The standard
gives the leadership of an organization
responsibility to define its objectives
in meeting its customer's requirements.
This commitment to the customer
must be written in a policy statement.
Once these customer objectives
are set they must then be achieved
in a planned manner. To do this,
the functional objectives must
be planned by the leadership and
the people in the organization
must know their responsibilities
in fulfilling the plan.
The organization needs to have a champion for this
system and this person is the management representative.
Their job is to first manage the development of the
quality system prior to ISO 9000 registration and then
later to report on the performance of the system to
the leadership. The people in the organization must
also be made aware of the performance of the organization
in meeting its objectives.
The leadership ensure the quality system is effective
through a regular review of the system performance.
The review process is very similar to the financial
review of the business.The resources which the leadership
allocate in this review may be people, skill development
or changes to equipment and facilities.
The customer's requirements must be clearly specified
and agreed. Then the organization must ensure it has
the capability to meet any order before it is accepted
from the customer. If the customer requires a unique
product or service to be designed for them the design
must be properly planned.
Next the products and services that are purchased externally
to enable the customer's product or service to be delivered,
must be managed to ensure they are delivered into the
organization at the right time and the correct requirements.
The core operations of the business which add value
for the customer then need to be operated so they deliver
right the first time and this is done by giving clear
instructions and keeping equipment in good condition.
The processes themselves, then need to be monitored
to ensure they perform as expected and activities must
be tracked at all stages to ensure there is no process
failure. Wherever instruments are used for the monitoring
of either process or product they must be calibrated
to ensure the results the instruments give are reliable.
Finally, the quality system as well as the business
processes must be monitored and measured to ensure
that they perform as planned and to drive continual
improvement.
The ultimate measure of whether the quality system
is effective is the satisfaction level of the customer
but preventive measurement will be achieved by internally
auditing the processes within the quality system. There
must also be continuous monitoring of individual processes
and products whenever they are critical to the final
delivery to the customer. If at any point requirements
are not met the product or service must be isolated
and a decision taken on whether to rework.
Data that is collected from the measurement activity
must be analyzed and the results of the analysis used
to drive improvement in both the quality system and
individual process. Improvement is achieved through
a defined Corrective Action process and this develops
with time into Preventive Action where problems are
eliminated on a proactive, not reactive basis. This
causes continuous improvement in both the business
processes and the quality system of the business (8.5).
