4 Context asks you to start by understanding
and its context before you start
developing its quality management
It asks you to consider the external
issues that are relevant to your organization's
purpose and strategic
direction and to think about the influence these issues could
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
parties before you develop its
QMS. Why? Because your QMS
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
QMS and to begin its development.
5 Leadership asks your organization's
top management to
for its QMS by showing that they support
expecting people to focus on quality and on customers, by
them to provide compliant
products and services, and by expecting
them to manage risks and opportunities. Section 5 also expects
management to establish a quality policy and to assign QMS
responsibilities, and authorities.
6 Planning asks you to plan the development of
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
its QMS and the results
it intends to achieve. Section 6 also asks
you to set quality objectives and to develop plans to achieve
Finally, it asks you to control changes to your QMS.
7 Support asks you to support your QMS by
communications and by providing
the necessary resources.
It asks you to provide competent people, to provide an
infrastructure and environment, to
provide suitable monitoring and
measuring technologies, to provide the knowledge that is needed
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
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
manage the creation and modification of this documentation and
control how it is used.
8 Operations asks you to develop, implement, and
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
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
nonconforming outputs in order to prevent unintended use.
9 Evaluation asks you to monitor, measure,
evaluate the performance of
your organization's QMS.
you to monitor customer satisfaction, to evaluate monitoring and
to audit conformance and
to review the suitability, adequacy, and effectiveness of your
10 Improvement asks you
to identify opportunities to improve
your organization's processes, products and services, and
customer satisfaction. It also asks
you to control nonconformities, to
take corrective actions, and to enhance the suitability,
effectiveness of your QMS.