128 Quality Assurance
through a third-party auditor recognized by the ISO organization. In general
terms, the structure follows the PDCA cycle.
• Plan: In this stage, we see the coverage of the overall quality sys-
tem and how it relates to the individual organization as well as how
management responds to it. Specically, it covers the
• Context of the organization: Here the standard focuses on the big
picture of the organization and its context as well as the needs
and expectations that are necessary for improvement. These are
expected to be appropriately dened, identied, and commu-
nicated throughout the organization. Furthermore, in this rst
item of the PDCA model, the inclusion of both scope and quality
management system/processes are dened.
• Leadership: Here the standard addresses the leadership respon-
sibility and commitment to quality. It focuses on having a policy;
roles, responsibility, and authority are clearly dened and cas-
caded throughout the organization.
• Planning: Here the standard focuses on how the organiza-
tion denes the risks and opportunity actions that bring about
improvement or need attention. This is done by making sure that
specic plans and planning changes are identied and incorpo-
rated in the organization. In other words, they become part of
the organizational culture.
• Support: Here, the standard addresses the need for dening,
developing resources, competence for needed skills, awareness,
and communication programs to make sure appropriate per-
sonnel are notied of the needs of the organization to improve,
and needed documented information exists to support manage-
ment’s commitment to continual improvement.
• Do: It is the stage where the standard is demanding some action to
verify that the planning activities are being carried out as planned.
Therefore, the focus here is on operations.
• Operation: By far the most important element of the PDCA model
is the verication and validation of what is being done and how this
action compares with what was planned. Its signicance is based on
the verication of what has been dened and implemented in the
planning stage. Without verication and validation, the planning
stage is not worth very much. Items recognized as important are
− Operational planning and control, that is, operational deni-
tions of requirements
− Determination of requirements that satisfy the customer
− Design and development of appropriate and applicable