ISO 9001:2000 contains five requirements sections, each dealing with one of the fundamental building blocks
required by any process. These are:
system: This section details the general and documentation requirements that
are the foundation of the management system. The general requirements ask you to
look at the processes of the management system, how they interact with each other,
what resources you need to run the processes; and how you will measure and monitor
the processes. The second part of the section then sets out the requirements for
the documentation needed to effectively operate the system and how the documentation
should be controlled.
Management responsibility: The management of the systems
is the responsibility of the “top management” at a strategic level in the organization.
The “top management” must know customers’ requirements at a strategic level and
make a commitment to meeting these as well as statutory and regulatory requirements.
“Top management” must also set policies; and to achieve these policies set objectives
through planning how the objectives will be met.
“Top management” should also ensure that there are clear internal communications
and that the management system is regularly reviewed.
This covers the people and physical resources needed to carry out the processes.
People should be competent to carry out their tasks and the physical resources and
work environment need to be capable of ensuring that the customers' requirements
Product/Service realization: These are the processes necessary
to produce the product or to provide the service. This is the act of converting
the input of the process to the output. For a manufacturing organization, this may
be the process of converting iron ore to steel via a blast furnace for example.
For a service organization, this may be the process of moving a product or person
from one place to another, for example, a taxi journey.
and improvement: These are the measurements to enable the systems to be monitored
to provide information on how the systems are performing with respect to the customer,
the management systems themselves through internal audits, the processes and the
product. Analyzing these, including any defect or shortfall in performance, will
provide valuable information for use in improving the systems and products where
this is required.