Section 4. Context
asks you to start by understanding your organization
and its context before you develop its process-based
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
all of this, you're ready to begin the development of
Leadership asks your organization's top
to provide leadership for its QMS by showing that they
support it, by
expecting people to focus on quality and on customers,
them to provide compliant products and services, and
them to manage risks and opportunities. Section 5 also
management to establish a quality policy and to assign
responsibilities, and authorities.
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
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
processes are carried out as planned and all the
it needs in order to comply with the AS9100D standard.
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 in
order to provide
products and services and to manage risks and
opportunities. It expects
you to establish and control an operational risk
a configuration management process, a product safety
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
verify them before you accept orders from customers, to
your review and verification activities, and to amend
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
controlled, to clarify how design outputs are managed,
review and control changes.
It also asks you to discuss
requirements with external providers
of processes, products, and services and to evaluate,
and control these providers.
Section 8 also asks you to manage
and control production and
service provision, to control equipment and software
to validate and control special processes, to verify and
production outputs and control their identity, and to
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
taken in order to prevent their unintended use or
Evaluation asks you to monitor, measure,
evaluate the performance of your organization's QMS. It
asks you to
monitor customer satisfaction, to evaluate monitoring
results, to audit conformance and performance, and to
suitability, adequacy, and effectiveness of your QMS.
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
take corrective actions, and to enhance the suitability,
and effectiveness of your QMS.