Quality Management Systems –
Guidelines for the Application of
ISO 9001: 2015
Clause 4
Context of the
Organization
1.1 Understanding the Organization and its
Context
intent :
understand the external and internal issues
◦relevant to the organization’s purpose and strategic
direction
◦can affect the organization’s ability to achieve
intended results or its quality management system.
External Issues relate to
oEconomic Factors
oSocial Factors
oPolitical Factors
oTechnological Factors
oMarket Factors
oStatutory and Regulatory Factors
Internal Issues relate to
oOverall performance of the organization
oResource factors
oHuman aspects
oOperational factors
oFactors in the governance of the organization
4.2 Understanding the needs and
expectations of interested parties
Intent:
ensure that the organization considers the relevant
requirements of relevant interested parties, beyond
just those of its customers
Determining relevant interested parties
oPossible influence on the organization’s
performance or decisions
oAbility to create risks and opportunities
oPossible influences or impact on the market
oAbility to affect the organization through their
decisions or activities
4.3 Determining the scope of quality
management system
Intent:
determine the boundaries of the quality
management system
◦defined in a manner that helps the organization meet
requirements and the intended results of the system.
The scope should be established based on
◦The external and internal issues as determined by
the requirements of ISO 9001:2015, 4.1
◦The relevant requirements of interested parties as
determined in accordance with the requirements of
ISO 9000:2015, 4.2
◦The products and services provided by the
organization
Issues to consider in determining the scope
◦The infrastructure of the organization
◦The organization’s different sites and activities
◦Commercial policies and strategies
◦Centralized or externally provided functions,
activities, processes, products, and services
4.4 Quality
management system
and its processes
4.4.1: The intent of this sub-clause is to ensure that
the organization determines the processes needed
for its quality management systemin accordance with
ISO 9001. This includes not only the processes for
production and service provision, but also the
processes that are needed for the effective
implementation of the system
4.4.2: The intent of this sub-clause is to ensure that
the organization determines the extent of
documented information that is needed.
The appropriate person should review what
information is used for the process to perform
consistently to deliver the intended output.
For information that is used, an analysis/review of
the value to support the process needs to be carried
out. The result will be the decision as to which
information will be treated as documented
information
Documented information is information required to
be controlled and maintained by an organization and
the medium on which it is contained