Section 4. Context asks you to start by understanding your organization
and its context before you develop its process-based 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 begin the development of your QMS.

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 process infrastructure and environment, to provide suitable monitoring and measuring technologies, to provide the knowledge that is needed
to facilitate operations, and to provide documented information.

It asks you to start by figuring out how extensive your documented
information must be and then asks you to select and include all the
documentation your organization needs in order to ensure that its
processes are carried out as planned and all the documentation
it needs in order to comply with the AS9100D standard. It also
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 risks and opportunities. It expects
you to establish and control an operational risk management process,
a configuration management process, a product safety management
process, and a counterfeit parts management process.

It also asks you to communicate with customers in order to clarify
product and service requirements, to review these requirements, to
verify them before you accept orders from customers, to document
your review and verification activities, and to amend documents
whenever product and service requirements change.

Section 8 also asks you to set up a design and development process
(if necessary), to plan design and development activities, to clarify
design inputs, to specify how design and development should be
controlled, to clarify how design outputs are managed, and to
review and control changes.

It also asks you to discuss requirements with external providers
of processes, products, and services and to evaluate, verify, select,
and control these providers.

Section 8 also asks you to manage and control production and
service provision, to control equipment and software programs,
to validate and control special processes, to verify and preserve
production outputs and control their identity, and to control
changes in production and service provision.

Finally, it asks you to identify and control nonconforming outputs.
It asks you to document these outputs and the actions that are
taken in order to prevent their unintended use or delivery.

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.