Section 4 Context asks you to start by understanding your organization
and its context before you start developing its quality management
system (QMS). 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.

Section 5 Leadership asks your organization's top management to
provide leadership for its QMS by showing that they support it, by
expecting people to focus on quality and on customers, by expecting
them to provide compliant products and services, and by expecting
them to manage risks and opportunities. Section 5 also expects top
management to establish a quality policy and to assign QMS roles,
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
influence your organization's QMS or disrupt its operation and
to consider how its context and its interested parties could affect
its QMS and the results it intends to achieve. Section 6 also asks
you to set quality objectives and to develop plans to achieve them.
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 resources.
It asks you to provide competent people, to provide an appropriate
infrastructure and environment, to provide suitable monitoring and
measuring technologies, to provide the knowledge that is needed to
support process operations, and to provide documented information.

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 documentation
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.

Section 8 Operations asks you to develop, implement, and control
the operational processes that your organization needs in order
to provide products and services and to manage and control risks
and opportunities. It asks you to clarify how product and service
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 externally
provided products and services, to manage production and service
provision, to supervise product and service release, and to control
nonconforming outputs in order to prevent unintended use.

Section 9 Evaluation asks you to monitor, measure, analyze, and
evaluate the performance of your organization's QMS. It asks
you to monitor customer satisfaction, to evaluate monitoring and
measuring results, to audit conformance and performance, and
to review the suitability, adequacy, and effectiveness of your QMS.

Section 10 Improvement asks you to identify opportunities to improve
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, adequacy, and
effectiveness of your QMS.