources
The organization does not use any resources, personnel, tools, or equipment for ensuring results of monitoring and measuring.
8.3—Design and development of products and services
The organization does not develop any products or services.
8.5.3—Property belonging to customers or external providers
The organization does not hold, store, maintain stocks, or inventory of property belonging to customers or external providers.
When you decide to exclude a requirement, make sure any activity, operation, or process is not included
in the QMS and that the does not refer to those requirements. For example, if you exclude the
requirements of clause 8.5.3 but do receive packages from a supplier, make sure that activities for
handling packages or containers of the supplier are not included in the processes.
Including New Process Operations and Product under the QMS
When the scope of the QMS is already defined and documented, and the organization decides to develop
a brand new product with new processes, operations, and activities, as long as the product is not included
in the scope of the QMS, it is not officially included in the QMS, although the development and
realization were done under the appropriate controls and all the records are maintained, and so on.
Documenting the Scope of the QMS
The scope of the QMS and the list of exclusions must be maintained as documented information; must be
created, updated, and controlled under the requirements of clause 7.5 (Documented information). One
option is to create a designated document for the scope. I (along this book) recommend to document and
maintain the scope of the QMS and the exclusions in the quality manual, if you still want to maintain this
type of documentation (the 2015 revision of the Standard does not require maintaining a quality manual
anymore).
Example Scopes for the QMS
Here are some example wordings for QMS scope from certificates I have seen:
• The design and development, manufacturing, and service for motor units and control
equipment for pumps, fire pumps, fans, blowers, and automatic water supply systems.
• Design, manufacture, supply, service, and customer support for diesel engines from
type XXX to type YYY.
22 ISO 9001:2015—A Complete Guide to Quality Management Systems
• Developing and manufacturing semiconductors components for the XXX industry.
• Developing and provision of construction engineering services, consulting services
including project management services. Included sites: New York branch, London
branch, Zurich branch.
• Provision of cleaning services at the customer premises and provision of cleaning
products and materials.
4.4 Quality Management System and Its Processes
4.4.1
Clause 4.4.1 is a declaration of the standard’s intention regarding the QMS. In this clause, the
requirements and main principles of a QMS are presented. This clause can be regarded as a foundation for
self-evaluation of whether the organization’s QMS follows the general requirements. First let me review
the basic requirements:
• The organization shall establish, implement, and maintain a QMS within the organization with conformity to the
requirements of the ISO 9001 Standard.
• The organization is required to continually improve the QMS and its processes in
accordance with the requirements of this International standard.
• The organization shall determine the processes needed for the QMS.
• The organization shall determine how these processes will be applied in the QMS.
• The processes included in the QMS shall be identified and planned, implemented,
controlled, and improved.
• The organization shall determine the required inputs and expected outputs of every
process.
• The organization shall determine the sequence and interaction of processes included
in the QMS.
• The organization shall determine how these processes and their controls will be
implemented in the organization.
• Methods, criteria, performance indicators, and measurements for ensuring effective
monitoring and control of the processes will be defined and implemented.
• Resources needed to support these processes shall be allocated and available.
• Responsibilities and authorities for these processes shall be assigned.
• Risks and opportunities identified and determined in accordance with the requirements of 6.1 shall be addressed.
• Changes necessary to ensure processes achieve their intended results shall be evaluated, planned, and
implemented.
• The organization will implement specific measures for the improvement of these
processes (achievement of objectives and maintenance of effectiveness).
4.4.2
• According to its needs and requirements, the organization shall maintain documented information to support the
operation of its processes.
• According to the needs and requirements, the organization shall retain documented
information to ensure that the processes are being carried out as planned.
Context of the Organization 23
Establishing a QMS according to Clear Principles
The ISO 9001:2015 declares in clause 4.4 quite clearly with which principles the QMS shall be
established:
• Establishment of a QMS according to the ISO 9001:2015 Standard Requirements
• Definition of processes and their interactions needed for the operation of this QMS
• Continually maintaining and the effectiveness of the QMS through improvement
The important message here is that in order to deliver a conformed product or service and to meet
customer requirements as well as other needs and expectations of other relevant interested parties in an
effective way, a QMS must be established and maintained—a QMS
• That is based on the quality principles suggested in the ISO 9001 Standard.
• That is defined, planned, implemented, and controlled.
• That is customer focused—the QMS should use methods to understand present and
future customer needs, and shall develop processes to meet customer requirements
and strive to exceed customer expectations.
• Whose activities and processes address the needs and expectations of interested
parties.
• Whose resources are planned, allocated, and controlled.
• Whose processes and activities are managed and whose interrelations are clear.
• That is constantly analyzed and controlled—analysis of data and information is
implemented and decisions are based on facts.
• Supports improvement through collection of evidences and their analysis.
• That is fueled by the top management leadership—through leadership the purpose
and strategic direction of the organization are established. Leadership shall create
the environment for establishing the appropriate quality policy, in which employees
can become fully involved and quality objectives can be achieved.
• That persons in the organization are aware of.