Section 4 Context
asks you to start by understanding your organization
and its context before
you start developing its quality
It asks you to consider the external and internal
issues that are relevant to your
organization's purpose and strategic
direction and to think about the influence these
issues could have
on its QMS and the results it intends to achieve.
This means that you need to
understand your organization's external
environment, its culture, its values, its performance,
and its interested
parties before you
develop its QMS. Why?
Because your QMS will
need to be able to manage all of these influences. Once you’ve
considered all of this, you're ready to define the
scope of your
QMS and to begin its development.
Leadership asks your organization's top management to
provide leadership for its QMS by
showing that they support
expecting people to focus on quality and on customers,
them to provide
compliant products and services, and by expecting
them to manage risks and opportunities. Section 5 also
management to establish a quality policy and to assign
responsibilities, and authorities.
Section 6 Planning
asks you to plan the development of your QMS.
It asks you to address the risks
and opportunities that could
organization's QMS or
disrupt its operation and
to consider how its context and its interested parties
its QMS and the results it intends to achieve.
Section 6 also asks
you to set quality objectives and to develop plans to
Finally, it asks you to control changes to your QMS.
Section 7 Support
asks you to support your QMS by managing
communications and by providing the necessary
It asks you to provide competent people, to provide an
environment, to provide suitable monitoring and
measuring technologies, to provide the knowledge that is
support process operations, and to provide documented
It asks you to start by figuring out
how extensive your documented
information should be and then asks you to select and
include all the
documentation your organization needs in order to
ensure that its
processes are being carried out as planned and all the
it needs in order to comply with the ISO 9001 standard.
It asks you to
manage the creation and modification of this
documentation and to
control how it is used.
Operations asks you to develop,
implement, and control
the operational processes that your organization needs
to provide products and services and to manage and
and opportunities. It asks you to clarify how product
requirements will be managed and how communications with
customers will be handled.
Section 8 also asks you to establish
a product and service design
and development process (when necessary), to monitor
provided products and services, to manage production and
provision, to supervise product and service release, and
nonconforming outputs in order to prevent unintended
Evaluation asks you to monitor, measure,
evaluate the performance of your organization's QMS. It asks
you to monitor customer satisfaction, to evaluate
measuring results, to audit conformance and
to review the suitability, adequacy, and effectiveness
of your QMS.
Improvement asks you
to identify opportunities
your organization's processes, products and
services, and to enhance
customer satisfaction. It
also asks you to control nonconformities, to
take corrective actions, and to enhance the suitability,
effectiveness of your QMS.