4. Context asks you to start by understanding
and its context before you develop its process-based quality
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
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 will
to be able to manage all of these influences. Once you’ve
all of this, you're ready to begin the development of your
5. Leadership asks your organization's top
to provide leadership 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
them to manage risks and opportunities. Section 5 also expects
management to establish a quality policy and to assign QMS
responsibilities, and authorities.
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
documentation your organization needs in order to ensure that
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.
8. Operations asks you to develop, implement, and
operational processes that your organization needs in order to
products and services and to manage risks and opportunities. It
you to establish and control an operational risk management
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,
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
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,
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
production outputs and control their identity, and to control
changes in production and service provision.
Finally, it asks you to identify and control
It asks you to document these outputs and the actions that are
taken in order to prevent their unintended use or delivery.
9. Evaluation asks you to monitor, measure,
evaluate the performance of your organization's QMS. It asks you
monitor customer satisfaction, to evaluate monitoring and
results, to audit conformance and performance, and to review the
suitability, adequacy, and effectiveness of your QMS.
10. Improvement asks you to identify
opportunities to improve
your organization's processes, products and services, and to
customer satisfaction. It also asks you to control
take corrective actions, and to enhance the suitability,
and effectiveness of your QMS.